Preliminary Program - American Association of Pharmaceutical ...

Preliminary Program 

2009 AAPS Annual Meeting and Exposition 

November 8–12, 2009 

Los Angeles Convention Center, Los Angeles, CA, USA 

Click here to Register 

Register as 

a Group and Save 

Hundreds of Dollars! 

See page 86 

for details 

Amgen, DPT, AstraZeneca, 

Lilly, Catalent and Pfizer 

Employees Received a $125.00 

registration discount. 

See page 87 for details 

For Up-to-Date Information, Log on to: 

www.aapspharmaceutica.com/annualmeeting

Letter from the President 

American Association of Pharmaceutical Scientists 

2107 Wilson Blvd. 

Suite 700 

Arlington, VA 

22201-3042 USA 

PH: +1 703-243-2800 

FX: + 1 703-243-9650 

EM: aaps@aaps.org 

www.aapspharmaceutica.com 

EXECUTIVE COUNCIL 

OFFICERS 

PATRICK P. DELUCA, PH.D. 

PRESIDENT 

DANNY D. SHEN, PH.D. 

PRESIDENT-ELECT 

KAREN HABUCKY, PH.D. 

IMMEDIATE PAST PRESIDENT 

PHILIP R. MAYER, PH.D. 

TREASURER 

MEMBERS-AT-LARGE 

ROBERT G. BELL, PH.D. (2009) 

PETER A. CROOKS, PH.D. (2010) 

DAVID Y. MITCHELL, PH.D. (2010) 

JEFFREY S. BARRETT, PH.D. (2011) 

GARY A. THOMPSON, PH.D. (2011) 

2009 SECTION CHAIRS 

CRAIG E. LUNTE, PH.D. 

ANALYSIS & PHARMACEUTICAL QUALITY 

DEEPA S. DESHPANDE, PH.D., RAC 

BIOTECHNOLOGY 

PETER L. BONATE, PH.D. 

CLINICAL PHARMACOLOGY & 

TRANSLATIONAL RESEARCH 

CHRISTOPHER R. MCCURDY, PH.D. 

DRUG DESIGN & DISCOVERY 

MANSOOR A. KHAN, R.PH., PH.D. 

FORMULATION DESIGN & DEVELOPMENT 

VISHAL K. GUPTA, PH.D. 

MANUFACTURING SCIENCE & ENGINEERING 

RAMAN VENKATARAMANAN, PH.D. 

PHARMACOKINETICS, PHARMACODYNAMICS & 

DRUG METABOLISM 

LAWRENCE X. YU, PH.D. 

PHYSICAL PHARMACY & BIOPHARMACEUTICS 

PRABU P. NAMBIAR, PH.D., RAC 

REGULATORY SCIENCES 

EXECUTIVE DIRECTOR 

JOHN LISACK, JR., CAE 

Dear Colleagues and Friends, 

I would like to invite you to attend the 2009 AAPS Annual Meeting and Exposition, 

November 8–12, in Los Angeles, California, USA. Every year scientists around the 

world anticipate the AAPS Annual Meeting as the event that showcases late-breaking 

research, validates scientific methodology, and showcases the latest technology, 

services, and supplies for their research needs. This year, AAPS is awaiting our return 

to the West Coast and exploring Los Angeles for the first time! 

With an anticipated attendance of 8,000 including representation from dozens 

of countries, the AAPS Annual Meeting is the one meeting you do not want to miss. 

It is a prime opportunity for you to showcase your research, network with other 

scientists performing similar work, and contact potential employers and clients. 

In addition, the educational program will include concentrated short courses, 

symposia, roundtables, sunrise sessions, and over 2,000 contributed papers 

covering the very latest research in the pharmaceutical sciences. At the 2009 AAPS 

Annual Meeting and Exposition you will have the opportunity to select from over 

90 programming sessions that include expert speakers from the U.S. Food and Drug 

Administration, National Institutes of Health, leading pharmaceutical companies, 

and academia. 

We encourage you to explore the preliminary program which contains all the 

information you need to make your trip to the 2009 Annual Meeting and Exposition 

a success. Enclosed you will find further details regarding programming, scheduling, 

AAPS section membership meetings and receptions, as well as travel and 

housing information. 

November 8–12, 2009 are dates to block out now so you don’t miss a single day 

of the AAPS Annual Meeting & Exposition; the biggest pharmaceutical sciences 

event of the year! 

See you in Los Angeles! 

Patrick P. DeLuca, Ph.D. 

2009 AAPS President

Letter from the Mayor

Keynote Speakers 

Trisha Meili 

Author of Best-Selling Memoir 

“I AM THE CENTRAL PARK JOGGER: A Story of Hope and Possibility” 

Trisha Meili’s story is about the capacity 

of the human body and spirit to heal. 

It is a story of hope and possibility. 

It didn’t begin that way. 

On April 19, 1989, Trisha went for a run in 

New York’s Central Park shortly after 9 PM. 

Hours later, two men wandering the park 

found her near death from a brutal beating 

and rape. In a coma, with 80 percent blood 

loss, a traumatic brain injury and severe 

exposure, doctors at Metropolitan Hospital 

worried that this young woman might not 

survive. The story seized the headlines, not 

only in New York, but also around the world 

as people contemplated what the savagery 

of the attack said about our society. 

Trisha, known to the world as The Central 

Park Jogger, revealed her amazing story 

of survival and recovery fourteen years 

later in her best-selling memoir 

“I AM THE CENTRAL PARK JOGGER: 

A Story of Hope and Possibility.” 

Born in Paramus, New Jersey, raised 

there and in Pittsburgh, Trisha was a Phi 

Beta Kappa economics major at Wellesley 

College and a double graduate degree 

recipient (MBA and MA) at Yale University. 

After graduation, she went on to work as 

an associate at the Wall Street Investment 

Bank Salomon Brothers, until her life was 

violently interrupted that terrible night 

in Central Park. Amazing her doctors and 

colleagues, Trisha returned to Salomon 

eight months after the attack, became 

a Vice President and continued her career 

there for another eight years. She then 

ran a nonprofit in New York City, The 

Bridge Fund of New York Inc., before 

writing her story. 

I AM THE CENTRAL PARK JOGGER is not 

a story of an attack, but rather, one of 

healing. The horror of her attack brought 

an outpouring of support and love from 

her family, friends, healthcare workers, 

co-workers and strangers. Trisha credits 

this support as part of the miracle of her 

recovery as she relearned how to do simple 

things, such as rolling over, telling time, 

buttoning her blouse or identifying simple 

objects. The support allowed her to move 

from victim to survivor, reclaim her life 

and become whole. 

Trisha gives her time to organizations vital 

to her healing: As an advocate trainer 

for the Sexual Assault and Violence 

Intervention Program (SAVI) at Mount 

Sinai Hospital, as an officer on the Board 

of Directors of Gaylord Hospital where 

she did much of her rehabilitation, and 

as Founding Chairman of the Board of the 

Achilles International that helped her run 

the New York City Marathon in 1995. 

Recently, Trisha was the recipient of the 

Leadership Award from the National Center 

for Victims of Crime, the National Courage 

Award from the Courage Center, the 

Pacesetter Award from New York Hospital 

Queens, the Spirit of Achievement Award 

from Albert Einstein College of Medicine, 

the Courage Award from Boston’s Magic 

106.7 Radio Exceptional Women Program 

and an Olympic Torchbearer in New 

York City. 

Trisha has appeared on numerous 

television shows including a Katie Couric 

Special, The Today Show, Dateline NBC, 

Larry King Live, The CBS Early Show, 

CNN and FOX News. 

Today, Trisha speaks to groups, including 

businesses, universities, brain injury 

associations, sexual assault centers and 

hospitals, about her journey of recovery 

and healing. She also gives workshops on 

transforming adversity. With her work, book 

and lectures, she offers lessons on how 

to manage through unpredictable change, 

whether personal, professional economic 

or spiritual. Her story has encouraged 

people worldwide to overcome life’s 

obstacles — regardless of what they might 

be — and get back on the road to life. 

Her website is www.centralparkjogger.org. 

Second Keynote speaker 

To be Determined

5 


3 Easy Ways to Register 

REGISTER BY September 11, 2009 AND SAVE! 

Secure online registration: 

(credit card payments only) 

Fax or Mail your completed registration form 

(check, wire transfer or money order payments only) 

Fax: +1 (301) 694-5124 

2009 AAPS Annual Meeting 

P.O. Box 590 

Frederick, MD 21705 USA 

Meeting Registration Questions/Confirmation: +1 (301) 694-5243, or +1 866-229-2386 

(toll free for U.S., Canada, and Mexico) 

Registration badge and event tickets will be mailed to registrants from the United States 

and Canada whose registrations are received by October 16, 2009. If you are not able to 

send your registration form to arrive by October 16, 2009, plan to register on-site. 

Reserve Your Hotel Room Early! 

new in 2009! 

AAPS has streamlined the housing and registration process. In one simple step, complete meeting 

registration and online housing reservation. Visit the AAPS Registration and Housing Website, 

click on “Attendee/Group Registration and Housing” to register for the Annual Meeting and AAPS 

housing. Once registration is complete the website will automatically direct attendees to the AAPS 

housing website. At that time, attendees have the option of securing housing reservations, 

or re-visiting the housing website at their convenience. Registrants also have the option to 

visit the AAPS housing webpage before registering for the meeting. If you wish to reserve 

your housing first, visit the AAPS Registration and Housing Website, and click on, “Housing 

Only”. After housing has been secured, attendees can log back into the website and 

register for the meeting by visiting the AAPS Annual Meeting registration and housing 

website, and clicking on “Attendee/Group Registration and Housing”. 

Rooms are assigned on a first-come, first-served basis. Reservations should be made 

by October 7, 2009. After October 7, 2009, all reservations will be accepted on 

a space-and rate-available basis. 

Click here to Book Housing! 

See pages 90–93 for more housing information.

Table of Contents 

5 Registration Information 

5 Online Registration 

104 Registration Form 

8 2009 Annual Meeting and Exposition Sponsors 

10 About Los Angeles 

11 AAPS Exposition 

12 Description of AAPS Sections 

15 Program 

15 Meeting at a Glance 

22 AAPS Pre-conference Workshops and Short Courses 

24 Section Programming Tracks 

24 AAPS General Programming Track 

27 AAPS Professional Development Track 

29 AAPS Analysis and Pharmaceutical Quality (APQ) Section Track 

35 AAPS Biotechnology (BIOTEC) Section Track 

40 AAPS Clinical Pharmacology and Translational Research (CPTR) 

Section Track 

46 AAPS Drug Design and Discovery (DDD) Section Track 

50 AAPS Formulation Design & Development (FDD) Section Track 

56 AAPS Manufacturing Science & Engineering (MSE) Section Track 

59 AAPS Physical Pharmacy & Biopharmaceutics (PPB) Section Track 

64 AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism 

(PPDM) Section Track 

77 AAPS Regulatory Sciences (RS) Section Track 

82 AAPS Student/PostDoc Outreach and Development (SPOD) 

Committee Track 

30 AAPS Short Courses (Pre-conference Events) 

36 Short Course #1: RNA-targeting Therapeutics: Issues and Advances 

47 Short Course #2: Learning the Drug Discovery and Delivery 

Interface Process 

30 Short Course #3: Developing Biorelevant Dissolution Test Methods 

with an Emphasis on QbD 

51 Short Course #4: Recent Advances in Oral Drug Delivery 

65 Short Course #5: Transporter Mediated Drug-drug Interactions: 

Possible Criteria that Warrant In Vivo Transporter-mediated DDI 

Studies via In Vitro Assessments 

60 Short Course #6: Rational Design and Development of Solid 

Dispersions with Amorphous Drug for Improving Oral Absorption 

34 AAPS Open Forums 

34 Analytical Challenges in Detecting and Preventing Counterfeits 

in Global Environment (APQ) 

39 Biosimilars — Development Considerations and Future Directions 

(BIOTEC/RS) 

43 Adequacy of PK/PD Model Validation and Simulation (CPTR) 

75 An Evolution or Revolution in Drug Metabolism: When, Where, 

Why, What, How? (PPDM) 

81 Global Regulatory Challenges for Genotoxic Impurities (RS) 

22 AAPS Workshops (Pre-conference Events) 

22 AAPS/FIP Workshop on Special Dosage Forms — What’s New with 

In Vitro Drug Release? 

23 CRS/AAPS Workshop on Development and Regulatory Challenges 

for Controlled Release Formulations 

23 AAPS Workshop on Quantitative Model-based Drug Development 

in Drug Discovery and Translational Research 

86 Registration Information 

87 Special Discounts 

88 Spouse/Guest 

88 Continuing Education (CE) Credits 

88 International Registrants 

88 Exposition Only 

88 Cancellations/Refunds/Substitutions 

90 Hotel/Site Information 

90 What’s Held Where 

90 AAPS Hotel Accommodations 

93 AAPS Hotel Map 

94 TRAVEL & TRANSPORTATION 

94 Air Travel 

94 Airport Transportation 

94 Car Rental 

94 Ground Transportation 

94 Public Transportation 

95 Parking 

95 Remote Airline Check-in Service 

97 GENERAL INFORMATION 

97 AAPS Annual Meeting Abstracts 

97 Professional Development 

97 Graduate Students 

97 About Children 

97 Childcare Service 

98 Speaker Information 

98 AAPS Expocard 

98 Photography 

98 Electronic Devices 

99 Recycling 

99 AAPS Message Center 

99 Business Center 

99 Smoking Policy 

99 What to Wear 

99 AAPS Central 

99 AAPS Fun Booth 

99 Get ROCK’d at the Annual Meeting! 

99 AAPS International Lounge 

99 AAPS Student Lounge 

99 Press Room 

100 MEMBERSHIP INFORMATION 

100 UPCOMING AAPS ANNUAL EVENTS 

101 AAPS TOURS 

102 AAPS Tour Registration Form 

103 Short Course Application Form 

104 REGISTRATION FORM

aaPS SuStaining SPonSor 

AAPS HonorS 

AstraZeneca 

1800 Concord Pike 

P.O. Box 15437 

Wilmington, DE 19850-5437 

www.astrazeneca.com 

For Its Support of the Association 

During 2008-2009 

Partnering to Build 

the Pharmaceutical 

ScienceS

2009 ANNUAL MEETING and EXPOSITION 

SPONSORS Thank you for your support! 

D I A M O N D 

L E V E L 

P L A T I N U M 

L E V E L 

SM 

S I L V E R L E V E L B R O N Z E L E V E L 

O F F I C I A L M E D I A P A R T N E R S 

as of May 1, 2009

2009 ANNUAL MEETING and EXPOSITION 

SCIENTIFIC AWARD SPONSORS 

Thank you for your support! 

SM 

Hoffmann-LaRoche, Inc. 

as of May 1, 2009

10 


About Los Angeles 

Los Angeles is the largest city in the state of California and the Western United States as well as the second largest in the United 

States. Often abbreviated as L.A. and nicknamed The City of Angels, Los Angeles has an estimated population of 3.8 million 

and spans over 498.3 square miles in Southern California. Additionally, the Los Angeles metropolitan area is home to nearly 

12.9 million residents, who hail from all over the globe and speak 224 different languages. 

Los Angeles is one of the world’s centers of 

business, international trade, entertainment, 

culture, media, fashion, science, technology, and 

education. It is home to renowned institutions 

covering a broad range of professional and cultural 

fields, and is one of the most substantial economic 

engines within the United States. Los Angeles leads 

the world in producing popular entertainment 

such as motion picture, video games, television, 

and recorded music which forms the base of its 

international fame and global status. 

For more information on all L.A. has to offer you, 

visit www.discoverlosangeles.com 

LOS ANGELES CONVENTION CENTER 

1201 South Figueroa Street 

Los Angeles, CA 90015 USA 

AAPS will hold the 2009 Annual Meeting and 

Exposition at the Los Angeles Convention Center 

(LACC), conveniently located to major points 

throughout the city. The LACC is one of the most 

efficiently designed and technologically advanced 

convention and exhibition facilities in the nation. 

The LACC complex is comprised of two state-ofthe 

art buildings, the South and West Halls. 

The 2009 AAPS Exposition and Attendee 

Registration will be located in the South Hall. The 

2009 AAPS Career Center and Poster Session will 

be located in the West Hall. See page ? for detailed 

information on AAPS events and their locations. 

The LACC is located at the South West corner of the 

city, giving it easy access to freeways, metrolink and 

metro rail, theaters, museums and extensive night 

life entertainment. The LACC is 17 miles from Los 

Angeles International Airport and 15 miles 

from Burbank Airport. 

For more information on the Los Angeles Convention 

Center, visit www.lacclink.com

11 


AAPS Exposition 

aaps exposition 

RESERVE EXHIBIT SPACE 

online expo

12 


Description of Sections 

Sessions are listed chronologically by AAPS Sponsoring Sections. To assist you in finding the section that best represents your 

interests, brief descriptions for each section are below. 

The APQ Section is composed of members whose 

interests are in the areas of analytical methods 

development for bulk drug substances as well 

as drugs in pharmaceutical dosage forms and 

biological matrices, and methods and procedures 

for assuring that quality is designed into 

pharmaceutical products. APQ provides a forum for 

the exchange of information pertaining to analytical 

techniques, bioanalytical techniques, regulatory and 

compendial issues, and assurance of quality. The 

APQ Section interacts with all disciplines involved 

in the discovery, development and production of 

pharmaceutical products, and many of its programs 

and activities are undertaken with other sections of 

the association. 

The BIOTEC Section is comprised of members from 

many diverse backgrounds in industry and academia 

who share a common interest in the evolving field 

of biotechnology. The primary goal of this section 

is to unite multiple scientific disciplines in a forum 

where they can share experimental results as well 

as concerns regarding the research, development, 

and commercialization of new biotechnology 

based pharmaceuticals. Members in this section 

can meet at national and regional meetings to 

exchange ideas and present scientific data. Applied 

and basic scientists, at all phases of research and 

development, for both therapeutic and diagnostic 

agents, are actively involved in the AAPS BIOTEC 

section. In particular, the successful discovery, 

production, delivery, and commercialization of 

biotechnology derived drugs requires input from 

many diverse fields including molecular biology, 

cell culture, recovery process, pharmacokinetics, 

metabolism, analytical biochemistry, regulatory 

affairs, and formulation sciences. 

The CPTR Section provides the clinical research 

dimension within the comprehensive range of 

pharmaceutical sciences represented in AAPS 

and is concerned with developing knowledge 

and understanding related to the clinical use 

of pharmaceuticals (chemical agents and 

biological agents). The CPTR Section serves as a 

forum for those scientists engaged in research 

on the therapeutics and clinical assessment of 

drugs and biologicals. This section addresses 

the rational application of pharmaceutical and 

related sciences in the clinical setting, including 

experimental design, conduct and analysis 

of clinical trials; regulatory aspects of clinical 

trials and drug registration; risk assessment, 

therapeutic extrapolation from animals to humans; 

pharmacoepidemiology; drug interactions; and in 

appropriate populations, therapeutic efficacy/safety 

and the response to alternative dosage forms. The 

CPTR Section provides an opportunity for interaction 

between scientists in academia, government, and 

industry who are engaged in clinical research. The 

section facilitates the interaction of AAPS members 

with scientists from other clinical organizations 

using joint formats such as symposia, workshops, 

and regional/national meetings. 

The DDD Section engages in all aspects of the 

design and discovery of molecular pharmaceutical 

entities, and fosters interactions at the interface 

between drug discovery and development. DDD 

provides leadership and a forum for interactions 

among scientists from academia, industry, and 

research institutions. The section invites and 

supports collaborative relationships with scientists 

in other disciplines within AAPS and other scientific 

and professional organizations whose efforts are 

directed toward the interface of drug design and 

discovery and drug development. The DDD Section 

is truly unique among scientific organizations 

serving the needs of medicinal and natural products 

chemists and scientists engaged in other emerging 

technologies and disciplines involved in drug 

development, including druggability, by providing a 

single organization for all members associated with 

pharmaceutical drug discovery and development. 

The FDD Section is comprised of members from 

many diverse backgrounds in industry, regulatory 

and academia who share a common interest in 

the area of formulation design, research and 

development — a multidisciplinary field drawing 

upon the physical, chemical, biological and 

engineering sciences. The primary goal of this 

section is to unite multiple scientific disciplines 

in a forum where they can share experimental 

results, consider new formulation and dosage 

form technologies, and discuss issues and 

concerns regarding the design and development 

of formulations/drug products for all dosage 

forms. This section collaboratively interfaces with 

other sections which focus on pre-formulation, 

biopharmaceutics, formulation strategies, and 

manufacturing process optimization. Aspects of 

formulation design and development include the 

study of dosage forms for drug delivery via all 

routes of administration wherein the dosage form 

encompasses the formulation, process by which 

it is made, and primary packaging. The section’s 

focus on development includes product design, 

delivery systems and technology, stability, quality, 

and performance both in vitro and in vivo that is 

appropriate to its development stage. 

The MSE Section of AAPS brings together all 

members who are interested in and contribute to 

the application and advancement of science and 

technology as it relates to process development 

and manufacture of pharmaceutical and 

pharmaceutically related products including medical 

devices and active pharmaceutical ingredients. It 

will provide a forum for exchange of information 

and networking between members and with 

members of allied sections and organizations. 

Areas of specific interest include pharmaceutical 

product manufacturing (both investigational and 

commercial), quality assurance and engineering 

principles as applied to manufacturing, process 

optimization, scale-up and technology transfer, and 

quality systems including manufacturing technical 

support and quality by design.

13 


Description of Sections 

The PPB Section is composed of members whose 

scientific interests are in the physicochemical 

and biological factors that impact the design 

and delivery of small molecules and biologics. 

PPB is a multidisciplinary section that focuses 

on preformulation, biopharmaceutics, drug 

absorption, nanotechnology, and drug delivery 

systems design and performance including targeted 

drug delivery. PPB provides an interactive forum 

for the exchange of information pertaining to the 

selection of developable drug candidates at the drug 

discovery-development interface, characterization 

of drug substance and excipients, studies of 

relationships between drugs’ physicochemical and 

biopharmaceutical properties and physiological 

considerations at the cellular, organ, and whole 

animal levels, and overcoming drug absorption 

and delivery barriers via drug delivery technologies. 

The PPDM Section provides an international forum 

to examine issues related to the biopharmaceutics, 

pharmacokinetics, pharmacodynamics, drug 

metabolism and transport of pharmaceutical 

products and therapies. PPDM brings together 

individuals whose research interests include 

characterization of drug and chemical actions, 

disposition, and biotransformation at the organism, 

tissue, cellular, and subcellular levels. The 

section provides an opportunity for networking, 

presentation of new data and an exchange of ideas 

by individuals actively engaged in various facets 

of pharmacokinetics, pharmacodynamics, drug 

metabolism and transport, biopharmaceutics, and 

related sciences. This scientific exchange enables 

scientists from academia, industry, and regulatory 

agencies to improve/develop better patient 

therapies while jointly advancing their professional 

development and respective disciplines. PPDM 

recognizes the need for education and training 

of new scientists through active recruitment of 

new students and post-doctoral fellows, support 

of graduate faculty, and encouraging student 

participation within PPDM. 

The RS Section of AAPS is composed of members 

whose interests focus on multidisciplinary scientific 

aspects of pharmaceutical development and 

regulatory approval as they relate to quality, safety 

and efficacy of the product (e.g., manufacturing, 

quality, pharmacology, toxicology, clinical trials, 

law, and intellectual property). 

Become Involved 

in your Section 

If you are not a member of AAPS and would 

like to join, visit the AAPS Annual Meeting 

registration website and include your 

primary section choice. 

If you are an AAPS Member and would like 

to become more involved in your section, visit 

www.aapspharmaceutica.com and contact 

the section leadership for more information.


AAPS HonorS 

Catalent Pharma Solutions 

14 Schoolhouse Road 

Somerset, NJ 08873 

www.catalent.com 


During 2008-2009 



ScienceS

15 


Meeting at a Glance 

Saturday, November 7, 2009 

AAPS Pre-conference Workshops 

An additional fee is required to attend 

pre-conference programs 

7:00 am – 5:00 pm 

AAPS Pre-conference Registration 

8:00 pm – 5:00 pm 

AAPS Annual Meeting and Exposition Registration 

8:00 am – 5:45 pm 

Special Dosage Forms — What’s New with In Vitro 

Drug Release? 

co-sponsored with 

An additional fee is required to attend this 

pre-conference workshop 

(Day One of Two Day Workshop) 

8:30 am – 5:00 pm 

CRS/AAPS Workshop on Development and 

Regulatory Challenges for Controlled Release 

Formulations 




8:30 am – 5:00 pm 

Quantitative Model-based Drug Development 

in Drug Discovery and Translational Research 



(One Day Workshop) 

8:30 am – 5:00 pm 

2009 AAPS Executive Council Meeting 

2:00 pm – 5:00 pm 

AAPS Speaker Ready Room 

Sunday, November 8, 2009 

7:00 am – 7:00 pm 

AAPS Registration 

7:00 am – 5:00 pm 


8:00 am – 5:00 pm 

AAPS Press Room 




8:30 am – 4:00 pm 



Formulations 



(Day Two of Two Day Workshop) 

8:30 am – 12:00 pm 

Special Dosage Forms — What’s New with In Vitro 

Drug Release? 




8:00 am – 4:00 pm 

Short Course #6 

Rational Design and Development of Solid 

Dispersions with Amorphous Drug for Improving Oral 

Absorption (PPB) 

An additional fee is required to attend this short course 

8:30 am – 4:00 pm 

AAPS Short Courses 

An additional fee is required to attend short courses 


RNA-targeting Therapeutics: Issues and Advances 

(BIOTEC & PPDM) 



Learning the Drug Discovery and Delivery 

Interface Process (DDD) 



Developing Biorelevant Dissolution Test Methods 

with an Emphasis on QbD (APQ) 



Recent Advances in Oral Drug Delivery (FDD) 



Transporter Mediated Drug-drug Interactions: 

Possible Criteria that Warrant In Vivo Transportermediated 

DDI Studies via In Vitro Assessments 

(PPDM) 


12:00 pm – 1:00 pm 

Short Course Luncheon 

4:30 pm – 6:30 pm 

AAPS Opening Session 

Keynote Addresses 

Trisha Meili 

The Central Park Jogger 

Second Keynote Speaker to be Determined 

Awards Ceremony 

6:30 pm – 7:45 pm 

AAPS Welcome Reception 

West Hall Pavilion 

Los Angeles Convention Center 

Funded by Grants from

16 



Monday, November 9, 2009 

7:00 am – 6:00 pm 


7:00 am – 5:00 pm 


7:00 am – 5:00 pm 


7:00 am – 5:00 pm 

AAPS Student Lounge 

Funded by a Grant from 

7:00 am – 5:00 pm 

AAPS International Lounge 

MONDAY MORNING ROUNDTABLES 


8:00 am – 10:00 am 

Myths and Misconceptions in the Value of Early 

Phase 1 Studies to Predict Risk of QT Prolongation 

(CPTR) 

Evaluation of the Regression Type in LC-MS/MS 

Bioanalytical Methods (APQ) 

Biotherapeutics and Modulation of Drug 

Transporters (PPDM) 

Optimization of Systemic Exposure in Preclinical and 

Clinical Development: “Success Stories” of Proven 

Methods for Challenging Drug Candidates — 

What You Did Not Already Know! (PPB & PPDM) 

Role of Excipient Impurities in Drug-excipient 

Interactions (FDD) 

MONDAY MORNING PROFESSIONAL 

DEVELOPMENT 

8:00 am – 10:00 am 

How to Survive a Merger 

AAPS PLENARY SESSION 

Drug Product Quality and Safety 

in a Global Environment 

10:00 am – 12:00 pm 

BD’s Role in Developing the Single-use Injection 

Device for Immunization in the Developing World 

Renuka Gadde, Ph.D. 

Becton, Dickinson and Company 

Worldwide Landscape of the Counterfeit Drug Trade 

Marvin D. Shepherd, Ph.D. 

The University of Texas at Austin 

Presentation Title to be Determined 

Jim Thompson 

Chair, The European Alliance for Access to Safe 

Medicines (EAASM) 

AAPS HOT TOPIC 

12:00 pm – 1:15 pm 

AAPS EXPOSITION 

12:00 pm – 5:30 pm 

AAPS FOCUS GROUP MEMBERSHIP MEETINGS 

12:15 pm – 1:15 pm 

AAPS Distinguished Pharmaceutical 

Scientist Award Winner Lecture 

12:15 pm – 1:30 pm 


AAPS CONTRIBUTED PAPERS POSTER 

SESSION and AAPS Career center 

1:00 pm – 5:00 pm 

AAPS Career Center 

Funded by Grants from 

MONDAY AFTERNOON ROUNDTABLES 

2:00 pm – 4:00 pm 

IVIVC for Establishing Clinically Relevant 

Specifications (APQ) 

Nanoparticles — Are They Ever Going to Amount 

to Anything? (FDD) 

Strategies for the Determination of a Robust 

Cut Point in Immunogenicity Assays: Impact 

of Immunogenicity White Paper (BIOTEC) 

Navigating the New Rules Regarding Patents Law: 

Decodifying ‘Obviousness’, ‘Limited Claims’, and 

How it Affects New Composition of Matter Patents 

(DDD & RS) 

STUDENT/POSTDOC OUTREACH AND 

DEVELOPMENT (SPOD) ROUNDTABLE 

2:00 pm – 4:00 pm 

Individualizing a Postdoctoral Position Based 

on Your Career Aspirations (SPOD) 

MONDAY AFTERNOON SYMPOSIA 


2:00 pm – 4:30 pm 

The Modeling and Simulation Frontier: Multilevel, 

Multi-scale, Multi-attribute, Adaptable, and 

Extensible Discrete Event Models (CPTR & PPDM) 

Regulatory Significance of Critical Quality Attributes 

and Critical Process Parameters in Successful 

Product Development and Commercialization (RS) 

Novel Sustained Release Formulation Techniques 

with Lipid Excipients (FDD) 

Leaner Development Strategies to Enrich 

Drug Pipeline (BIOTEC) 

Process Analytical Technologies in API Manufacturing 

(APQ) 

AAPS/ACCP Joint Symposium: Strategic Biomarkers 

for Treating Diseases in Younger Children Safely 

and Effectively (CPTR & PPDM) 

Global Health Symposium (AAPS General 

Programming) 

AAPS JOINT MEMBERSHIP MEETINGS 

AND RECEPTIONS 

5:30 pm – 7:30 pm 

Analysis and Pharmaceutical Quality (APQ) Section 

Biotechnology (BIOTEC) Section 

Clinical Pharmacology and Translational Research 

(CPTR) Section 

Drug Design and Discovery (DDD) Section 

Formulation Design and Development (FDD) Section 

Manufacturing Science and Engineering 

(MSE) Section 

Physical Pharmacy and Biopharmaceutics 

(PPB) Section 

Regulatory Sciences (RS) Section

SM 

17 



Tuesday, November 10, 2009 

6:00 am – 5:00 pm 


7:00 am – 5:30 pm 


7:00 am – 5:00 pm 


7:00 am – 5:00 pm 



7:00 am – 5:00 pm 


TUESDAY SUNRISE SESSIONS 

7:00 am – 8:15 am 

Solve Your Problems in a Smarter Way: Use Design 

of Experiments (PPB) 

The Blood Brain Barrier (DDD & PPDM) 

The Story of the Three Bears: Too Big, Too Small, 

Just Right! Size Issues in Drug Development 

(CPTR & PPDM) 

Practical Considerations in Using Excipients for Drug 

Testing in Early Toxicology Studies (FDD) 

Sterile Filtration — Principles and Case Studies 

(MSE) 

CONTRIBUTED PAPERS POSTER 

SESSION and career center 

8:00 am – 5:00 pm 



TUESDAY MORNING PROFESSIONAL 

DEVELOPMENT 

8:00 am – 10:00 am 

Facilitation Skills 

TUESDAY MORNING SYMPOSIA 

8:30 am – 11:00 am 

Impact of the Variability of Ligand Binding PK Assays 

on the Outcome of Comparability Assessments for 

Follow-on Biologics (BIOTEC) 

Application of Nanoparticulate Technology in the 

Development of Oral Dosage Forms: Impact on Drug 

Product Performance (PPB) 

Freeze-drying of Biologics/Small Molecules: 

Case Studies that Touch on Formulation, Process, 

and Packaging Challenges (MSE) 

AAPS GRADUATE STUDENT SYMPOSIA AND 

RESEARCH ACHIEVEMENT AWARDS 

8:30 am – 11:00 am 

AAPS Graduate Student Symposium in Analysis 

and Pharmaceutical Quality (APQ) 

Sponsored by 

AAPS Graduate Student Symposium 

in Biotechnology (BIOTEC) 

Sponsored by 

AAPS Graduate Student Symposium in Drug 

Design and Discovery (DDD) 

Sponsored by 

AAPS Graduate Student Symposium in 

Formulation Design and Development (FDD) 

Sponsored by 


Manufacturing Science and Engineering (MSE) 

Sponsored by 

During this Symposium, a presentation from the 

Research Achievement Award winner will be given. 

AAPS Research Achievement Award in Manufacturing 

Science and Engineering 

Sponsored by 


Physical Pharmacy and Biopharmaceutics 

(PPB) 

Sponsored by 



AAPS David Grant Research Achievement Award 

in Physical Pharmacy 

Sponsored by 


Pharmacokinetics, Pharmacodynamics and 

Drug Metabolism and Clinical Pharmacology 

and Translational Research (PPDM & CPTR) 

Sponsored by 



AAPS Research Achievement Award in Clinical 

Pharmacology and Translational Research 

Sponsored by

18 



TUESDAY MORNING ROUNDTABLES 

9:00 am – 11:00 am 

How to Face and Successfully Defend FDA and Other 

Regulatory Audits (APQ & RS) 

Latest Developments of Drug Targeting to Cancer 

Stem Cells (BIOTEC) 

Critical Role of CMC Project Management in the Drug 

Development Process (MSE) 

To Test or Not to Test? Risk Assessment Approaches 

for Human Metabolites (PPDM) 

Impact of Changing Regulations on Post-approval 

CMC Changes: U.S. and E.U. Perspectives (RS) 


9:30 am – 6:15 pm 

TUESDAY AFTERNOON PROFESSIONAL 

DEVELOPMENT 

11:00 am – 12:00 pm 

Transitioning between Academia and Industry 

12:00 pm – 1:00 pm 

Transitioning between Small and Large Pharma 


12:00 pm – 1:00 pm 


12:00 pm – 1:15 pm 

STUDENT/POSTDOC OUTREACH AND 

DEVELOPMENT (SPOD) ROUNDTABLE 

12:00 pm – 1:15 pm 

Paths Less Traveled: Opportunities for 

Pharmaceutical Scientists beyond Industry 

and Academia 

TUESDAY AFTERNOON ROUNDTABLES 


TUESDAY AFTERNOON PROFESSIONAL 

DEVELOPMENT 

2:00 pm – 4:00 pm 


TUESDAY AFTERNOON SYMPOSIA 

2:00 pm – 4:30 pm 

New Frontiers in Biologics: Advances & Challenges 

in PEGylation and Alternatives to PEGylation 

(BIOTEC) 

State-of-the-Art Approaches to Drug Design: Case 

Studies of Successful Applications of Drug Design 

Techniques to Identify Clinical Candidates (DDD) 

Challenges and Application of Dissolution for 

Testing Nutraceuticals, Natural Products, and 

Traditional Medicines (APQ) 

Reactive Metabolites in Drug Discovery and 

Development: How Can We Handle the Risk? 

(PPDM) 

Pros and Cons of Emerging Methods in Population 

PK and Exposure/Response Analysis (PPDM) 

Leveraging Prior Quantitative Knowledge in Guiding 

Pediatric Drug Development (CPTR & PPDM) 

AAPS EXPOSITION COCKTAIL RECEPTION 

4:45 pm – 6:15 pm 

Funded by Grants from AAPS Exhibitors 

AAPS SECTION MEMBERSHIP MEETING AND 

RECEPTION 

5:45 pm – 7:30 pm 

AAPS Pharmacokinetics, Pharmacodynamics and 

Drug Metabolism (PPDM) Section 

AAPS CLINICAL PHARMACOLOGY AND 

TRANSLATIONAL RESEARCH (CPTR) SECTION 

OPEN FORUM 

funded by grants from 

2:00 pm – 4:00 pm 

Bioequivalence Requirements: Challenges in Global 

Drug Development and Harmonization (RS) 

Inclusion of Women in Clinical Trials and Drug 

Development — How Far Have We Gone 

(CPTR & PPDM) 

The Pros and Cons of Development Approaches to 

Poorly Soluble Compounds (In-house Development 

and Manufacture vs. Outsourcing) (MSE) 

Stability Evaluations Using Alternate 

Accelerated Conditions (RS & APQ) 

Characterization of Amorphous Pharmaceutical 

Solids and Solid Dispersions (PPB) 

7:00 pm – 9:30 pm 


Adequacy of PK/PD Model Validation and Simulation

19 



Wednesday, November 11, 2009 

6:00 am – 5:00 pm 


7:00 am – 5:30 pm 


7:00 am – 5:00 pm 


7:00 am – 5:00 pm 



7:00 am – 5:00 pm 


WEDNESDAY SUNRISE SESSIONS 

7:00 am – 8:15 am 

Pharmacogenetics: Methods and Clinical 

Applications (CPTR & PPDM) 

Innovative Colonic Drug Delivery Systems with a Case 

Study in Formulation and Temporal Gastrointestinal 

Transit Analysis (FDD) 

Today, Tomorrow, and Beyond: Approaches and 

Challenges in Modeling Pharmacodynamic Effects 

with Long Time Delays (PPDM) 

Rational Design of a Freeze-dried Formulation 

for a Biologic (BIOTEC) 

Minimizing the Guesswork of Early Human 

Dose Predictions: Application of PK Prediction 

Methodologies Including PBPK (PPDM) 

AAPS MENTORING BREAKFAST 

7:00 am – 8:30 am 

CONTRIBUTED PAPERS POSTER SESSION 

and career center 

8:00 am – 5:00 pm 



WEDNESDAY MORNING PROFESSIONAL 

DEVELOPMENT 

8:00 am – 10:00 am 

Strategic Job Search 

WEDNESDAY MORNING SYMPOSIA 


8:30 am – 11:00 am 

What Can the Pharmaceutical Industry Learn About 

Process Development and Manufacturing from 

Other Businesses? (MSE) 

Pharmacoproteomics: Targeted Absolute 

Quantitative Proteomics in ADME (PPDM) 

Pharmacokinetic-pharmacodynamic Aspects 

of Inhaled Lung-targeted Agents (FDD & PPDM) 

The Influence of Excipient Functionality on Quality 

by Design for Drug Product (FDD & RS) 

Extrapolation Preclinical Data to Predict Human 

Pharmacokinetics: Understanding and Practice (PPB) 

WEDNESDAY MORNING ROUNDTABLES 

9:00 am – 11:00 am 

ISR Failure: Avoiding and Resolving Through 

Investigation (BIOTEC) 

Impact of Pharmacogenomics on Drug Development: 

An Industrial Perspective (BIOTEC & PPDM) 

Facilitating the Transition to Model-based 

Drug Development (PPDM) 

Translational Challenges in PK/PD/TD of 

Biotechnology-derived Products (CPTR & PPDM) 

WEDNESDAY MORNING MINI-SYMPOSIA 

9:00 am – 11:00 am 

Intestinal Delivery of Lipidic Drug Complexes and 

Conjugates: Case Studies (FDD) 

Repurposing Old Drugs for New Uses (DDD) 


9:30 am – 4:30 pm 

Wednesday Morning/AFTERNOON 

Professional Development 

11:00 am – 12:00 pm 

How to Build, Broaden and Use Your Network 

11:00 am – 1:00 pm 

Networking A to Z 

12:00 pm – 1:00 pm 

Speed Networking for Science 


12:00 pm – 1:00 pm 


12:00 pm – 1:15 pm 

WEDNESDAY AFTERNOON ROUNDTABLES 

2:00 pm – 4:00 pm 

Salts, Co-crystals, Polymorphs/Solvates, 

Nanoparticles, or Amorphous: How to Pick 

the Winner (PPB) 

Tumor Targeting Using Nanotechnology-based Drug 

Delivery Systems (PPB) 

Alcohol Dose Dumping for Extend Release Solid Oral 

Dosage Products (APQ) 

In Vivo Animal Models for Prediction of Drug-drug 

Interactions (PPDM) 

Comparator Products – Untold Stories (APQ & RS) 

WEDNESDAY AFTERNOON SYMPOSIA 

funded by a grant from 

2:00 pm – 4:30 pm 

Microdialysis Role in the Development and 

Optimization of Drug Topical Delivery 

(APQ, PPB, PPDM & RS) 

With Scientific and Risk-based Approaches, Can QbD 

Reduce Industry’s Stability Burden? (APQ) 

Mechanism-based PKPD Modeling: Its Role in 

Discovery and Early Development of Biologics 

(PPDM) 

The Graying Globe — Drug Development in the 

Elderly (CPTR & PPDM) 

Toxicological Considerations in Early Drug Discovery: 

Avoiding Failures by Applying Rational Drug Design 

(DDD) 

Using the Quality-by-Design Principle to Establish 

Pharmaceutical Equivalence and Bioequivalence of 

Advanced Dosage Forms (RS) 


5:00 pm – 6:00 pm

20 



Thursday, November 12, 2009 

6:00 am – 12:00 pm 


7:00 am – 2:30 pm 


7:00 am – 12:00 pm 


7:00 am – 12:00 pm 



THURSDAY SUNRISE SESSIONS 

7:00 am – 8:15 am 

Physiologically Based Pharmacokinetic Modeling: 

Concepts and Applications in Drug Discovery and 

Development (PPDM) 

Humanized Transgenic Transporter Models — 

Update on State-of-the-Art (PPDM) 

Modeling Ophthalmic Drug Delivery and Disposition 

(FDD & PPDM) 

Non-clinical Dosage Testing GMP or GLP? (APQ) 

Protein-based Vaccines (BIOTEC) 

CONTRIBUTED PAPERS POSTER SESSION 

8:00 am – 12:00 pm 

THURSDAY SYMPOSIA 

8:30 am – 11:00 am 

Hot-melt Extrusion: A Novel Oral Solids Processing 

Technology (FDD) 

Impact of Unstable Metabolites During Drug 

Quantification in Regulated Bioanalysis (APQ) 

The Role of ATP Binding Cassette Transporters 

in Tissue Defense and Organ Regeneration (PPDM) 

Advances in the Injectable Combination Products 

(FDD) 

Using Modeling and Simulation to Safely Adjust 

Dose Regimens for Obese Patients (CPTR & PPDM) 

Excipient Variability: Why Some Lots Pass and 

Others Fail (PPB) 

THURSDAY ROUNDTABLES 

9:00 am – 11:00 am 

Predicting Oral Drug Absorption: Fiction and Facts 

(PPB & PPDM) 

What Can Computational Design Do for Drug 

Discovery and Development? Current State-of-the-Art 

(DDD) 

First Time in Human Dosing — Gimmicks, Luck, 

and Science (PPDM) 

Evaluating Fit-for-Purpose Models: Consensus 

or Controversy (CPTR & PPDM) 

THURSDAY MINI-SYMPOSIA 

9:00 am – 11:00 am 

Role of Models in Design Space (MSE) 

2009 AAPS ANNUAL MEETING ADJOURNMENT 

11:00 am 

POST-CONFERENCE EVENTS 

OPEN FORUMS 

1:30 pm – 5:00 pm 

An additional fee is required to attend open forums 

AAPS Analysis and Pharmaceutical Quality Section 

(APQ) Open Forum 

An additional fee is required to attend this open forum 

Analytical Challenges in Detecting and Preventing 

Counterfeits in Global Environment 

AAPS Biotechnology Section (BIOTEC) and 

Regulatory Sciences (RS) Open Forum 


Biosimilars — Development Considerations and 

Future Directions 

AAPS Pharmacokinetics, Pharmacodynamics and 

Drug Metabolism (PPDM) Open Forum 


An Evolution or Revolution in Drug Metabolism: 

When, Where, Why, What, How? 

AAPS Regulatory Sciences (RS) Open Forum 


Global Regulatory Challenges for Genotoxic 

Impurities


AAPS HonorS 

Amgen Inc. 

One Amgen Center Drive 

Thousand Oaks, CA 91320-1799 

www.amgen.com 


During 2008-2009 



ScienceS

22 


AAPS Pre-conference Workshop Programming 

at a glance 

Saturday 

8:00 am – 5:45 pm 

AAPS Workshop on Special Dosage Forms – 

What’s New with In Vitro Drug Release? 

Co-sponsored with 




8:30 am – 5:00 pm 



Formulations 




8:30 am – 5:00 pm 

AAPS Workshop on Quantitative Model-based 

Drug Development in Drug Discovery and 

Translational Research 




Sunday 

8:30 am – 12:00 pm 

AAPS Workshop on Special Dosage Forms — 

What’s New with In Vitro Drug Release? 




8:30 am – 4:00 pm 



Formulations 





8:00 am – 5:45 pm 

AAPS Workshop on Special Dosage 

Forms — What’s New with In Vitro 

Drug Release? 

co-sponsored with 




Background 

Dissolution testing is a very important tool in drug 

development and quality control. Application 

of dissolution testing has widened to a variety 

of novel or special dosage forms and is referred 

as drug release test. The test is used for the 

biopharmaceutical characterization of the drug 

product, and as a tool to assure consistent product 

(batch) quality within a defined set of specification 

criteria. Ideally, the drug release method should 

correlate with the in vivo performance of the 

product. However, because of the complexity of the 

novel dosage form and simplicity of in vitro release 

methodology, it may not be possible to achieve 

this. Nevertheless, the in vitro release methodology 

should serve to test the key performance of 

the formulation. 

Goals and Objectives 

This workshop will present drug release 

methodologies to evaluate the product performance 

for special dosage forms, such as, buccal, topical, 

ophthalmic, inhalation, stent and nanoparticle 

formulations. It will provide opportunities for the 

participants to interact with the faculty in panel 

discussions. 

The workshop presentations and discussions should 

be of interest to scientists working in academia, 

pharmaceutical industry and regulatory agencies. 

Planning Committee 

Horst-Dieter Friedel, Ph.D. 

Bayer HealthCare AG, Germany, Co-chair 

Cynthia K. Brown, Ph.D. 

Eli Lilly & Company, Co-chair 

Lucinda Buhse, Ph.D. 

U.S. Food and Drug Administration 

Todd Cecil, Ph.D. 

United States Pharmacopeia 

Susanne Keitel, Ph.D. 

European Directorate for the Quality of Medicines 

& Healthcare, France 

Johannes Kraemer, Ph.D. 

PHAST, Germany 

J. Michael Morris, Ph.D. 

Irish Medicines Board, Ireland 

Vinod P. Shah, Ph.D. 

FIP Scientific Secretary 

Mary Stickelmeyer, Ph.D. 

Eli Lilly & Company 

Chikako Yomota, Ph.D. 

National Institute of Health, Japan 

For more information, visit: 

www.aapspharmaceutica.com/specialdosageforms

23 


AAPS Pre-conference Workshop Programming 

8:30 am – 5:00 pm 

CRS/AAPS Workshop on Development 

and Regulatory Challenges for 

Controlled Release Formulations 

An additional fee is required to attend this pre-conference 

workshop 


Background 

In November 2007, AAPS and CRS together held the 

workshop, Development and Regulatory Challenges 

for Controlled Release Formulations, which was 

an enormous success. Workshop attendees, AAPS 

members, and CRS members have all asked for the 

next phase of the workshop, and we are pleased to 

announce that it is coming your way! 

Goals 

For 2009, the workshop will include a combination 

of U.S. Food and Drug Administration (FDA) and 

European regulatory perspectives on developing controlled 

release formulations. There will be speakers 

participating in open discussions on newly emerging 

technologies to help individuals understand the 

challenges in developing the technology of controlled 

release formulations as well as the regulatory 

hurdles that these technologies may face. There will 

also be speakers who are well known experts talking 

about mature technologies and the associated 

developmental and regulatory challenges that were 

encountered along the road to success. We encourage 

and expect a lively discussion among the attendees, 

speakers, and regulatory officials that can shed 

some light on what is expected when working to get 

a controlled release product to market. The topics 

were chosen to cover a number of different routes of 

administration, as each has their own unique 

challenges. Case studies will be used to demonstrate 

the speakers’ points and engage the attendees. 

Educational Objectives 

• To provide an understanding of the developmental 

and regulatory challenges for controlled release 

formulations utilizing mature and evolving new 

technologies in Europe and North America; 

• to provide a venue for young and/or established 

scientists to informally meet with other scientists 

and regulatory authorities; 

• to share and discuss fundamental science and 

experiences that may be of value to individuals 

dealing with various CR technologies; 

• to gain an understanding of the differences 

between the regulatory bodies of the E.U. 

and the FDA; 

• to increase an individual’s knowledge about a 

variety of controlled release technologies that 

may not be found in the literature through shared 

experiences and panel discussions; and 

• to apply newly acquired knowledge and a suitable 

approach to the potential design of the attendees 

own pharmaceutical products. 

Topics to Be Presented 

• The Regulatory Challenges During the Development 

of Long-acting Injectables 

• Rapid Disintegrating Tablets 

• Development of Nanocrystal Technology for Poorly 

Soluble Compounds 

• Developmental and Regulatory Challenges with 

Liposomes 

• Development and Regulatory Challenges 

Associated with the Transdermal Delivery of Small 

Molecules 

• The Science and Regulatory Perspectives of Controlled 

Release Products with Mature Technologies 


Microparticle Formulations 

• Intracutaneous Immunization 

• Developing a New Combination Vaccine-device 

Product 

• Controlled Release and Immunogenicity — 

A Vaccine Perspective 

• Immediate Release Formulation for AMD 


RNAi Therapeutics 

• The Science and Regulatory Perspectives of Controlled 

Release Products with Emerging Technologies 


Ron Ortiz, Ph.D. 

Upsher-Smith Laboratories, U.S.A. 

Dody Reimer, Ph.D. 

Northern Lipids, Inc., Canada 

Louise Rosenmayr-Templeton, Ph.D. 

Tower Pharma Consulting, Austria 

Avinash Thombre, Ph.D., 

Pfizer, Inc., U.S.A. 


www.aapspharmaceutica.com/CRS 

8:30 am – 5:00 pm 

AAPS Workshop on Quantitative Modelbased 

Drug Development in Drug 

Discovery and Translational Research 


workshop 


Goals and Objectives 

The area of Preclinical PK/PD Modeling & Simulation 

encompasses a multitude of quantitative 

approaches to integrate preclinical pharmacology, 

bio-marker response and safety data toward the 

selection of the most promising drug targets and the 

development of the most optimal drug candidates. 

In recent years, this rapidly evolving area has 

been recognized as critical for the pharmaceutical 

companies to reduce high rates of failures 

in advancing compounds from the bench 

to the bedside. 

In this one-day workshop, we will provide basic 

education and hands-on training on technical and 

theoretical aspects of the preclinical PK/PD modeling 

via a combination of lectures, case studies and 

break-out sessions demonstrating the key mathematical 

strategies to build dose-response relationships, 

efficacy and human dose projections. We will 

• introduce the concept and fundamental principles 

of PK/PD modeling and simulation, particularly in 

preclinical phase; 

• discuss case studies demonstrating the 

applications and values of preclinical PK/PD 

modeling within the framework of industrial 

and academic drug discovery and translational 

research efforts; 

• provide practical hands-on training on the key 

aspects of preclinical PK/PD modeling; 

• cover topics include PK/PD modeling and 

simulation for drug target selection, mechanismbased 

PK/PD modeling for biomarker development, 

and human dose projection for both small and 

large molecule (e.g. antibody) compounds; and 

• introduce strategies to overcome challenges 

associated with the implementation of PK/ 

PD modeling and simulation in drug discovery 

and development, including silo-structure, 

interdisciplinary communication and decisionmaking 

infrastructure. 


Anjaneya Chimalakonda, Ph.D. 

Bristol-Myers Squibb 

Cheryl S. W. Li, Ph.D. 

Pfizer, Inc. 

Pratap Singh, Ph.D. 

Pfizer, Inc. 

Melvin H. Weinsburg, Ph.D., University of Wisconsin- 

Madison, Continuing Education 


www.aapspharmaceutica.com/qmbdd

SM 

24 


AAPS General Programming 

at a glance 

Sunday Monday Tuesday Wednesday 

8:30 am – 11:00 am 


Analysis and Pharmaceutical Quality 

(APQ) 

Sponsored by 

8:30 am – 11:00 am cont... 


in Physical Pharmacy and 

Biopharmaceutics (PPB) 

Sponsored by 

10:00 am – 12:00 pm 

AAPS Plenary 

Session 

Drug Product Quality 

and Safety in a Global 

Environment 

12:15 pm – 1:30 pm 

AAPS Distinguished 

Pharmaceutical Scientist 

Award Winner Lecture 


12:00 pm – 1:15 pm 

Hot Topic #1 

Topic and Speakers to be 

Determined 

2:00 pm – 4:30 pm 

Global Health 

inaugural 

Symposium 

4:30 pm – 6:30 pm 


Keynote Addresses 

6:30 pm – 7:45 pm 

AAPS Welcome 

Reception 






Sponsored by 


in Drug Design and Discovery (DDD) 

Sponsored by 


in Formulation Design and 

Development (FDD) 

Sponsored by 


in Manufacturing Science and 

Engineering (MSE) 

Sponsored by 

During this Symposium, a 

presentation from the Research 

Achievement Award winner will 

be given. 

AAPS Research Achievement Award 

in Manufacturing Science and 

Engineering 

Sponsored by 

12:00 pm – 1:15 pm 

Hot Topic #2 

Topic and Speakers to be Determined 




be given. 

AAPS David Grant Research 

Achievement Award in Physical 

Pharmacy 

Sponsored by 

AAPS Graduate Student 

Symposium in Pharmacokinetics, 

Pharmacodynamics and Drug 

Metabolism and Clinical 

Pharmacology and Translational 

Research (PPDM & CPTR) 

Sponsored by 




be given. 


in Clinical Pharmacology and 


Sponsored by 

12:00 pm – 1:15 pm 

Hot Topic #3 

Topic and Speakers 

to be Determined 

Hot Topic #4 

Topic and Speakers 

to be Determined 

4:45 pm – 6:15 pm 

AAPS Exposition Hall Cocktail Reception 

Funded by Grants from AAPS Exhibitors

25 




4:30 pm – 6:30 pm 


The AAPS Opening Session marks the formal 

opening to the 2009 AAPS Annual Meeting 

and Exposition and features 

Opening Remarks 

John Lisack, Jr., CAE 

AAPS Executive Director 

Presidential Remarks 


2009 AAPS President 

Keynote Presentations 

Trisha Meili 

The Central Park Jogger 

Second Keynote Speaker to be Determined 

Incoming President’s Remarks 

Danny D. Shen, Ph.D. 


Awards Ceremony 

6:30 pm – 7:45 pm 

AAPS Welcome Reception 




Meet your peers and see old friends during 

the 2009 AAPS Annual Meeting and Exposition 

Welcome Reception. 


PLENARY SESSION 

10:00 am – 12:00 pm 

AAPS Plenary Session 

Drug Product Quality and Safety in a Global 

Environment 

Moderator 

Anthony DeStefano, Ph.D. 

United States Pharmacopeia (USP) 

BD’s Role in Developing the Single-use 

Injection Device for Immunization in the 

Developing World 

Renuka Gadde, Ph.D. 

Becton, Dickinson and Company 

Worldwide Landscape of the Counterfeit 

Drug Trade 

Marvin D. Shepherd, Ph.D. 

The University of Texas at Austin 


Jim Thompson 

Chair, The European Alliance for Access to Safe 

Medicines (EAASM) 

12:15 pm – 1:30 pm 

AAPS Distinguished Pharmaceutical Scientist 

Award Winner Lecture 


12:00 pm – 1:15 pm 

Hot Topic #1 


2:00 pm – 4:30 pm 

Symposium 

Inaugural AAPS Global Health Symposium 

Inadequate access to affordable and effective 

medicines and healthcare in developing countries 

leads to devastating illnesses and millions of deaths 

annually. Furthermore, for certain prevalent but 

“neglected” diseases, effective drugs and vaccines 

have not yet been developed. These global health 

problems are being addressed by numerous organizations 

that strive to improve the health of people 

in developing countries. This symposium will focus 

on efforts to discover, develop and distribute drug 

treatments and vaccines for neglected diseases and 

on programs to improve healthcare infrastructure 

and access to care in developing countries. The talks 

will serve to inform and inspire, as they highlight 

some of the challenges and successes of collaborative 

programs — such as public-private partnerships 

(involving pharmaceutical companies, universities, 

governments and nongovernmental organizations). 

The symposium will highlight the range of opportunities 

for pharmaceutical scientists to contribute 

and positively impact these essential programs 

ranging from discovery, development and the myriad 

of issues related to drug access. It is hoped this 

inaugural symposium will lead to a sustained focus 

on global health and social responsibility by AAPS, 

its members and its sponsors. 

Moderator 




William N. Charman, Ph.D. 

Monash University 

Further Speakers and Topics to be Determined

SM 

26 




AAPS Graduate Student Symposia and 

Research Achievement Awards 


Analysis and Pharmaceutical Quality (APQ) 

Sponsored by 


Biotechnology (BIOTEC) 

Sponsored by 

AAPS Graduate Student Symposium in Physical 

Pharmacy and Biopharmaceutics (PPB) 

Sponsored by 



AAPS David Grant Research Achievement 

Award in Physical Pharmacy 

Sponsored by 


12:00 pm – 1:15 pm 

Hot Topic #3 


Hot Topic #4 


AAPS Graduate Student Symposium in Drug 


Sponsored by 



Sponsored by 



Sponsored by 



AAPS Research Achievement Award in 


Sponsored by 


Pharmacokinetics, Pharmacodynamics and 

Drug Metabolism and Clinical Pharmacology 

and Translational Research (PPDM & CPTR) 

Sponsored by 



AAPS Research Achievement Award in 

Clinical Pharmacology and Translational 

Research 

Sponsored by 

12:00 pm – 1:15 pm 

Hot Topic #2 


4:45 pm – 6:15 pm 

AAPS Exposition Hall Cocktail Reception 

Funded by Grants from AAPS Exhibitors 

Attend the Exposition Hall Reception and check out 

the new technologies and innovative services the 

exhibitors have to offer. Complimentary beverages 

and light fare will be served.

27 


AAPS Professional Development Programming 

at a glance 

Sunday Monday Tuesday Wednesday Thursday 

8:00 am – 10:00 am 


8:00 am – 10:00 am 


11:00 am – 12:00 pm 

Transitioning between 

Academia and Industry 

12:00 pm – 1:00 pm 

Transitioning between Small 

and Large Pharma 

2:00 pm – 4:00 pm 


8:00 am – 10:00 am 


11:00 am – 12:00 pm 

How to Build, Broaden and 

Use Your Network 

11:00 am – 1:00 pm 


12:00 pm – 1:00 pm 



8:00 am – 10:00 am 


Megan Driscoll 

PharmaLogics Recruiting 

Panelists to be Determined 

In a world that is contracting, more and more 

companies are facing the possibility of a merger. 

Don’t be caught off guard when one comes to 

your company. Come learn what to expect before 

a potential merger occurs and how to survive once 

the transaction has taken place. 


8:00 am – 10:00 am 


Jey Wagner 

Dale Carnegie of Greater Los Angeles 

and Ventura County 

The secret to a successful meeting is to “try honestly 

see things from the other person’s point of view.” 

Leaders bring people, ideas and productivity 

together through providing needs and expectations 

and creating a riskfree environment. Guidelines for 

facilitation effectiveness will be discussed in this 

interactive session. The essential elements that 

need to be incorporated before, during and after 

any session will be discussed to improve quality, 

outcome and follow-up. The ultimate goal is to build 

cooperation and trust. 

• Preparation skills 

• Identify necessary skills/objectives for a 

“productive” session 

• Learn strategies for running an effective dialogue 

• Dealing with assertive/aggressive/passive behaviors 

• Use communications cushions to “soften the 

blow” from difficult participants 

• Conduct a group question and answer session 

• Discuss the 10 tips for productivity 

• Discuss the 10 tips for presenting and responding 

to participants 

• “Prime the pump” in getting an audience to 

participate either in questions, participating 

or focusing 

• Tips on running an effective meeting or roundtable 

discussion 

• Learn a quick 4-step process for running a meeting 

• Determine some decision making criteria for 

ending a meeting on a proactive note 

• Discuss green-light vs. red-light thinking 

The complexity of facilitation skills is generally in 

the mind of the leader. Once those paradigms are 

broken and the leader has a plan, can incorporate 

their own personality, eliminate personal agendas 

and incorporate the ideas listed above, a meeting 

can virtually run itself with the leader simply moving 

the elements along at the right pace!

28 


AAPS Professional Development Programming 

11:00 am – 12:00 pm 

Transitioning between Academia 

and Industry 




Are you currently considering a career in Academia 

or are you interested in leaving Academia for the 

corporate world? If so, this session will prepare you 

on how to make those moves, and what to expect 

when you get on the other side. 

12:00 pm – 1:00 pm 

Transitioning between Small and Large 

Pharma 




Do you wonder what it would be like to work in a 

small start up environment or do you dream about 

joining one of the pharmaceutical giants? This 

session will give you an overview of how to make 

that change, what it will be like when you do, and 

why it is important to diversify your experience in 

this way. 

2:00 pm – 4:00 pm 


Jey Wagner 

Dale Carnegie of Greater Los Angeles and 

Ventura County 

The secret to a successful meeting is to “try honestly 

see things from the other person’s point of view.” 

Leaders bring people, ideas and productivity 

together through providing needs and expectations 

and creating a riskfree environment. Guidelines for 

facilitation effectiveness will be discussed in this 

interactive session. The essential elements that 

need to beincorporated before, during and after 

any session will be discussed to improve quality, 

outcome and follow-up. The ultimate goal is to build 

cooperation and trust. 

• Preparation skills 

• Identify necessary skills/objectives for a 

“productive” session 

• Learn strategies for running an effective dialogue 

• Dealing with assertive/aggressive/passive 

behaviors 

• Use communications cushions to “soften the 

blow” from difficult participants 

• Conduct a group question and answer session 

• Discuss the 10 tips for productivity 

• Discuss the 10 tips for presenting and responding 

to participants 

• “Prime the pump” in getting an audience to 

participate either in questions, participating or 

focusing 

• Tips on running an effective meeting or roundtable 

discussion 

• Learn a quick 4-step process for running a meeting 

• Determine some decision making criteria for 

ending a meeting on a proactive note 

• Discuss green-light vs. red-light thinking 

The complexity of facilitation skills is generally in 

the mind of the leader. Once those paradigms are 

broken and the leader has a plan, can incorporate 

their own personality, eliminate personal agendas 

and incorporate the ideas listed above, a meeting 

can virtually run itself with the leader simply moving 

the elements along at the right pace! 


8:00 am – 10:00 am 




Despite the current economic climate, employment 

opportunities within BioPharma do exist for job 

seekers. This session will focus on how to conduct 

a strategic job search that leverages both your skills 

and your network to achieve your career goals. 

Attendees will also receive “inside” information from 

panelists HR managers who will explain what they’re 

specifically looking for in applicants. 

11:00 am – 12:00 pm 

How to Build, Broaden and Use Your 

Network 



11:00 am – 1:00 pm 




In this economy, everyone knows that networking 

is critical, but many people just don’t know how 

to network effectively. Come learn some networking, 

“Best Practices” and leave with a better approach 

to meeting people in person and on line. 

12:00 pm – 1:00 pm 


Bring a stack of business cards and participate in 

an easy and fun speed networking event. You’ll walk 

away with valuable contacts and get an opportunity 

to practice and put your networking skills to work.

29 


AAPS Analysis and Pharmaceutical Quality (APQ) Programming 

at a glance 


8:30 am – 4:00 pm 


Developing Biorelevant 

Dissolution Test Methods 


An additional fee is required 

to attend this short course 

8:00 am – 10:00 am 

Monday Morning 

Roundtables Funded 

by a Grant from 

Roundtable 

Evaluation of the Regression 

Type in LC-MS/MS 

Bioanalytical Methods 

8:30 am – 11:00 am 


Symposium in Analysis and 

Pharmaceutical Quality (APQ) 

Sponsored by 

7:00 am – 8:15 am 

Sunrise Session 

Non-clinical Dosage Testing 

GMP or GLP? 

8:30 am – 11:00 am 

Symposium 

Impact of Unstable 

Metabolites during Drug 

Quantification in Regulated 

Bioanalysis 

9:00 am – 11:00 am 

Roundtable 

How to Face and Successfully Defend 

FDA and Other Regulatory Audits 

2:00 pm – 4:00 pm 

Roundtable 

IVIVC for Establishing 

Clinically Relevant 

Specifications 

2:00 pm – 4:30 pm 

Monday Afternoon Symposia 


2:00 pm – 4:00 pm 

Tuesday Afternoon Roundtables 


Roundtable 

Stability Evaluations Using 

Alternate Accelerated Conditions 

2:00 pm – 4:00 pm 

Roundtables 

Alcohol Dose Dumping for 

Extended Release Solid 

Oral Dosage Products 

Comparator Products – 

Untold Stories 

2:00 pm – 4:30 pm 

1:30 pm – 5:00 pm 

Open Forum 

Analytical Challenges in 

Detecting and Preventing 

Counterfeits in Global 

Environment 


to attend this open forum 

Symposium 

Process Analytical 

Technologies in API 

Manufacturing 

2:00 pm – 4:30 pm 

Symposium 

Challenges and Application 

of Dissolution for Testing 

Nutraceuticals, Natural Products, 

and Traditional Medicines 

wednesday afternoon 

symposia funded by 

a grant from 

SymposiA 

With Scientific and Riskbased 

Approaches, Can 

QbD Reduce Industry’s 

Stability Burden? 

Microdialysis Role in 

the Development and 

Optimization of Drug 

Topical Delivery 

5:30 pm – 7:00 pm 

Analysis and Pharmaceutical 

Quality (APQ) Section Joint 

Membership Meeting and 

Reception

30 



New INTERACTIVE FEATURE for all Roundtable Sessions! 

Click on roundtable moderator names to submit questions that you would like to be addressed at the roundtable session in Los Angeles. 


8:30 am – 4:00 pm 

Developing Biorelevant Dissolution Test 

Methods with an Emphasis on QbD 



Biorelevant dissolution testing is playing a critical 

role in guiding early phase formulation development 

and linking product/process design space and 

patient needs. This short course will provide 

pharmaceutical scientists and regulatory personnel 

with fundamental training on dissolution method 

development, following the principles of QBD. A 

presentation by a representative from the U.S. Food 

and Drug Administration will stress the importance 

of having a discriminating biorelevent dissolution 

test, and what is now expected in the quality of 

the dissolution test. Modeling and simulation 

will be presented as a helpful tool in the early 

phase efforts to link dissolution methods to in vivo 

performance. There will be an emphasis on finding 

pertinent product and substance information in the 

early phases. Case studies for dissolution method 

development that focuses on in vivo relevance and 

correlation will be presented. The use of Design 

of Experiments (DOE) in dissolution method 

development and understanding will be discussed. 

Moderators 

Vivian Gray 

V.A. Gray Consulting, Inc. 

Qingxi Wang, Ph.D. 

Merck and Co., Inc. 

Biorelevant Dissolution Testing: Characterizing 

the Product for the Patient 

Arzu Selen, Ph.D., invited 


Biorelevant Dissolution Method in Early Phase 

Drug Development 

Yin Mao, Ph.D. 


Developing a Biorelevant Dissolution Method: 

Points for Consideration and Case Studies 

Nikoletta Fotaki, Ph.D. 

University of Bath 

Modeling and Simulation Approaches for 

Designing and Understanding In Vitro 

Dissolution Tests 

John Crison, Ph.D. 

Simulations Plus, Inc. 

QbD Approach to Dissolution through 

Understanding of the Release Mechanisms 

and Critical In Vivo Parameters 



Role of DoE in Developing Biorelevant 

Methods 

Kimberly Gallagher, M.S. 





8:00 am – 10:00 am 

Evaluation of the Regression Type in 

LC-MS/MS Bioanalytical Methods 

Roundtable 

U.S. Food and Drug Administration (FDA) guidelines 

for bioanalytical method validation clearly state 

that the calibration curve should cover the entire 

anticipated range, the simplest model that 

adequately describes the concentration — response 

relationship should be used, and selection 

of weighting and use of a complex regression 

equation should be justified. In many bioanalytical 

methods, the range only fits complex regression 

equations or requires the dilution of higher 

concentration samples to fit a linear regression. 

At present, the FDA guidelines do not mention 

which is the best approach to follow. Therefore, 

this topic is still debated in the pharmaceutical 

industry. This roundtable will focus on discussing 

the precision and accuracy of QCs and diluted QCs 

read off linear and quadratic calibration curves to 

determine which option is preferable. Moreover, 

current industry practice for GLP bioanalytical 

methods assesses precision/accuracy at 4 levels: 

LLOQ, QC-Low, QC-Mid, and QC-High. Often, no 

evaluation of precision/accuracy above the QC-High 

is performed which leaves the concentrations 

between QC-High and ULOQ considered to be less 

rigorously evaluated. Since the entire span of the 

calibration curve is considered validated, backcalculated 

concentrations of unknown samples 

falling in the upper portions of calibration curves 

are routinely reported. This practice could be 

considered acceptable for linear curves but it could 

be considered questionable for quadratic curves. 

Indeed, for quadratic curves a given change in 

instrument response can have more impact on the 

back-calculated concentrations in the upper part 

of the curve compared to the lower portion due to 

changing slope. Data in the literature suggest that 

quantitation in upper portions of calibration curves, 

even employing quadratic regression algorithms, 

produces the same reliable back-calculated results 

as in mid or lower portions of the calibration curve. 

However, since the “quadraticity” of a non-linear 

calibration curve could be significantly accentuated 

by low ionization efficiency, detector saturation and 

solubility issues, it is further suggested to always 

evaluate accuracy/precision at the ULOQ level during 

method development. 

Moderator 

Fabio Garofolo, Ph.D. 

Algorithme Pharma Inc. 

Evaluation of Precision, Accuracy and Dilution 

Reliability in Upper Portions of Quadratic 

Calibration Curves 



The Importance of Using the Linear Fit and the 

Simplest Fit Over the Best Fit 

Douglas M. Fast, Ph.D. 

Pfizer Global R&D 

The Importance of Using the Quadratic Fit and 

the Best Fit Over the Simplest Fit 

Saleh Hussain, Ph.D. 

Consultant 


2:00 pm – 4:00 pm 

IVIVC for Establishing Clinically Relevant 

Specifications 

Roundtable 

In vitro release dissolution testing plays a dual 

role in the drug development life cycle. In one role, 

laboratory test results are used as an indicator of 

product quality. In the other role, the test results 

can indicate or predict in vivo performance. In both 

cases, test specifications that are meaningful are 

desired. This round table represents an opportunity 

to bridge a knowledge gap between the two 

practices (clinical and laboratory) for those seeking 

in vitro/in vivo correlations. The presentations will 

include case studies, ideas, and methodologies for 

designing and interpreting in vitro release tests that 

indicate in vivo performance of dosage forms and 

drug delivery systems. The session will also include 

a discussion of the situations where IVIVC can be 

expected to work and conversely when success is 

not likely.

31 



Moderators 

Ali Rajabi-Siahboomi, Ph.D. 

Colorcon 

Alger D. Salt, M.S. 

GlaxoSmithKline plc 

Challenges in Setting Clinically Relevant 

Dissolution Specification from In Vivo and 

In Vitro Correlations 

Arzu Selen, Ph.D., invited 


Challenges in Setting Clinically Relevant 

Dissolution Specification from In Vivo and 

In Vitro Correlations 

Nikoletta Fotaki, Ph.D. 

University of Bath 

IVIVC: Factors and Conditions for Success 

Mario González, Ph.D. 

P’Kinetics International, Inc. 



2:00 pm – 4:30 pm 

Process Analytical Technologies in API 

Manufacturing 

Symposium 

Currently, pharmaceutical industry uses different 

on-line monitoring techniques (PAT) to understand 

and control manufacturing processes (reaction 

monitoring, crystallization and polymorphic 

transformations, particle engineering, drying, 

milling, solvent recovery and fractionation, etc.). 

In this symposium, the application of different 

process analytical technologies (online LC, Raman, 

FT-IR, and Near IR spectroscopy), and the challenges 

to the implementation of PAT in API manufacturing 

area will be discussed. 

Moderators 

Arya P. Jayatilaka, Ph.D. 

Pfizer, Inc. 

Mukund “Mike” Yelvigi 

Wyeth Pharmaceuticals 

PAT in Support of API Manufacturing: Some 

Case Studies 

Steve Hammond, Ph.D. 

Pfizer, Inc. 

Raman Spectroscopy for Understanding 

API Crystallization 

Lynne Taylor, Ph.D. 

Purdue University 

On-line HPLC for Improved Monitoring and 

Control of Pharmaceutical API Processes 

Rick Cooley 

Dionex Corp 

Overcoming Challenges to the Implementation 

of PAT in API Manufacturing 

Andrew Lange, Ph.D. 

Vertex Pharmaceuticals, Inc. 

JOINT MEMBERSHIP MEETING AND 

RECEPTION 

5:30 pm – 7:00 pm 


(APQ) Section Joint Membership 

Meeting and Reception 


Graduate Student Symposium 

8:30 am – 11:00 am 



(APQ) 

Sponsored by 


9:00 am – 11:00 am 



Roundtable 

In this session, we will share the experiences of 

U.S. Food and Drug Administration (FDA) officers, 

and clients’ experience on how to face FDA scientific 

compliance or routine audits. This discussion will 

provide an insight on how to manage a crisis into 

a less painful and manageable exercise. 

Moderators 

Prasad N.V. Tata, Ph.D., F.C.P. 

Covidien/Mallinckrodt, Inc. 

Raja Velagapudi, Ph.D. 

Barr Laboratories 

Audits Have a Purpose — Understand Them 

and Comply with Them 

C.T. Vishwanathan, Ph.D. 


Preparation of a Bioanalytical Laboratory for 

a Successful and Regulatory Audit 

Chinna Pamidi, Ph.D. 

Cetero Research 

My CRO is Under Audit – What Should I Do? 





2:00 pm – 4:00 pm 


Accelerated Conditions 

Roundtable 

In the current environment, clinical materials 

are manufactured, packaged, tested, and 

distributed worldwide. During transition, there 

are inherent changes of degradation, physical 

stability, dissolution rate, and particle size that 

may be affected; thus increasing risk to clinical 

materials. This session will explore options to 

effectively maximize the data collected using 

predictive stability tools to support establishment 

of shelf-life for clinical materials and minimize 

the number of stability studies to support clinical 

program. This roundtable will discuss the use of 

alternate accelerated/stress conditions, scientific 

understanding and predictive stability tools as an 

aid in the development to reduce risk and increase 

extrapolation robustness while maintaining 

product safety. Challenges to establish alternative 

accelerated conditions for unusual dosage forms 

and implication of physical and chemical changes 

on formulation/packaging and shipping strategies. 

Studies supporting shipment of clinical and 

commercial product, including controlling the 

shipment, monitoring and justifying excursions 

that may be observed. 

Moderators 

Kim Huynh-Ba, M.S. 

PHARMALYTIK 

Andrea Panaggio, Ph.D., M.S., R.Ph. 

Bristol-Myers Squibb

32 



Utilizing Stability and Analytical Tools to 

Improve Product Knowledge to Facilitate 

Support of a Global Clinical Program 

Frank Diana, Ph.D. 

Endo Pharmaceuticals 

Formulation Development Study Strategies 

to Support Controlled Temperature Shipping 

Sailesh A. Varia, Ph.D. 


Stability Conditions for Product Development 

Evaluations Pre-IND to Assure Acceptable 

Product During Shipment and Storage 

Edward Koch 

McNeil Consumer Healthcare 


2:00 pm – 4:30 pm 

Challenges and Application of 

Dissolution for Testing Nutraceuticals, 

Natural Products, and Traditional 

Medicines 

Symposium 

The complexity of phytochemical mixtures in herbal 

dietary supplements and traditional medicines 

causes multiple challenges in formulation, 

manufacturing, processing, storage, and 

distribution; in particular, the establishment of 

compendial standards and practices for content, 

toxicity, and stability. For supplements, natural 

products and traditional medicines, it is generally 

accepted that disintegration is representative of the 

dissolution and release of herbal actives. This is not 

necessarily true, but phytochemical complexities 

of herbal materials make dissolution testing 

extremely challenging. There are currently only 

four herbal monographs published in the USP that 

suggest dissolution parameters, and there is very 

little published on the applications of dissolution 

in the development and testing of natural and 

nutraceutical products. Speakers will address some 

of these challenges, and present current research 

in the area of natural products dissolution. 

Moderator 

Mary A. Murray, Ph.D. 

Nutrilite Health Institute 

Perspectives on Dissolution of Natural 

Products 

Raimar Loebenberg, Ph.D. 

University of Alberta 

Use of Dissolution Technology to Identify and 

Develop Standards, Leading to Analysis of 

Actives from Dissolutes of Feverfew 

Robert Chapman, Ph.D. 

Midwestern University 

Method Development for Dissolution Testing 

of Immediate Release Tablets Containing 

Standardized Botanical Extracts 

Janjira Intra, Ph.D. 

Nutrilite Health Institute 

Some Common Issues in Dissolution: 

A Regulatory Perspective 

John Duan, Ph.D., invited 




2:00 pm – 4:00 pm 

Alcohol Dose Dumping for Extended 

Release Solid Oral Dosage Products 

Roundtable 

This roundtable is designed to stimulate discussion 

and questions around alcohol dose dumping of 

extended release products. We will be looking at 

the safety aspects from the U.S. Food and Drug 

Administration perspective for both “drugs of 

abuse” and narrow therapeutic range drugs. The 

historical perspective will be presented. There 

will be a presentation on in vitro approaches to 

determining alcohol dose dumping. Also, discussion 

on approaches to formulation development that 

can reduce the effects of alcohol on dose dumping. 

Additionally, presentations on the formulation 

perspective will be discussed. 

Moderator 

Stephen P. Mayock 


Effects of Alcohol on In Vitro Release of Various 

Commercially Available Extended Release 

Formulations 

Stephen P. Mayock 


U.S. Food and Drug Administration Perspective 

on Alcohol Dose Dumping Including a 

Historical Perspective 

Mansoor Khan, Ph.D., M.S., R.Ph. 


2:00 pm – 4:00 pm 

Comparator Products — Untold Stories 

Roundtable 

Conducting global clinical studies for later phases 

of development (Phase II – Phase III) requiring the 

use of comparator products presents an array of CMC 

challenges. These challenges are further enhanced 

in double-blinded studies where a placebo matching 

the comparator is required. Pharmaceutical 

companies use over-encapsulation as a tool to blind 

the comparator and its matching placebos. This 

technique has its limitations, and CMC challenges, 

some of which include the need for conducting BA/ 

BE studies, setting comparators’ specifications, the 

utility of the appropriate analytical tests and the 

accompanying validation studies to support these 

tests, and conducting the appropriate stability program 

to establish the shelf-life of these comparators 

once over-encapsulated. Pharmaceutical companies 

also manufacture matching placebo products that 

look exactly the same as the comparator product 

used. The main CMC challenge encountered when 

conducting these studies include the successful 

manufacture of a matching placebo with no 

infringement on trademarks. Additional challenges 

include the setting of the appropriate specifications 

and shelf-life for the matching placebo. Formulation 

changes, excipient changes, and variations 

in dosage strengths are also critical issues to be 

addressed when conducting global clinical studies. 

The strategy for selecting the appropriate “comparator 

product” requires close collaboration between 

regulatory, regulatory-CMC, clinical supplies operations, 

manufacturing, and clinical to successfully 

conduct these studies. This roundtable will address 

the blinding strategies, best practices, and interfunctional 

collaboration leading to the appropriate 

choice of comparator product and the successful 

conduct of these global studies. 

Moderators 


PHARMALYTIK 

Ruben Lozano, Ph.D. 


Development of Dissolution Methods for 

Comparator Products — The Unspoken 

Challenges 



Bioavailability Challenges for Comparator 

Products 

Dakshina M. Chilukuri, Ph.D. 


Regulatory Expectations for Comparator 

Product Use in Clinical Trials 

Speaker to be Determined

33 





2:00 pm – 4:30 pm 

With Scientific and Risk-based 

Approaches, Can QbD Reduce Industry’s 

Stability Burden? 

Symposium 

This symposium will discuss strategies and 

case studies for effective utilization of studies to 

characterize the long-term stability profile across 

defined formulation, process, and packaging 

design spaces. 

Moderator 

Abbie Gentry, Ph.D. 


Applications of QbD to Stability-indicating 

Method Development 

Oscar Liu, Ph.D. 

Schering-Plough Research Institute 

QbD: Leveraging Science and Risk-based 

Approaches for API Stability Programs 

Throughout the Product Life Cycle 

Stephen Colgan, Ph.D. 

Pfizer Global Research & Development 

QbD for Stability… a Science and Risk-based 

Approach 

Anthony Mazzeo, Ph.D. 


A Regulatory Perspective on Gaining Global 

Acceptance of Scientifically-driven Risk-based 

Stability Strategies 

Elaine Morefield, Ph.D., invited 


2:00 pm – 4:30 pm 

Microdialysis Role in the Development 

and Optimization of Drug Topical 

Delivery 

Symposium 

The rapid and efficient development and evaluation 

of topical delivery systems is still a challenge, 

particularly when new approaches or devices 

like iontophoresis are tested. In vivo cutaneous 

microdialysis allows studying drug delivery and 

pharmacokinetics as close as possible to the site of 

action and provides a tremendous tool for a better 

understanding of how the formulation affects drug 

PK into the skin. The proposed symposium will start 

with an overview of the microdialysis technique 

as applied to skin issues and will compare it with 

the other methods used to study PK in skin or 

skin layers. Then some of the available studies 

that utilized MD in skin will be presented and 

discussed. An expert from the U.S. Food and Drug 

Administration (FDA) will also be invited to provide 

insights into the regulatory aspects of the technique. 

The symposium will provide the attendee with the 

opportunity to evaluate the contribution of MD to 

improve our understanding of skin delivery. 

Moderators 

Carryn Purdon, Ph.D. 

Nycomed 

Chinmay Shukla, Ph.D. 


Microdialysis in Skin: Overview and 

Comparison with Other Techniques 

Chris D. Anderson, M.D. 

Linköping University 

Microdialysis in the Selection of Optimal 

Formulations for Iontophoretic Drug Delivery 

Grazia Stagni, Ph.D., M.S. 

Long Island University 

Determination of Drug Penetration 

in Diseased Skin 

Speaker to be Determined 

The Regulatory View Point 

Edward Bashaw, Pharm.D., invited 




7:00 am – 8:15 am 

Non-clinical Dosage Testing GMP or GLP? 


What can the pharmaceutical industry learn about 

process development and manufacturing from other 

businesses? Many other businesses, have adopted 

systems for product development and monitoring 

and control of manufacturing, which are far more 

sophisticated than those used in a typical solid oral 

manufacturing production facility. Are there lessons 

which the pharmaceutical industry can learn from 

the chemical industry, automobile, aero industries, 

those making other industrial, or consumer products 

in highly controlled manufacturing environments? 

Speakers will address what could be learned 

from other industries focusing on issues such as 

knowledge management, and the use of lean, 6 

sigma, and parametric release in the pharmaceutical 

industry in comparison to others. 

Moderators 



Peter Bryan, Ph.D. 

Celgene Corporation 

Why is Dose Formulation Analysis Needed — 

A Regulatory Toxicologist Perspective 

Ravi Harpnnahalli, Ph.D., invited 


What are the Similarities and Differences 

between Bioanalytical and Dose Formulation 

Validation and Analysis? 

Yuan-Shek Chen, Ph.D. 

QPS, L.L.C. 

What Acceptance Criteria and Specifications 

Should Be Used? 

Peter Bryan, Ph.D. 

Celgene Corporation

34 




8:30 am – 11:00 am 

Impact of Unstable Metabolites during 

Drug Quantification in Regulated 

Bioanalysis 

Symposium 

Drug metabolism is a process that structurally 

converts chemical compounds to more polar 

entities. This biochemical modification, usually 

through specialized enzymatic systems, 

facilitates their excretion in human body. Drug 

biotransformation should be thoroughly considered 

during bioanalysis in order to evaluate the 

possible impact of unstable metabolites on drug 

quantification. In fact, unstable metabolites, 

such as lactones, N-oxides, and acyl glucuronides 

are found to be labile, and may revert back to 

the parent drug under particular physiological 

conditions. Furthermore, in the same case, lack 

of detailed literature on the metabolites stability 

and pharmacokinetic data may significantly hinder 

the course of method development. Therefore, it is 

essential to experimentally determine the impact of 

the unstable metabolites on the quantitation of the 

parent drug at each step of method development 

by using incurred sample reanalysis (ISR). This 

symposium will present a detailed overview of 

the points to consider for Pharma and CROs for 

the evaluation of the possible impact of unstable 

metabolites in regulated bioanalyis. The symposium 

will cover the different approaches used in the 

industry to evaluate unstable metabolites during 

bioanalytical method development and by using 

incurred sample reanalysis. The advantages and 

challenges of each bioanalytical approaches will be 

considered for metabolites like lactones, N-oxides 

and acyl glucoronides. Special emphasis will be put 

on the importance to provide accurate bioanalytical 

data in presence of unstable metabolites. This 

program will benefit attendees from bioanalytical 

and pharmacokinetic areas from pharmaceutical 

companies and CROs involved in the development 

of methods, interpretation and application of the 

bioanalytical assays to support PK. 

Moderator 



Impact of Unstable Metabolites During Drug 

Quantification and Specific Evaluation of Acyl 

Glucuronide Metabolites in Bioanalysis 



Evaluation of Unstable Metabolites in 

Bioanalysis 

Ajai Chaudhary, Ph.D. 

Eli Lilly and Company 

Importance of Unique and/or Major Human 

Metabolites Quantification During Drug 

Development 

Brian P. Booth, Ph.D., invited 


EBF’s Perspective on Metabolite 

Quantifications 

Philip Timmerman, M.S. 

Johnson & Johnson 

OPEN FORUM 

1:30 pm – 5:00 pm 

Analytical Challenges in Detecting 

and Preventing Counterfeits in Global 

Environment 

AAPS Analysis and Pharmaceutical Quality 

Section (APQ) Open Forum 


Counterfeits have penetrated our global 

marketplace, compromising the quality of 

pharmaceutical products and endangering public 

health. Regardless of efforts in drug regulations, 

all countries are affected by this epidemic concern; 

and developing countries are in greater risks. With 

the ease of purchasing medicine on the internet, it 

is estimated that as least 50% of the global markets 

are rapidly growing. Recent news shows that the 

threat not only affects finished products, but also 

Active Pharmaceutical Ingredients (API), excipients, 

and packaging. Counterfeits can range from using 

sub-standard, sub-potent materials to incorrect, 

ineffective ingredients. Increased initiatives from 

the regulators and pharmaceutical manufacturers 

have been invested to find rapid ways to identify 

counterfeits or brand the supply chain. This 

Open Forum will focus on current analytical 

technologies and research to detect counterfeits, 

and new developments to investigate copy cats and 

strengthen product security. 

Moderators 


PHARMALYTIK 

Moheb Nasr, Ph.D. 


Near-infrared Spectroscopy (NIR) and Direct 

Analysis in Real Time (DART) to Quickly Screen 

for Counterfeit Medicines 

Tony Moffat, Ph.D. 

Pharmaceutical Press 

Rapid Screening Methods: Opportunities 

and Challenges 

Lucinda Buhse, Ph.D. 


Spectroscopic Tools and Approaches for 

Investigating Suspect Counterfeit Medicines 

Bernard A. Olsen, Ph.D. 

Aptuit Consulting 

Forensic Analysis of Suspected Counterfeit 

Products 

Anthony Zook, Ph.D. 

Merck & Co., Inc.

35 


AAPS Biotechnology (BIOTEC) Programming 

at a glance 


7:00 am – 8:15 am 


Rational Design of a Freezedried 

Formulation for a Biologic 

7:00 am – 8:15 am 


Protein-based 

Vaccines 

8:30 am – 4:00 pm 


RNA-targeting 

Therapeutics: Issues 

and Advances 

An additional fee is 

required to attend this 

short course 

8:30 am – 11:00 am 

Symposium 

Impact of the Variability of Ligand 

Binding PK Assays on the Outcome 

of Comparability Assessments for 

Follow-on Biologics 



Sponsored by 

9:00 am – 11:00 am 

Roundtable 

Latest Developments of Drug 

Targeting to Cancer Stem Cells 

9:00 am – 11:00 am 

Roundtables 

Impact of Pharmacogenomics 

on Drug Development: 

An Industrial Perspective 

ISR Failure: Avoiding and 

Resolving Through Investigation 

2:00 pm – 4:00 pm 

Roundtable 

Strategies for the Determination of a 

Robust Cut Point in Immunogenicity 

Assays: Impact of Immunogenicity 

White Paper 

2:00 pm – 4:30 pm 

Monday Afternoon Symposia Funded 


2:00 pm – 4:30 pm 

Symposium 

New Frontiers in Biologics: 

Advances & Challenges in 

PEGylation and Alternatives 

to PEGylation 

1:30 pm – 5:00 pm 

Open Forum 

Biosimilars- 

Development 

Considerations and 


(BIOTEC & RS) 



open forum 

Symposium 

Leaner Development Strategies to 

Enrich Drug Pipeline 

5:30 pm – 7:00 pm 

Biotechnology (BIOTEC) Section Joint 

Membership Meeting and Reception

36 




8:30 am – 4:00 pm 

RNA-targeting Therapeutics: Issues and 

Advances 



The use of oligonucleotides as therapeutic 

agents has elicited a great deal of interest. Basic 

understanding of the pharmacokinetics and 

delivery of antisense oligonucleotides and siRNA 

as tools for silencing genes or regulatory RNAs 

is foundational to their appropriate design and 

application. The short course will consist of the 

following lecture topics: basic knowledge of siRNA 

and antisense and in vivo uptake mechanisms/ 

pathways of oligonucleotide uptake into cells, 

overview of RNA-targeting therapeutics-basic 

primer, siRNA promise and challenges of RISC based 

targeting of mRNA, specific in vivo targeting of siRNA 

advances and challenges, antisense advances and 

challenges of single-strand, pharmacokinetics and 

ADME characterization of siRNA in animal models, 

pharmacokinetics and ADME characterizations of 

siRNA in humans, MicroRNA, a new target for RNAtargeting 

therapeutics, and regulatory pathways for 

oligonucleotide therapeutics. 

Moderators 

Pei Fan (Jane) Bai, Ph.D. 


Richard Geary, Ph.D. 

ISIS Pharmaceuticals, Inc. 

Antisenseantisense: Advances and Challenges 

of Single-strand Antisense 



Uptake Mechanisms of Oligoneucleotides 

Frank Bennett, Ph.D. 


Therapeutic Development of MicroRNA: 

Promises and Challenges 

Peter Linsley, Ph.D. 


Progress in the Delivery of siRNA 

Mark Tracy, Ph.D. 

Alnylam Pharmaceuticals 

Oligonucleotide Therapeutics: Regulatory 

Pathway 

Pei Fan (Jane) Bai, Ph.D., invited 


Clinical Pharmacokinetic and Safety Studies 

of RNAi in Humans 

John DeVincenzo, Ph.D. 

University of Tennessee Health Science Center 



2:00 pm – 4:00 pm 

Strategies for the Determination of 

a Robust Cut Point in Immunogenicity 

Assays: Impact of Immunogenicity 

White Paper 

Roundtable 

The accurate prediction of pharmacokinetic 

parameters in humans and anticipation of human 

dose (AHD) for early human studies based on 

preclinical and/or physicochemical data remains a 

major challenge, in spite of coverage of this topic 

in the literature and at AAPS meetings (e.g. P. Lowe 

et. al., Xenobiotica, 2007). While many methods 

are known, such as allometry, or physiology based 

pharmacokinetic modeling (PBPK), and IVIVC. Many 

questions remain for pharmaceutical scientists on 

how to predict human dosing regimen for “difficult” 

compounds with confidence, such as those with 

species dependent or formulation dependent PK, 

i.e. BCS class II and IV compounds with solubility/ 

dissolution limited exposure. Some companies 

have developed their own strategies, and others 

have published their methods, but often specifics 

are not covered in detail. In this session recent 

case examples for human PK and dose projections 

of compounds with new data will be covered. The 

session will focus on current compounds, and 

will not be a review of text book examples. The 

session will cover latest AHD applications using 

practical and tested methods, including human PK 

parameter projections including for clearance, (CL) 

distribution (Vd) and bioavailability (F). How to use 

multiple approaches to verify human PK parameters, 

and how to establish and judge confidence in 

predictions methods with tools such as metabolic 

IVIVC and reverse pharmacology approaches — 

thus minimizing “Guesswork”. How to integrate 

Human PK projections with PK/PD modeling results 

for predicting human plasma concentration-time 

profiles and a suitable dosing regimen using a PBPK 

modeling approach. How to integrate formulation 

parameters into human PK profile predictions for 

BCS class II and IV drugs using GastroPlus. How to 

assess human PK profiles with new modified release 

formulations, with dissolution data and establish 

IVIVC for all BCS classes. How to establish and use 

IVIVC for new formulations of marketed drugs or 

drugs in clinical trials. This event will benefit all 

pharmaceutical scientists who are involved with 

first-in-human (FIH) dose projections, or are in early 

to late development, where human PK and dose 

projections are sought. This event will cover latest 

trouble-shooting, modeling, and IVIVC strategies 

that have been successfully used. 

Moderator 

Masood U. Khan, Ph.D. 

Covance Laboratories, Inc. 

Cut-point Determination: Impact of 

Immunogenicity White Paper and Current 

Industry Practices 

Gopi Shankar, Ph.D. 

Centocor R & D 

A Statistical Primer to Deal with the Cut-point 

Issues 

Viswanath Devanarayan, Ph.D. 

Abbott Laboratories 






2:00 pm – 4:30 pm 

Leaner Development Strategies to Enrich 

Drug Pipeline 

Symposium 

The pharmaceutical industry is facing rising 

challenges of enormous drug development costs. 

It is highly desirable to reduce development cost 

and time for early stage drug candidates and delay 

major investments to later stage. However, it is 

also critical to ensure quality and safety of early 

stage drug products. To achieve cost-effectiveness, 

a good balance is to employ smart approaches 

such as high-throughput analytical assays, faster 

formulation screens, and platform experimental 

protocols. Obviously, technological advancements 

play key role to accomplish such audacious goals. 

This session will focus on high-throughput analytical 

assays, automated techniques, and minimizing 

API consumption. Development of key stabilityindicating 

methods, smarter formulation screens as 

opposed to successive ones, platform process for 

drug product manufacturing, and predictive stability. 

Moderators 

Tapan K. Das, Ph.D. 

Pfizer, Inc. 

Satish Singh, Ph.D. 

Pfizer, Inc.

37 



Platform Process for Drug Product 

Development and Manufacturing — Cycle Time 

and Resources 

Nicholas Warne, Ph.D. 

Wyeth 

Predictive Stability to Accelerate 

Biotherapeutics Development 

Tapan K. Das, Ph.D. 

Pfizer, Inc. 

Novel Methods for Accelerating Formulation 

Development of Biotherapeutics 

Judy Chou, Ph.D. 

Genentech, Inc. 

High Throughput Formulation of 

Biopharmaceuticals: Case Studies 

Tudor Arvinte, Ph.D. 

School of Pharmaceutical Sciences, University 

of Geneva & University of Lausanne 

JOINT MEMBERSHIP MEETING 

AND RECEPTION 

5:30 pm – 7:00 pm 

Biotechnology (BIOTEC) Section Joint 

Membership Meeting and Reception 



8:30 am – 11:00 am 

Impact of the Variability of Ligand 

Binding PK Assays on the Outcome 

of Comparability Assessments for 

Follow-on Biologics 

Symposium 

Manufacturing changes are frequently introduced 

during the lifecycles of biologic products to continue 

to improve their quality and/or processes. However, 

due to the heterogeneity and complexity of biologic 

products and the manufacturing processes, batch 

to batch differences are expected. Demonstration 

of product comparability is necessary to show that 

these modifications have no adverse impact on the 

quality, safety and efficacy of the biologic product 

before implementation of the changes. Ideally, if 

product comparability can be established through 

in vitro analytical testing, nonclinical, and clinical 

studies are not warranted. However, when the 

relationship between specific quality attributes 

and safety and efficacy has not been established, 

and differences between quality attributes of 

the pre-and post-change product are observed, 

nonclinical and/or clinical studies may be warranted 

to provide the assurance of comparability of preand 

post-modification products. Ligand binding or 

functional assays are often used for quantification 

of biotherapeutics in biologic matrices to support PK 

characterization. Due to the heterogeneous nature of 

biologic products and/or key reagents (antibodies), 

the performance of binding or functional assays 

can have a direct impact on the study design and 

the outcome of comparability assessment. This 

symposium will provide the statistical bases on how 

assay performance impacts study design as well 

as case studies provided by both regulators and 

researchers from pharmaceutical/biotech companies. 

Moderators 

Marie T. Rock, Ph.D. 

Midwest BioResearch LLC 

Huifen F. Wang, Ph.D. 

Pfizer, Inc. 

Regulatory Considerations Related to Followon 

Protein Products 



Connecting the Dots: Integrating Assay 

Performances in the Clinical Development 

Plans 

Bruno Boulanger, Ph.D. 

UCB 

Ligand Binding Assays Supporting 

Comparability Studies of Macromolecules — 

Can We Confirm what We are Measuring in the 

Absence of Orthogonal Methods? 

Binodh DeSilva, Ph.D. 

Amgen Inc. 

Biosimilars, Follow on Biologics, and 

Bioequivalence: A Study of Recombinant 

Versus Plasma Derived Factor Replacement 

Therapies 

Ann Gooding 

Wyeth 


8:30 am – 11:00 am 



Sponsored by 


9:00 am – 11:00 am 

Latest Developments of Drug Targeting 

to Cancer Stem Cells 

Roundtable 

It has been increasingly evident that cancer is 

probably initiated from and maintained by a small 

sub-population of undifferentiated, tumorigenic 

cells called cancer stem cells (CSCs). Production 

of the main mass of the tumor may be attributed 

to this minor population of CSCs through a 

particular process of continuous self-renewal 

and differentiation. Thus, CSCs have come into 

sight as a potential target of cancer therapy. Up to 

date, many types of cancer stem cells have been 

identified in various cancers including breast, 

colorectal, pancreatic, head and neck cancers. 

Since cancer stem cells are resistant to current 

available chemotherapeutic regimen, it is important 

to explore new molecular target to eliminate these 

drug resistant cancer stem cells. In this roundtable, 

we will provide a forum to debate cancer stem cell 

concept, targeted drug delivery and drug targeting 

strategy to eliminate cancer stem cells. 

Moderators 

Duxin Sun, Ph.D. 

University of Michigan 

Tycho Heimbach, Ph.D., M.S. 

Novartis 

Cancer Stem Cells: The Emerging Challenge 

of Drug Targeting 

Maguer-Satta Véronique, Ph.D. 

Léon Bérard Multidisciplinary Center 

Targeting Breast Cancer Stem Cells 

Suling Liu, Ph.D. 


Targeted Therapy and Chemoprevention for 

Cancer Stem Cells 


University of Michigan

38 




2:00 pm – 4:30 pm 

New Frontiers in Biologics: Advances 

& Challenges in PEGylation and 

Alternatives to PEGylation 

Symposium 

Biotechnology derived drugs have become a 

significant proportion of marketed therapeutic 

drugs. Traditional monoclonal antibodies as the 

classical members of therapeutic biologics bind 

to targets with high specificity. However, they 

are complex, expensive to manufacture, and 

have immunogenicity issues. A need for more 

efficient and cost-effective alternatives has led 

to the development of a new class of protein 

scaffolds ca. antibody fragments that retain the 

binding properties and are easier to process. 

But these alternatives suffer from the loss of 

desirable PK properties due to their small size. 

PEGylation has been classically used to improve 

the plasma half-life, increase bioavailability, 

decrease immunogenicity, and enhance solubility 

and stability. Nonetheless, there are inherent 

challenges associated with the use of PEG. Several 

newer alternatives to PEGylation are emerging 

with great potential to solve these issues. This 

symposium is designed to review the latest 

advances in pharmaceutical development of 

biologics. Particularly, this symposium will cover the 

advances and challenges associated with PEGylation 

of biologics. Some alternative technologies to 

PEGylation to achieve the desirable properties will 

be discussed as well. This symposium will benefit 

anyone interested in learning the advances in 

developing PEGylated protein drugs. 

Moderators 

Rajesh B. Gandhi, Ph.D. 


Pankaj V. Paranjpe, Ph.D. 


PEGylated Proteins: An Updated Review 

Francesco M. Veronese, Ph.D. 

Padova University 

Challenges in the Downstream Processing 

of PEGylated Products 

Peter Ihnat, Ph.D. 


Analytical Resolution of PEGylated Proteins 

Anna-Maria A. Hays Putnam, Ph.D. 

Ambrx, Inc. 

Genetic Engineering Approaches to Enhance 

Half-life of Proteins 

Volker Schellenberger, Ph.D. 

Amunix, Inc. 



7:00 am – 8:15 am 

Rational Design of a Freeze-dried 

Formulation for a Biologic 


Approaches to freeze-dried formulations are often 

empirical or semi-empirical and frequently overlook 

the intimate relationship between the formulation, 

the freeze-drying process, and the package. This 

session will outline the basic precepts that need to be 

considered when developing a freeze-dried protein 

candidate. Emphasis is also placed on reducing 

commonly encountered freeze-drying problems 

and cycle time through judicious use of excipients, 

packaging, and processing considerations. 

Moderator 

Lavinia M. Lewis, Ph.D. 

Pfizer, Inc. 

Rational Design of Freeze-dried Formulation 

for a Biologic 

Dirk Teagarden, Ph.D. 

Pfizer, Inc. 

WEDNESDAY morning roundtables 

9:00 am – 11:00 am 

Impact of Pharmacogenomics on Drug 

Development: An Industrial Perspective 

Roundtable 

Pharmacogenomics has emerged as an important 

tool for discovering new therapeutic agents as well 

as re-evaluating existing drugs for improving their 

efficacy and/or applications. The pharmaceutical 

industry continues to contribute significantly to 

development of high-throughput technologies 

applied to pharmacogenomic research. Efficient 

translation of the scientific data into clinical 

applications requires careful analyses, prioritization 

and streamlining of the information at various levels 

even as the regulatory approvals are sought. While 

pharmaceutical organizations follow their own set 

of internal standard operating protocols and process 

guidelines, it would be useful to provide a common 

platform to researchers from the industry to share 

their experiences and perspectives on what strategies 

worked, how challenges were overcome, what do they 

foresee as emerging issues in the near future, and 

what is the impact of the pharmacogenomic approach 

on the overall economics of the drug development/ 

approval process. 

Moderators 

Lawrence Fleckenstein, Pharm.D. 

University of Iowa 

Pramod Mahajan, Ph.D. 

Drake University 



Allen Roses, M.D. 

Cabernet Pharmaceuticals Inc. 


Development: A Medco Perspective 

Felix Frueh, Ph.D. 

Medco Health Solutions, Inc. 


Development: A Lilly Perspective 

Sandra Close Kirkwood, Ph.D. 

Eli Lilly and Co. 

9:00 am – 11:00 am 

ISR Failure: Avoiding and Resolving 

through Investigation 

Roundtable 

In 2006 the U.S. Food and Drug Administration (FDA) 

presented guidance instructing the pharmaceutical 

industry to perform sample re-analysis for regulated 

studies to ensure method reproducibility. In February 

of 2007, AAPS hosted a workshop specifically 

designed for the open discussion of Incurred Sample 

Reanalysis (ISR) and to implement a standard, 

industry wide practice. As part of this guidance, 

failure of ISR could lead to a full stop on study 

sample analysis until an investigation is satisfactorily 

conducted as to the cause and resolution of 

the discrepancy. These investigations may have 

significant consequences including delaying a 

therapeutics’ release to market. The purpose of this 

roundtable is to discuss strategies to avoid a failure 

of ISR as well as different approaches to conducting 

a successful investigation when necessary. 

Moderator 

Suzanne Brignoli 


Investigative Procedures When ISR Fail 

Dick Tacey, B.S. 

PPD, Inc. 

ISR Failure Investigation: Strategies to Avoid 

Failure and Increase Success 

Joseph F. Bower, Ph.D., M.B.A. 

Covance Laboratories

39 





7:00 am – 8:15 am 

Protein-based Vaccines 


An introduction to protein-based vaccines platform 

and the challenges associated with development. 

This session will introduce the platforms (antigenic 

proteins, VLPs, conjugates, etc.), their use, 

mechanisms of action, characteristics, and a 

survey of current state of preclinical and 

clinical development. 

Moderator 

Satish Singh, Ph.D. 

Pfizer, Inc. 

Protein-based Vaccines Platforms 

Indresh Srivastava, Ph.D. 

Novartis 

OPEN FORUM 

1:30 pm – 5:00 pm 

Biosimilars-Development 

Considerations and Future Directions 




As global sales for biologic products is on the 

rise, this market represents an attractive target 

for generic companies. The approaches related to 

biosimilar products in the various regions across 

the world are divergent, with a clear need for 

defining regulatory expectations for these products 

at the global level. In the USA, legal pathways 

exist for review and approval of some smaller, 

well characterized proteins such as human growth 

hormone and insulin, which are regulated under 

the Federal Food, Drug, & Cosmetic Act; however, 

for other biotherapeutics such as interleukins 

and interferons, which are regulated under the 

Public Health Service Act (PHSA), there is currently 

no abbreviated authorization pathway. However, 

there are signs of some momentum in this regard, 

with the recent support expressed by the Obama 

administration, and proposed legislation H.R. 

1427 “Promoting Innovation and Access to Life- 

Saving Medicines Act.” recently introduced by a 

bipartisan group of Congressional representatives 

that would open the door to approval of biosimilar 

products. Contrary to the USA a legal framework for 

biosimilars exists in the EU since the review of EU 

legislation. The first biosimilar product in the EU 

was Somatotropin / Sandoz (Omnitrope ® ). Countries 

such as China, India and South Korea also have 

reported a high number of licensed biosimilars 

within their existing regulatory framework. Examples 

of such products marketed in these countries 

include interleukins, interferons, erythropoietins, 

growth factors, hormones, enzymes and monoclonal 

antibodies. This is expected to be a topic that will 

be a center of debate between legislators, the 

biotechnology and generic industry. The open forum 

will feature experts who will address the regulatory 

framework for approval of biosimilars in the key 

regions, and address challenges and considerations 

for development of these products. 

Moderator 

Deepa Deshpande, Ph.D. 

Universal Regulatory, Inc. 

E.U. Considerations 

Marie-Christine Bielsky, M.D. 

Medicines and Healthcare Products Regulatory 

Agency (MHRA) 

Legal and IP Issues for Biosimilars 

Anie Roche, Ph.D. 

Wilson, Sonsini, Goodrich and Rosati 


Islah Ahmed, M.D. 

Hospira, Inc.

SM 

40 


Clinical Pharmacology and Translational Research (CPTR) Programming Track 

at a glance 

Monday Tuesday Wednesday Thursday 

8:00 am – 10:00 am 

Monday Morning Roundtables 


Roundtable 

Myths and Misconceptions in the Value 

of Early Phase 1 Studies to Predict Risk 

of QT Prolongation 

7:00 am – 8:15 am 


The Story of the Three Bears: Too Big, Too Small, Just 

Right! Size Issues in Drug Development 

8:30 am – 11:00 am 

Symposium 


Pharmacokinetics, Pharmacodynamics and Drug 

Metabolism and Clinical Pharmacology and 

Translational Research (PPDM & CPTR) 

Sponsored by 


Research Achievement Award winner will 

be given. 

7:00 am – 8:15 am 


Pharmacogenetics: Methods 

and Clinical Applications 

9:00 am – 11:00 am 

Roundtable 

Translational Challenges in 

PK/PD/TD of Biotechnologyderived 

Products 

8:30 am – 11:00 am 

Symposium 

Using Modeling and Simulation 

to Safely Adjust Dose Regimens 

for Obese Patients 

9:00 am – 11:00 am 

Roundtable 

Evaluating Fit-for-Purpose 

Models: Consensus or 

Controversy 



Sponsored by 

2:00 pm – 4:30 pm 



2:00 pm – 4:00 pm 

Tuesday Afternoon Roundtables Funded 


2:00 pm – 4:30 pm 



a grant from 

SymposiA 

The Modeling and Simulation Frontier: 

Multi-level, Multi-scale, Multi-attribute, 

Adaptable, and Extensible Discrete 

Event Models 

AAPS/ACCP Joint Symposium: Strategic 

Biomarkers for Treating Diseases in 

Younger Children Safely and Effectively 

Roundtable 

Inclusion of Women in Clinical Trials and 

Drug Development — How Far Have We Gone 

2:00 pm – 4:30 pm 

Symposium 

Leveraging Prior Quantitative Knowledge in Guiding 

Pediatric Drug Development 

Symposium 

The Graying Globe — Drug 

Development in the Elderly 

5:30 pm – 7:00 pm 


Research (CPTR) Section Joint 


7:00 pm – 9:30 pm 

Open Forum 

Adequacy of PK/PD Model Validation and Simulation 


An additional fee is required to attend this open forum

41 








8:00 am – 10:00 am 

Myths and Misconceptions in the Value 

of Early Phase 1 Studies to Predict Risk 

of QT Prolongation 

Roundtable 

This roundtable is intended to specifically address 

the following controversial issues facing the 

community in the area of evaluation of QT risk. 

Resolution to the questions below has a direct 

bearing on the cost (may be reduced by up to 50%) 

and the efficiency of QT studies. The overall goal of 

this roundtable is to begin to develop consensus 

around these issues. To aid an interactive session, 

there will be no formal presentation but only 

responses to the following questions from the 

industry and regulatory points of view, followed by 

panel discussion. Do first-in-human and multipledose-tolerance 

studies, as they are typically 

designed, have the ability to always quantify 

clinically relevant QT prolongation using exposureresponse 

analyses? If early Phase 1 studies such 

as above include a positive control, can the data 

be considered adequate to waive a thorough QT 

study? There have been conflicting messages from 

regulatory agencies on the inclusion of a therapeutic 

dose (in addition to a supra-therapeutic dose) in the 

TQT study because supra therapeutic doses often 

show QT prolongation. Does the wealth of experience 

suggest that this is the case? If so, what are the 

limitations in using exposure-response modeling 

to derive labeling statements for the therapeutic 

dose? What is the value of triplet versus singlet ECG 

when exposure-response analyses are used to draw 

inferences regarding QT prolongation in addition 

to the intersection-union test? What is our current 

understanding of the link between the magnitude of 

QTc increase and torsade de pointes? Should a >10 

msec increase in QTc mean an automatic termination 

of the new molecular entity? Does Moxifloxacin have 

to be administered in a blinded manner in the 

TQT study? 

Moderator 

Sriram Krishnaswami, Ph.D. 


An Industry View Based on a Survey 

Jack Cook, Ph.D. 

Pfizer, Inc. 

A Regulator’s View 

Yaning Wang, Ph.D., invited 




2:00 pm – 4:30 pm 




Event Models 

Symposium 

This session will allow attendees to better 

understand how multi-level, multi-scale, multiattribute, 

adaptable, and extensible, discrete event 

models can be used to advance pharmaceutical 

research. Understand the uses and capabilities 

of different classes of models and methods. 

Understand how new classes of models can help 

bridge the gap between current PK/PD models 

and the wet-lab, animal, and clinical trial models 

on which pharmaceutical research depends. 

Pharmaceutical R&D can benefit greatly from 

adopting important advances in discrete event 

M&S methods, which have occurred within the 

past decade. The time is ripe to begin exploring the 

insights that can be achieved using these methods; 

they provide capabilities beyond those of traditional 

analytical, inductive, equation-based PK and PD 

modeling and simulation (M&S) methods. These 

new M&S methods make it easier to instantiate 

increasingly realistic, multi-level, multi-scale, multiattribute, 

adaptable, and extensible models relevant 

to pharmaceutical R&D. The models are suitable for 

use in research and in testing hypotheses about the 

pharmacological and toxicological mechanisms that 

are relevant to pharmaceutical R&D. This symposium 

will provide the audience an overview of these 

new methods. Presentations will draw on specific, 

pharmaceutically relevant models. Because the 

new methods are intended to be synergistic 

with traditional PK/PD M&S methods, the new 

and traditional methods will be compared 

and contrasted. 

Moderator 

Steven Chang, M.S. 

Immunetrics Inc. 

Dynamic Knowledge Representation Using an 

Agent-based Modeling Paradigm 

Gary An, M.D. 

Northwestern University 

Measuring, Modeling, and Modulating 

Inflammation in Mice and Men 

Yoram Vodovotz, Ph.D. 

University of Pittsburgh 

Bridging the Gap Between Mathematical 

Models and Wet-lab Models 

C. Anthony Hunt, Ph.D. 

University of California San Francisco 

Using Agent-directed Simulation to Accelerate 

Unraveling the Complexities of Adaptive 

Biological Systems 

Levent Yilmaz, Ph.D. 

Auburn University 

2:00 pm – 4:30 pm 




Symposium 

Recent implementation of removing children 

(ages 0-4) from the labels of various OTC coldrelief 

medicines is due to a finding that there 

have been more adverse events in this age group. 

Pediatric patients are a vulnerable population 

that needs special attention to the efficacy and 

safety of medicines administered. What are the 

biomarkers for extrapolating adult doses for 

younger children (age 0-4)? Is the body-weight 

based approach reasonable? What biomarkers 

(ontogenic development of phase I and phase 

III metabolizing enzymes) should we explore? Is 

systemic exposure of drug a reliable biomarker for 

selecting pediatric dose and predicting adverse 

events in younger children? What is known about 

the difference between adults and younger children 

of this age group in terms of the pharmacological 

and pharmacodynamic responses? This symposium 

will have a panel of clinical experts and regulatory 

authority to discuss dose selection biomarkers 

for younger children based on our understanding 

of drug absorption, ontogenic development of 

metabolizing enzymes, and pharmacological 

receptors that affect the efficacy and safety of 

pediatric medical use. The FDA’s pediatric guidance 

update and drug-disease interactions in pediatrics 

will be discussed as well. Our symposium has been 

aligned with the symposium, entitled “Leveraging 

Prior Quantitative Knowledge in Guiding Pediatric 

Drug Development,” which is scheduled for 

2:00 pm – 4:30 pm, November 10, 2009. The 

goal of our alignment is to give the attendees a 

complete overview of pediatric drug development.

SM 

42 



Moderators 

Bernd Meibohm, Ph.D. 




Ontogeny of Drug Metabolizing Enzymes and 

Transporters: Potential Biomarkers for Drug 

Disposition in Newborns and Infants 



Predicting Pediatric Doses for Therapeutic 

Success via Simulation and Modeling 

Jeffrey Barrett, Ph.D. 

University of Pennsylvania 

Experience with Infants and Young Children in 

Drug Studies Performed Under BPCA and PREA 

Gilbert Burckart, Pharm.D., invited 


Clinical Biomarkers: Nice to Have or a Clinical 

Imperative? 

Paul J. Desjardins, D.M.D., Ph.D. 

Wyeth Consumer Healthcare 


RECEPTION 

5:30 pm – 7:00 pm 


Research (CPTR) Section Joint 




7:00 am – 8:15 am 

The Story of the Three Bears: Too Big, 

Too Small, Just Right! Size Issues in Drug 

Development 


Determining the most appropriate dose for a new 

pharmaceutical one must take into account two 

different perspectives — the patient and the drug. 

Patients come in a variety of sizes and drugs vary 

in their therapeutic range, and the necessity to 

customize the dose for individual patients. Healthy 

volunteers participating in phase 1 studies are 

usually within 15% of ideal body weight. Subjects 

participating in phase 2 and 3 trials are also 

usually within a reasonably narrow range of weight, 

compared to the people who will eventually be 

treated including premature neonates (0.5kg) to the 

very obese (200 kg+). How can adequate information 

be collected during drug development on the best 

way to dose patients who are either much smaller 

than average, or much larger than average to avoid 

increased incidence of adverse events or inadequate 

treatment? Some medications are prescribed in 

‘flat’ doses expressed in mg for example, while 

others are dosed on a mg/m2 or mg/kg basis. 

When is it appropriate to do either? Biologics have 

conventionally been doses by weight, as have drugs 

used to treat cancer, yet in some cases, normalizing 

for size increases variability and potential for 

dose administration error. What factors should be 

considered in developing dosing recommendations? 

At the end of the session participants will be able 

to describe the different ways that size is described 

(ideal body weight, actual body weight, lean body 

weight, fat free mass, dry weight, body surface area, 

body mass index, growth charts), list the data/ 

conventions upon which dosing per kg and dosing 

per m2 is based, become familiar with study design 

and analysis methods to determine if dosing needs 

to be adjusted for size, and describe the potential 

impact of over and underdosing on patient outcome. 

Moderator 

Joan M. Korth-Bradley, Pharm.D., Ph.D., R.Ph. 

Wyeth Research 

How Big? How Small? Methods and 

Conventions of Describing Size 



Size is Not Everything — Life Beyond Allometry 

Nick Holford, M.D., M.S. 

University of Auckland 

AAPS Graduate Student Symposia 

and Research Achievement Awards 

8:30 am – 11:00 am 


Pharmacokinetics, Pharmacodynamics 

and Drug Metabolism and Clinical 



Sponsored by 

During this Symposium, a presentation from the Research 

Achievement Award winner will be given. 



Sponsored by 



2:00 pm – 4:00 pm 

Inclusion of Women in Clinical Trials 

and Drug Development — How Far Have 

We Gone 

Roundtable 

Women were initially excluded from clinical research 

due to liability concerns and historical precedence. 

The result was the “male norm” of research. 

Research subjects were predominately men since 

most researchers thought men and women were 

biologically the same except for their reproductive 

organs. By the 1980’s, it was clear that the exclusion 

of women from clinical studies compromised the 

health care they received. This created a scientific 

knowledge gap that has resulted in health care 

disparity for women over the past many years. 

Sex affects health and health care; the following 

examples illustrate why it is imperative that 

diseases and treatments be studied for the different 

effects they can have on women and men. A 2001 

report from the General Accounting Office (GAO) 

on the U.S. Food and Drug Administration (FDA) 

revealed that eight of 10 drugs recently withdrawn 

from the market caused more adverse events in 

women than men. Heart disease kills 500,000 

American women each year, over 50,000 more 

women than men, and strikes women, on average, 

10 years later than men. Women are 2.7 times more 

likely to acquire an autoimmune disease, such as 

multiple sclerosis, lupus or rheumatoid arthritis. 

Women wake up from anesthesia an average four 

minutes before men do. 

Moderator 

Emmanuel O. Fadiran, R.Ph., M.S., Ph.D. 


Inclusion of Women in Clinical Trials & Drug 

Development — Regulatory Perspectives 

Ameeta Parekh, Ph.D. 



Development — Clinical Perspectives 

C. Noel Bairey Merz, M.D. 

Cedars-Sinai Medical Center, UCLA 


Development — Industry Perspectives 

Poornima Sood, M.D. 

Abbott Laboratories

43 




2:00 pm – 4:30 pm 

Leveraging Prior Quantitative Knowledge 

in Guiding Pediatric Drug Development 

Symposium 

The U.S. Food and Drug Administration and 

European Medicines Agency have recently renewed 

their call for innovative model-based approaches 

to pediatric drug development. It is evident in the 

requirements for sponsors to include a modeling 

and simulation plan, where applicable, in their 

pediatric investigational plans (PIP) and use of 

clinical trial simulations to support pediatric written 

request. The key issues facing us today are high 

pediatric trial failure rate due to lack of powerful and 

innovative clinical trial designs, failure to establish 

informative pediatric dosing recommendations due 

to lack of appreciation for differences in exposureresponse 

relationship between pediatric and adult 

population. Traditionally, studies have focused on PK 

differences only. Inappropriate or lack of use of prior 

quantitative knowledge to better design pediatric 

development programs. The objectives of this 

session are to demonstrate through case studies the 

value of designing pediatric developing programs 

using model-based approaches, and demonstrate 

through case studies the impact of prior quantitative 

knowledge on pediatric development/dosing 

decisions. This symposium has been aligned with 

the symposium, entitled “Strategic Biomarkers for 

Treating Diseases in Younger Children Safely and 

Effectively” scheduled for Monday, November 9, 

2009 at 2:00 pm. The goal of this alignment is to 

give the attendees a complete overview of pediatric 

drug development. 

Moderator 

Pravin Jadhav, Ph.D. 


Transforming Pediatric Drug Development by 

Informed Decision Making 

Pravin Jadhav, Ph.D., invited 


Role of Modeling and Simulation in 

Developing PIP and Regulatory Decision 

Making 

Anja Henningsson, Ph.D. 

Medical Products Agency (MPA Swedish Agency) 

Efficient Decision Making for Clinical Trials 

Using a Model Based Approach 

Steven Kern, Ph.D. 

University of Utah 

Bayesian Model-based Approaches to 

Pediatric Trial Design and Dosing Rule 

Determination: Case Studies 

Marc Gastonguay, Ph.D. 

Metrum Research Group LLC 

OPEN FORUM 

7:00 pm – 9:30 pm 

Adequacy of PK/PD Model Validation 

and Simulation 


AAPS Clinical Pharmacology and Translational 

Research (CPTR) Section Open Forum 


As PK/PD modeling (M) and clinical trial simulation 

(S) are becoming routine in drug development, 

success ultimately depends on the robustness 

of the chosen model. Yet Brendel, et. al. recently 

concluded that only 26% to 28% of PK and PD 

models were adequately evaluated following a 

review of 324 articles published from 2002 to 

2004 (Clin. Pharmacokinet. 2007; 46(3):221-34). 

While this article’s conclusion may be subject to 

dispute, it does raise a legitimate question on 

how much model validation should be practiced 

in the M&S community. For example, the following 

questions may be considered: what are the 

minimum validation requirements for internal 

data? Among the more advanced internal validation 

methodologies, e.g. bootstrapping, jackknifing, 

Monte Carlo simulation, and etc., which approach 

is preferred? What is the rationale of choosing that 

approach? When and how should external validation 

be considered? What are the limitations to external 

validation and how might these limitations be 

overcome? What lessons can we learn from other 

industries with regard to validation, e.g. the 

aerospace and defense industries? Taking the PK/ 

PD model validation question one step further, 

one might want to consider what type of quality 

requirements are needed before attempting clinical 

trial simulation (CTS)? What types of assumption 

are considered acceptable? While the successful 

examples of CTS have been well documented within 

the past few years, what lessons can we learn from 

them? If you would like to share your opinion with 

us, come join us at the 2009 CPTR Open Forum. 

We will survey the standards and practices to 

probe the questions stated above in greater depth. 

The results will be shared with the participants 

during the meeting. Similar to last year’s event, 

no speakers are planned as the goal is to have 

an open discussion among participants about 

their experiences and opinions on these topics. 

It promises to be a lively evening of food, drink, 

and exchange of scientific ideas. Our intent is 

to publish the proceedings in a refereed journal. 

Come join us! We look forward to having you in 

an enlightening open forum. 

Moderators 

Dale K. Yu, Ph.D., R.Ph. 

Allergan, Inc. 

Peter Lockwood, Ph.D. 

Pfizer, Inc. 



7:00 am – 8:15 am 

Pharmacogenetics: Methods and 

Clinical Applications 

Sunrise Sessions 

This session will introduce the building tools 

and technologies that are currently used in 

pharmacogenomics (PGx) testing in laboratory 

diagnostics, drug therapy, and drug and biomarkers 

discovery. The clinical application of molecular 

diagnostics and relevant SNPs and gene expression 

technology used in PGx will be discussed to 

illustrate that patient outcome can be optimized and 

adverse drug reactions can be minimized through 

a combination of genetic testing and serum drug 

therapeutic level monitoring. 

Moderator 



Building Tools of Pharmacogenetics 

Majid Moridani, Pharm.D., Ph.D. 

Texas Tech Health Sciences Center 

The Application of Pharmacogenetics in 

Clinical Medicine and Drug Discovery 


U.S. Food and Drug Administration

44 


Clinical Pharmacology and Translational Research (CPTR) Programming 


9:00 am – 11:00 am 

Translational Challenges in PK/PD/TD of 

Biotechnology-derived Products 

Roundtable 

The unique complexities associated with the PK 

and PK/PD of biotechnology-derived products 

including immunogenicity, species specificities, 

and target/immune-mediated clearance pose 

special challenges in translation of PK/PD/TD from 

preclinical to clinical domain. In preclinical safety 

assessment, a loss of exposure of humanized 

antibody due to neutralizing immune response 

may prevent appropriate end-organ toxicity or 

safety margin estimation and may not have human 

relevance, and translation of safety biomarkers from 

early to late stage of clinical development. 

Moderator 

Anis A. Khan, Ph.D. 

Merck & Co., Inc. 

PK/PD Translational Issues with Biologics 


Merck & Co., Inc. 

Translation of Safety Biomarkers from Early to 

Late Stage of Clinical Development 

Joy A. Cavagnaro, Ph.D., D.A.B.T., R.A.C 

AccessBio 



2:00 pm – 4:30 pm 

The Graying Globe — Drug Development 

in the Elderly 

Symposium 

The U.S. Food and Drug Administration Guidance 

for Industry for the study of drugs likely to be used 

in the elderly was first published in 1989 and was 

followed by the Guideline for Industry for Studies in 

Support of Special Populations: Geriatrics in 1994. 

The corresponding ICH guidance was published the 

same year. In the 15 years since that time, so many 

new tools useful in clinical pharmacology have been 

developed, and so much data on drug use in the 

elderly have been collected. With the Baby Boom 

generation entering their senior years, and with the 

large increase in the number of the individuals in 

their 80’s and 90’s, as well as the large increase 

in age-related morbidity associated with cancer 

and Alzheimer’s disease, it is time to review our 

understanding of the issues of drug development 

and the elderly. The topics to be discussed include 

current and projected demographic statistics 

including anticipated consumption of medical and 

pharmaceutical services, physiology of healthy aging 

as well as disease progression in the elderly, study 

design issues in phase 1, 2, and 3 associated with 

the elderly – including appropriate comparisons, 

and summarization of data to link what is learned 

in the young healthy volunteers to what is actually 

happening in the elderly receiving the drug; dosage 

form considerations for the elderly. At the end of the 

session, participants will understand the increasing 

number of elderly, especially those older than 75 

years of age, and the magnitude of the demand for 

clinical and pharmaceutical services in the next 25 

years; be able to describe the physiological changes 

associated with aging as well as those associated 

with common disease progression and the 

interaction; and be able to formulate a strategy for 

study design, analysis, and interpretation to develop 

the information needed to demonstrate exposure 

effect relationships in the elderly and other patients 

likely to receive medications. 

Moderators 

Vijay Tammara, Ph.D., M.Pharm. 




Physiological Changes Associated with Aging 

and Aging-related Disease 

James E. Tisdale, Pharm.D. 


Implications of Aging on Clinical 

Pharmacology: Regulatory Perspective 

Chandrahas G. Sahajwalla, Ph.D., invited 



Pharmacology: Pharmaceutical Industry 

Perspective 


Merck and Co., Inc.

45 


Clinical Pharmacology and Translational Research (CPTR) Programming 



8:30 am – 11:00 am 

Using Modeling and Simulation to 

Safely Adjust Dose Regimens for Obese 

Patients 

Symposium 

Obesity has reached epidemic proportions 

worldwide. Obesity presents major health, social, 

and economic implications. Obese patients are 

more susceptible to a variety of chronic diseases 

than individuals with normal body composition. 

For example, obese patients frequently have 

hypertension, arterial sclerosis, and other 

cardiovascular diseases. Diabetes is also common in 

obese patients. Despite increased pharmacotherapy 

among obese patients, there is little information 

about dose adjustments for this population. 

Particularly for drugs with a narrow therapeutic 

index. The main factors affecting tissue distribution 

are body composition, regional blood flow, and the 

affinity of the drug for plasma proteins and/or tissue 

components. All these factors are altered in obese 

patients. The obese have larger absolute lean body 

masses as well as fat masses than lean patients. 

However, the percentage of fat per kilogram of total 

body weight is markedly increased. Drug clearance 

can also be altered in obese patients. Morbid 

obesity is strongly associated with non-alcoholic 

fatty liver disease, and cytochrome P450 isoform 

expression is altered, but no clear overview of drug 

hepatic metabolism in obesity is currently available. 

Pharmacology studies have reported different 

results on renal function in obese patients as well, 

making it difficult to forecast the pharmacokinetic 

behavior of drugs in obese patients. There have 

been several published reviews of various strategies 

for dose adjustments in obese patients. These 

reports suggest that a number of widely used 

empiric strategies for dose adjustments in obese 

patients, including a priori dose reduction or 

dose capping, are inappropriate and should be 

discouraged. However there have been no suitable 

size descriptors developed for dose adjustments 

across a wide range of body compositions. The lack 

of information on mechanisms for dose adjustment 

in the obese may be partly attributed to insufficient 

knowledge about pharmacokinetic parameters as 

a function of body composition due to the exclusion 

of obese subjects from clinical trials. Contributing 

to the problem is the myriad of concomitant health 

issues associated with obesity. Modeling and 

simulation during drug development may provide 

insights about safe dose adjustments in drugs in 

the obese patient population. 

Moderator 

Diane R. Mould, Ph.D. 

Projections Research Inc 

Thoughts on a Mechanistic Approach to Build 

Predictive PK Models for the Overweight 

and Obese 

Bruce Green, Ph.D. 

Projections Research, Inc. 

Estimating Lean Body Weight in Children 

Stephen Duffull, Ph.D. 

University of Otago 

Anesthetics Drugs and Morbid Obesity 

Hendrikus J. Lemmens, M.D., Ph.D. 

Stanford University 

Considerations for Dose Adjustment in Obesity 

Rajnikanth Madabushi, Ph.D., invited 



9:00 am – 11:00 am 

Evaluating Fit-for-Purpose Models: 

Consensus or Controversy 

Roundtable 

Disease/PK/PD/Trial Models are now being 

increasingly used to aid decisions in industry, 

hospital, and regulatory settings. It is generally 

agreed that the adequacy of a model should be 

judged mainly based on its intended application. 

While modeling zealots continue to debate on 

what term best fits the process of evaluating model 

adequacy (model validation, model evaluation, etc.) 

the more critical issue is the lack of consensus on 

what constitutes an adequate model for a specific 

application. The objective of this roundtable is to 

debate on the appropriateness of models frequently 

used in 3 areas of drug development; models 

derived from in vitro, preclinical and literature 

(study-level) data on competitors to inform decisions 

in preclinical and clinical development, models 

used to select doses for Phase 3 testing, and models 

used for regulatory decisions, specifically to derive 

labeling statements. The overarching question 

is, what are the minimally acceptable statistical, 

biological, and predictive (S, B, P) properties of 

such models? To encourage an interactive session 

on specific items, panel presentations will focus on 

the following scenarios of model application. First, 

intended application using exposure-response 

models for efficacy and safety to design a dose 

response study to find optimal dose(s) for Phase 

3 testing. What are minimally acceptable S/B/P 

properties for such models? What visual and 

statistical tools would you use to judge model 

adequacy? Second, intended application 

benchmark the magnitude of efficacy of your 

compound relative to competitors based on 

literature data to make a go/no-go decision. 

What are minimally acceptable S/B/P properties 

for such a model that combines subject level data 

for your compound with study level data with 

competitors? What visual and statistical tools 

would you use to judge model adequacy? Finally, 

intended application labeling statement to include 

the estimated magnitude of mean change in PK/ 

efficacy/safety under conditions of an interacting 

agent or in a special population. What are minimally 

acceptable S/B/P properties for such models? What 

visual and statistical tools would you use to judge 

model adequacy? 

Moderator 



A Pharmacologist’s View 



A Statistician’s View 

Kenneth Kowalski, M.S. 

A2PG 




46 


AAPS Drug Design and Discovery (DDD) Programming 

at a glance 


7:00 am – 8:15 am 


The Blood Brain Barrier 

8:30 am – 4:00 pm 


Learning the Drug Discovery 

and Delivery Interface Process 

An additional fee is required to 

attend this short course 

8:30 am – 11:00 am 

Symposium 


Symposium in Drug Design 

and Discovery (DDD) 

Sponsored by 

9:00 am – 11:00 am 

Mini-symposium 

Repurposing Old Drugs for 

New Uses 

9:00 am – 11:00 am 

Roundtable 

What Can Computational 

Design Do for Drug Discovery 

and Development? Current 

State-of-the-Art 

2:00 pm – 4:00 pm 

Roundtable 

Navigating the New Rules 

Regarding Patent Law: 

Decodifying ‘Obviousness’, 

‘Limited Claims’, and How it 

Affects New Composition of 

Matter Patents 

2:00 pm – 4:30 pm 

SYMPOSIA 

State-of-the-Art Approaches 

to Drug Design: Case Studies 

of Successful 

Applications of Drug Design 

Techniques to Identify Clinical 

Candidates 

2:00 pm – 4:30 pm 



a grant from 

Symposium 

Toxicological Considerations 

in Early Drug Discovery: 

Avoiding Failures by Applying 

Rational Drug Design 

5:30 pm – 7:00 pm 

Drug Design and Discovery 

(DDD) Section Joint 

Membership Meeting and 

Reception

47 






8:30 am – 4:00 pm 

Learning the Drug Discovery and 

Delivery Interface Process 



The main goal of this Short Course is to provide 

scientists with an overview of the multidisciplinary 

concepts that underpin the drug discovery and 

delivery interface (D3I) for small molecules. This will 

be accomplished using traditional teaching modules 

followed by application of these concepts via group 

participation in a game format. This short course will 

be divided into two parts. In the morning, facilitators 

will provide an introduction to the basic concepts 

of hit identification, lead optimization, and clinical 

development. This will be accomplished using 

prepared course materials. This introduction will 

be followed by a detailed overview of the structureactivity 

relationships (SAR) that are necessary for a 

new molecular entity to have pharmacologic activity 

in a human disease state, and the structure-property 

relationships (SPR) that are necessary to enable 

delivery of the drug to patients. This session will be 

concluded by a review of the expected attributes 

of a successful clinical candidate. The afternoon 

session will reinforce these concepts through group 

participation in a D3I game. Participants will be 

assigned to groups consisting of representatives 

of the various disciplines responsible for drug 

discovery and drug delivery (e.g., medicinal chemist, 

biologist, ADME scientist, toxicologist, process 

chemist, formulator, etc.). Each team will be given 

identical product profiles, a timeline, and a budget; 

there will be 2 to 3 rounds in the game. In each 

round, the teams will be expected to work together 

to create a plan within timeline and budget for 

their molecule. Challenges in the game will come 

from unexpected obstacles which often appear 

when least expected in drug discovery. To this 

end, the teams will receive a Gotcha Card and then 

asked to adjust their plan in response to this new 

information. At the end of the round, the teams will 

present their proposal and explain how they arrived 

at their solution. They will be given a score based on 

their solutions and whether they were able to deliver 

the plan within the allotted timeline, and budget. 

The teams will also be asked to compare notes for 

each Product Profile since it is likely that each team 

will arrive at a different solution depending on the 

experience level of the participants on the team. It 

is also expected that the course facilitators will use 

this game format to help the participants learn more 

about the significant challenges and stark realities 

of contemporary drug discovery. 

Moderators 

Jeffrey Silverman, Ph.D. 

Consultant 

Debra Luffer-Atlas, Ph.D. 




2:00 pm – 4:00 pm 

Navigating the New Rules Regarding 

Patent Law: Decodifying ‘Obviousness’, 

‘Limited Claims’, and How it Affects New 

Composition of Matter Patents 

Roundtable 

There have been continuous changes implemented 

by the US PTO to streamline the patent filing and 

approval process, and reduce patent prosecution 

times. With it have come several changes to the 

content of patents and continuation filings, which 

significantly impact/limit patenting chemical, 

pharmaceutical and biotech inventions. For 

example, U.S. and international law denies 

patentability to subject matter which is “obvious” 

or which lacks an “inventive step”. However, 

such rulings differ from country to country. This 

roundtable will invite discussion from patent law 

experts regarding these recent developments, 

such as what counts as “obvious” in the context of 

chemical, pharmaceutical, and biotechnological 

inventions, limits on claims and continuation 

applications. 

Moderators 

Michael Bornstein, Ph.D. 

Bornstein Consulting, LLC 

Jeffrey A. Lindeman, Ph.D. 

O’Brien Jones PLLC 

New Regulations in Patent Law for the Pharma 

Industry 

Scott Bornstein, J.D. 

Greenberg Traurig, LLP 

Presentation Title to Be Determined 

Barry Schindler, J.D. 


A Look at Post-KSR Cases: Is the Perceived 

Change Really that Great? 

Irem (Remy) Yucel, Ph.D. 

U.S. Patent and Trademark Office 


RECEPTION 

5:30 pm – 7:00 pm 

Drug Design and Discovery (DDD) 

Section Joint Membership Meeting 

and Reception 



7:00 am – 8:15 am 



Pharmacokinetic assessment in early drug discovery 

is now a commonly accepted approach to increase 

the chances of identifying candidates with suitable 

properties for further development. For CNS 

therapeutics, there is the additional requirement 

of blood brain barrier (BBB) penetration and brain 

localization. Several tools, both old and new, are 

being applied to guide drug design and medicinal 

chemistry to increase brain penetration. This 

sunrise session will contain presentations about 

in silico prediction tools for BBB, discuss in vitro 

models of the BBB, and present a case study of BBB 

enhancements in drug discovery. 

Moderator 

Nurulain Zaveri, Ph.D. 

Molecular Medicine Research Institute 

Key Principles for Optimization of CNStargeted 

Therapeutics 

Stephen Hitchcock, Ph.D. 

Amgen Inc. 

Opioids, Pgp, and the Blood-Brain Barrier 

Andrew Coop, Ph.D. 

University of Maryland School of Pharmacy 


8:30 am – 11:00 am 


in Drug Design and Discovery (DDD) 

Sponsored by

48 




2:00 pm – 4:30 pm 

State-of-the-Art Approaches to Drug 

Design: Case Studies of Successful 

Applications of Drug Design Techniques 

to Identify Clinical Candidates 

Symposium 

In the quest for new chemical entities and new 

drugs to treat diseases, the medicinal chemist 

uses several approaches that start with either 

conventional screening, rational drug design of 

starting leads, or newer approaches like fragmentbased 

lead discovery. Optimization of hits or leads 

can be carried out using several knowledge-based 

approaches such as structure-based drug design, 

quantitative structure-activity relationship studies, 

NMR-assisted drug design, etc. The repertoire 

of drug design techniques is further enhanced 

by advances in supportive techniques such as 

x-ray crystallography of protein targets and GPCR 

homology modeling. Most success stories of hit 

to clinical candidates encompass the application 

of one or more of the above techniques. The 

symposium will provide an engaging set of speakers 

that will talk about the use of the above techniques 

for the discovery of clinical candidates. Some 

examples might be the discovery of PPARalpha/ 

gamma agonists for metabolic syndrome, discovery 

of Hsp90 inhibitors for oncology applications, design 

of histone deacetylase inhibitors, design of GPCR 

ligands using GPCR homology models. 

Moderator 

Nurulain T. Zaveri, Ph.D. 


From Virtual Screening to the Clinic: Discovery 

of a PPARalpha/Gamma Agonist Cevoglitazar 



Efficient Drug Lead Optimization Guided by 

Free-energy Calculations 

William L. Jorgensen, Ph.D. 

Yale University 


Brian S. J. Blagg, Ph.D. 

The University of Kansas 


Jack J. Lin, Ph.D. 

Plexxikon Inc. 



9:00 am – 11:00 am 

Repurposing Old Drugs for New Uses 


It takes too long and costs too much to bring new 

drugs to market. Despite a doubling in research 

spending by US pharma and NIH, the number of 

new drugs approved by the U.S. Food and Drug 

Administration (FDA) each year remains constant at 

20–30 compounds. The current paradigm of drug 

discovery is ill-equipped to combat rapidly emerging 

diseases, and diseases that have a small financial 

market. One solution is to identify new uses for 

existing drugs. As stated by the nobel laureate and 

pharmacologist James Black, “the most fruitful 

basis for the discovery of a new drug is to start with 

an old drug,” because existing drugs have known 

pharmacokinetics, safety profiles, and are often 

approved by regulatory agencies for human use. Any 

new use can be rapidly evaluated directly in phase II 

clinical trials, and bypass almost 40% of the overall 

cost of bringing a drug to market by eliminating 

much of the toxicological and pharmacokinetic 

assessments. Drug repurposing may be an effective 

strategy to pursue under several scenarios. The 

most common being ‘new indication based on 

observed side-effects or action on non-target 

tissues’. Another approach ‘old drug-new indication’ 

is also common (e.g. Celgene’s Thalidomide). 

Biotech companies with a ‘repurposing’ business 

model often use several strategies to identify new 

opportunities for existing drugs. In this roundtable, 

some of these strategies will be discussed, in 

addition to a discussion on the development and 

regulatory implications of repurposing. Another 

form of ‘repurposing’ old drugs and not-too-optimal 

pharmacokinetics or toxicology is to use approaches 

such as prodrug or transporter technology. Such 

strategies have recently been very successful, but 

do they need to go through the same regulatory and 

development path as a new chemical entity? This 

topic will also be discussed in this roundtable. 

Moderator 




Ritu Lal, Ph.D. 

XenoPort, Inc 



2:00 pm – 4:30 pm 

Toxicological Considerations in Early 

Drug Discovery: Avoiding Failures by 

Applying Rational Drug Design 

Symposium 

Longer development times, costly late-stage 

failures and recent withdrawal of several key 

drugs due to unforeseen side-effects have forced 

the pharmaceutical industry to take a hard look 

at introducing toxicology testing in the early 

discovery process. This symposium will focus on 

case studies and approaches for testing for drug 

toxicity and drug interactions, early in the drug 

design and optimization process. Some of the 

topics to be discussed will be chemical strategies 

to alter P-glycoprotein efflux of drug molecules, 

mouse models to predict chemical safety and 

metabolism, prediction of cytochrome P450-based 

drug-drug interactions from in vitro information, and 

computational assessment of toxicological liabilities 

of novel chemotypes. 

Moderator 

Okezie I. Aruoma, M.B.A., Ph.D., D.Sc. 

Touro College of Pharmacy 

Computational Toxicology in Drug 

Development 

Wolfgang Muster, Ph.D. 

Hoffmann-La Roche Inc. 

Predicting QT Prolongation in the Early Stage 

of Drug Discovery: A Strategy Using hERG 

Inhibition and an Anaesthetized Guinea 

Pig Model 

Xiaozhou Yao, M.D., Ph.D. 


Prioritizing Lead Matter in Discovery with 

Competitive and Time Dependent DDI Issues 

Michael A. Zientek 

Pfizer, Inc.

49 





9:00 am – 11:00 am 

What Can Computational Design Do 

for Drug Discovery and Development? 

Current State-of-the-Art 

Roundtable 

The talks in this roundtable session give a brief 

overview of drug discovery through state-of-the-art 

computational modeling/simulation and discuss 

the general trend of computational drug design and 

discovery/development through specific examples 

for illustration. The examples to be discussed 

include computational design and discovery of 

both small molecule drugs (e.g. inhibitors of 

enzymes) and engineered protein drugs (with an 

improved activity and/or thermostability). It will 

be demonstrated that computational drug design 

is being evolved from traditional ligand-based 

or structure-based design to structure-andmechanism-based 

design, with recent development 

of computational design methodology and 

computing power. The presentations will show 

how the state-of-the-art computational modeling 

and design can effectively be integrated with 

wet experimental tests (in vitro and in vivo) for 

drug discovery and development. Appropriately 

integrated with wet experimental studies, state-ofthe-art 

computational design is of great value not 

only for small molecule drug discovery, but also for 

protein drug discovery and engineering. Integrated 

computational-experimental drug design and 

discovery efforts have led to exciting discovery of 

promising drug candidates. The presentations will 

be followed by debate. 

Moderators 

Chang-Guo Zhan, Ph.D. 

University of Kentucky 



Rational Design Approaches to Drug Discovery 

and Development 

Chang-Guo Zhan, Ph.D. 


Efficient Lead Generation and Optimization 

William L. Jorgensen, Ph.D. 

Yale University 

Integration of Genomic, Computational, and 

Experimental Data: A Unified Approach to Drug 

Discovery 

Herschel J. Weintraub, Ph.D. 

CADDinformatics, Inc.

50 


AAPS Formulation, Design and Development (FDD) Programming 

at a glance 


8:00 am – 10:00 am 




7:00 am – 8:15 am 


Practical Considerations in Using 

Excipients for Drug Testing in Early 

Toxicology Studies 

7:00 am – 8:15 am 


Innovative Colonic Drug Delivery 

Systems with a Case Study 

in Formulation and Temporal 

Gastrointestinal Transit Analysis 

7:00 am – 8:15 am 


Modeling Ophthalmic 

Drug Delivery and 

Disposition 

8:30 am – 4:00 pm 


Recent Advances in 

Oral Drug Delivery 



short course 

Roundtable 

Role of Excipient Impurities in 

Drug-excipient Interactions 

8:30 am – 11:00 am 

Symposium 


in Formulation Design and 

Development (FDD) 

Sponsored by 

8:30 am – 11:00 am 

Wednesday Morning Symposia Funded 


SymposiA 

Pharmacokinetic-pharmacodynamic 

Aspects of Inhaled Lung-targeted Agents 

8:30 am – 11:00 am 

SymposiA 

Hot-melt Extrusion: 

A Novel Oral Solids 

Processing Technology 

Advances in 

the Injectable 

Combination Products 

The Influence of Excipient Functionality 

on Quality by Design for Drug Product 

9:00 am – 11:00 am 


Intestinal Delivery of Lipidic Drug 

Complexes and Conjugates: Case Studies 

2:00 pm – 4:00 pm 

Roundtable 

Nanoparticles – Are They Ever 

Going to Amount to Anything? 

2:00 pm – 4:30 pm 



Symposium 

Novel Sustained Release 

Formulation Techniques with 

Lipid Excipients 

5:00 pm – 7:30 pm 

Formulation, Design and 

Development (FDD) Section 

Joint Membership Meeting 

and Reception

51 






8:30 am – 4:00 pm 

Recent Advances in Oral Drug Delivery 



The program focus is on new technologies and 

various aspects of formulation development for oral 

drug delivery, especially for sustained and controlled 

release applications. Topics of interest include, but 

are not limited to the following areas: sustained 

release dosage form/process design as driven by 

pharmacokinetic attributes of drug substances; 

improvements in solubility characteristics of 

poorly soluble active ingredients through the 

use of sustained release formulation/processing 

approaches; opportunities for alteration of in vivo 

profiles of active ingredients (such as minimization 

of food effects) through the use of sustained 

release technology in dosage form design; in vivo 

and in vitro correlation challenges for sustained 

release products; and targeted delivery of drug 

substances through dosage form design. This course 

is suitable for scientists in pharmaceutical product 

development. 

Moderators 

Orapin P. Rubino, Ph.D. 

Glatt Air Techniques, Inc. 

Robert A. Femia, Ph.D. 


Development of Oral Controlled Release 

Dosage Forms 

Orapin P. Rubino, Ph.D. 


Oral Controlled Release Multi-particulate 

Systems: Development Perspectives 

Wantanee Phuapradit, Ph.D. 

Teva Pharmaceuticals 

Consideration in Designing Oral Drug Delivery 

Systems 

Atul M. Mehta, Ph.D. 

Mehta Consulting 

Strategies in the Development of Extended 

Release Drug Products and IVIVC 

Vinod Shah, Ph.D. 

Consultant 

Enhancement of the Solubility of Poorlysoluble 

Drug Substances Through the Use 

of Formulation Additives 

Harry Brittain, Ph.D. 

Center for Pharmaceutical Physics 

Drug Delivery Strategy for Intestinally 

Metabolized Drugs 

Jae Seung Kim, Ph.D. 

TSRL Inc. 

The IVIVC for Sustained Release Products: 

Principles and Applications 

Harald Rettig, Ph.D. 

BioVista LLC 




8:00 am – 10:00 am 

Role of Excipient Impurities in Drugexcipient 

Interactions 

Roundtable 

Study of drug-excipient interactions provides the 

basis for the design of a stable dosage form. In 

addition to the possible physical and chemical 

interactions between the drug substance and 

the excipient itself, recent experiences suggest 

that interaction between the drug molecule and 

impurities in the excipient can have major impact 

on dosage form stability. Those interactions are 

more difficult to identify due to the low and variable 

level of the impurities in the excipient, depending 

on the specific excipient batch and excipient 

manufacturer. The low level of impurities in the 

excipient also makes it an analytical challenge to 

develop appropriate methods for the control of those 

impurities. This roundtable will provide an overview 

of the most common excipient impurities associated 

with drug product instability and the analytical 

methods and strategy used for their control. 

Moderators 

Sherif I. Badawy, Ph.D. 


Otilia M. Koo, Ph.D. 


Mechanisms of Drug Degradation in the 

Presence of Excipient Impurities 

Bradley Anderson, Ph.D. 


Profiling of Reactive Impurities in Commonly 

Used Excipients 

Venkatramana Rao, Ph.D. 


Challenges in Controlling Reactive Impurities 

in Excipients 

Timothy Bee, Ph.D. 

International Specialty Products 


2:00 pm – 4:00 pm 

Nanoparticles — Are They Ever Going 

to Amount to Anything? 

Roundtable 

“Nanoparticle” has been a drug delivery buzz word 

for years, yet the technology seems to be stuck 

in the concept phase. In fact, there isn’t even a 

consensus as to what a nanoparticle is. What is 

holding us back? When are we going to see products 

based on this technology? For practical reasons, will 

nanoparticles be only applicable to niche products, 

or will they gain broader utility? This session will 

try to separate the fantasy from the reality. In a 

roundtable format, speakers with experience in the 

area will discuss where the field is today, the likely 

applications of nanoparticle technologies, and what 

pitfalls arise as these technologies move from the 

concept phase into development. 

Moderator 

Brian Rohrs, Ph.D. 

Bausch & Lomb 

Nanoparticle Roundtable 

Russell J. Mumper, Ph.D. 

University of North Carolina at Chapel Hill 


Panayiotis P. Constantinides, Ph.D. 

Biopharmaceutical and Drug Delivery Consulting, LLC 




52 





2:00 pm – 4:30 pm 

Novel Sustained Release Formulation 

Techniques with Lipid Excipients 

Symposium 

Sustained-release (SR) oral drug delivery is of great 

interest for a number of reasons, including reduced 

dosing frequency, improved efficacy and reduced 

frequency of adverse effects, all of which lead to 

improved patient compliance and greater product 

acceptance. The profile of drug release is determined 

by the relatively complex excipient matrix in which 

the drug is dispersed. Thus, a comprehensive 

arsenal of excipient materials and novel methods of 

preparation are needed to meet the unique needs of 

each drug. Much like cellulosic polymers, acrylates 

and polyacrylamide copolymers, lipid excipients 

have been successfully applied in SR delivery. 

References in currently marketed dosage forms 

prove their utility, especially in conventional direct 

compression and capsule filling methods. Owing 

to their thermo-plastic properties, lipid excipients 

have enormous and largely un-exploited potential 

in sustained release drug delivery. More recently, 

lipids have been applied in melt granulation/ 

pelletization, spray cooling and hot melt coating 

techniques. There are also a number of publications 

on preparation of solid lipid nanoparticles (SLN) and 

nano structured lipid carriers (NLC) through high 

pressure homogenization. These novel approaches 

allow solvent-free preparations of SR matrices 

adaptable to the needs of each drug. This session 

will bring the latest SR formulation techniques 

employing lipid excipients. The presentations are 

aimed at understanding the nature of lipid matrices 

and their influence on drug release profile. As such, 

considerations in selecting materials and methods 

for optimal and yet stable release profiles will 

be discussed. 

Moderator 

Avinash Thrombre, Ph.D. 


Contribution of Lipid Based Ingredients to 

Advanced Oral Modified Release Formulations 

Guy G. Vergnault, Ph.D. 

Skye Pharma AG 

Spray Cooling with Lipids: Considerations 

in Development of Sustained Release Lipid 

Particles 

Duncan Q. Craig, Ph.D. 

University of East Anglia 

Novel Sustained-release Multiparticulates: 

A Case Study Demonstrating Performance, 

Manufacturability, and Stability 

Jim Nightingale, Ph.D. 

Bend Research Inc. 


RECEPTION 

5:30 pm – 7:30 pm 

Formulation, Design and Development (FDD) Section 

Joint Membership Meeting and Reception 



7:00 am – 8:15 am 

Practical Considerations in Using 

Excipients for Drug Testing in Early 

Toxicology Studies 


Drug candidates are becoming more challenging to 

formulate in early toxicology studies; low aqueous 

solubility, poor oral bioavailability, and transporters 

substrates. There are a number of different practices 

currently adopted in the industry to overcome 

these challenges; in terms of excipients selection 

and the safety levels chosen. Frequently, there 

is a balance of applying the excipients at high 

enough dose to facilitate toxicology testing without 

causing unwanted effects. In this sunrise session, 

current formulation, considerations, and practices 

in industry will be reviewed. In addition, we will 

explore if standardized approaches can be a reality. 

Moderator 

Otilia M. Koo, Ph.D. 


Current Practices in Formulation Selection for 

Early Toxicology Studies 

Yunxia (Vivian) Bi, Ph.D. 

AstraZeneca 

Excipients in Early Toxicology Testing — 

Will Standardization Help or Hinder Drug 

Discovery? 

Michael J. Hageman, Ph.D. 



8:30 am – 11:00 am 


Formulation Design and Development 

(FDD) 

Sponsored by

53 





7:00 am – 8:15 am 

Innovative Colonic Drug Delivery 

Systems with a Case Study 

in Formulation and Temporal 



Inflammatory bowel disease can affect both the 

small and large intestines. Mesalamine is an 

anti-inflammatory drug used to treat inflammation 

of the digestive tract (Crohn’s disease) and mild 

to moderate ulcerative colitis. This presentation 

will share with the audience the knowledge in 

gastrointestinal physiology and different formulation 

strategies so that a product targeted to the colon to 

provide superior patient care may be achieved. The 

total aims are five fold. First, available commercial 

dosage forms (enema, rectal suppository, extended 

release oral capsule and delayed release oral tablet 

and parenteral preparations) and their ingredients 

will be thoroughly reviewed. Second, in vitro drug 

release patterns of two commercial oral products, 

Pentasa extended release capsule coated with 

ethylcellulose and Asacol delayed release tablet 

coated with Eudragit S conducted by the presenter 

and coauthors will be presented. Third, the current 

innovative technologies such as Oros-CT, Pulsicap, 

Capsule within Capsule, Targit, Eudrapulse, 

Eudramode, Eudracol, Port, Eaglet, 

Code, COLAL, will be discussed according 

to the mechanisms of release such as swelling, 

erosion, bacterial degradation or combination. 

Fourth, a product of delayed release Mesalamine 

beads formulated by the presenter and coauthors 

will be instituted to show step by step procedure 

including how to make core beads by using Caleva 

Bench Top Extruder/Granulator (Model 10/25), 

Caleva Spheronizer, how to prepare the aqueous 

Eudragit S coating solution, how to spray coat 

core beads with Wurster spray coater, and how 

to quantify percent of coating thickness, determine 

total weight of coated pellets to achieve the desired 

strength and select the right size of hard gelatin 

capsule for loading. Five, use of temporal G.I. transit 

simulations to formulate and predict sustained 

input of target-site directed, single and multiple 

dose orally administered in fasting state, light 

versus heavy meals, exclusively into the colon will 

be demonstrated. 

Moderator 

Dave Wallick, Ph.D. 

The Dow Chemical Company 

Tutorial Overview of Colonic Drug Delivery 

Brahma N. Singh, Ph.D, F.C.P. 

Forest Laboratories, Inc. 

Innovative Colonic Drug Delivery Systems with 

a Case Study in Formulation and Temporal 


Monica C. Chuong, Ph.D. 

Massachusetts College of Pharmacy and 

Health Sciences 



8:30 am – 11:00 am 



Symposium 

Discovery and development of inhaled lung-targeted 

therapeutic agents such as bronchodilators 

and corticosteroids present substantial PKPD 

challenges; lung PK is not easily measurable in 

preclinical models and may not be measurable in 

clinical studies. Systemic PK is relevant for systemic 

effects but may not be so for airway effects such as 

bronchodilation. Sufficient understanding of the 

lung as an absorption barrier for small molecules 

is not currently available to allow for inference of 

lung PK from systemic observations. Quantitative 

dose-exposure-response analysis is rarely possible 

because of lack of relevant exposure data. Therefore, 

basic research is needed in order to characterize 

the ADME profile of lung-targeted inhaled agents. 

This symposium will provide specific information 

on the gaps that exist in our understanding of the 

lung as an ADME barrier, and in the absence of 

requisite clinical information, what quantitative 

tools exist to help develop PKPD understanding 

of lung-targeted agents. 

Moderators 

Dennis K. O’Connor, B.S. 

Boehringer Ingelheim Pharmaceuticals, Inc. 

Balaji M. Agoram, Ph.D. 


Lung ADME 

Ann Tronde, Ph.D. 

AstraZeneca 

Inhalation by Design 

Rhys Jones, M.S. 


PK-PD Considerations of Inhaled Agents — 

Corticosteroids as an Example 

Gunther Hochhaus, Ph.D. 

University of Florida 

Bioequivalence Testing for Inhaled Lungtargeted 

Agents 

Wallace Adams, Ph.D. 


8:30 am – 11:00 am 



Symposium 

Excipients facilitate manufacturing, enhance or 

support stability, and/or aid in vivo performance 

of a product. Certificates of analysis provide little 

information about what the industry has termed 

excipient functionality. This demands thorough 

understanding of material characteristics such 

as particle size and morphology, solid-state 

characterization and processing to name a few. 

Functionality has become a hot topic since the 

European Pharmacopoeia (EP) listed specific 

functionality-related characteristics (FRCs) in 

some of its excipient monographs. USP has looked 

into including a General Chapter on Excipient 

Performance Testing suggesting it could be part of 

the labeling section and non-mandatory. Excipient 

manufacturers are voicing concerns because 

in their view functionality may mean different 

things to different people. The characterization of 

functionality is very simply process understanding 

in accordance with the philosophy of the U.S. Food 

and Drug Administration (FDA), PAT and 21st century 

GMP initiatives. QbD is an approach to product 

development that seeks to find the limits within 

which acceptable product can be manufactured 

(edge of failure) and thereby the approvable design 

space. Standardized testing for excipients could 

play a critical role in the definition of design space 

and any quality-by-design endeavor must define 

the materials properly. There is a growing need for 

a systematic process to evaluate the interaction 

between components of a product to increase 

scientific understanding and correlation between 

physical and mechanical properties of materials 

and their functionality and ways in which the 

design space can be expanded by development 

of relevant functionality tests. This symposium 

will address the role the functionality tests of 

excipients will play in the QbD world through 

how we perform the functionality tests, how this 

test helps in establishing the design space, and 

the appropriate control strategies. A regulatory 

perspective will provide in-sight into this concept. 

In addition, the challenges and opportunities facing 

the excipient manufacturers and also the role of the 

pharmacopoeia as it pertains to supporting such 

changes will also be discussed as part of 

this symposium.

54 



Moderator 

Umang Shah, Ph.D. 

Solvay 

FDA’s Perspective 

Moheb Nasr, Ph.D., invited 


USP Perspective on Performance Related 

Tests for Excipients 

Kevin Moore, Ph.D. 


Excipient User’s Perspective 

Mohan Ganapathy, Ph.D. 


Excipient Manufacturer’s Perspective 

Richard C. Moreton, Ph.D. 

Finnbrit Consulting 


9:00 am – 11:00 am 

Intestinal Delivery of Lipidic Drug 

Complexes and Conjugates: 

Case Studies 


Lipid-drug complexes arise from non-covalent 

association of a drug with a lipidic carrier usually 

mediated by electrostatic and/or hydrogen bonding 

interactions. In contrast, lipid-drug conjugates 

comprise covalent conjugates of drug and a lipidic 

moiety, such as a fatty acid, a glyceride, other 

neutral lipid, or a phospholipid. The development 

of lipidic drug complexes and conjugates for 

pharmaceutical applications is driven primarily 

by the need to target drugs to specific sites in the 

body and/or to improve their biopharmaceutical or 

physicochemical properties. Lipidic drug conjugates 

are generally designed to exhibit characteristics 

which mimic those of dietary lipids, a key 

consideration in their utilization for oral delivery. 

These conjugates may provide enhanced intestinal 

permeability, improved GI stability, tolerability, 

and increased potential for intestinal lymphatic 

transport. In the latter case, for drugs with high 

first pass metabolism, recruitment of lymphatic 

transport via a prodrug strategy can provide for 

very significant increases in oral bioavailability. 

Alternatively, drug lipid/phospholipid conjugates 

can significantly alleviate the GI-injury induced 

by NSAIDs, such as aspirin and indomethacin. In 

contrast, the generation of drug:lipid complexes 

via drug complexation with excipients in lipidbased 

drug delivery systems, such as SEDDS, can 

reduce drug solubility, absorption, and is an often 

overlooked but critical aspect of formulation design. 

The objective of this symposium is to discuss recent 

advances in understanding and present case studies 

in the use of drug-lipid conjugates and drug-lipid 

complexes. Product development challenges 

and considerations particularly in reference to 

the impact of complexation and conjugation on 

pharmacokinetic and pharmacodynamic endpoints 

and the implications in terms of regulatory approval 

will be highlighted throughout the symposium. 

Moderator 

Panayiotis P. Constantinides, Ph.D. 

Biopharmaceutical and Drug Delivery Consulting, LLC 

Targeting Lipidic Prodrugs to the Lymphatics 

Christopher J. H. Porter, Ph.D. 

Monash Institute of Pharmaceutical Sciences, 

Monash University 

Drug-excipient Complexation in Selfemulsifying 

Drug Delivery Systems and 

Implications for Excipient Selection in 

Lipid-based Drug Delivery Systems 

Shirlynn Chen, Ph.D. 


Improving Gastrointestinal Safety of 

Non-steroidal Anti-inflammatory Drugs 

with Phospholipids 

Upendra Marathi, Ph.D. 

PLx Pharma 



7:00 am – 8:15 am 

Modeling Ophthalmic Drug Delivery 

and Disposition 


Sophisticated models for ocular drug disposition 

are becoming available, but there is little literature 

information on how accurate the models are, and 

to what problems they have been applied. This 

session will offer case studies in how these models 

have been applied, what insights have been gained, 

and what limitations have been experienced. Since 

sophisticated modeling and simulation of drug 

delivery is a relatively young field, this session is of 

broader interest not only for those scientists trying 

to build PK models, but also for the pharmacokinetic 

and drug delivery scientists trying to utilize those 

models to speed up drug development. 

Moderator 


Bausch & Lomb 

Modeling for Ophthalmic Drug Development 




8:30 am – 11:00 am 

Hot-melt Extrusion: A Novel Oral Solids 

Processing Technology 

Symposium 

The advent of high throughput screening in the drug 

discovery has resulted in compounds with high 

lipophilicity and poor solubility. Various approaches 

have been adopted to address these solubility 

issues including preparation of solid dispersions/ 

solid solutions. Any new chemical entities, as well as 

existing drugs that demonstrate poor bioavailability 

due to solubility issues are prime candidates for 

hot-melt extrusion (HME). The numerous advantages 

of HME technology include shorter and more 

efficient times to the final product, environmental 

advantages due to elimination of solvents in 

processing, and increased efficiency of drug delivery 

to the patient. HME has been demonstrated to 

provide rapid, sustained, modified, and targeted 

drug delivery. A variety of hot-melt polymers (both 

hydrophilic as well as hydrophobic) and lipid-based 

matrices have been used in different applications 

to obtain tailored release profiles for selected active 

pharmaceutical ingredients (APIs). Improvements in 

bioavailability utilizing HME techniques demonstrate 

the value of the technology as a potential drug 

delivery-processing tool. Amorphous forms of 

drugs with high amounts of energy produced from 

the HME process aid in enhancement of solubility 

of such drugs. The interest in HME technology for 

pharmaceutical applications is evident from the 

increasing number of patents and publications in 

the scientific literature. Although some aspects of 

HME dosage forms were presented in earlier AAPS 

meetings, there was no comprehensive discussion 

of various applications and advancements in 

this technology. The proposed objective of this 

symposium is to present the latest developments 

and myriad of applications of HME technology for 

pharmaceutical dosage forms including granules, 

pellets, tablets, implants, and transmucosal 

systems. For example, low temperature HME 

techniques will be discussed. Topics will cover case 

studies including HME applied to the formulation 

design of highly water insoluble and thermodegradable 

drugs. It will also deal with the specific 

problems associated with these techniques and its 

plausible solutions (technology and formulation 

design related) so that the span of this technology 

widens. The challenges related to HME dosage forms 

will be discussed from the regulatory perspective 

for the improvement of our understanding of the 

regulatory issues faced by these techniques and the 

products produced by this innovative technology. 

This symposium is targeted to reveal the novel 

applications of HME technology for constantly 

evolving oral solid dosage form technology, which is 

continuing to shift the paradigm of pharmaceutical 

processing and drug delivery systems.

55 



Moderators 

Dave Miller, Ph.D. 

Hoffmann-La Roche Inc. 

Sampada B. Upadhye, M.S. 

University of Mississippi 

Hot-melt Extruded Films, Pellets and Tablets: 

Affording Flexibility to the Process via Polymer 

Blends 

Michael A. Repka, D.D.S., Ph.D. 


Physical-chemical Characterization of 

Polymers and Actives to Modulate Successful 

Melt Extrusion 

Andreas Gryczke, Ph.D. 

Evonik Pharma Polymers 

Melt Extrusion — Future of an Exciting 

Technology 

Jörg Breitenbach, Ph.D. 

Soliqs 

Quality by Design for Pharmaceutical Hot-melt 

Extrusion 

Scott Martin, Ph.D. 

Thermofisher 

8:30 am – 11:00 am 

Advances in the Injectable Combination 

Products 

Symposium 

It has been increasingly evident that cancer 

probably be initiated from and maintained 

by a small sub-population of undifferentiated, 

tumorigenic cells called cancer stem cells (CSCs). 

Production of the main mass of the tumor may be 

attributed to this minor population of CSCs through 

a particular process of continuous self-renewal 

and differentiation. Thus, CSCs have come into 

sight as a potential target of cancer therapy. To 

date, many types of cancer stem cells have been 

identified in various cancers including breast, 

colorectal, pancreatic, head and neck cancers. 

Since cancer stem cells are resistant to current 

available chemotherapeutic regimen, it is important 

to explore new molecular target to eliminate these 

drug resistant cancer stem cells. This roundtable will 

provide a forum to debate cancer stem cell concept, 

targeted drug delivery, and drug targeting strategy 

to eliminate cancer stem cells. 

Moderators 

Sandeep Nema, Ph.D. 

Pfizer Global Biologics Pharmaceutical R&D 

Yatin Gokarn, Ph.D. 


Case Study 1: Developing a mAb-autoinjector 

Device 


Case Study 2: Lessons Learned from Druginjector 

Products 

Jessica M. Ballinger, Ph.D. 


Case Study 3: Challenges During Development 

of a Single-use Needle-free Drug Product 

Stephen Farr, Ph.D. 

Zogenix, Inc. 

Regulatory Requirements for Injection 

Drug-device Combination: An Update 

Scott A. Colburn, Ph.D., invited 


56 


Manufacturing, Science and Engineering (MSE) Programming 

at a glance 


7:00 am – 8:15 am 


Sterile Filtration — Principles and 

Case Studies 

8:30 am – 11:00 am 

SymposiA 

Freeze-drying of Biologics/Small Molecules: 

Case Studies that Touch on Formulation, Process, 

and Packaging Challenges 



Sponsored by 


Research Achievement Award winner will 

be given. 

8:30 am – 11:00 am 

Wednesday Morning Symposia 


Symposium 

What Can the Pharmaceutical 

Industry Learn About Process 

Development and Manufacturing 

from Other Businesses? 


in Manufacturing Science and Engineering 

sponsored by 

9:00 am – 11:00 am 

Roundtable 

Critical Role of CMC Project Management in the 

Drug Development Process 

9:00 am – 11:00 am 


Role of Models in 

Design Space 

2:00 pm – 4:00 pm 

Tuesday Afternoon Roundtables Funded by 

a Grant from 

Roundtable 

The Pros and Cons of Development Approaches 

to Poorly Soluble Compounds (In-House 

Development and Manufacture vs. Outsourcing) 

5:30 pm – 7:30 pm 

Manufacturing, Science and 

Engineering (MSE) Section 

Joint Membership Meeting 

and Reception

57 







RECEPTION 

5:30 pm – 7:30 pm 

Manufacturing, Science and Engineering 

(MSE) Section Joint Membership 

Meeting and Reception 



7:00 am – 8:15 am 

Sterile Filtration — Principles and 

Case Studies 


Reliable sterility assurance through sterile filtration 

of liquid products is a key regulatory requirement. 

This session will describe the fundamental 

principles of sterile filtration including the theory of 

VMax- which is a method for predicting the throughput 

of sterilizing filters, based on the gradual pore 

plugging model. In addition, sterile filtration case 

studies will also be discussed. 

Moderator 

Dawn D. Downey, Ph.D. 

Patheon Inc. 

Sterile Filtration 

Ruta Y. Waghmare, Ph.D. 

Millipore Corporation 


8:30 am – 11:00 am 

Freeze-drying of Biologics/Small 

Molecules: Case Studies that Touch on 

Formulation, Process, and Packaging 

Challenges 

Symposium 

Freeze-drying is a preferred and established way 

of stabilizing molecules despite the disadvantages 

of cost and processing time. Moreover, it is a proven 

and trusted aseptic processing operation that meets 

finished product sterility assurance requirements 

without the stress of terminal sterilization that a 

biologic typically cannot withstand. A key component 

to the development of a sterile freeze-dried product 

is the understanding that the product is a sum of 

the formulation, process, and package. This session 

will be a compilation of practical case studies that 

capture the essence of freeze-drying a candidate 

molecule (both biologics and small molecules) from 

a formulation, packaging and process viewpoint. 

Proposed speakers will be from both academia and 

industry (both U.S. and E.U.) and case studies will 

touch on the following areas: micro-collapsed state 

in amorphous formulations, the micro-collapsed 

regime encompasses temperature ranges above 

the classical collapse temperature as measured 

by freeze-drying microscopy. For biologics, the 

window between micro and macro-collapse is quite 

wide and is dependent on numerous factors and 

can be exploited to reduce drying time especially 

for biologics. Challenges in freeze-drying in a dual 

chambered syringe, the issues encountered when 

freeze-drying in a dual chamber can be quite 

different when compared to drying in a standard 

vial. Special emphasis will be placed on challenges 

such as poor heat and mass transfer and moisture 

transmission across chambers. Application of PAT 

in freeze-drying, Process Analytical Technology (PAT) 

in freeze-drying should not only monitor the process 

but should also create feedback loops that allow 

process changes and control. The implementation of 

PAT in freeze-drying is challenging since the mode of 

operation needs to be non-invasive and compatible 

with sterile practices. Either a review of the current 

state of art PAT approaches or a case study that 

utilizes PAT for different unit operations will be 

presented. Classical lab to pilot plant to commercial 

scale-up, in the freeze-drying process there are many 

factors that are critical to an acceptable product and 

these include shelf temperature, chamber pressure, 

processing time, stoppering pressure and condenser 

temperature to name a few. Because deviations 

from any one of these factors could result in product 

collapse, melt-back, high moisture content and affect 

stability of the product, a correlation between scales 

should be performed for products being scaled from 

lab to pilot and final manufacturing scale. 

Moderator 


Pfizer, Inc. 

Classical Lab to Pilot Plant to Commercial 

Scale-up: A Case Study 

Jim Searles, Ph.D. 

Aktiv-Dry LLC 

Challenges in Freeze-drying in a Dual 

Chambered Syringe: A Case Study 

Susan W. Martin, Ph.D. 


Application of PAT in Freeze-drying: 

A Case Study 

Thomas De Beer, Ph.D. 

University of Ghent 

Exploiting the Micro-collapsed State in Freezedrying 

of Biologics: A Case Study 


Pfizer, Inc. 



8:30 am – 11:00 am 



(MSE) 

Sponsored by 



AAPS Research Achievement Award in Manufacturing 

Science and Engineering 

sponsored by 


9:00 am – 11:00 am 

Critical Role of CMC Project Management 

in the Drug Development Process 

Roundtable 

This roundtable will focus on the ever increasing 

complexity of the project management function for 

chemistry, manufacturing, and control aspects of 

drug development. Speakers will address the key 

milestones of drug development for CMC functions 

and how to expedite and shorten the development 

cycles, including discussion on technology 

transfer models. 

Moderator 

Walter Chambliss, Ph.D. 


Critical Role of CMC Project Management for 

Large Molecule Development — Genentech, 

Inc. Model 

Marjorie Winkler, Ph.D. 


Critical Role of CMC Project Management 

for Small Molecule Development — Wyeth 

Pharmaceuticals Model 

Mukund “Mike” Yelvigi 

Wyeth Pharmaceuticals

58 





2:00 pm – 4:00 pm 

The Pros and Cons of Development 

Approaches to Poorly Soluble 

Compounds (In-House Development and 

Manufacture vs. Outsourcing) 

Roundtable 

An increasing number of poorly soluble new 

chemical entities exhibit poor water solubility. 

This makes them difficult to develop into traditional 

solid dosage forms. Liquid and solid dispersion 

formulations have been used as possible dosage 

form approaches to enhance bioavailability for these 

poorly soluble compounds. Even though a solid 

formulation may be more difficult to characterize, 

some pharmaceutical companies still prefer to 

pursue liquid dosage forms only as a last resort 

if it means outsourcing the work to a CRO/CMO. 

This roundtable will focus on the decision process 

used by different companies to select the dosage 

form or forms they will pursue, and reasoning 

why liquid or solid dispersion dosage forms may 

or may not be the preferred route. It will examine 

if misconceptions exist regarding the difficulty to 

manufacture these dosage forms as well as the 

concern by some pharma companies to outsource 

the work using a contract company, which is often 

required for non-solid formulations. The impact of 

the in-house vs. CRO/CMO decision on the quality 

of the product, development timeline, and cost will 

also be discussed. 

Moderators 

Yunxia (Vivian) Bi, Ph.D. 

AstraZeneca 

David Fulper, Ph.D. 

Patheon Inc. 

Getting Over the “NIH” (Not Invented Here) 

Syndrome: Why Outsourcing of Liquidsemisolid 

Dosage Forms for Poorly Soluble 

Compounds Makes Sense 

Jeff Browne, Ph.D. 


Early Development of Poorly Water-soluble 

NCEs: Potential Advantages of Keeping 

Development Activities in House 

Abu T.M. Serajuddin, Ph.D. 

St. John’s University 




8:30 am – 11:00 am 

What Can the Pharmaceutical Industry 

Learn About Process Development and 

Manufacturing from Other Businesses? 

Symposium 

What can the pharmaceutical industry learn about 

process development and manufacturing from other 

businesses? Many other businesses, have adopted 

systems for product development and monitoring 

and control of manufacturing which are far more 

sophisticated than those used in a typical solid 

oral manufacturing production facility. Are there 

lessons which the pharmaceutical industry can 

learn from the chemical industry, automobile or 

aero industries, or those making other industrial 

or consumer products in highly controlled 

manufacturing environments? This symposium 

will have four speakers. These will include a senior 

executive from Pharma who will outline the current 

status in this industry. Other speakers will include a 

representative from the chemical industry, and two 

additional speakers with a wide range of experience 

across a range of industries who have consulted for 

Pharma companies and advised U.S. Food and Drug 

Administration (FDA). These speakers will address 

what could be learned from other industries focusing 

on issues such as knowledge management, and the 

use of lean, 6 sigma and parametric release in the 

pharmaceutical industry in comparison to others. 

Moderator 

Paul Sheskey, Ph.D. 


Current Pharma Industry Perspectives 

Parimal Desai, Ph.D. 

Wyeth Pharmaceuticals 

Quality by Design – Comparison with Other 

Industries 

Prabit Basu, Ph.D. 


Chemical Industry Perspectives 

Clark Cummings, Ph.D. 


Leveraging the Knowledge Life Cycle to Better 

Enable Drug Development 

Michael Bregger 

Tunnell Consulting 


THURSDAY MINI-SYMPOSIA 

9:00 am – 11:00 am 

Role of Models in Design Space 


A key element of the Quality by Design (QbD) 

paradigm of drug development is a delineation of 

design space for material and process parameters. 

Mathematical models can serve as a powerful tool 

in this approach. They can be used at every stage 

of design space development including but not 

limited to risk analysis to determine parameters that 

define a design space, gain process understanding 

and to optimize a process, propose a design space, 

and scale up/down a design space. In addition, 

learning from models could be leveraged to gain 

an understanding of impact of movements within/ 

outside the proposed design space, with minimal 

experimentation. The objective of this symposium is 

to illustrate the contribution of models in all phases 

of drug development following the QbD approach. 

Moderators 

Sharmista Chatterjee, Ph.D. 


Cynthia Oksanen, Ph.D. 

Pfizer, Inc. 

Risk Analysis Using Drug Product Design 

Space Models 

Craig Dunbar, Ph.D. 

Vertex Pharmaceuticals 

Use of Mechanistic Models to Develop Design 

Spaces for Drug Substance Production 

Peter Clark, Ph.D. 

DynoChem, Inc. 

Using Modeling to Establish Clinical Relevance 

in Design Space 

Kazuko Sagawa, Ph.D. 

Pfizer Global Research & Development

59 


Physical Pharmacy and Biopharmaceutics (PPB) Programming 

at a glance 


8:00 am – 4:00 pm 


Rational Design and 

Development of Solid 

Dispersions with 

Amorphous Drug 

for Improving Oral 

Bioavailability 



short course 

8:00 am – 10:00 am 




Roundtable 

Optimization of 

Systemic Exposure in 

Preclinical and Clinical 

Development: “Success 

Stories” of Proven 

Methods for Challenging 

Drug Candidates — 

What You Did Not 

Already Know! 

7:00 am – 8:15 am 


Solve your Problems in a Smarter 

Way: Use Design of Experiments 

8:30 am – 11:00 am 

Symposium 

Application of Nanoparticulate 

Technology in the Development of 

Oral Dosage Forms: Impact on Drug 

Product Performance 




Sponsored by 

During this Symposium, a presentation 

from the Research Achievement Award 

winner will be given. 

AAPS David Grant Research 

Achievement Award in Physical 

Pharmacy 

Sponsored by 

8:30 am – 11:00 am 



Symposium 

Extrapolation Preclinical Data to 

Predict Human Pharmacokinetics: 

Understanding and Practice 

8:30 am – 11:00 am 

Symposium 

Excipient Variability: 

Why Some Lots Pass 

and Others Fail 

9:00 am – 11:00 am 

Roundtable 

Predicting Oral Drug 

Absorption: Fiction 

and Facts 

2:00 pm – 4:00 pm 



Roundtable 

Characterization of Amorphous 

Pharmaceutical Solids and Solid 

Dispersions 

2:00 pm – 4:00 pm 

Roundtables 


Nanoparticles, or Amorphous: How to 

Pick the Winner 

Tumor Targeting Using Nanotechnologybased 

Drug Delivery Systems 

2:00 pm – 4:30 pm 

wednesday afternoon symposia funded 

by a grant from 

Symposium 


and Optimization of Drug Topical Delivery 

5:30 pm – 7:30 pm 

Physical Pharmacy 

and Biopharmaceutics 

(PPB) Section Joint 

Membership Meeting 

and Reception

60 






8:00 am – 4:00 pm 

Rational Design and Development of 

Solid Dispersions with Amorphous Drug 

for Improving Oral Bioavailability 



It has been estimated that over 50% of the new 

chemical entities (NCEs) are too insoluble for 

efficient oral absorption. Increasing dissolution 

rate and in vivo exposure of poorly soluble drugs 

by the use of high energy solids (e.g., amorphous 

state) and the application of polymer matrices for 

delivery purpose have been broadly employed. In 

recent years, there has been a large increase in the 

number of scientific publications and patents in 

this area of research. Reports in the literature have 

shown remarkable enhancement in dissolution 

rates and enhanced oral absorption of high energy 

solids generated by spray drying, antisolvent 

precipitation, and hot-melt extrusions. The advances 

in fundamental understanding of high energy solids 

as well as development of practical approaches 

to overcome inherent limitations with high energy 

solids have made the field highly attractive for 

pharmaceutical scientists. However, discussions on 

recent exploration of high energy solids and related 

technical challenges at national and international 

forums have been limited. Although some aspects 

of amorphous systems, solid dispersions, crystal 

engineering, etc., were presented in different 

meetings, there was no general discussion of 

various aspects of amorphous solids in one forum. 

This short course will focus on all aspects of high 

energy, amorphous solids and related drug product 

development, including generating amorphous 

materials via different manufacturing processes, 

selecting polymer to stabilize the amorphous state, 

making appropriate formulations intended for oral 

administration, characterizing and understanding 

solid state physical stability, applying appropriate 

analytical methodologies, etc. All of these 

aspects will profoundly influence the scientific 

community of formulation scientists and analytical 

scientists for exploration of amorphous solids and 

facilitating technical breakthroughs in this field. 

Numerous challenges exist in consistently and 

reproducibly generating amorphous solid materials, 

characterizing of amorphous solids regarding its 

in vitro performance, selecting and optimizing 

the appropriate polymeric matrices for achieving 

physical stability, selecting desired manufacturing 

process (e.g., spray drying, hot-melt extrusion, etc.) 

with optimal conditions, and achieving improved in 

vivo exposure, and developing formulation products 

intended for oral use. This short course will focus on 

all aspects of amorphous solids towards successful 

oral delivery of insoluble compounds. 

Moderators 

Ping Gao, Ph.D. 


Jiansheng Tang, Ph.D. 

Mylan Pharmaceuticals, Inc. 

Eric Munson, Ph.D. 

University of Kansas 

Crystallization and Stabilization of 

Amorphous Solids 

Lian Yu, Ph.D. 

University of Wisconsin-Madison 

Enablement of Drug Discovery through 

Supersaturation and Amorphous Solids 

Michael J. Hageman, Ph.D. 


Crystallization from Amorphous Systems 



Assessing and Optimizing Supersaturation 

in Amorphous Solids and Dispersions 

Marcus Brewster, Ph.D. 

Johnson & Johnson 

Predicting Amorphous Drug Stability in Drug 

Formulations 



Characterization of In Vitro Release Attributes 

of Amorphous Solids and their Relevance to 

In Vivo Absorption 



Turning Challenges into Opportunities: 

Formulation Development for Poorly Soluble 

Drugs — The Meltrex Approach 

Ulrich Westedt, Ph.D. 


Enhancing Bioavailability of Low Solubility 

Compounds: Amorphous Dispersion Delivery 

Platforms 

David Vodak, Ph.D. 

Bend Research Inc. 




8:00 am – 10:00 am 

Optimization of Systemic Exposure in 

Preclinical and Clinical Development: 

“Success Stories” of Proven Methods for 

Challenging Drug Candidates — What 

You Did Not Already Know! 

Roundtable 

The identification and development of new drug 

candidates with a desirable systemic exposure 

that is both efficacious and safe in humans 

with “developable” formulations based on 

preclinical data remains a major challenge in the 

pharmaceutical sciences. One reason is that oral 

systemic exposure is determined by a variety of 

physicochemical and metabolic factors including 

drug solubility, permeability, dissolution, dosage 

forms, as well as, first-pass, transporter effects, 

and varying gastrointestinal physiology. Another 

reason is that multidisciplinary teams often cannot 

reach consensus which formulation and modeling 

approaches can be used with confidence to select 

a dosage form for first in human studies. Thus, 

science driven strategies to determine the systemic 

exposure rate limits will be presented based on 

new compounds and new data to correct analysis 

of factors controlling exposure for drugs of all 

BCS classes. When low exposure is seen, there 

can be the incorrect perception that formulation 

improvement works for every compound. In other 

cases, controlled release formulations should be 

attempted to optimize the PK profiles. Modeling and 

simulation are also meaningful tools in designing 

PK/formulation/ADME/TK studies, as well as, 

species scaling to human. Specific formulation 

strategies, and proven modeling approaches that 

can be used when facing different BCS classification 

compounds will be shared. In addition, the role 

of transporters in drug disposition with a focus 

on BCS Class II-IV drugs will be discussed, as well 

as, science-driven optimization of formulation 

selection studies for clinical trials and final 

marketing formulations. 

Moderators 


Novartis 

Hyo-Kyung Han, Ph.D. 

Chosun University

61 



Successful Methods for Systemic Exposure 

Optimization: IVIVC and Proven Formulation 

Strategies to Predict Clinical and Preclinical 

Outcome for Drugs of All BCS Classes 

Handan He, Ph.D. 

Novartis 

Systemic Exposure and Oral Absorption 

Assessment of Poorly Water-soluble Drugs in 

the Fasted and Fed State to Predict Clinical 

Outcome 

Makoto Kataoka, Ph.D. 

Setsunan University 

BDDCS vs. BCS as an Enabling Tool in Drugs 

Discovery: Evolving Understandings of 

Disposition for BCS Class II-IV Drugs 

Leslie Benet, Ph.D. 



RECEPTION 

5:30 pm – 7:30 pm 

Physical Pharmacy and 

Biopharmaceutics (PPB) Section Joint 




7:00 am – 8:15 am 

Solve Your Problems in a Smarter Way: 

Use Design of Experiments 


Too many variables to control in your experiments? 

What is the optimal set of conditions that will lead 

you to the desired results? The traditional approach 

to answer the above questions is to do experiments 

and evaluate the contribution of the different 

factors (variables), one factor at a time, while the 

other factors are held constant. One problem in this 

approach arises when there are too many factors to 

test. You can bypass this frustration and reach your 

goal by designing experiments in an intelligent way, 

using Design of Experiments. Design of Experiments 

(DOE) is a strategy to gather data from experiments 

in order to optimize a process, understand a 

phenomenon,or improve a performance. DOE 

consists of designing a set of ten to twenty 

experiments in which all relevant factors are varied 

in a systematic way. The analysis of the results of 

these experiments will help us discover the factors 

that most influence the results and the factors that 

do not, and spot patterns of interactions between 

factors. In other words, DOE helps to identify the 

optimal conditions of a process based on a few key 

experiments. DOE’s beauty is that it allows you to 

find the best answer much more quickly and has 

broad applications across all natural sciences. In 

this session, we will give the basics of DOE, discuss 

real-life case scenarios and learn how to organize 

experiments in order to get the right type and 

number of data to answer our questions. 

Moderator 

Maria Polikandritou-Lambros, Ph.D. 

Western University of Health 

The Basics of Experimental Design 

Mike Nicolaou, Ph.D. 

Nicopharm Pharmaceutical Solutions 


8:30 am – 11:00 am 

Application of Nanoparticulate 

Technology in the Development of Oral 

Dosage Forms: Impact on Drug Product 

Performance 

Symposium 

Session description not available at time 

of publication. 

Moderators 

S. Russ Lehrman, Ph.D. 

Lehrman Biopharma 

Vijai Kumar, Ph.D. 

Pharmaceuticals International, Inc. 

Pharmaceutical Nanoparticles: Current Design 

Concepts and Challenges 



Oral Delivery of Poorly Water-soluble Drugs 

by In Situ Nanoparticle Formation Applying 

Microemulsion and Solid Dispersion 

Technologies 

Abu T.M. Serajuddin, Ph.D. 

St. John’s University 

Application of Nanocrystal Technology to 

Poorly Water Soluble Compounds 

Gary Liversidge, Ph.D. 

Elan Drug Delivery Inc. 

Engineering Pharmaceutical Nanoparticles 

Cory J. Berkland, Ph.D. 




8:30 am – 11:00 am 




Sponsored by 



AAPS David Grant Research Achievement Award in 

Physical Pharmacy 

Sponsored by 



2:00 pm – 4:00 pm 

Characterization of Amorphous 

Pharmaceutical Solids and Solid 

Dispersions 

Roundtable 

Discussions on recent exploration of amorphous 

pharmaceutical solids and related solid dispersion 

technology at national and international forums 

have been limited. Numerous challenges exist 

in consistently and reproducibly generating high 

energy solid materials, characterizing high energy 

solids regarding its in vitro performance, selecting 

and optimizing the appropriate polymeric matrices 

for achieving physical stability, selecting desired 

manufacturing process with optimal conditions, 

achieving improved in vivo exposure, and 

developing formulation products intended for oral 

use. It is proposed that this roundtable will focus 

on key aspects of amorphous solids and related 

drug product development, including generating 

amorphous materials via different manufacturing 

processes, selecting polymer to stabilize the 

amorphous state, making appropriate formulations 

intended for oral administration, characterizing and 

understanding solid state physical stability, applying 

appropriate analytical methodologies, etc. This will 

profoundly influence the scientific community of

62 



formulation scientists and analytical scientists for 

exploration of high energy solids and facilitating 

technical breakthroughs in this field. 

Moderators 



Jun Huang, Ph.D. 


Crystallization of Amorphous Drug in Solid 

Dispersions 



Development of Amorphous Solid Dispersions: 

Formulation Selection and Risk Management 

Feng Qian, Ph.D. 


Assessing the Commercialization Potential of 

Solid Dispersions 

Marshall D. Crew, Ph.D. 

Agere Pharmaceuticals, Inc. 




8:30 am – 11:00 am 

Extrapolation Preclinical Data to 

Predict Human Pharmacokinetics: 

Understanding and Practice 

Symposium 

Screening, understanding, and optimizing the in 

vivo performance of drug products is required to 

achieve desirable clinical efficacy target and safety 

profiles in patients. Even though the drug products 

are ultimately investigated in human, the use of 

human subjects is clearly limited by ethical concerns 

and restrictions of cost. As the use of animal models 

in drug research and development is evident, careful 

and educated utilization of this preclinical approach 

is required. In this symposium, understanding 

of physiologies of animal species relevant to 

PK assessment will be highlighted. Attempts of 

using animal models to increase the precision 

and accuracy of PK predictions and to enable a 

better understanding of complex ADME behavior in 

humans will be discussed. 

Moderators 

Lillian (Hua) Zhang, Ph.D. 


Jennifer J. Sheng, Ph.D. 

AstraZeneca 

Integrated Approaches in Utilizing Preclinical 

Models for Human Predictive Absorption 

Bertil Abrahamsson, Ph.D. 

AstraZeneca 

Volume of Distribution Prediction: 

Physiologically Based Methodologies 

Patrick Poulin, Ph.D. 

Consultant in Pharmaceutical Research 

Prediction of Human Hepatic Metabolism and 

Clearance from In Vivo Animal Experiments 



Scaling Pharmacokinetics/Pharmacodynamics 

from Animal Studies to Humans 

William J. Jusko, Ph.D. 

University at Buffalo, The State University 

of New York 


2:00 pm – 4:00 pm 


Nanoparticles, or Amorphous: How to 

Pick the Winner 

Roundtable 

In the past the most common approach was to 

choose the most stable crystalline form to go 

forward into development. However, many of the 

new drug candidates have extremely poor solubility, 

which can result in poor bioavailability. There are 

multiple methods to increasing the bioavailability 

of a compound, including generating a salt form, 

a metastable crystalline form, a co-crystal, a 

nanoparticle formulation, an amorphous form, or 

an amorphous dispersion. Choosing which form is 

often a balance between the benefits of enhanced 

solubility/bioavailability and the detriment of 

form interconversion to a different form and 

correspondingly reduced bioavailability. In this 

roundtable the speakers will discuss the advantages 

and disadvantages of choosing each of the different 

forms, including the issues of producing a less 

stable form that does not interconvert and the scaleup 

and manufacturing of metastable forms. 

Moderator 

Brian Padden, Ph.D. 


Introduction to Methods to Increase Solubility: 

Salts, Co-crystals, and Amorphous Solids 

Geoff Zhang, Ph.D. 


Co-crystals: The Future of Improving 

Solubility? 

Nair Rodriguez-Hornedo, Ph.D. 


Which to Choose? A Contract Lab Perspective 

Rolf Hilfiker, Ph.D. 

Solvias AG 

2:00 pm – 4:00 pm 

Tumor Targeting Using Nanotechnologybased 

Drug Delivery Systems 

Roundtable 

The method of delivery plays an important role in 

ensuring that the drug reaches its target site for 

therapeutic effect. Novel modes of delivery methods 

using nanosphere technology are receiving wide 

attention as these have shown superior delivery 

compared to conventional dosage forms. Recently, 

nanotechnology has galvanized practically every 

sector of research, engineering and the business 

community. From a pharmaceutical standpoint, 

new functions arising from nanosizing such as 

improved solubility, targetability and adhesion 

to tissues allow the design of new drug delivery 

systems. In the therapeutic arena, nanotechnologybased 

systems with drug targeting properties 

promises to expand the repertoire of innovative 

systems, thereby revolutionizing health care delivery 

especially in cancer therapy. This roundtable will 

provide attendees with an overview of the current 

progress and opportunities as well as challenges in 

the design of nanotechnology-based drug delivery 

systems bearing tumor-targeting properties. 

Moderators 

Jeffrey Wang, Ph.D. 

Western University of Health Sciences 



Targeted Delivery of siRNA: Concept to Clinic 

Mark Davis, Ph.D. 

California Institute of Technology 

Nanotechnology-based Drug Delivery Systems 

Targeting to Glioma 

Xinguo Jiang, Ph.D. 

Fudan University 

Targeted Multifunctional Nanocarriers for 

Tumor Treatment and Imaging 

Tamara Minko, Ph.D. 

Rutgers University

63 





2:00 pm – 4:30 pm 



Delivery 

Symposium 





















Moderators 


Nycomed 











Determination of Drug Penetration in 

Diseased Skin 







8:30 am – 11:00 am 

Excipient Variability: Why Some Lots 

Pass and Others Fail 

Symposium 

Many common macromolecular excipients such 

as celluloses are derived from natural products. 

Changes in harvest time, location, species, and 

climate can significantly change the properties of 

the excipients. This can result in significant lot-to-lot 

variations in the structural and functional properties 

of the excipients. When developing a pharmaceutical 

dosage form, it is important to ensure that the same 

form of an excipient is consistently used during 

formulation, that the function of the excipient 

does not become compromised during processing, 

and that the excipient does not undergo a form 

change over time. This is particularly important in 

the production of amorphous dispersions of API 

in macromolecular excipients, as this product has 

significant drug-excipient interactions. Despite 

this need for reliable and accurate characterization 

methods of excipients, many macromolecular 

excipients used by the pharmaceutical industry 

are amorphous and can be difficult to characterize 

and understand in the solid state. The focus of 

this symposium is on the characterization of 

macromolecular excipients. Specific topics include 

impact of lot-to-lot variations of excipients on final 

product quality, characterization of structurefunction 

relationships in macromolecular excipients, 

role of impurities in excipient properties, and 

influence of drug-excipient interactions upon stable 

amorphous formulations. 

Moderator 

Joseph Lubach, Ph.D. 


Advanced Characterization of Macromolecular 

Excipients 



Amorphous Dispersions and Drug-excipient 

Interactions 



Excipient Variability — Why One Lot is 

Different than Another 

Bruno Hancock, Ph.D. 


Excipient Impurities — Small Amounts Mean 

Big Problems 

Venkatramana Rao, Ph.D. 



9:00 am – 11:00 am 

Predicting Oral Drug Absorption: Fiction 

and Facts 

Roundtable 

Finding a safe and effective compound amongst the 

hoards of available chemical moieties is challenging 

and costly. To bring a single drug to market may 

take years, cost hundreds of millions of dollars, and 

generally require testing in thousands of human 

subjects. Most drug candidates never make it as far 

as human testing and many that do are rejected for 

various reasons. In an effort to minimize time and 

costs of drug discovery and creation, pharmaceutical 

manufacturers have produced numerous screening 

techniques to identify the drug candidates most 

likely to take them to market. Some of these 

tests are aimed at drug absorption, distribution, 

metabolism, and elimination (ADME). Others 

are aimed at the effectiveness of drugs. In silico 

methods (i.e. computer models) are the fastest and 

one of the most efficient means for screening large 

numbers of drugs for oral absorption. For drugs 

that have survived the screening process, in silico 

methods continue to play an important role. This 

session will review models for predicting oral 

drug absorption. 

Moderators 

Lawrence X. Yu, Ph.D. 



Novartis 

Mechanistic Approaches to Predicting Oral 

Drug Absorption 

Gordon Amidon, Ph.D. 


Roles of Oral Drug Absorption and Exposure 

Prediction in Drug Development 


Novartis 

Roles of Oral Drug Absorption Prediction in 

Regulatory Review 

Robert Lionberger, Ph.D. 


SM 

64 


AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming 

at a glance 


8:30 am – 

4:00 pm 

Short 

Course #1 

RNA-targeting 

Therapeutics: 

Issues and 

Advances 

An additional 

fee is required 

to attend this 

short course 

Short 

Course #5 

Transportermediated 

Drug-drug 

Interactions: 

Possible 

Criteria that 

Warrant In Vivo 

Transportermediated 

DDI Studies 

via In Vitro 

Assessments 

An additional 

fee is required 

to attend this 

short course 

8:00 am – 10:00 am 




Roundtables 

Biotherapeutics and 

Modulation of Drug 

Transporters 

Optimization of 

Systemic Exposure in 

Preclinical and Clinical 

Development: “Success 

Stories” of Proven 

Methods for Challenging 

Drug Candidates – What 

You Did Not Already 

Know! 

2:00 pm – 4:30 pm 

Monday Afternoon 

Symposia Funded by a 

Grant from 

SymposiA 

AAPS/ACCP Joint 

Symposium: Strategic 

Biomarkers for Treating 

Diseases in Younger 

Children Safely and 

Effectively 

The Modeling and 

Simulation Frontier: 

Multi-level, Multiscale, 

Multi-attribute, 

Adaptable, and 

Extensible Discrete 

Event Models 

7:00 am – 8:15 am 




Too Small, Just Right! Size Issues in 


8:30 am – 11:00 am 


in Pharmacokinetics, Pharmacodynamics 

and Drug Metabolism and 



Sponsored by 

During this Symposium, a presentation 

from the Research Achievement 

Award winner will be given. 


in Clinical Pharmacology and 


Sponsored by 

9:00 am – 11:00 am 

Roundtable 

To Test or Not to Test? Risk 

Assessment Approaches for Human 

Metabolites 

2:00 pm – 4:00 pm 


Funded by a Grant From 

Roundtable 

Inclusion of Women in Clinical 

Trials and Drug Development – 

How Far Have We Gone 

2:00 pm – 4:30 pm 

Symposia 

Reactive Metabolites in Drug 

Discovery and Development: 

How Can We Handle the Risk? 

Pros and Cons of Emerging Methods 

in Population PK and Exposure/ 

Response Analysis 

Leveraging Prior Quantitative 

Knowledge in Guiding Pediatric 


7:00 am – 8:15 am 


Minimizing the Guesswork of Early 

Human Dose Predictions: Application 

of PK Prediction Methodologies 

Including PBPK 

Today, Tomorrow, and Beyond: 

Approaches and Challenges in Modeling 

Pharmacodynamic Effects with Long 

Time Delays 

Pharmacogenetics: Methods 

and Clinical Applications 

8:30 am – 11:00 am 



Symposia 


Quantitative Proteomics in ADME 


Aspects of Inhaled Lung-targeted 

Agents 

9:00 am – 11:00 am 

Roundtables 

Facilitating the Transition to Modelbased 




Translational Challenges in PK/PD/TD 

of Biotechnology-derived Products 

2:00 pm – 4:00 pm 

Roundtable 

In Vivo Animal Models for Prediction 

of Drug-drug Interactions 

2:00 pm – 4:30 pm 

wednesday afternoon symposia 


Symposia 

Mechanism-based PKPD Modeling: 

Its Role in Discovery and Early 

Development of Biologics 


and Optimization of Drug Topical Delivery 



7:00 am – 8:15 am 


Humanized Transgenic 

Transporter Models — 

Update on State-of-the-Art 

Physiologically Based 

Pharmacokinetic Modeling: 

Concepts and Applications 

in Drug Discovery and 

Development 

Modeling Ophthalmic Drug 

Delivery and Disposition 

8:30 am – 11:00 am 

Symposia 

The Role of ATP Binding Cassette 

Transporters in Tissue Defense 

and Organ Regeneration 

Using Modeling and Simulation 

to Safely Adjust Dose Regimens 

for Obese Patients 

9:00 am – 11:00 am 

Roundtables 

First Time in Human Dosing – 

Gimmicks, Luck, and Science 

Predicting Oral Drug 

Absorption: Fiction and Facts 

Evaluating Fit-for-Purpose 

Models: Consensus or 

Controversy 

1:30 pm – 5:00 pm 

Open Forum 

An Evolution or Revolution 

in Drug Metabolism: When, 

Where, Why, What, How? 


to attend this open forum.

65 







8:30 am - 4:00 pm 

RNA-targeting Therapeutics: Issues and 

Advances 


An additional fee is required to attend this short course. 

The use of oligonucleotides as therapeutic 

agents has elicited a great deal of interest. Basic 

understanding of the pharmacokinetics and 

delivery of antisense oligonucleotides and siRNA 

as tools for silencing genes or regulatory RNAs 

is foundational to their appropriate design and 

application. The short course will consist of the 

following lecture topics: basic knowledge of siRNA 

and antisense and in vivo uptake mechanisms/ 

pathways of oligonucleotide uptake into cells, 

overview of RNA-targeting therapeutics-basic 

primer, siRNA promise and challenges of RISC based 

targeting of mRNA, specific in vivo targeting of siRNA 

advances and challenges, antisense advances and 

challenges of single-strand, pharmacokinetics and 

ADME characterization of siRNA in animal models, 

pharmacokinetics and ADME characterizations of 

siRNA in humans, MicroRNA, a new target for RNAtargeting 

therapeutics, and regulatory pathways for 

oligonucleotide therapeutics. 

Moderators 





Antisenseantisense: Advances and Challenges 

of Single-strand Antisense 



Uptake Mechanisms of Oligoneucleotides 

Frank Bennett, Ph.D. 


Therapeutic Development of MicroRNA: 

Promises and Challenges 

Peter Linsley, Ph.D. 


Progress in the Delivery of siRNA 

Mark Tracy, Ph.D. 

Alnylam Pharmaceuticals 

Oligonucleotide Therapeutics: Regulatory 

Pathway 

Pei Fan (Jane) Bai, Ph.D., invited 


Clinical Pharmacokinetic and Safety Studies 

of RNAi in Humans 

John DeVincenzo, Ph.D. 


8:30 am – 4:00 pm 

Transporter-mediated Drug-drug 

Interactions: Possible Criteria that 

Warrant In Vivo Transporter-mediated 




It is widely recognized that membrane transporters 

play an important role in modulating drug 

absorption, distribution, and elimination. 

Superfluity of publications in the recent years 

advances the understanding of these processes, 

and enables the interpretation of underlying 

mechanisms responsible for the modification 

of pharmacokinetic and pharmacodynamics. 

Furthermore, an increased interest has been shown 

by both regulatory agencies and pharmaceutical 

industry to understand the potential clinical 

implications of transporter-mediated drug-drug 

interactions for new drugs. For pharmaceutical 

scientists, the challenge ahead will be the 

successful translation of this basic awareness of 

drug transporters to applications in drug discovery 

and development. This short course will introduce 

the basic concepts of drug transport, the role of 

transporters in drug-drug interactions (DDI), the role 

of transporters in toxicity, models for characterizing 

drug transporters, and give examples of translation 

of preclinical knowledge into the clinical setting. 

Moderators 

Yurong Lai, Ph.D. 

Pfizer, Inc. 

Joseph Polli, Ph.D. 


Overview of Efflux Transporters Mediated 

Drug-drug Interaction 

Douglas H. Sweet, Ph.D. 

Virginia Commonwealth University 

Overview of Uptake Transporters Mediated 

Drug-drug Interaction 

Richard Kim, Ph.D. 

University of Western Ontario 

In Vitro Drug Transport Drug Interaction 

Studies-Design, Data Analysis, and 

Recommendation for Clinical Studies 

Shiew Mei Huang, Ph.D., invited 


Possible Criteria that Warrant In Vivo Renal 

Transporters Mediated DDI Studies and 

In Vitro Assessments 

Kathy Giacomini, Ph.D. 

University of California, San Fransisco 

Possible Criteria that Warrant In Vivo Hepatic 

Transporters Mediated DDI Studies and In 

Vitro Assessments 


Pfizer, Inc. 

Possible Criteria that Warrant In Vivo 

Gastrointestinal Efflux Transporters-mediated 

DDI Studies and In Vitro Assessments 






8:00 am – 10:00 am 

Biotherapeutics and Modulation of Drug 

Transporters 

Roundtable 

Therapeutic proteins (cytokines, interleukins, 

and monoclonal antibodies) are becoming widely 

popular for many therapeutic area and diseases. 

However, the interaction of drug transporters/ 

enzymes and biotherapeutics remains largely 

unknown. It has been shown that interferons can 

have an impact on drug transporters that may alter 

the pharmacokinetics and pharmacodynamics of a 

conventional drug. For example, interferon-alpha 

induces a significant dose-dependent inhibitory 

effect on P-gp intestinal activity and results in 

increased bioavailability of digoxin. The findings 

could have important clinical relevance because 

interferon-alpha is widely used in cancer, antiviral 

therapy, and could be associated with efflux 

transporter substrates, such as anticancer drugs. 

The goal of this session is to increase awareness 

among the audience about this rapidly emerging 

area, and to share case studies that highlight the 

interplay between these systems.

66 



Moderators 


Pfizer, Inc. 

Marilyn Morris, Ph.D. 



Regulation of Transporters by Nuclear 

Hormone Receptors: Implications During 

Inflammation 

Micheline Piquette-Miller, Ph.D. 

University of Toronto 

Impact of Inflammation on Hepatobiliary 

Transporters 


Pfizer, Inc. 

Drug Interaction Studies of Therapeutic 

Protein or Monoclonal Antibodies 

Iftekhar Mahmood, Ph.D., invited 


8:00 am – 10:00 am 

Optimization of Systemic Exposure in 

Preclinical and Clinical Development: 

“Success Stories” of Proven Methods for 

Challenging Drug Candidates — What 

You Did Not Already Know! 

Roundtable 

The identification and development of new drug 

candidates with a desirable systemic exposure 

that is both efficacious and safe in humans 

with “developable” formulations based on 

preclinical data remains a major challenge in the 

pharmaceutical sciences. One reason is that oral 

systemic exposure is determined by a variety of 

physicochemical and metabolic factors including 

drug solubility, permeability, dissolution, dosage 

forms, as well as, first-pass, transporter effects, 

and varying gastrointestinal physiology. Another 

reason is that multidisciplinary teams often cannot 

reach consensus which formulation and modeling 

approaches can be used with confidence to select 

a dosage form for first in human studies. Thus, 

science driven strategies to determine the systemic 

exposure rate limits will be presented based on new 

compounds and new data. Correct analysis of factors 

controlling exposure for drugs of all BCS classes. 

When low exposure is seen, there can be the 

incorrect perception that formulation improvement 

works for every compound. In other cases, controlled 

release formulations should be attempted to 

optimize the PK profiles. Modeling and simulation 

are also meaningful tools in designing PK/ 

formulation/ADME/TK studies, as well as, species 

scaling to human. Specific formulation strategies, 

and proven modeling approaches that can be used 

when facing different BCS classification compounds 

will be shared. In addition, the role of transporters 

in drug disposition with a focus on BCS Class II-IV 

drugs will be discussed, as well as, science-driven 

optimization of formulation selection studies for 

clinical trials and final marketing formulations. 

Moderators 


Novartis 

Hyo-Kyung Han, Ph.D. 

Chosun University 

Successful Methods for Systemic Exposure 

Optimization: IVIVC and Proven Formulation 

Strategies to Predict Clinical and Preclinical 

Outcome for Drugs of All BCS Classes 

Handan He, Ph.D. 

Novartis 

Systemic Exposure and Oral Absorption 

Assessment of Poorly Water-soluble Drugs in 

the Fasted and Fed State to Predict Clinical 

Outcome 

Makoto Kataoka, Ph.D. 

Setsunan University 

BDDCS vs. BCS as an Enabling Tool in Drugs 

Discovery: Evolving Understandings of 

Disposition for BCS Class II-IV Drugs 

Leslie Benet, Ph.D. 




2:00 pm – 4:30 pm 




Symposium 

Recent implementation of removing children 

(ages 0-4) from the labels of various OTC coldrelief 

medicines is due to a finding that there 

have been more adverse events in this age group. 

Pediatric patients are a vulnerable population 

that needs special attention to the efficacy and 

safety of medicines administered. What are the 

biomarkers for extrapolating adult doses for 

younger children (age 0-4)? Is the body-weight 

based approach reasonable? What biomarkers 

(ontogenic development of phase I and phase 

III metabolizing enzymes) should we explore? Is 

systemic exposure of drug a reliable biomarker for 

selecting pediatric dose and predicting adverse 

events in younger children? What is known about 

the difference between adults and younger children 

of this age group in terms of the pharmacological 

and pharmacodynamic responses? This symposium 

will have a panel of clinical experts and regulatory 

authority to discuss dose selection biomarkers 

for younger children based on our understanding 

of drug absorption, ontogenic development of 

metabolizing enzymes, and pharmacological 

receptors that affect the efficacy and safety of 

pediatric medical use. The FDA’s pediatric guidance 

update and drug-disease interactions in pediatrics 

will be discussed as well. Our symposium has been 

aligned with the symposium, entitled “Leveraging 

Prior Quantitative Knowledge in Guiding Pediatric 

Drug Development,” which is scheduled for 

2:00 pm – 4:30 pm, November 10, 2009. The goal 

of our alignment is to give the attendees a complete 

overview of pediatric drug development. 

Moderators 





Ontogeny of Drug Metabolizing Enzymes and 

Transporters: Potential Biomarkers for Drug 

Disposition in Newborns and Infants 



Predicting Pediatric Doses for Therapeutic 

Success via Simulation and Modeling 

Jeffrey Barrett, Ph.D. 

University of Pennsylvania 

Experience with Infants and Young Children in 

Drug Studies Performed Under BPCA and PREA 



Clinical Biomarkers: Nice to Have or a Clinical 

Imperative? 

Paul J. Desjardins, D.M.D., Ph.D. 

Wyeth Consumer Healthcare 

2:00 pm – 4:30 pm 




Event Models 

Symposium 

This session will allow attendees to better 

understand how multi-level, multi-scale, multiattribute, 

adaptable, and extensible, discrete event 

models can be used to advance pharmaceutical 

research. Understand the uses and capabilities 

of different classes of models and methods. 

Understand how new classes of models can help 

bridge the gap between current PK/PD models 

and the wet-lab, animal, and clinical trial models 

on which pharmaceutical research depends.

SM 

67 



Pharmaceutical R&D can benefit greatly from 

adopting important advances in discrete event 

M&S methods, which have occurred within the 

past decade. The time is ripe to begin exploring the 

insights that can be achieved using these methods; 

they provide capabilities beyond those of traditional 

analytical, inductive, equation-based PK and PD 

modeling and simulation (M&S) methods. These 

new M&S methods make it easier to instantiate 

increasingly realistic, multi-level, multi-scale, multiattribute, 

adaptable, and extensible models relevant 

to pharmaceutical R&D. The models are suitable for 

use in research and in testing hypotheses about the 

pharmacological and toxicological mechanisms that 

are relevant to pharmaceutical R&D. This symposium 

will provide the audience an overview of these 

new methods. Presentations will draw on specific, 

pharmaceutically relevant models. Because the 

new methods are intended to be synergistic 

with traditional PK/PD M&S methods, the new 

and traditional methods will be compared 

and contrasted. 

Moderator 

Steven Chang, M.S. 

Immunetrics Inc. 

Dynamic Knowledge Representation Using an 

Agent-based Modeling Paradigm 

Gary An, M.D. 

Northwestern University 

Measuring, Modeling, and Modulating 

Inflammation in Mice and Men 

Yoram Vodovotz, Ph.D. 


Bridging the Gap Between Mathematical 

Models and Wet-lab Models 

C. Anthony Hunt, Ph.D. 


Using Agent-directed Simulation to Accelerate 

Unraveling the Complexities of Adaptive 

Biological Systems 

Levent Yilmaz, Ph.D. 

Auburn University 



7:00 am – 8:15 am 



Pharmacokinetic assessment in early drug discovery 

is now a commonly accepted approach to increase 

the chances of identifying candidates with suitable 

properties for further development. For CNS 

therapeutics, there is the additional requirement 

of blood brain barrier (BBB) penetration and brain 

localization. Several tools, both old and new, are 

being applied to guide drug design and medicinal 

chemistry to increase brain penetration. This 

sunrise session will contain presentations about 

in silico prediction tools for BBB, discuss in vitro 

models of the BBB, and present a case study of BBB 

enhancements in drug discovery. 

Moderator 

Nurulain Zaveri, Ph.D. 


Key Principles for Optimization of CNStargeted 

Therapeutics 

Stephen Hitchcock, Ph.D. 

Amgen Inc. 


Andrew Coop, Ph.D. 

University of Maryland School of Pharmacy 

7:00 am – 8:15 am 


Too Small, Just Right! Size Issues in Drug 

Development 


Determining the most appropriate dose for a new 

pharmaceutical one must take into account two 

different perspectives the patient and the drug. 

Patients come in a variety of sizes and drugs vary 

in their therapeutic range, and the necessity to 

customize the dose for individual patients. Healthy 

volunteers participating in phase 1 studies are 

usually within 15% of ideal body weight. Subjects 

participating in phase 2 and 3 trials are also 

usually within a reasonably narrow range of weight, 

compared to the people who will eventually be 

treated including premature neonates (0.5kg) to the 

very obese (200 kg+). How can adequate information 

be collected during drug development on the best 

way to dose patients who are either much smaller 

than average, or much larger than average to avoid 

increased incidence of adverse events or inadequate 

treatment? Some medications are prescribed in 

‘flat’ doses expressed in mg for example, while 

others are dosed on a mg/m2 or mg/kg basis. 

When is it appropriate to do either? Biologics have 

conventionally been doses by weight, as have drugs 

used to treat cancer, yet in some cases, normalizing 

for size increases variability and potential for 

dose administration error. What factors should be 

considered in developing dosing recommendations? 

At the end of the session participants will be able 

to describe the different ways that size is described 

(ideal body weight, actual body weight, lean body 

weight, fat free mass, dry weight, body surface area, 

body mass index, growth charts), list the data/ 

conventions upon which dosing per kg and dosing 

per m2 is based, become familiar with study design 

and analysis methods to determine if dosing needs 

to be adjusted for size, and describe the potential 

impact of over and underdosing on patient outcome. 

Moderator 



How Big? How Small? Methods and 

Conventions of Describing Size 



Size is Not Everything — Life Beyond Allometry 





8:30 am – 11:00 am 






Sponsored by 





Sponsored by

68 




9:00 am – 11:00 am 

To Test or Not to Test? Risk Assessment 

Approaches for Human Metabolites 

Roundtable 

This session is intended to take the U.S. Food and 

Drug Administration Guidance on Safety Testing of 

Drug Metabolites to the next logical step by focusing 

on strategic approaches for risk assessment of major 

and unique human metabolites. Currently, many 

companies have accepted the guidance, but are at 

a loss for how to implement its recommendations 

in the real world of drug development. Industry 

speakers will present case studies that did 

and did not result in stand-alone nonclinical 

safety assessment of a human metabolite. The 

presenters will also address inherent issues with 

conducting risk assessment on metabolites that are 

administered directly to an animal instead of formed 

in situ by normal metabolic processes. Finally, a 

U.S. Food and Drug Administration representative 

familiar with this area will address situations where 

actual metabolite safety testing can be instrumental 

in deconvoluting toxicity observed in the clinic. The 

roundtable should be very interactive as audience 

members are likely to provide their own perspectives 

and experiences on this hot topic. 

Moderators 

Debra Luffer-Atlas, Ph.D. 


K. Sandy Pang, Ph.D. 

University of Toronto 

Addressing Metabolite-related Safety 

Concerns in Early Development 

William G. Humphreys, Ph.D. 


Complicating Factors in Risk Assessment of 

Drug Metabolites 

Shelby Anderson, Ph.D. 


A Regulatory Perspective on Characterizing 

Human Metabolites 

Aisar Atrakchi, Ph.D. 




2:00 pm – 4:00 pm 

Inclusion of Women in Clinical Trials 

and Drug Development — How Far Have 

We Gone 

Roundtable 

Women were initially excluded from clinical research 

due to liability concerns and historical precedence. 

The result was the “male norm” of research. 

Research subjects were predominately men since 

most researchers thought men and women were 

biologically the same except for their reproductive 

organs. By the 1980’s, it was clear that the exclusion 

of women from clinical studies compromised the 

health care they received. This created a scientific 

knowledge gap that has resulted in health care 

disparity for women over the past many years. 

Sex affects health and health care; the following 

examples illustrate why it is imperative that 

diseases and treatments be studied for the different 

effects they can have on women and men. A 2001 

report from the General Accounting Office (GAO) 

on the U.S. Food and Drug Administration (FDA) 

revealed that eight of 10 drugs recently withdrawn 

from the market caused more adverse events in 

women than men. Heart disease kills 500,000 

American women each year, over 50,000 more 

women than men, and strikes women, on average, 

10 years later than men. Women are 2.7 times more 

likely to acquire an autoimmune disease, such as 

multiple sclerosis, lupus or rheumatoid arthritis. 

Women wake up from anesthesia an average four 

minutes before men do. 

Moderator 

Emmanuel O. Fadiran, R.Ph., M.S., Ph.D. 



Development — Regulatory Perspectives 

Ameeta Parekh, Ph.D. 



Development — Clinical Perspectives 

C. Noel Bairey Merz, M.D. 

Cedars-Sinai Medical Center, UCLA 


Development — Industry Perspectives 

Poornima Sood, M.D. 



2:00 pm – 4:30 pm 

Reactive Metabolites in Drug Discovery 

and Development: How Can We Handle 

the Risk? 

Symposium 

Safety-related issues continue to significantly 

contribute to the overall attrition statistics in the 

pharmaceutical industry. The metabolic formation of 

reactive metabolite intermediates in vivo represent a 

risk in the drug discovery and development process 

which can manifest itself as drug-induced toxicity 

later on in patients as unforeseen idiosyncrasies. 

Significant advances in our knowledge of 

biotransformation pathways over the last 20 years 

have resulted in a better understanding of the 

underlying chemical mechanisms, which drive the 

formation of reactive intermediates. An increasingly 

integrative approach of medicinal chemistry, 

computational chemistry, biology and toxicology 

holds the promise that academic and industry 

research has become more capable of designing 

out unwanted toxicity risks from drug candidates, 

which will ultimately lead to safer drugs for patients. 

The present symposium will discuss the current 

state of the art in reactive metabolite (RM) research 

regarding compound design, RM detection, RM 

toxicological implications and RM risk assessment in 


Moderators 

Raimund M. Peter, Ph.D. 

AstraZeneca 

Dhiren Thakker, Ph.D. 


Chemically-induced Toxicity: Concepts 

Frederick P. Guengerich, Ph.D. 

Vanderbilt University 

Reactive Metabolites: Biological and 

Pharmacological Consequences 

B. Kevin Park, M.D., Ph.D. 

University of Liverpool 

Chemical Toxicophores: Potential for Trouble 

Amit Kalgutkar, Ph.D. 


Structure/Toxicity Relationships in Reactive 

Metabolite-mediated Drug Toxicities 

Sidney D. Nelson, Ph.D. 

University of Washington 

Reactive Metabolites: Risk Management in 

Discovery & Development 

David C. Evans, Ph.D. 

Johnson & Johnson Pharmaceutical Research & 

Development, L.L.C

69 



2:00 pm – 4:30 pm 

Pros and Cons of Emerging Methods in 

Population PK and Exposure/Response 

Analysis 

Symposium 

This session will discuss the advantages and 

limitations of emerging and established algorithms 

and software implementations of population 

PKPD analysis methods. The following algorithms 

(software) will be discussed, with a focus on the 

versatility of the methods to specify and estimate 

complex PKPD models (such as mechanistic disease 

progression models, and models with categorical or 

time-to-event endpoints): SAEM (MONOLIX), MCMC 

(BUGS), and MCPEM (S-ADAPT), NLME (MATLAB 

and NONMEM). 

Moderator 

Amit Roy, Ph.D. 


Likelihood Estimation in Population 

PKPD Analyses Using the SAEM Algorithm 

Implemented in MONOLIX 

Radojka Savic, Ph.D. 

INSERM 

Modeling and Nonlinear Mixed-effects 

Methods in MATLAB and SimBiology 

Ricardo Paxson, M.S. 

The MathWorks, Inc. 

Pros and Cons of Bayesian PKPD Modeling 

Using BUGS 

William R. Gillespie, Ph.D. 


Comparison of Population Estimation Methods 

for Complex PKPD Systems 

Chee Ng, Ph.D., Pharm.D. 


2:00 pm – 4:30 pm 

Leveraging Prior Quantitative Knowledge 

in Guiding Pediatric Drug Development 

Symposium 

The U.S. Food and Drug Administration and 

European Medicines Agency have recently renewed 

their call for innovative model-based approaches 

to pediatric drug development. It is evident in the 

requirements for sponsors to include a modeling 

and simulation plan, where applicable, in their 

pediatric investigational plans (PIP) and use of 

clinical trial simulations to support pediatric written 

request. The key issues facing us today are high 

pediatric trial failure rate due to lack of powerful and 

innovative clinical trial designs, failure to establish 

informative pediatric dosing recommendations due 

to lack of appreciation for differences in exposureresponse 

relationship between pediatric and adult 

population. Traditionally, studies have focused on PK 

differences only. Inappropriate or lack of use of prior 

quantitative knowledge to better design pediatric 

development programs The objectives of this 

session are to demonstrate through case studies the 

value of designing pediatric developing programs 

using model-based approaches, and demonstrate 

through case studies the impact of prior quantitative 

knowledge on pediatric development/dosing 

decisions. This symposium has been aligned with 

the symposium, entitled “Strategic Biomarkers for 

Treating Diseases in Younger Children Safely and 

Effectively” scheduled for Monday, November 9, 

2009 at 2:00 pm. The goal of this alignment is to 

give the attendees a complete overview of pediatric 


Moderator 

Pravin Jadhav, Ph.D. 


Transforming Pediatric Drug Development by 

Informed Decision Making 

Pravin Jadhav, Ph.D., invited 


Role of Modeling and Simulation in 

Developing PIP and Regulatory Decision 

Making 

Anja Henningsson, Ph.D., invited 

Medical Products Agency (MPA Swedish Agency) 

Efficient Decision Making for Clinical Trials 

Using a Model Based Approach 

Steven Kern, Ph.D. 

University of Utah 

Bayesian Model-based Approaches to 

Pediatric Trial Design and Dosing Rule 

Determination: Case Studies 

Marc Gastonguay, Ph.D. 



RECEPTION 

5:45 pm – 7:30 pm 

AAPS Pharmacokinetics, 

Pharmacodynamics and Drug 

Metabolism (PPDM) Section Joint 




7:00 am – 8:15 am 

Minimizing the Guesswork of Early 

Human Dose Predictions: Application 

of PK Prediction Methodologies 

Including PBPK 


The accurate prediction of pharmacokinetic 

parameters in humans and anticipation of human 

dose (AHD) for early human studies based on 

preclinical and/or physicochemical data remains a 

major challenge, in spite of coverage of this topic 

in the literature and at AAPS meetings (e.g. P. Lowe 

et. al., Xenobiotica, 2007). While many methods 

are known, such as allometry, or physiology based 

pharmacokinetic modeling (PBPK) and IVIVC, many 

questions remain for pharmaceutical scientists on 

how to predict human dosing regimen for “difficult” 

compounds with confidence, such as those with 

species dependent or formulation dependent PK, 

i.e. BCS class II and IV compounds with solubility/ 

dissolution limited exposure. Some companies have 

developed their own strategies, and others have 

published their methods, but often specifics are 

not covered in detail. In this sunrise session recent 

case examples for human PK and dose projections 

of compounds with new data will be covered. The 

session will focus on current compounds and 

will not be a review of text book examples. The 

session will cover latest AHD applications using 

practical and tested methods, including; human PK 

parameter projections including for clearance, (CL) 

distribution (Vd), and bioavailability (F). How to use 

multiple approaches to verify human PK parameters, 

and how to establish and judge confidence in 

predictions methods with tools such as metabolic 

IVIVC and reverse pharmacology approaches — 

thus minimizing “Guesswork”. How to integrate 

Human PK projections with PK/PD modeling results 

for predicting human plasma concentration-time 

profiles and a suitable dosing regimen using a PBPK 

modeling approach. How to integrate formulation 

parameters into human PK profile predictions for 

BCS class II and IV drugs using GastroPlus, assess 

human PK profiles with new modified release 

formulations with dissolution data and establish 

IVIVC for all BCS classes, and establish and use 

IVIVC for new formulations of marketed drugs or 

drugs in clinical trials. This event will benefit all 

pharmaceutical scientists who are involved with 

first-in-human (FIH) dose projections, or are in early 

to late development, where human PK and dose 

projections are sought. This event will cover latest 

trouble-shooting, modeling, and IVIVC strategies 

that have been successfully used. The speakers will 

include speakers from DMPK and biopharmaceutical 

development departments.

70 



Moderators 


Novartis 

Jennifer J. Sheng, Ph.D. 

AstraZeneca 



Methodologies Including PBPK (Part 1) 

Steven C. Sutton, Ph.D., R.Ph. 

Simulation Consultation Services 



Methodologies Including PBPK (Part 2) 

Natilie Hosea, Ph.D. 

Pfizer, Inc. 

7:00 am – 8:15 am 

Today, Tomorrow, and Beyond: 

Approaches and Challenges in Modeling 

Pharmacodynamic Effects with Long 

Time Delays 


This session will provide a comprehensive summary 

of empirical, semi-mechanistic, and mechanistic 

approaches for modeling long time delays in 

exposure-response relationships and discuss their 

advantages and limitations. Modeling & simulation 

activities are widely applied in various stages of drug 

development, and quantitative model-based drug 

development is strongly promoted by U.S. Food and 

Drug Administration (FDA) and many pharmaceutical 

companies. Establishment of exposure-response 

relationships and their prospective application 

in drug development is oftentimes hampered by 

long time delays between drug concentration-time 

profiles and effect-time profiles in the order of 

days, weeks or even months. The development of 

small molecule NCEs as well as biologics may be 

complicated by these time delays between exposure 

and response. Examples of safety as well as efficacy 

endpoints include myelosuppression and/or the 

antiproliferative effect of cancer chemotherapy, the 

interaction with processes such as erythropoiesis 

and granulocytopoiesis, and the inhibition of 

cytokine signaling leading to clinical disease 

improvement. Different approaches to model this 

kind of delayed effects have emerged in recent 

years, for example transit compartment and cell 

lifespan models. This sunrise session intends to 

provide a comprehensive overview on the available 

modeling approaches for delayed PD responses 

and will discuss their advantages, disadvantages 

and limitations. 

Moderators 

Nageshwar Budha, Ph.D. 




Empirical and Semi-mechanistic Modeling 

Approaches for Long Time Delays in 

Concentration Response Profiles 

Lena Friberg, Ph.D. 

Uppsala University 

Mechanistic Approaches for Modeling Long 

Time Delays in Drug Response 

Juan Jose Perez Ruixo, Ph.D. 

Amgen Inc. 

7:00 am – 8:15 am 

Pharmacogenetics: Methods and 

Clinical Applications 


This session will introduce the building tools 

and technologies that are currently used in 

pharmacogenomics (PGx) testing in laboratory 

diagnostics, drug therapy, and drug and biomarkers 

discovery. The clinical application of molecular 

diagnostics and relevant SNPs and gene expression 

technology used in PGx will be discussed to 

illustrate that patient outcome can be optimized and 

adverse drug reactions can be minimized through 

a combination of genetic testing and serum drug 

therapeutic level monitoring. 

Moderator 



Building Tools of Pharmacogenetics 

Majid Moridani, Pharm.D., Ph.D. 

Texas Tech Health Sciences Center 

The Application of Pharmacogenetics in 

Clinical Medicine and Drug Discovery 





8:30 am – 11:00 am 


Quantitative Proteomics in ADME 

Symposium 

Proteins are intimately responsible for modulating 

drug disposition, as binding proteins, enzymes of 

metabolism and uptake/efflux transporters. Novel 

protein therapeutics are also an increasing fraction 

of new drugs and endogenous proteins are being 

identified as biomarkers of disease. Proteins are 

often measured in drug development and discovery 

though most quantitative measurements of specific 

proteins are done using semi-quantitative western 

blotting or with ELISA assays. Western blots are 

tedious, not very reproducible between or within 

labs, are relative quantification, and have a limited 

dynamic range. ELISA assays require significant 

validation and are often non-specific. Most limiting 

is the requirement of a specific antibody that 

often precludes successful quantitation, since 

many proteins have resisted extensive efforts to 

develop specific antibodies. Moreover, often a 

specific antibody developed for one species will not 

be applicable to another, thus necessitating the 

laborious development of additional antibodies. 

Clearly, improved methods to quantify specific 

targeted proteins are desirable, and if available, 

would benefit drug discovery and development. 

Recent reports have demonstrated the ability 

of LC-MS/MS to quantify proteins in complex 

biological matrixes. Targeted absolute quantitative 

proteomics (TAQP) is the use of LC-MS to quantify 

unique peptides characteristic of a specific protein. 

TAQP is a novel technology to quantify proteins 

and should create a new research field, i.e., 

“Pharmacoproteomics” defined as targeted absolute 

quantitative proteomics based pharmacokinetics, 

pharmacodynamics, toxicokinetics and 

toxocodynamics. This symposium will introduce 

TAQP and contrast it to other methods for absolute 

and relative protein quantitation and global protein 

quantification, provide rationale and examples 

for the use of the method in understanding drug 

metabolism, provide rationale, application, and 

examples for the use of the method in studying drug 

transport, and describe how TAQP may be employed 

for following protein therapeutics and biomarkers 

relevant to disease and drug effects. The speakers 

will integrate the use and applicability of TAQP to 

drug development and pharmacoproteomics. 

Moderators 

Tetsuya Terasaki, Ph.D. 

Tohoku University 

Philip C. Smith, Ph.D. 


Emerging Techniques in Quantitative 

Proteomics for Biomedical Research 

Christie Hunter, Ph.D. 

Applied Biosystems 

Prediction of In Vivo ADME Based on the 

Transporter Protein Quantification 

Tetsuya Terasaki, Ph.D. 

Tohoku University 

Improved Extrapolation of Hepatobiliary 

Secretion via Transporter Quantification 


Pfizer, Inc. 

Quantitative Proteomics of Glucuronidation 

Philip C. Smith, Ph.D. 

University of North Carolina at Chapel Hill

71 



8:30 am – 11:00 am 



Symposium 

Discovery and development of inhaled lung-targeted 

therapeutic agents such as bronchodilators 

and corticosteroids present substantial PKPD 

challenges; lung PK is not easily measurable in 

preclinical models and may not be measurable in 

clinical studies. Systemic PK is relevant for systemic 

effects but may not be so for airway effects such as 

bronchodilation. Sufficient understanding of the 

lung as an absorption barrier for small molecules 

is not currently available to allow for inference of 

lung PK from systemic observations. Quantitative 

dose-exposure-response analysis is rarely possible 

because of lack of relevant exposure data. Therefore, 

basic research is needed in order to characterize the 

ADME profile of lung-targeted inhaled agents. This 

symposium will provide specific information on the 

gaps that exist in our understanding of the lung as 

an ADME barrier, and in the absence of requisite 

clinical information, what quantitative tools exist 

to help develop PKPD understanding of lungtargeted 

agents. 

Moderators 

Dennis K. O’Connor, B.S. 




Lung ADME 

Ann Tronde, Ph.D. 

AstraZeneca 

Inhalation by Design 

Rhys Jones, M.S. 


PK-PD Considerations of Inhaled Agents — 

Corticosteroids as an Example 

Gunther Hochhaus, Ph.D. 

University of Florida 

Bioequivalence Testing for Inhaled Lungtargeted 

Agents 

Wallace Adams, Ph.D. 



9:00 am – 11:00 am 

Facilitating the Transition to Modelbased 


Roundtable 

The goal of this roundtable session is to elicit 

discussion regarding the issues surrounding 

the implementation of quantitative modeling 

and simulation strategies and their integration 

into drug development project timelines. Use of 

these strategies in a model-based development 

paradigm has been proposed as a mechanism to 

improve both the efficiency and productivity of drug 

development. However, recognition of common 

obstacles to the seamless integration of these 

methods as a critical component of decision-making 

may facilitate systematic changes to achieve the 

optimal benefit. Brief presentations addressing the 

role of integrated project teams in supporting this 

paradigm, the essential infrastructure elements 

required for successful implementation, and the 

team communication and integration issues to be 

addressed for optimal management buy-in and 

efficient and informed decision-making will come 

before an open discussion of lessons learned 

and strategies for success. The presentation, the 

Other Critical Path: The Role of Integrated Project 

Teams in Drug Discovery and Development, will 

explore the following areas: how do we structure 

integrated project teams for maximum efficiency and 

effectiveness; what are the roles and responsibilities 

of the members of a drug development integrated 

project team; how can an integrated project team 

assist a pharmacometrician and facilitate modelbased 

drug development; how can integrated 

project teams be used to meet aggressive timelines 

and facilitate informed decision-making. The 

presentation, the Engineering the Pharmacometrics 

Enterprise: Science in Support of Science, will 

discuss the following areas: what are the key 

components of the pharmacometrics enterprise; 

how do we move from model-supported drug 

development to model-based drug development; 

and what can be done to improve the efficiency and 

effectiveness of pharmacometrics. 

Moderator 

Jill B. Fiedler-Kelly, M.S. 

Cognigen Corporation 

The Other Critical Path: The Role of Integrated 

Project Teams in Drug Discovery and 

Development 

David Y. Mitchell, Ph.D. 

Mitchell Pharmaceutical Consulting, LLC 

Engineering the Pharmacometrics Enterprise: 

Science in Support of Science 

Thaddeus H. Grasela, Pharm.D., Ph.D. 


9:00 am – 11:00 am 



Roundtable 

Pharmacogenomics has emerged as an important 

tool for discovering new therapeutic agents as well 

as re-evaluating existing drugs for improving their 

efficacy and/or applications. The pharmaceutical 

industry continues to contribute significantly to 

development of high-throughput technologies 

applied to pharmacogenomic research. Efficient 

translation of the scientific data into clinical 

applications requires careful analyses, prioritization 

and streamlining of the information at various levels 

even as the regulatory approvals are sought. While 

pharmaceutical organizations follow their own 

set of internal standard operating protocols and 

process guidelines, it would be useful to provide a 

common platform to researchers from the industry 

to share their experiences and perspectives on 

what strategies worked, how challenges were 

overcome, what do they foresee as emerging 

issues in the near future, and what is the impact 

of the pharmacogenomic approach on the overall 

economics of the drug development/ 

approval process. 

Moderators 



Pramod Mahajan, Ph.D. 

Drake University 



Allen Roses, M.D. 

Cabernet Pharmaceuticals Inc. 


Development: A Medco Perspective 

Felix Frueh, Ph.D. 

Medco Health Solutions, Inc. 


Development: A GSK Perspective 

Ann Saunders, Ph.D. 

GlaxoSmithKline plc

72 



9:00 am – 11:00 am 

Translational Challenges in PK/PD/TD 

of Biotechnology-derived Products 

Roundtable 

The unique complexities associated with the PK 

and PK/PD of biotechnology-derived products 

including immunogenicity, species specificities, 

and target/immune-mediated clearance pose 

special challenges in translation of PK/PD/TD from 

preclinical to clinical domain. In preclinical safety 

assessment, a loss of exposure of humanized 

antibody due to neutralizing immune response 

may prevent appropriate end-organ toxicity or 

safety margin estimation and may not have human 

relevance. Translation of safety biomarkers from 

early to late stage of clinical development. 

Moderator 


Merck & Co, Inc. 

PK/PD Translational Issues with Biologics 


Merck & Co, Inc. 

Translation of Safety Biomarkers from Early to 

Late Stage of Clinical Development 

Joy A. Cavagnaro, Ph.D., D.A.B.T., R.A.C 

AccessBio 


2:00 pm – 4:00 pm 

In Vivo Animal Models for Prediction of 

Drug-drug Interactions 

Roundtable 

With the advent of polytherapy it has become 

prudent to minimize, as much as possible, the 

potential for drug-drug interactions. Conducting 

drug-drug interaction studies is expensive and there 

is great emphasis to proactively minimize potential 

for drug-drug interactions. Towards this end, the 

metabolic and transporter pathways involved in the 

disposition of a drug candidate (phenotyping) are 

evaluated in vitro employing available human tissue 

and specific reagents. Likewise, in vitro screening 

for inhibition and induction of drug-metabolizing 

enzymes and transporters is conducted also. Such 

in vitro human data can be made available prior to 

human dosing and enable in vitro to in vivo-based 

predictions of clinical outcomes. Despite some 

success, however, in vitro systems are not dynamic 

and sometimes fail to predict drug-drug interactions 

for a variety of reasons. In comparison, relatively 

less effort has been made to evaluate predictions 

based on data derived from in vivo animal models. 

The focus of this roundtable is to provide examples 

where animal models can be used to predict 

cytochrome P450-and transporter-based drug-drug 

interactions. Following brief presentations, there 

will be discussion surrounding caveats in employing 

these animal models and their utility in conjunction 

with in vitro-in vivo extrapolation methods. Such 

an integrated data set can be used to select drug 

candidates with a reduced drug interaction potential. 

Moderator 

Punit H. Marathe, Ph.D. 


In Vivo Animal Models for Prediction of CYP 

Inhibition-mediated Drug-drug Interactions 

Cuyue Tang, Ph.D. 


In Vivo Animal Models for Prediction of CYP 

Induction-mediated Drug-drug Interactions 

Michael Sinz, Ph.D. 


In Vivo Animal Models for Prediction of 

Transporter-mediated Drug-drug Interactions 

Gary Bowers, Ph.D. 




2:00 pm – 4:30 pm 

Mechanism-based PKPD Modeling: Its 

Role in Discovery and Early Development 

of Biologics 

Symposium 

Pharmacokinetic-Pharmacodynamic (PKPD) 

modeling is being increasingly applied early on in 

the discovery and development of all therapeutics. 

This technology has even higher relevance for 

biologics such as antibodies, because of their 

unique PKPD properties. The increase in computing 

power and higher resolution in analytical techniques 

for measuring cellular reactions has prompted 

increased confidence in in silico approaches such 

as computational systems biology in the design 

of therapeutics with optimal PKPD properties. The 

regulatory environment has also changed in recent 

years and PKPD modeling using preclinical data may 

be required to support first-in-human trial designs 

for “high-risk” biologics such as some antibodies. 

This symposium will discuss the importance 

of early investment in a PKPD modeling and 

simulation platform, discovery through preclinical 

development, and support the optimal progress of 

biologic programs. 

Moderators 

Ellen Q. Wang, Ph.D. 


Joseph P. Balthasar, Ph.D. 



Integration Not Isolation: The Role of 

Computational Systems Biology on the 

Discovery of Antibody Therapeutics 

John Burke, Ph.D. 


PKPD Modeling of Preclinical Data Using a 

Surrogate Antibody to Underwrite Reprotoxicology 

Safety 

Saileta Prabhu, Ph.D. 


PKPD vs. Toxicology-based Approach to 

Starting Dose Selection in First-in-Human 

Trials 



Application of Mechanistic PKPD Modeling for 

Predicting Human PKPD Response 

Philip Lowe, Ph.D. 

Novartis Pharma AG 

2:00 pm – 4:30 pm 



Delivery 

Symposium 





















Moderators 


Nycomed 



73 












Diseased Skin 





2:00 pm – 4:30 pm 



Symposium 

The U.S. Food and Drug Administration Guidance 

for Industry for the study of drugs likely to be used 

in the elderly was first published in 1989 and was 

followed by the Guideline for Industry for Studies in 

Support of Special Populations: Geriatrics in 1994. 

The corresponding ICH guidance was published the 

same year. In the 15 years since that time, so many 

new tools useful in clinical pharmacology have been 

developed, and so much data on drug use in the 

elderly have been collected. With the Baby Boom 

generation entering their senior years, and with the 

large increase in the number of the individuals in 

their 80’s and 90’s, as well as the large increase 

in age-related morbidity associated with cancer 

and Alzheimer’s disease, it is time to review our 

understanding of the issues of drug development 

and the elderly. The topics to be discussed include 

current and projected demographic statistics 

including anticipated consumption of medical and 

pharmaceutical services, physiology of healthy aging 

as well as disease progression in the elderly, study 

design issues in phase 1, 2, and 3 associated with 

the elderly — including appropriate comparisons, 

and summarization of data to link what is learned 

in the young healthy volunteers to what is actually 

happening in the elderly receiving the drug; dosage 

form considerations for the elderly. At the end of the 

session, participants will understand the increasing 

number of elderly, especially those older than 75 

years of age, and the magnitude of the demand for 

clinical and pharmaceutical services in the next 25 

years; be able to describe the physiological changes 

associated with aging as well as those associated 

with common disease progression and the 

interaction; and be able to formulate a strategy for 

study design, analysis, and interpretation to develop 

the information needed to demonstrate exposure 

effect relationships in the elderly and other patients 

likely to receive medications. 

Moderators 





Physiological Changes Associated with Aging 

and Aging-related Disease 

James E. Tisdale, Pharm.D. 



Pharmacology: Regulatory Perspective 

Chandrahas G. Sahajwalla, Ph.D., invited 



Pharmacology: Pharmaceutical Industry 

Perspective 





7:00 am – 8:15 am 

Humanized Transgenic Transporter 

Models — Update on State-of-the-Art 


This sunrise session will provide up-to-date 

information on the state of the art with the various 

humanized transporter models. The human 

relevance of transporter based DDI’s can benefit via 

development of such humanized transporter models 

that expresses human transporters in animal 

models. The session will provide insights into all 

aspects of these project’s background, rationale, 

challenges, strategies, models, validations, 

implementation, future direction, etc. Leading 

scientists from academia and industry will be 

presenting the overview, as well as, the practical 

relevance of the humanized transporter models in 

drug discovery and development. Emphasis will 

be on the practical, and bottom line relevance of 

these models in facilitating clinical relevance of 

transporter based DDI’s. 

Moderator 

Praveen Balimane, Ph.D. 


Humanization Approaches: Technology and 

Strategic Approaches 

Kader Thiam, Ph.D. 

Gelita AG, Eberbach, Germany 

Use of Humanized Transporter Mice Models: 

ADME Applications 

Nico Scheer, Ph.D. 

Galderma 

7:00 am – 8:15 am 

Physiologically Based Pharmacokinetic 

Modeling: Concepts and Applications in 

Drug Discovery and Development 


This session will discuss the generic framework 

of Physiologically Based Pharmacokinetic (PBPK) 

models, and their applicability in drug discovery and 

development. In comparison to non-compartmental 

and compartmental approaches used routinely in 

drug discovery and development Physiologically 

Based Pharmacokinetic modeling (PBPK) provides 

a more mechanistic and physiological approach 

for integrating data and generating knowledge. 

Although, PBPK modeling has long been proposed 

as a modeling option, its application has only 

increased recently, in part, due to availability of in 

silico/in vitro prediction tools and generic easy-touse 

PBPK software. Over the past decade, multiple 

publications in both academia and industry have 

demonstrated the applicability of PBPK modeling in 

drug discovery and development. These applications 

range from use of PBPK models for candidate 

nomination in drug discovery, prediction of human 

pharmacokinetics from preclinical species, to 

clinical study design and efficacy predictions in 

drug development. This sunrise session intends to 

present the basic framework of generic PBPK models 

commonly used in literature and discuss selected 

case studies of their applicability in preclinical and 

clinical studies. 

Moderator 

Anjaneya P. Chimalakonda, Ph.D. 


Generic Physiologically Based 

Pharmacokinetic Models: Conceptual 

Framework 

Peter F. Thiel, Ph.D. 


Selected Case Studies on Application of PBPK 

Modeling in Preclinical and Clinical Studies 

Thierry Lave, Ph.D. 

F. Hoffmann-La Roche Ltd.

74 



7:00 am – 8:15 am 

Modeling Ophthalmic Drug Delivery 

and Disposition 


Sophisticated models for ocular drug disposition 

are becoming available, but there is little literature 

information on how accurate the models are, and 

to what problems they have been applied. This 

session will offer case studies in how these models 

have been applied, what insights have been gained, 

and what limitations have been experienced. Since 

sophisticated modeling and simulation of drug 

delivery is a relatively young field, this session is of 

broader interest not only for those scientists trying 

to build PK models, but also for the pharmacokinetic 

and drug delivery scientists trying to utilize those 

models to speed up drug development. 

Moderator 


Bausch & Lomb 

Modeling for Ophthalmic Drug Development 




8:30 am – 11:00 am 

The Role of ATP Binding Cassette 

Transporters in Tissue Defense and 

Organ Regeneration 

Symposium 

ATP binding cassette (ABC) transporters are 

membrane proteins predominantly expressed in 

excretory organs where they play an important 

role in the absorption, distribution, and excretion 

of drugs, xenobiotics and their metabolites. 

This session will review the current knowledge 

on the clinical impact of ABC transporters on 

the pharmacokinetics, pharmacodynamics, and 

toxicological effects of substrate drugs. In addition, 

the ABC transporters P-glycoprotein (P-gp/ABCB1) 

and breast cancer resistance protein (BCRP/ABCG2) 

are highly expressed in a population of primitive 

stem cells, the Side Population (SP). In this session, 

the role of the two transport proteins as phenotypic 

markers of bone marrow stem cells will be discussed 

along with their role in SP cells of other, nonhematopoietic 

tissues. The expression levels of BCRP 

and P-gp are tightly controlled and may determine 

the differentiation of SP cells towards other more 

specialized cell types. Overall, this session will 

provide background on the contribution of ABC 

transporters in tissue defense and present some 

recent findings on their role in organ regeneration 

and repair. 

Moderator 

Douglas H. Sweet, Ph.D. 

Virginia Commonwealth University 

ABC Transporters in Tissue Defense 

Mary Vore, Ph.D. 


ABC Transporters as Phenotypic Markers and 

Regulators of Stem Cells 

Kevin D. Bunting, Ph.D. 

Case Western 

ABCG2 and Myocardial Regeneration 

Cindy Martin, M.D. 

University of Minnesota 

Role of P-gp and BCRP in Regeneration After 

Acute Kidney Injury 

Rosalinde Masereeuw, Ph.D. 

Radboud University Nijmegen Medical Center 

8:30 am – 11:00 am 

Using Modeling and Simulation to 

Safely Adjust Dose Regimens for Obese 

Patients 

Symposium 

Obesity has reached epidemic proportions 

worldwide. Obesity presents major health, social, 

and economic implications. Obese patients are 

more susceptible to a variety of chronic diseases 

than individuals with normal body composition. 

For example, obese patients frequently have 

hypertension, arterial sclerosis, and other 

cardiovascular diseases. Diabetes is also common in 

obese patients. Despite increased pharmacotherapy 

among obese patients, there is little information 

about dose adjustments for this population. 

Particularly for drugs with a narrow therapeutic 

index. The main factors affecting tissue distribution 

are body composition, regional blood flow, and the 

affinity of the drug for plasma proteins and/or tissue 

components. All these factors are altered in obese 

patients. The obese have larger absolute lean body 

masses as well as fat masses than lean patients. 

However, the percentage of fat per kilogram of total 

body weight is markedly increased. Drug clearance 

can also be altered in obese patients. Morbid 

obesity is strongly associated with non-alcoholic 

fatty liver disease, and cytochrome P450 isoform 

expression is altered, but no clear overview of drug 

hepatic metabolism in obesity is currently available. 

Pharmacology studies have reported different 

results on renal function in obese patients as well, 

making it difficult to forecast the pharmacokinetic 

behavior of drugs in obese patients. There have 

been several published reviews of various strategies 

for dose adjustments in obese patients. These 

reports suggest that a number of widely used 

empiric strategies for dose adjustments in obese 

patients, including a priori dose reduction or 

dose capping, are inappropriate and should be 

discouraged. However there have been no suitable 

size descriptors developed for dose adjustments 

across a wide range of body compositions. The lack 

of information on mechanisms for dose adjustment 

in the obese may be partly attributed to insufficient 

knowledge about pharmacokinetic parameters as 

a function of body composition due to the exclusion 

of obese subjects from clinical trials. Contributing 

to the problem is the myriad of concomitant health 

issues associated with obesity. Modeling and 

simulation during drug development may provide 

insights about safe dose adjustments in drugs in the 

obese patient population. 

Moderator 

Diane R. Mould, Ph.D. 

Projections Research Inc 

Thoughts on a Mechanistic Approach to Build 

Predictive PK Models for the Overweight 

and Obese 

Bruce Green, Ph.D. 

Model Answers Pty Ltd 

Estimating Lean Body Weight in Children 

Stephen Duffull, Ph.D. 

University of Otago 

Anesthetics Drugs and Morbid Obesity 

Hendrikus J. Lemmens, M.D., Ph.D. 

Stanford University 

Considerations for Dose Adjustment in Obesity 

Rajnikanth Madabushi, Ph.D., invited 



9:00 am – 11:00 am 

First Time in Human Dosing — 

Gimmicks, Luck, and Science 

Roundtable 

This roundtable will discuss the rational approach of 

the design regimen in first time in human studies in 

clinical drug development. Occasionally, the dosing 

regimen in these studies is very much empirical 

and left to the guess work of an investigator. In this 

roundtable scientific basis of dose selection in first 

time in humans will be evaluated. 

Moderator 

Prasad Tata, M.Pharm, Ph.D. 

Covidien/Mallinckrodt, Inc.

75 



Clinical Pharmacology Rationale of First Time 

in Human Dosing Study 

Waldemar Radziszewski, M.D. 


Regulatory Insight and Experience of First Time 

in Human Dosing Studies 

Mehul Mehta, Ph.D., invited 


9:00 am – 11:00 am 

Predicting Oral Drug Absorption: 

Fiction and Facts 

Roundtable 

Finding a safe and effective compound amongst the 

hoards of available chemical moieties is challenging 

and costly. To bring a single drug to market may 

take years, cost hundreds of millions of dollars, and 

generally require testing in thousands of human 

subjects. Most drug candidates never make it as far 

as human testing and many that do are rejected for 

various reasons. In an effort to minimize time and 

costs of drug discovery and creation, pharmaceutical 

manufacturers have produced numerous screening 

techniques to identify the drug candidates most 

likely to take them to market. Some of these 

tests are aimed at drug absorption, distribution, 

metabolism, and elimination (ADME). Others 

are aimed at the effectiveness of drugs. In silico 

methods (i.e. computer models) are the fastest and 

one of the most efficient means for screening large 

numbers of drugs for oral absorption. For drugs 

that have survived the screening process, in silico 

methods continue to play an important role. This 

session will review models for predicting oral drug 

absorption. 

Moderators 




Novartis 

Mechanistic Approaches to Predicting Oral 

Drug Absorption 

Gordon Amidon, Ph.D. 


Roles of Oral Drug Absorption and Exposure 

Prediction in Drug Development 


Novartis 

Roles of Oral Drug Absorption Prediction in 

Regulatory Review 

Robert Lionberger, Ph.D. 


9:00 am – 11:00 am 

Evaluating Fit-for-Purpose Models: 

Consensus or Controversy 

Roundtable 

Disease/PK/PD/Trial Models are now being 

increasingly used to aid decisions in industry, 

hospital, and regulatory settings. It is generally 

agreed that the adequacy of a model should be 

judged mainly based on its intended application. 

While modeling zealots continue to debate on 

what term best fits the process of evaluating model 

adequacy (model validation, model evaluation, etc.) 

the more critical issue is the lack of consensus on 

what constitutes an adequate model for a specific 

application. The objective of this roundtable is to 

debate on the appropriateness of models frequently 

used in 3 areas of drug development; models 

derived from in vitro, preclinical and literature 

(study-level) data on competitors to inform decisions 

in preclinical and clinical development, models 

used to select doses for Phase 3 testing, and models 

used for regulatory decisions, specifically to derive 

labeling statements. The overarching question 

is, what are the minimally acceptable statistical, 

biological, and predictive (S, B, P) properties of 

such models? To encourage an interactive session 

on specific items, panel presentations will focus on 

the following scenarios of model application. First, 

intended application using exposure-response 

models for efficacy and safety to design a dose 

response study to find optimal dose(s) for Phase 

3 testing. What are minimally acceptable S/B/P 

properties for such models? What visual and 


adequacy? Second, intended application benchmark 

the magnitude of efficacy of your compound relative 

to competitors based on literature data to make a 

go/no-go decision. What are minimally acceptable 

S/B/P properties for such a model that combines 

subject level data for your compound with study 

level data with competitors? What visual and 


adequacy? Finally, intended application labeling 

statement to include the estimated magnitude of 

mean change in PK/efficacy/safety under conditions 

of an interacting agent or in a special population. 

What are minimally acceptable S/B/P properties for 

such models? What visual and statistical tools would 

you use to judge model adequacy? 

Moderator 



A Pharmacologist’s View 



A Statistician’s View 

Kenneth Kowalski, M.S. 

A2PG 




OPEN FORUM 

1:30 pm – 5:00 pm 

An Evolution or Revolution in Drug 

Metabolism: When, Where, Why, 

What, How? 

AAPS Pharmacokinetics, Pharmacodynamics 

and Drug Metabolism (PPDM) Open Forum 


The critical aspects and fundamentals for 

understanding the metabolism of new drugs are in 

continual change driven by technological innovation, 

regulatory expectations and the ubiquitous 

pressures of logistics, timing, and cost. Because of 

the diversity of different platforms and development 

programs, it is impossible to adopt a “one-size-fitsall” 

strategy for metabolism studies. Every molecule 

has unique characteristics and the development 

process represents complex and difficult challenges 

that pivot around the drug’s potency, efficacy, safety, 

toxicity, metabolic pathways and routes of excretion. 

Even greater challenges are poised on the horizon 

as human genomics and a deeper understanding 

of the impact of metabolic enzyme and transporter 

systems magnify the potential research complexity 

for metabolism studies. Technology is friend and 

foe providing incredible tools that facilitate greater 

sensitivity for metabolite identification but creating 

the difficult challenge of putting a meaningful 

perspective on the findings and observations. 

The questions that encapsulate drug metabolism 

studies are numerous and often escape any simple 

answer. At the PPDM Open Forum participants will 

discuss various aspects of the design, conduct 

and regulatory utility of mass balance and drug 

metabolism studies. Among the issues to be 

debated and discussed are: When is it best to 

perform human metabolism studies? Where will 

the greater understanding of human genomics 

take the next generation of metabolism studies? 

Why should samples be pooled or not and is there 

an optimal approach? What exactly is a “major” 

metabolite? How can 14C-tracer multiple dose study 

be conducted most efficiently and should they be?

76 



In addition, recent technological developments 

such as MALDI and AMS will be discussed. Are 

these newer technologies for drug metabolism 

really useful and how do they provide additional 

understanding of the drug’s metabolism and 

distribution? Why do various Pharma companies 

conduct drug metabolism research differently? Is 

cost a principle factor that drives how small or big 

companies approach metabolism issues? What are 

the pros and cons of NMR based methods? Can 

or should “light-label” ADME studies replace the 

conventional 14C mass balance approach? These 

and your questions about metabolism studies are 

the basis for the PPDM Open Forum. 

There likely will never be an absolute answer to 

many of these perplexing questions but through an 

open debate and dialog each participant can begin 

to narrow down the extensive array of possible 

answers based upon the collective experience 

of colleagues across the diverse pharmaceutical 

industry that includes regulatory and academic 

institutions. A consensus among scientific 

colleagues can be a powerful tool for reaching a 

pragmatic basis that leads to the implementation 

of appropriate technologies and leverages specific 

study designs that yield scientifically robust results 

maintaining the rigorous standards set within a 

regulatory framework. 

The PPDM Open Forum will be an opportunity 

for a dynamic exchange of ideas and thoughts 

about the current status and future opportunities 

for metabolism studies. We will have a panel of 

experts to engage all the participants in a lively 

exchange of ideas, challenges, proposals, and 

discourse. Don’t miss this chance to understand 

the new opportunities embodied in MALDI and 

AMS as well as the occasion to discuss with your 

colleagues the significant challenges that lie ahead 

for anyone involved in drug metabolism research. 

Please plan to join us at the PPDM Open Forum in 

Los Angeles. Bring your most challenging questions, 

your most perplexing problems, and most of all your 

passion for seeking meaningful answers that help 

to point the path forward to the next generation of 

metabolism research strategies. 

Moderators 

Richard F. Bergstrom, Ph.D. 

RFBergstrom PK/PD Consulting LLC 





Raimund M. Peter, Ph.D. 

AstraZeneca 

Raman Venkataramanan, Ph.D., M.S. 


Bonnie A. Avery, Ph.D. 


Lloyd Stevens, Ph.D. 

Pharmaceutical Profiles Limited 

Lane J. Brunner, Ph.D. 

Regis University

77 


AAPS Regulatory Sciences (RS) Programming 

at a glance 


8:30 am – 11:00 am 

Wednesday Morning Symposia 


9:00 am – 11:00 am 

Roundtables 

Impact of Changing Regulations on Postapproval 

CMC Changes: U.S. and E.U. 

Perspectives 

How to Face and Successfully Defend FDA 

and Other Regulatory Audits 

Symposium 

The Influence of Excipient 

Functionality on Quality by 

Design for Drug Product 

2:00 pm – 4:00 pm 

Roundtable 

Navigating the New Rules Regarding Patent 

Law: Decodifying ‘Obviousness’, ‘Limited 

Claims’, and How it Affects New Composition 

of Matter Patents 

2:00 pm – 4:30 pm 



Symposium 

Regulatory Significance of Critical Quality 

Attributes and Critical Process Parameters 

in Successful Product Development 

and Commercialization 

2:00 pm – 4:00 pm 



Roundtables 



Bioequivalence Requirements: 

Challenges in Global Drug Development 

and Harmonization 

2:00 pm – 4:00 pm 

Roundtable 

Comparator Products – 

Untold Stories 

2:00 pm – 4:30 pm 



a grant from 

Symposia 

Using the Quality-by-Design 

Principle to Establish 

Pharmaceutical Equivalence 

and Bioequivalence of 

Advanced Dosage Forms 

Microdialysis Role in 

the Development and 

Optimization of Drug 

Topical Delivery 

1:30 pm – 5:00 pm 

Open Forums 

Global Regulatory Challenges 

for Genotoxic Impurities 


attend this open forum 

Biosimilars- Development 

Considerations and Future 

Directions (BIOTEC & RS) 


attend this open forum 

5:30 pm – 7:30 pm 

Regulatory Sciences (RS) Section Joint 

Membership Meeting and Reception

78 







2:00 pm - 4:00 pm 

Navigating the New Rules Regarding 

Patent Law: Decodifying ‘Obviousness’, 

‘Limited Claims’, and How it Affects New 

Composition of Matter Patents 

Roundtable 

There have been continuous changes implemented 

by the US PTO to streamline the patent filing and 

approval process, and reduce patent prosecution 

times. With it have come several changes to the 

content of patents and continuation filings, which 

significantly impact/limit patenting chemical, 

pharmaceutical and biotech inventions. For 

example, U.S. and international law denies 

patentability to subject matter which is “obvious” 

or which lacks an “inventive step”. However, 

such rulings differ from country to country. This 

roundtable will invite discussion from patent law 

experts regarding these recent developments, 

such as what counts as “obvious” in the context of 

chemical, pharmaceutical, and biotechnological 

inventions, limits on claims and continuation 

applications. 

Moderators 

Michael Bornstein, Ph.D. 

Bornstein Consulting, LLC 

Jeffrey A. Lindeman, Ph.D. 

O’Brien Jones PLLC 

New Regulations in Patent Law for the Pharma 

Industry 

Scott Bornstein, J.D. 

Greenberg Traurig, LLC 

Presentation Title to Be Determined 

Barry Schindler, J.D. 


A Look at Post-KSR Cases: Is the Perceived 

Change Really that Great? 

Irem (Remy) Yucel, Ph.D. 

U.S. Patent and Trademark Office 



2:00 pm – 4:30 pm 

Regulatory Significance of Critical 

Quality Attributes and Critical Process 

Parameters in Successful Product 

Development and Commercialization 

Symposium 

Identification of the right critical quality attributes 

(CQA) of pharmaceutical materials and critical 

process parameters (CPP) of various manufacturing 

steps is extremely important for defining the designspace 

for a given pharmaceutical product. Defining 

an appropriate design space offers operational 

flexibility within the defined design-space and thus 

regulatory flexibility. However, given the multitude of 

quality attributes and process parameters, this can 

be a very complicated and time consuming exercise. 

The objective of this symposium is to provide case 

studies on how to establish the CQAs and CPPs for 

drug substance and various dosage forms. 

Moderators 



Prabu Nambiar, Ph.D., M.B.A. 


Introduction — Regulatory Significance of 

CQAs and CPPs 

Prabu Nambiar, Ph.D., M.B.A. 


CQA and CPP — FDA Perspectives 

Elaine Morefield, Ph.D., invited 


CQAs and CPPs for Drug Substance 

Stephen Colgan, Ph.D., invited 


CQA and CPP for Immediate & Modified 

Release Dosage Forms 

Shailesh Singh, Ph.D. 

Wyeth 


RECEPTION 

5:30 pm – 7:30 pm 

Regulatory Sciences (RS) Section Joint 




9:00 am – 11:00 am 

Impact of Changing Regulations on Postapproval 

CMC Changes: U.S. and E.U. 

Perspectives 

Roundtable 

An open discussion with regulators from North 

America and Europe with counterparts from industry. 

The focus will be on variations and changes when 

the process space has been defined by QbD 

methodology. 

Moderator 

Abbie Gentry, Ph.D. 


Strategies to Meet International Change 

Control Requirements by a U.S. Company 

Thirunellai Venkateshwaran, Ph.D. 

Wyeth 

9:00 am – 11:00 am 



Roundtable 

In this session, we will share the experiences of 

U.S. Food and Drug Administration (FDA) officers, 

and clients’ experience on how to face FDA scientific 

compliance or routine audits. This discussion will 

provide an insight on how to manage a crisis into a 

less painful and manageable exercise. 

Moderators 




Barr Laboratories 

Audits Have a Purpose — Understand Them 

and Comply with Them 

C.T. Vishwanathan, Ph.D. 


We had an Audit, No Citation, No 483 

Good News 

Chinna Pammidi, Ph.D. 

Cetero Research 

My CRO is Under Audit — What Should I Do? 


Covidien/Mallinckrodt, Inc.

79 





2:00 pm – 4:00 pm 



Roundtable 

In the current environment, clinical materials 

are manufactured, packaged, tested, and 

distributed worldwide. During transition, there 

are inherent changes of degradation, physical 

stability, dissolution rate, and particle size that 

may be affected; thus increasing risk to clinical 

materials. This session will explore options to 

effectively maximize the data collected using 

predictive stability tools to support establishment 

of shelf-life for clinical materials and minimize 

the number of stability studies to support clinical 

program. This roundtable will discuss the use of 

alternate accelerated/stress conditions, scientific 

understanding and predictive stability tools as an 

aid in the development to reduce risk and increase 

extrapolation robustness while maintaining 

product safety. Challenges to establish alternative 

accelerated conditions for unusual dosage forms 

and implication of physical and chemical changes 

on formulation/packaging and shipping strategies. 

Studies supporting shipment of clinical and 

commercial product, including controlling the 

shipment, monitoring and justifying excursions 

that may be observed. 

Moderators 


PHARMALYTIK 

Andrea Panaggio, Ph.D., M.S., R.Ph. 


Utilizing Stability and Analytical Tools to 

Improve Product Knowledge to Facilitate 

Support of a Global Clinical Program 

Frank Diana, Ph.D. 

Endo Pharmaceuticals 

Formulation Development Study Strategies 

to Support Controlled Temperature Shipping 

Sailesh A. Varia, Ph.D. 


Stability Conditions for Product Development 

Evaluations Pre-IND to Assure Acceptable 

Product During Shipment and Storage 

Edward Koch 


2:00 pm – 4:00 pm 

Bioequivalence Requirements: 

Challenges in Global Drug Development 

and Harmonization 

Roundtable 

The pharmaceutical drug industry has become 

increasingly global. Bioequivalence and 

interchangeability requirements for registration 

of multisource (generic) pharmaceutical products 

vary in each domestic market place. Harmonization 

of these requirements would decrease duplication 

of studies and unnecessary human drug exposure. 

This symposium will bring together pharmaceutical 

scientists from industry and regulatory agencies 

to review scientific and regulatory issues that would 

begin a process of harmonization of bioequivalence 

requirements. Some issues to be discussed will 

include the selection of a reference listed drug 

product; the design of bioequivalence studies both 

in vivo and in vitro approaches; and the acceptance 

criteria for bioequivalence. 

Moderators 

Leon Shargel, Ph.D. 

Applied Biopharmaceutics 


Barr Pharmaceuticals, Inc. 

International Bioequivalence Requirements 

Gordon Johnston, M.S. 

Generic Pharmaceutical Association 

International Reference Listed Drug Product 

Leon Shargel, Ph.D. 

Applied Biopharmaceutics 

Harmonization of Bioequivalence 

Requirements 

Paul Fackler, Ph.D. 

Teva Pharmaceuticals 




8:30 am – 11:00 am 



Symposium 

Excipients facilitate manufacturing, enhance or 

support stability, and/or aid in vivo performance 

of a product. Certificates of analysis provide little 

information about what the industry has termed 

excipient functionality. This demands thorough 

understanding of material characteristics such 

as particle size and morphology, solid-state 

characterization and processing to name a few. 

Functionality has become a hot topic since the 

European Pharmacopoeia (EP) listed specific 

functionality-related characteristics (FRCs) in 

some of its excipient monographs. USP has looked 

into including a General Chapter on Excipient 

Performance Testing suggesting it could be part of 

the labeling section and non-mandatory. Excipient 

manufacturers are voicing concerns because 

in their view functionality may mean different 

things to different people. The characterization of 

functionality is very simply process understanding 

in accordance with the philosophy of the U.S. Food 

and Drug Administration (FDA), PAT and 21st century 

GMP initiatives. QbD is an approach to product 

development that seeks to find the limits within 

which acceptable product can be manufactured 

(edge of failure) and thereby the approvable design 

space. Standardized testing for excipients could 

play a critical role in the definition of design space 

and any quality-by-design endeavor must define 

the materials properly. There is a growing need for 

a systematic process to evaluate the interaction 

between components of a product to increase 

scientific understanding and correlation between 

physical and mechanical properties of materials 

and their functionality and ways in which the design 

space can be expanded by development of relevant 

functionality tests. This symposium will address 

the role the functionality tests of excipients will 

play in the QbD world through how we perform the 

functionality tests, how this test helps in establishing 

the design space, and the appropriate control 

strategies. A regulatory perspective will provide 

in-sight into this concept. In addition, the challenges 

and opportunities facing the excipient manufacturers 

and also the role of the pharmacopoeia as it pertains 

to supporting such changes will also be discussed as 

part of this symposium.

80 



Moderator 

Umang Shah, Ph.D. 

Solvay 

FDA’s Perspective 

Moheb Nasr, Ph.D., invited 


USP Perspective on Performance Related Tests 

for Excipients 

Kevin Moore, Ph.D. 

United States Pharmacopeia 

Excipient User’s Perspective 

Mohan Ganapathy, Ph.D. 


Excipient Manufacturer’s Perspective 

Richard C. Moreton, Ph.D. 

Finnbrit Consulting 


2:00 pm – 4:00 pm 

Comparator Products — Untold Stories 

Roundtable 

Conducting global clinical studies for later phases 

of development (Phase II – Phase III) requiring the 

use of comparator products presents an array of CMC 

challenges. These challenges are further enhanced 

in double-blinded studies where a placebo matching 

the comparator is required. Pharmaceutical 

companies use over-encapsulation as a tool to blind 

the comparator and its matching placebos. This technique 

has its limitations, and CMC challenges, some 

of which include the need for conducting BA/BE studies, 

setting comparators’ specifications, the utility 

of the appropriate analytical tests and the accompanying 

validation studies to support these tests, 

and conducting the appropriate stability program to 

establish the shelf-life of these comparators once 

over-encapsulated. Pharmaceutical companies also 

manufacture matching placebo products that look 

exactly the same as the comparator product used. 

The main CMC challenge encountered when conducting 

these studies include the successful manufacture 

of a matching placebo with no infringement on trademarks. 

Additional challenges include the setting of 

the appropriate specifications and shelf-life for the 

matching placebo. Formulation changes, excipient 

changes, and variations in dosage strengths are also 

critical issues to be addressed when conducting 

global clinical studies. The strategy for selecting the 

appropriate “comparator product” requires close 

collaboration between regulatory, regulatory-CMC, 

clinical supplies operations, manufacturing, and 

clinical to successfully conduct these studies. This 

roundtable will address the blinding strategies, best 

practices, and inter-functional collaboration leading 

to the appropriate choice of comparator product 

and the successful conduct of these global studies. 

Moderators 


PHARMALYTIK 

Ruben Lozano, Ph.D. 


Development of Dissolution Methods for 

Comparator Products — The Unspoken 

Challenges 



Bioavailability Challenges for Comparator 

Products 

Dakshina M. Chilukuri, Ph.D. 


Regulatory Expectations for Comparator 

Product Use in Clinical Trials 




2:00 pm – 4:30 pm 

Using the Quality-by-Design Principle 

to Establish Pharmaceutical Equivalence 

and Bioequivalence of Advanced 

Dosage Forms 

Symposium 

With the advances in pharmaceutical science and 

technology, there is increasing growth in novel dosage 

forms and drug delivery systems. Including many 

modified release dosage forms, liposomal products, 

drug-eluting stents, and possibly nanotech-derived 

pharmaceuticals in the near future. Given the complexicity 

of these advanced dosage forms, a number 

of challenges have been presented to industry and 

regulatory scientists in assessing pharmaceutical 

equivalence and bioequivalence, hence therapeutic 

equivalence. To achieve equivalence of these dosage 

forms, the U.S. Food and Drug Administration is 

currently encouraging drug sponsors to use a more 

systematic approach, such as quality-by-design 

(QbD) principle, for pharmaceutical development and 

manufacturing. Recently, it has been proposed that 

equivalence may be established by matching the test 

and reference in vivo drug delivery profiles (iDDPs) 

before drug absorption. With the application of QbD 

principle, this can be achieved by first characterizing 

the key component(s) of the reference iDDP and then 

using this information as the target for development 

of a test product. Critical variables or parameters 

may be identified to serve as in vitro markers or 

biomarkers for mapping the desired iDDP. Successful 

design of an equivalent test product can ultimately be 

accomplished with a better understanding of relevant 

factors that may have potential impact on the iDDPs 

of products in comparison. This session will bring 

together pharmaceutical scientists from industry, academia; 

and the regulatory agency to discuss how to 

use QbD principle and iDDPs to demonstrate equivalence 

of these dosage forms pre- and post-approval, 

identify critical factors that may have impact on iDDPs 

and product quality/performance, hence equivalence 

of advanced dosage forms, and explore various tools 

to assess the iDDPs of these dosage forms. 

Moderator 

Vincent H.L. Lee, Ph.D. 

The Chinese University of Hong Kong 

Equivalence-by-Design: Targeting Preabsorption 

Drug Delivery Profiles to Ensure 

Equivalence 

Mei-Ling Chen, Ph.D. 


Critical Formulation Factors for Establishing 

Equivalence of Modified Release Dosage 

Forms 

James Polli, Ph.D. 

University of Maryland 

Application of Imaging Technique in 

Bioequivalence Testing 

Karsten Madar, Ph.D. 

Martin-Luther-University of Halle 

Biorelevant Dissolution and QbD for ANDAS 



2:00 pm – 4:30 pm 



Delivery 

Symposium 




















improve our understanding of skin delivery.

81 



Moderators 


Nycomed 












Diseased Skin 






OPEN FORUMS 

1:30 pm – 5:00 pm 

Global Regulatory Challenges for 

Genotoxic Impurities 

AAPS Regulatory Sciences (RS) Open Forum 


Controlling the quality of medicines is one of the 

critical aspects of assuring safety and efficacy 

of pharmaceutical products. The International 

Conference on Harmonization (ICH) has published 

general guidance (Q3A) on the quality and safety 

assessment of impurities in pharmaceutical 

drug substances and drug products but is not 

specific to Genotoxic impurities. The European 

Medicines Agency (EMEA) has published a guideline 

focusing on limits for genotoxic impurities, and 

the U.S. Food and Drug Administration (FDA) has 

recently issued draft guidance on genotoxic and 

carcinogenic impurities in drug substances and 

drug product. These guidance documents have 

many similarities including limits based on a 

Threshold of Toxicological Concern (TTC) derived 

from animal carcinogenicity data to estimate a 

daily dose (1.5 µg/day) for genotoxic/carcinogenic 

impurities in human medicines. There are however 

differences including the FDA mandated genotoxic 

testing of impurities above the ICH qualification 

threshold, even in the absence of structural alerts. 

Presentation of the TTC as a single figure infers 

an unwarranted level of control and supports the 

adoption of a more flexible approach by regulatory 

authorities when evaluating new drug products. 

Furthermore, the limit is based on 70 years of 

continuous daily exposure, a scenario that is 

uncommon for most medicines and not applicable 

to the pre-registration clinical development phase. 

To address this latter point, a staged TTC has been 

developed that proposes limits based on shorter 

durations of treatment, e.g., up to 1 year. Based on 

recent history, this approach has been acceptable 

to some authorities but not to others. This Open 

Forum will address these challenges by reviewing 

the current regulatory views from the US and EU and 

how industry has applied recent guidance globally to 

drug candidates in development and on established 

products. Questions that could be addressed in 

the open forum include; will a shortened duration 

of therapy allow for increased regulatory flexibility? 

How can in silico tools be leveraged when control 

strategies for genotoxics are developed? How will 

the current guidances be applied to innovative 

dosage forms (trans-dermals, depots, etc.)? What 

are the practical challenges to achieving TTC levels 

(including manufacturing processes and analytical 

method limitations? Should controls be different for 

pediatric medicines? An Expert Panel would facilitate 

discussion for at least 60 minutes. The discussion 

from the forum could be captured in a variety of 

publications, including the AAPS Journal, the DIA 

Journal, or Regulatory Rapporteur. 

Moderators 



Ganapathy Mohan, Ph.D. 


Control of Genotocix Impurities and the 

Regulatory Impact of this: A Case Study 

Ganapathy Mohan, Ph.D. 


Continuing Challenges of GTIs 

Gopi Vudathala, Ph.D. 

Sanofi-Aventis 

FDA Point of View 

David Jacobson-Kram, Ph.D., invited 


E.U. Point of View 

Peter Kasper, Ph.D. 

Federal Institute for Drugs and Medical Devices 

Panel Discussion: Regulatory Queries and 

Strategies Related to Genotoxics for NCES, 

Generics, and Established Products 

Facilitator 


Pfizer Global Research and Development 

1:30 pm - 5:00 pm 

Biosimilars-Development 

Considerations and Future Directions 



An additional fee is required to attend this open forum. 

As global sales for biologic products is on the 

rise, this market represents an attractive target 

for generic companies. The approaches related to 

biosimilar products in the various regions across 

the world are divergent, with a clear need for 

defining regulatory expectations for these products 

at the global level. In the USA, legal pathways 

exist for review and approval of some smaller, 

well characterized proteins such as human growth 

hormone and insulin, which are regulated under 

the Federal Food, Drug, & Cosmetic Act; however, 

for other biotherapeutics such as interleukins 

and interferons, which are regulated under the 

Public Health Service Act (PHSA), there is currently 

no abbreviated authorization pathway. However, 

there are signs of some momentum in this regard, 

with the recent support expressed by the Obama 

administration, and proposed legislation H.R. 

1427 “Promoting Innovation and Access to Life- 

Saving Medicines Act.” recently introduced by a 

bipartisan group of Congressional representatives 

that would open the door to approval of biosimilar 

products. Contrary to the USA a legal framework for 

biosimilars exists in the EU since the review of EU 

legislation. The first biosimilar product in the EU 

was Somatotropin / Sandoz (Omnitrope ® ). Countries 

such as China, India and South Korea also have 

reported a high number of licensed biosimilars 

within their existing regulatory framework. Examples 

of such products marketed in these countries 

include interleukins, interferons, erythropoietins, 

growth factors, hormones, enzymes and monoclonal 

antibodies. This is expected to be a topic that will 

be a center of debate between legislators, the 

biotechnology and generic industry. The open forum 

will feature experts who will address the regulatory 

framework for approval of biosimilars in the key 

regions, and address challenges and considerations 

for development of these products. 

Moderator 

Deepa Deshpande, Ph.D. 

Universal Regulatory, Inc. 

E.U. Considerations 

Marie-Christine Bielsky, M.D. 

Medicines and Healthcare Products Regulatory 

Agency (MHRA)

82 


AAPS Student/PostDoc Outreach and Development (SPOD) Programming 

at a glance 

AAPS STUDENT 

LOUNGE HOURS: 


7:00 am – 5:00 pm 


7:00 am – 5:00 pm 


7:00 am – 5:00 pm 


7:00 am – 12:00 pm 



8:30 am – 11:00 am 

AAPS Graduate Student Symposium in Analysis and 

Pharmaceutical Quality (APQ) 

Sponsored by 

> 

7:00 am – 8:30 am 

AAPS Mentoring Breakfast 

AAPS Graduate Student Symposium in Biotechnology (BIOTEC) 

Sponsored by 

AAPS Graduate Student Symposium in Drug Design and 

Discovery (DDD) 

Sponsored by 

AAPS Graduate Student Symposium in Formulation Design 

and Development (FDD) 

Sponsored by 

AAPS Graduate Student Symposium in Manufacturing Science 

and Engineering (MSE) 

Sponsored by 

AAPS Graduate Student Symposium in Physical Pharmacy 

and Biopharmaceutics (PPB) 

Sponsored by 

AAPS Graduate Student Symposium in Pharmacokinetics, 

Pharmacodynamics and Drug Metabolism and Clinical 

Pharmacology and Translational Research (PPDM & CPTR) 

Sponsored by 

2:00 pm - 4:00 pm 

Roundtable 

Individualizing a Postdoctoral Position 

Based on Your Career Aspirations 

12:00 pm – 1:15 pm 

Roundtable 

Paths Less Traveled: Opportunities for Pharmaceutical Scientists 

beyond Industry and Academia

83 



AAPS STUDENT 

LOUNGE HOURS: 


7:00 am – 5:00 pm 


7:00 am – 5:00 pm 


7:00 am – 5:00 pm 


7:00 am – 12:00 pm 



Roundtable 

2:00 pm – 4:00 pm 

Individualizing a Postdoctoral Position 


There is a growing demand for pharmaceutical and 

biomedical scientists with postgraduate experience. 

A wide-range of postgraduate experiences are 

available, but choosing the right one based on 

your career aspirations takes careful thought. The 

objective of this roundtable is to familiarize graduate 

students with the various types of postdoctoral 

experiences that exist and to facilitate a discussion 

on their value for different career choices. For 

example, a student that is interested in a career 

in academia at a teaching focused college may be 

interested in postdoctoral experiences that have 

greater opportunities for teaching, or a graduate 

student that is interested in clinical pharmacology 

may look for opportunities in industry or clinical 

research groups. It is the goal of this roundtable 

that graduate students can discuss the varying 

postdoctoral opportunities that best suit their career 

aspirations with those vested in creating meaningful 

postgraduate training programs. 

Moderators 

Bob Berendt, M.S. 


Allison Radwick 

Affiliation to be Determined 

Postdoctoral Positions in Academia 

and the NIH 

Donald Mager, Pharm.D., Ph.D. 

University at Buffalo 

Postdoctoral Opportunities in the 

Pharmaceutical and Biotech Industries 


GlaxoSmithKline Inc. 



8:30 am – 11:00 am 



(APQ) 

Sponsored by 

Graduate students whose research has been 

competitively judged as outstanding will present 

findings of their research efforts. 

Moderator to be announced 

8:30 am – 11:00 am 



Sponsored by 





8:30 am – 11:00 am 


Drug Design and Discovery (DDD) 

Sponsored by 





8:30 am – 11:00 am 


Formulation Design and Development 

(FDD) 

Sponsored by 





8:30 am – 11:00 am 



(MSE) 

Sponsored by 





8:30 am – 11:00 am 




Sponsored by 




Moderator to be announced

84 



8:30 am – 11:00 am 






Sponsored by 





Roundtable 

12:00 pm – 1:15 pm 

Paths Less Traveled: Opportunities 

for Pharmaceutical Scientists beyond 

Industry and Academia 

Pharmaceutical industry and academia provide 

the most common employment opportunities for 

the recent graduates in pharmaceutical sciences. 

Recent graduates, graduate students and postdoctoral 

fellows are less informed and aware of 

the opportunities that exist in other areas such as 

regulatory agencies (USP and FDA), government 

funded research institutes (NIH, NSF, NASA etc), 

public and private research centers, contract 

research organizations (CROs) and consultancies. 

Goal of this roundtable is to inform the students 

and post-doctoral fellows about some of the 

opportunities that are available to pharmaceutical 

and biomedical scientists that are playing an 

increasing role in drug discovery, development, 

and clinical use. The speakers will provide a brief 

overview of responsibilities of pharmaceutical 

scientists in their respective areas, discuss the 

pros and cons of working at these organizations 

and guide the audience about searching and 

approaching available positions. The objective is to 

stimulate the audience interest in careers in areas 

other than academia and industry and discuss their 

aspirations with the speakers. 

Opportunities for Pharmaceutical Scientists in 

Regulatory Agencies and Affiliated Institutes 

and Research Centers 

Anthony DeStefano, Ph.D. 


So Many Interesting Problems: Turbo-charge 

Your Career at a CRO 

Thaddeus H. Grasela, Pharm.D., Ph.D. 



7:00 am – 8:30 am 

AAPS Mentoring Breakfast 

Are you a graduate student ready to enter the job 

market? Have you been working for a few years and 

need some advice? In response to our members’ 

needs, the AAPS Student/PostDoc Outreach and 

Development (SPOD) Committee is proud to host 

its 6th AAPS Annual Meeting Mentoring Breakfast. 

Pharmaceutical scientists from academia, 

government and industry will be on-hand to answer 

your questions and provide a kick-start for your 

career in an educational roundtable discussion. You 

will be able to discuss, with a small group, issues 

related to opportunities/selecting career pathways, 

tools for success, and balancing multiple priorities, 

to name a few. 

Moderator 

Parag Budukh, Ph.D. 

St. John Fisher College


AAPS HonorS 


Lilly Corporate Center 

Indianapolis, IN 46285 

www.lilly.com 


During 2008-2009 



ScienceS

86 


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and Translational Research 

This is a one day event 


workshop 

Saturday, November 7, 2009 – Sunday, November 

8, 2009 



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This is a two day event 


workshop 

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Forms — What’s New with In Vitro Drug 

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workshop 

SHORT COURSES 



RNA-targeting Therapeutics: Issues and Advances 


Learning the Drug Discovery and Delivery Interface 

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Recent Advances in Oral Drug Delivery 


Transporter Mediated Drug-drug Interactions: 

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87 



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Thursday, November 12 1:30 pm – 5:00 pm 

APQ Open Forum 

Analytical Challenges in Detecting and Preventing 

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BIOTEC & RS Open Forum 

Biosimilars — Development Considerations and 


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An Evolution or Revolution in Drug Metabolism: 

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88 



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Continuing Education (CE) Credits 

NEW! CE POLICIES FOR 2009 AAPS 

Annual Meeting and Exposition 

New ACPE regulations require AAPS to change 

their policies and procedures on CE’s for the 2009 

Annual Meeting. In 2009, symposia sessions 

(2.5 credit hours per session) are the only sessions 

eligible to receive CE. In addition, all AAPS Short 

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Course CE counts for 7 credit hours, and Workshop 

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sessions, 7 hours for each short course, and 

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certificates is $50 for the Annual Meeting and 

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Development in Drug Discovery and Translational 

Research: 8 hours 

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DPT Laboratories, Ltd. 

4040 Broadway, Ste 401 

San Antonio, TX 78209 

www.dptlabs.com 


During 2008-2009 



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Hotel/Site Information 

The 2009 AAPS Annual Meeting and Exposition will take place at the Los Angeles Convention Center 

located in Los Angeles, California. 

Los Angeles Convention Center, 1201 South Figueroa Street, Los Angeles, CA 90015 USA 

Phone: +1 (404) 223-4000 

What’s Held Where 



West Hall 



Concourse 

Short Courses 

Concourse 

Registration 

South Hall 

Sunday Opening Session and Welcome 

Reception 

West Hall 

Monday Plenary Session 

West Hall 

All Symposia, Roundtables, Sunrise 

Sessions, Poster/Podia, etc. 

Concourse and West Hall 

Open Forums 

Concourse 

Exposition 

South Hall 

Poster Sessions 

West Hall 

Section Membership Meetings 


Focus Group Membership Meetings 


Alumni Breakfasts and Luncheons 

South Hall 

Westin Bonaventure Hotel 

Alumni Receptions 

Affiliate Breakfasts, Luncheons 

and Receptions 

Section Receptions 

Hotel Accommodations 

The Westin Bonaventure is the headquarter hotel 

for the 2009 AAPS Annual Meeting and Exposition. 

Registrants are responsible for making hotel 

reservations. Contact the AAPS Housing Bureau 

to secure hotel reservations. 

NEW IN 2009! 

AAPS has streamlined the housing and registration 

process. In one simple step, complete meeting 

registration and online housing reservation. Visit 

the AAPS Registration and Housing Website, click 

on “Attendee/Group Registration and Housing” to 

register for the Annual Meeting and AAPS housing. 

Once registration is complete the website will 

automatically direct attendees to the AAPS housing 

website. At that time, attendees have the option 

of securing housing reservations, or re-visiting the 

housing website at their convenience. Registrants 

also have the option to visit the AAPS housing 

webpage before registering for the meeting. If you 

wish to reserve your housing first, visit the AAPS 

Registration and Housing Website, and click on, 

“Housing Only”. After housing has been secured, 

attendees can log back into the website and register 

for the meeting by visiting the AAPS Annual Meeting 

registration and housing website, and clicking on 

“Attendee/Group Registration and Housing”. 

Rooms are assigned on a first-come, first-served 

basis. Reservations should be made by October 9, 

2009. After October 7, 2009, all reservations will 

be accepted on a space- and rate-available basis. 

Reserve your room online today! 

Phone: +1 (301) 694-5243 

U.S. & Canada; International: +1 (866) 229-2386 

Fax: +1 (301) 694-5124 

Address: AAPS Annual Meeting 

P.O. Box 4088 

Frederick, MD 

21705 USA 

There is a major commitment to the Los Angeles 

hotel community in order to secure a large number 

of convenient, quality hotel rooms at competitive 

prices. AAPS’ commitment to hotels includes 

penalties if AAPS does not fill each hotel in the 

official block. Please assist us in this endeavor 

by booking your hotel through the housing bureau. 

Select hotels will be serviced by the AAPS shuttle. 

Please note: there is a 10 room limit per company 

at the Westin Bonaventure. 

If you are interested in blocking a suite or 

reserving ten (10) or more hotel reservations 

(at a non-AAPS headquarter hotel) during the 

AAPS Annual Meeting and Exposition Hotel, 

please contact the housing bureau: 

aapsexh@experient-inc.com 

Do not contact the hotels directly; ALL reservations 

must be made through the AAPS Housing Bureau 

to secure hotel reservations. 

Reserve Your Hotel Room Early! 

Rooms are assigned on a first-come, first-served 

basis. Reservations should be made by October 7, 

2009. After October 7, 2009, all reservations will 

be accepted on a space- and rate-available basis. 

Room Deposit Required to Secure 

Reservations 

All L.A. hotels require a credit card guarantee or 

a one night’s deposit via credit card or check with 

each reservation request. Requests received without 

a credit card guarantee or check deposit will 

be returned. 

Reserve your room online today! 

Deadline: October 7, 2009 

AAPS Convention Center Shuttle 

Sponsored by 

Shuttle bus service will be provided from select 

Annual Meeting hotels to the Los Angeles 

Convention Center. These hotels are indicated below. 

The shuttle routes and schedule will be available in 

the Convention Center lobby, the hotel lobbies and 

the final program. 

See page 95 for new shuttle polices in 2009

91 


Annual Meeting Hotel Accommodations 

Reserve your room early, space is limited! Reserve your room online by October 7, 2009. 

Hotel 

(Name links 

to hotel map) 

Hotel Description 

Distance from L.A. Convention Center amd 

Shuttle Route 

AAPS Single/Double 

Discounted Room Rate 

AAPS Headquarters 

Hotel 

Westin Bonaventure 

Hotel & Suites 

404 South Figueroa 

Street, Los Angeles, 

CA 90071 

Hilton Checkers 

Hotel Los Angeles 

535 South Grand 

Avenue, Los 

Angeles, CA 90071 

Holiday Inn L.A. 

City Center 

1020 S. Figueroa 


CA 90015 

The Westin Bonaventure is the Headquarters Hotel for the 2009 AAPS 

Annual Meeting and Exposition and is the largest hotel in L.A. The hotel 

features five towers, a six story atrium lobby with shopping and 20 

restaurants and five lounges, heated outdoor pool and garden deck, 

a fully equipped Business Center, and a Fitness Center/Spa. All rooms are 

appointed with spectacular floor to ceiling views of the city, in room safes, 

iron & board, cable TV, Sony Playstation and in-room movies and hair dryer. 

Hilton Checkers Los Angeles is a historic Los Angeles hotel that dates 

back to the 1920s, fully restored to its original splendor. Hilton Checkers 

is the only four-diamond boutique hotel in Downtown Los Angeles. 

Its twelve stories offer extensive hotel luxuries combined with an intimate 

ambiance and personalized service. One feature not to be overlooked: 

a stunning rooftop deck, truly a four-star Los Angeles luxury hotel. 

The new destination in Los Angeles is Downtown, and in the center of it 

all is the Holiday Inn L.A. City Center. Across the street from the Staples 

Center and the Convention Center, the hotel has recently undergone 

a multi-million dollar renovation that included all of its 195 rooms, 

restaurant and lounge, meeting spaces and the lobby. Discriminating 

travelers will appreciate the impeccable service, state of the art business 

conveniences and special amenities. Stunning interior design and crown 

moldings provide an atmosphere of a fine downtown residence. 

1 mile/9 blocks 

Shuttle bus service provided to and from 

the convention center. Shuttles will 

operate from this location on Saturday, 

November 7. 

0.75 mile/7 blocks 


the convention center. To catch shuttle 

service, guests will need to walk to the 

Millennium Biltmore Hotel Los Angeles 

(1 block). The shuttle will pick up at the 

Grand Avenue 

entrance. 

0.30 mile/1 block 



service on Saturday, November 7, guests 

will need to walk to the Sheraton Los 

Angeles Downtown Hotel (5 blocks). 

The shuttle will pick up at the 

Hope Street entrance. 

$235.00/$255.00 

$236.00 

$201.00 

Hotel Figueroa 



CA 90015 

Los Angeles 

Athletic Club 

431 West Seventh 


CA 90014 

Los Angeles 

Marriott Downtown 



CA 90071 

Hotel Figueroa is a limited service hotel, please visit the hotel’s 

website, www.figueroahotel.com, before booking. Hotel Figueroa is an 

an anti-corporate-style accommodation that has been transformed from 

a 1925-vintage former YWCA residence into L.A.’s best moderately priced 

hotel for Downtown lodging. This 12-story property sits in an increasingly 

gentrified corner of Downtown, within shouting distance of the STAPLES 

Center. The big, airy lobby exudes a romantic Spanish Colonial, Gothic 

vibe with beamed ceilings and soaring columns, tile flooring, ceiling fans, 

Moroccan chandeliers, and medievalist furnishings such as big floor 

pillows made of Kurdish grain sacks, Persian kilims, and exotic fabrics 

draped from the ceiling. Elevators lead to equally artistic guest rooms 

that, though a bit dark and small, are very comfortable. Each comes with 

a firm, well-made bed with a wrought-iron headboard or canopy and 

a Georgia O’Keeffe-reminiscent spread, a Mexican-tiled bathroom, 

and Indian fabrics that double as blackout drapes. 

A luxury property with three restaurants and two bars. Olympic sized 

indoor swimming pool, Jacuzzi, sauna, indoor running track, racquetball 

courts. Full privileges to the L.A. Athletic Club. Rooms have tile baths, 

robes, hair dryers, irons/boards, and mini-bars. No rooms with two 

double beds. Roll-aways allowed only in deluxe rooms. 

The Marriott Los Angeles Downtown is convenient to the Financial 

District, Civic Center, Bunker Hill, L.A. Live and Los Angeles Convention Center. 

Each of the 400 guest rooms and 69 suites are spacious and inviting, 

equipped with luxurious Marriott bedding, floor to ceiling windows, marble 

bathrooms and high speed internet access. This Los Angeles hotel offers 

an alluring outdoor heated pool, modern fitness center with cardio-theater, 

business center, California-inspired restaurant and lively lounge. 

0.30 mile/1 block 



service on Saturday, November 7, guests 

will need to walk to the Sheraton Los 

Angeles Downtown Hotel. The shuttle 

will pick up at the Hope Street entrance 

(6 blocks). 

1.10 miles/6 blocks 





(2 blocks). The shuttle will pick up at 

the Grand Avenue 

entrance. 


Shuttle bus service provided to and from the 

convention center. To catch shuttle 

service, guests will need to walk to 

the Westin Bonaventure (1 block). 

The shuttle will pick 

up at the Figueroa 

Street entrance. 

$164.00 

$161.00 

$201.00

92 


Annual Meeting Hotel Accommodations 

Hotel 

(Name links 

to hotel map) 

Hotel Description 

Distance from L.A. Convention Center amd 

Shuttle Route 

AAPS Single/Double 

Discounted Room Rate 

Millennium Biltmore 

Hotel Los Angeles 

506 South Grand 

Avenue, Los Angeles, 

CA 90071 

O Hotel 

819 S. Flower Street, 

Los Angeles, 

CA 90017 

The premier choice for celebrities, presidents and dignitaries for over 80 years, 

the Millennium Biltmore Hotel offers historic grandeur and modern convenience 

in the heart of exciting downtown Los Angeles. Find yourself steps away from 

major attractions like the Staples Center, Walt Disney Concert Hall, Dodger Stadium 

and the Museum of Contemporary Art, and a short drive from Hollywood 

and the beaches. Experience distinctive service and classic European style in 

one of our 683 guest rooms and suites, with amenities such as a Roman-style 

indoor swimming pool and health club. Dine at any of our four unique bars and 

restaurants, from contemporary Asian cuisine at Sai Sai to modern California 

cuisine at Smeraldi’s, or traditional tea in the famed Rendezvous Court. 

Renewed and resplendent, the historic 1920s hotel re-opened its glass 

doors to a refreshing launch in 2007. A serene haven for the business 

traveler, urbanite and out-of-towner, O Hotel offers 68 deluxe rooms with 

upgraded comforts, and gracious and efficient service expected of welltended 

boutique establishments. 





November 7. 





Sheraton Los Angeles Downtown Hotel 

(2 blocks). The shuttle will pick up at the 

Hope St. entrance. 

$202.00 

$175.00 

Omni Los Angeles 

Hotel at California 

Plaza 

251 South Olive 


CA 90012 

The Omni Los Angeles Hotel at California Plaza sits atop historic Bunker 

Hill in the heart of sophisticated downtown Los Angeles. Downtown’s 

only four-diamond convention hotel, the Omni Los Angeles Hotel features 

luxurious accommodations and modern conveniences that suit the needs 

of business and leisure travelers alike. All rooms have climate control, 

2 dual-line phones with voice mail and bathroom extension, TV. Hotel 

has one restaurant, 24-hour room service, newstand, fitness center, 

and outdoor heated pool. 


Shuttle bus service provided to and 

from the convention center. To catch 

shuttle service on Saturday, November 

7, guests will need to walk to the 




entrance. 

$205.00 

Sheraton Los 

Angeles Downtown 

Hotel 

711 South Hope 


CA 90017 

Contemporary business and convention hotel located in the heart of the 

downtown financial district, within walking distance of Staples Center. 

Adjacent to Macy’s Plaza, minutes to museums, theater, sports and 

entertainment attractions. All guests have complimentary access 

to Bally’s Total Fitness, located in the Macy’s Plaza. 





November 7. 

$225.00 

Standard Downtown 

Hotel 

550 South Flower 


CA 90071 

The Standard Hotel offers a playful yet sophisticated atmosphere. 

Spacious guestrooms, with 14 ft. of workspace; unlimited complimentary 

internet access and platform beds with cozy duvet covers. The Restaurant 

open 24/7 serves international comfort food. A rooftop infinity swimming 

pool and private waterbed cabanas; and a poolside lounge and bar with 

panoramic views of the Downtown skyline. This hotel caters to a variety 

of travelers as well as people from the local neighborhood. 








entrance. 

$186.00 

Wilshire Grand Hotel 

930 Wilshire Blvd., 

Los Angeles, 

CA 90017 

At the Wilshire Grand, standard rooms provide secure and comfortable 

accommodations with amenities that include complimentary wireless 

internet access, writing desk, remote control TV with LodgeNet, multiline 

phones, clock radio, iron and board, makeup mirror, hair dryer, custom 

climate control and double panel glass windows. Executive Rooms are 

on the top floors with upgraded decor and have access to the executive 

lounge. The hotel has a fitness center, four restaurants, and a bar. 




service on Saturday, November 7, 

guests will need to walk to the Sheraton 

Los Angeles Downtown Hotel (3 blocks). 

The shuttle will pick up 

at the Hope St. entrance. 

$199.00/$218.00 

Student Housing 

*Radisson Hotel Los 

Angeles Midtown 

at USC 



CA 90007 

The Radisson Hotel Los Angeles Midtown at USC is the official AAPS Student 

Hotel. AAPS will not provide transportion to and from the convention center to the 

hotel. Students should utilize the DASH downtown. Visit, www.ladottransit.com/ 

dash, for more information. Just 20 minutes from LAX and conveniently located 

off I-110, the Radisson hotel in Los Angeles provides convenient access to the best 

of the city. This University of Southern California hotel is within walking distance 

from the L.A. Memorial Coliseum and 1.5 miles from downtown Los Angeles. 

1.5 miles (not within walking distance) 

Shuttle bus service NOT provided to and 

from the convention center. Please utilize 

the DASH downtown. 

$145.00 

*This housing is 

reserved exclusively 

for students 

attending the AAPS 

Annual Meeting 

and Exposition.

93 


Annual Meeting Hotel Map 

1 The Westin Bonaventure Hotel and Suites* 

404 S. Figueroa St. 

2 Figueroa Hotel 


3 Hilton Checkers Los Angeles 

535 S. Grand Ave. 

4 Holiday Inn City Center 


5 The Los Angeles Athletic Club 

431 W. Seventh St. 

6 Marriott Los Angeles Downtown 


7 Millennium Biltmore Hotel 

506 S. Grand Ave. 

8 O Hotel 

819 S. Flower St. 

9 OMNI Los Angeles Hotel 

251 S. Olive St. 

10 Radisson Hotel at USC Los Angeles*** 


11 Sheraton Los Angeles Downtown Hotel 

711 S. Hope St. 

12 The Standard Downtown 

550 S. Flower St. 

13 Wilshire Grand Los Angeles 

930 Wilshire Blvd. 

*Headquarter Hotel 

***AAPS Student Hotel — Transportation to the 

Convention Center not provided by AAPS

94 


Travel and Transportation 

AIR TRAVEL 

Airports 

Los Angeles International Airport (LAX) 

Just 17 miles from downtown L.A., LAX is the fifth 

busiest passenger airport in the world, with more 

than 55 million people passing through every year. 

Approximately 80 passenger carriers (including all 

major airlines) serve LAX. If you’re traveling from the 

airport to the Los Angeles Convention Center, taxi 

and shuttle service is a short 25-minute ride away. 

The FlyAway Bus Service provides frequent, nonstop 

transportation between LAX and the downtown area. 

Bob Hope Airport — Burbank (BUR) 

Just 15 miles from downtown L.A., Bob Hope Airport 

is the closest airport to Downtown L.A. This airport 

has limited service provided by America West, 

Alaska Airlines, Delta Air Lines, JetBlue Airways, 

Southwest Airlines and United Airlines. 

Air Fare 

Discounted air fares are available for attendees 

traveling to/from Los Angeles for the 2009 AAPS 

Annual Meeting and Exposition. To take advantage of 

these discounts, call the official AAPS Travel Agency, 

Carlson Wagonlit, and mention this meeting. You 

may also call the airlines directly. Certain restrictions 

apply and seats are limited. Times are listed as 

Eastern Standard Time (EST). 

Carlson Wagonlit 

Phone: +1 800-535-9117 in the U.S. only 

Email (U.S. only): 

Washington.remote@carlsonwagonlit.com 

Email (outside the U.S.): 

SiSmith@carlsonwagonlit.com 

9:00 am – 5:30 pm, Monday to Thursday 

9:30 am – 4:00 pm, Friday 

AirTran Airways 

AirTran Airways is offering discounted air fares 

and unique benefits for AAPS Annual Meeting and 

Exposition attendees. These benefits include: 

• A 10% discount on the lowest available AirTran 

Airways one-way fare 

• No minimum stay or Saturday night requirement 

• Advance seat assignments at time of booking 

• Confirmed upgrade to business class, when 

available, for passengers booking in the “B” and 

“Y” fare levels 

• One-time waiver of change fee per reservation for 

any name or itinerary change 

• Attendees have the option of contacting the 

EventSavers Desk directly or booking their reservations 

through their designated travel agency 

• Attendees may travel three (3) days prior to the 

event start date and three (3) days after the event 

close date if they wish to spend any additional 

time at the event location. 

To take advantage of this special program, contact 

the AirTran Airways EventSavers Desk at (866) 

68EVENT or (866) 683-8368 for reservations. 

Please provide the EventSavers Coordinator with 

event code: LAX110809. 

NOTE: Travel agents must book all EventSavers 

reservations directly with the EventSavers Desk to 

receive the discount. Reservations booked through 

a travel agent General Data System or online will 

not qualify for the discount. 

American Airlines 

Book with American Airlines and save up to 5% 

on published fares! 

Phone: (800) 433-1790 

5:00 am – 12:00 pm, Monday – Sunday 

www.aa.com 

Authorization #A56N9AE 

AIRPORT TRANSPORTATION 

AAPS Airport Shuttle 

Shuttle bus service will be available from the Los 

Angeles Convention Center to the Los Angeles 

International Airport on Thursday, November 12, 

2009 from 9:00 am – 5:00 pm for $15.00. Payment 

will be accepted on-site at the Tour Desk located near 

the Registration Area at the Los Angeles Convention 

Center. Advance reservations are required. The 

motor coaches will run on the hour every hour to LAX. 

We suggest booking the motor coach at least 21/2 

hours prior to flight. 

Tour Desk hours are 

Sunday, November 8 

Monday, November 9 


Wednesday, November 11 

Thursday, November 12 

CAR RENTAL 

8:00 am – 5:00 pm 

8:30 am – 5:00 pm 

8:00 am – 5:00 pm 

8:00 am – 5:00 pm 

8:00 am – 5:00 pm 

Hertz Car Rental is the official car rental provider 

for the 2009 AAPS Annual Meeting and Exposition. 

AAPS Annual Meeting attendees will receive the 

benefits of unlimited mileage! To ensure availability 

reserve early. 

To reserve your rental car, visit www.hertz.com. 

To take advantage of this discount, click on the icon 

labeled “I have a Discount”. In the field labeled 

“Enter Convention Number (CV):” type 031L0004. 

Reserve your car rental online! 

GROUND TRANSPORTATION 

Shuttle Service 

A fast, affordable ride ($4 each way) between 

Downtown and Los Angeles International Airport 

(LAX) the FlyAway Bus Service provides frequent, 

nonstop transportation. All FlyAway buses drop-off 

passengers on the Upper/Departures Level of each 

terminal at LAX. Passengers board buses on the 

Lower/Arrivals Level in front of each terminal under 

the green “FlyAway, Buses and Long Distance Vans” 

signs. Each bus is marked with its service location. 

FlyAway departs from LAX every thirty minutes. 

Public Transportation 

Metro Rail System 

Six fast, easy-to-use, and environmentally friendly 

color-coded subway, light-rail, and rapid bus transit 

lines offer visitors an affordable way of getting from 

one destination to the next. The Metro Rail Blue 

Line connects with all Metro Rail and Metro Link 

lines at Union Station and stops on Flower at Pico 

(PICO STATION), directly across from the Los Angeles 

Convention Center. Detailed schedules, fares, 

interactive maps, multilanguage pocket guides, and 

more information are online. For more information, 

visit www.metro.net. 

Metro Bus System 

Three types of bus service are available throughout 

the Greater Los Angeles area. With 200 different 

lines, buses travel all over the city to every major 

destination including state parks, area attractions 

and shopping districts. For more information, visit 

www.metro.net. 

DASH Downtown* 

Six quick bus routes through Downtown depart every 

five to 10 minutes between 6:30 am and 6:00 pm on 

weekdays, and every 15 minutes between 10:00 am 

and 5:00 pm on Saturdays and Sundays. For more 

information, visit www.ladottransit.com/dash. 

*Any student staying at the AAPS Student Hotel, 

Radisson Hotel Los Angeles Midtown at USC, will 

need to utilize the DASH to travel to and from the 

Los Angeles Convention Center. AAPS will not provide 

shuttle service from the Student Hotel. 

Taxi Service 

Yellow Cab Company +1 (310) 965-5816 offers 

transportation from LAX to the conference hotels. 

With preset rates for trips to and from the airport 

and downtown taxis provide an economical mode 

of transportation. Taxi fees from/to the airport are 

approximately $40.00. There is a $2.00 charge for 

each additional person.

95 


Travel and Transportation 

Parking 

Getting to the Los Angeles Convention Center is easy; 

it is conveniently located at the intersection of the 

Santa Monica Freeway (10) and the Harbor Freeway 

(110) offering five (5) parking structures/lots on 

the LACC property all are in close proximity to the 

convention complex. The Los Angeles Convention 

Center parking rates are $12 for all-day parking with 

no in/out privileges. Please see directions below for 

parking locations. 

DRIVING TO THE LOS ANGELES 

CONVENTION CENTER 

From the South 

From 110 NORTH, transition to the 10 WEST, and exit 

immediately from the LEFT lane to PICO Blvd. The 

PICO off-ramp becomes CHERRY St. Turn RIGHT into 

the West Hall parking garage. 

From the North 

From 110 South, exit at Olympic Blvd. Left at bottom 

of ramp onto Blaine. Left on 11th St. Immediate right 

on Cherry St, and left into the West Hall garage. 

From the East 

From 10 West, transition to the 110 North 

(Downtown). Exit at Pico Blvd. The Pico off-ramp 

becomes Cherry St. Turn right into the West Hall 

parking garage. 

From the West 

From 10 East, exit at Grand Ave. Turn Left on Olive 

St., and left on Pico Blvd. Turn right on Cherry St. 

and right into the West Hall parking garage. 

From the Los Angeles International Airport 

(LAX) 

Take the Century Boulevard exit to the Century 

Freeway (105) East. Take the Harbor Freeway (110) 

North to the Santa Monica Freeway (10) West. 

Exit at Pico Boulevard and proceed northward. 

South Hall Parking: Turn right on Pico Boulevard, 

turn right on Figueroa Boulevard, turn right on 

Venice Boulevard, turn right on Convention Center 

Drive and proceed to the parking entrance. 

West Hall Parking: Cross Pico Boulevard and make 

a right turn at the intersection of Cherry and 12th 

Street into the parking garage entrance. 

From the Burbank Airport 

Exit the airport via Empire Avenue. Turn left on 

Hollywood Way (note direction sign to the Golden 

State Freeway (5) South at Empire and Hollywood 

Way Intersection), take the Golden State Freeway 

(5) South to the Harbor Freeway (110) South. Exit 

at Olympic Boulevard. Turn left at the bottom of the 

off-ramp onto Blaine St. Turn left on 11th Street. 

South Hall Parking: Turn right on Figueroa. Turn 

right on Venice. Turn right on Convention Center 

Drive and proceed to the parking garage entrance. 

West Hall Parking: Turn right at Cherry Street. Turn 

left at the intersection of Cherry St. and 12th Street 

and into the parking garage entrance. 

AAPS CONVENTION CENTER SHUTTLE 

Sponsored by 

Complimentary shuttle bus service will be provided 

from select AAPS Annual Meeting hotels to the Los 

Angeles Convention Center. The shuttle routes and 

schedule will be available in the Convention Center 

lobby, the hotel lobbies and the final program. 

Please note new shuttle policies in 2009: 

AAPS will not provide mid-day service between the 

Los Angeles Convention Center and Annual Meeting 

Hotels. Shuttles will not operate between the 

hours of 11:30 am – 2:00 pm. 

Shuttle service will run approximately every twenty 

minutes between the Los Angeles Convention Center 

and select Annual Meeting Hotels before 11:30 am 

and after 2:30 pm. 

Some hotels on the shuttle routes require attendees 

to walk to a neighboring hotel to catch the shuttle. 

Please refer to the hotel grid on pages 91–92 and 

the hotel map on page 93 for further details. 

Saturday, November 7, 2009 shuttle service will 

operate on a limited basis. Please refer to hotel grid 

on page 91–92 to identify which hotels the shuttle 

will be picking up and dropping off. 

REMOTE AIRLINE CHECK-IN SERVICE 

You can check-in at the Los Angeles Convention 

Center and bypass the airport lines! 

This unique service allows you to check your bags 

and receive your boarding pass at the Los Angeles 

Convention Center, leaving you more time to visit the 

show floor or take in more of what Los Angeles has 

to offer. 

Participating Airlines (Domestic Flights Only): 

• Air Tran 

• Delta 

• Alaska 

• Northwest 

• American • United 

• Continental 

Pre-enrollment Cost: $10.00 

On-site Enrollment Cost: $15.00 

Please note, normal airline baggage restrictions 

apply. Cost does not include airline’s baggage fee(s). 

Baggage must be checked a minimum of three 

(3) hours prior to flight departure time. Payment 

requested in cash only. 

Save $5.00 and pre-register! 

In order to expedite the check-in process, AAPS 

strongly encourages attendees to pre-enroll for this 

service. Once on-site, pre-enrolled attendees will 

have documents printed and processed in less than 

a minute. Simply visit the following pre-registration 

website, https://onvoy.arincmuse.net/rps and 

use the following event ID and passcode to enter 

the pre-registration website. 

Event ID: 15043 

Passcode: AAPS09 

Safe and Secure: 

• The first TSA-approved remote skycap service. 

• All agents are highly trained and credentialed 

to issue boarding passes and print bag tags 

on demand. 

• Proprietary sophisticated technology is used to 

ensure accurate, safe, and secure multi-airline 

baggage check-in and transport to the airport. 

Flight check-in is available anytime on the day of 

departure. Luggage must be checked in a minimum 

of three hours before scheduled flight departure. 

Location of Service: 

Service is located adjacent to the coat check area 

at the Los Angeles Convention Center 

Questions or Comments on the service may be 

directed to JMecca@airportbags.com 

Please make sure to reference AAPS at the Los 

Angeles Convention Center in the subject line.


AAPS HonorS 

Pfizer Inc. 

235 East 42nd Street 

New York, NY 10017 

www.pfizer.com 


During 2008-2009 



ScienceS

97 


General Information 

AAPS Annual Meeting Abstracts 

Visit our Online Exposition website for a 

complete listing of Contributed Papers that 

will be presented and for program updates. 

Visit, www.aapspharmaceutica.com/amexpo, 

to view the online exposition. Service 

available beginning August 25, 2009. 

The AAPS Journal Supplement CD 

The AAPS Journal Supplement CD is discontinued 

in 2009. 

Professional Development 

Enhance Your Skills and Knowledge 

Continuous learning is crucial in today’s forwardthinking 

society and is a valuable investment for 

future success. To accommodate the professional 

development needs of pharmaceutical scientists, 

AAPS is offering the following sessions during the 

2009 AAPS Annual Meeting and Exposition: 

Don’t miss this opportunity to enhance your personal 

development. Detailed session descriptions are 

included in the program pages 27–28. 

Graduate Students 

The 2009 AAPS Annual Meeting and Exposition 

offers graduate students opportunities to learn, 

network, and explore new scientific research and 

technologies through the following programs: 

• AAPS Career Center 

• AAPS Graduate Student Symposium in Analysis 

and Pharmaceutical Quality (APQ) 

Sponsored by 

• AAPS Graduate Student Symposium in 


Sponsored by 

• AAPS Graduate Student Symposium in Drug 


Sponsored by 



Sponsored bY 



Sponsored by 

• AAPS Graduate Student Symposium in Physical 

Pharmacy and Biopharmaceutics (PPB) 

Sponsored by 


Pharmacokinetics, Pharmacodynamics and Drug 

Metabolism and Clinical Pharmacology and 

Translational Research (PPDM & CPTR) 

Sponsored by 

• Outstanding Graduate Student Research Award 

in Pharmaceutical Technologies 

• AAPS Student Lounge 

Funded by a Grant From 

• AAPS Mentoring Breakfast 

• University Alumni Receptions 

• Student/PostDoc Outreach and Development 

(SPOD) Committee Roundtables: 

• Paths Less Traveled: Opportunities for 

Pharmaceutical Scientists beyond Industry 

and Academia 

• Individualizing a Postdoctoral Position 


• Student Chapter Chairs Meeting 

• Student Representatives to Section Meetings 

• Sunrise Sessions 

Graduate Student Reduced Short Course 

Registration Fee 

A reduced Short Course registration fee of $50 is 

available for graduate students and postdoctoral 

fellows. To qualify for this fee, you must be an AAPS 

Student Member. To become an AAPS Member, visit 

the AAPS Annual Meeting registration website to 

apply online. 

The first five applicants per Short Course will be 

selected to purchase Short Course registration at 

a reduced rate of $50. You may apply for up to three 

Short Courses. Applications are not transferable. 

To qualify, you must fill out the short course 

application form and register for receipt by 

September 11, 2009. Incomplete applications 

will not be considered. Notification will be sent via 

fax or email on September 11, 2009. Questions 

regarding the application form may be directed to: 

Kate McHugh, Registration Manager 

Phone: +1 (703) 248-4793 

Fax: +1 (703) 243-5582 


Deadline: September 11, 2009 

About Children 

Due to liquor being served at the evening receptions, 

youth (18 years and younger) are prohibited from 

attending. For their safety, children are also 

restricted from entering the Exposition Hall and 

Poster Sessions at all times. Our program is geared 

for adult participation and we appreciate your 

cooperation and understanding. 

NEW! Children at the AAPS Welcome 

Reception 

Due to the 2009 AAPS Welcome Reception being 

held at the Los Angeles Convention Center, AAPS 

will not offer a specialized Children’s Welcome 

Reception this year. Please note that AAPS will 

not allow children to attend the AAPS Welcome 

Reception, see list of childcare services available 

in Los Angeles. 

AAPS does not provide childcare. Below you will find 

a listing of reputable child care services; attendees 

are responsible for arranging childcare. 

L.A. Enrichment Academy*** 

Phone: +1 (310) 796-0800 

Email: info@laenrichmentacademy.com 

www.laenrichmentacademy.com 

Nina’s Nursery 

Phone: +1 (323) 937-7498 

1339 S Genesee Ave, Los Angeles, CA 90019 

We Sit Better** 

Phone: +1 (818) 997-1421 

Jennifer Hart, President 

Westside Baby Sitters Agency 

Phone: +1 (310) 979-3324 

12325 Santa Monica Boulevard, Los Angeles, 

CA 90025 

A Nanny & Staffing Co. 

Phone: +1 (310) 622-4542 

11257 National Blvd 

Nannies Etc. 

Phone: +1 (310) 470-7776 

Los Angeles Baby Sitters —The Baby Sitters Guild ** 

Phone: +1 (310) 837-1800 

3614 Empire Dr., 205

98 



Busy Bee Child Care 

Phone: +1 (310) 836-2856 

10737 Tabor St, Los Angeles, CA 90034 

Best Babysitters Services 

Phone: +1 (323) 857-0023 

Los Angeles Baby Sitters — Bright Beginnings 

Child Care 

Phone: +1 (323) 777-2202 

Los Angeles, CA 90047 

Kiddie Corp. 

Phone: +1 (858) 455-1718 

10455 Sorrento Valley Road, 200 

Mandy Merriefield 

Email: mandy@kiddiecorp.com 

Family Care Agency** 

Phone: +1 (818) 345-2950 

Claudia Jenkins 

Email: jenkins_claudia@yahoo.com 

Rusty Goheen 

Email: rusty_fcms@yahoo.com 

www.afamilycare.com 

***L.A. INC. Member 

** Highly recommended by Downtown Los Angeles Hotels 

FAMILY FRIENDLY ACTIVITIES IN 

LOS ANGELES 

Universal Studios Hollywoods 

Immerse yourself in the movie action with 

pulse-pounding rides and full-sensory attractions; 

visit “Revenge of the Mummy — The Ride,” 

and the upcoming new mega-attraction based 

on the blockbuster hit movie and TV series, 

“The Simpsons.” 

California Science Center 

Offers fun and informative exhibits presented in 

interactive worlds. Through hands-on experiences 

in the galleries, you’ll learn about human inventions 

and innovations, the life processes of living things 

and more. Also features a seven-story IMAX theater. 

La Brea Tar Pits 

One of the world’s most famous fossil sites with 

more than 3 million fossils where huge mammoths, 

fierce saber toothed cats, and giant ground sloths 

became trapped and entombed in the asphalt that 

has been seeping out of the ground for the past 

40,000 years. 

Griffith Observatory 

Nonprofit educational institution that provides 

information on astronomy and related sciences to 

the public. An ambitious $93-million renovation 

project to renew the Observatory’s world-class 

standing and restore and enhance the Observatory’s 

ability to pursue its public astronomy mission was 

recently completed. 

The Getty Center 

Overlooking the California coastline and the L.A. 

skyline, the Getty Center surrounds guests with 

breathtaking views and a world-class art collection 

including European paintings, contemporary 

photographs and decorative arts. 

Cabrillo Marine Aquarium 

What sets Cabrillo Marine Aquarium apart from 

other aquariums? We specialize exclusively on 

the marine life of Southern California. Visitors 

can appreciate that every animal they see in our 

exhibits can be found in and around the coast 

of Southern California. 

Speaker Information 


The Speaker Ready Room is located in the Los 

Angeles Convention Center. Speakers are required 

to sign in at the Speaker Ready Room minimally two 

hours prior to their session. The audiovisual staff 

will assist you with downloading your presentation, 

verify your advance equipment request, answer any 

audiovisual questions, and confirm your arrival with 

the appropriate session moderator. Moderators 

are required to stop by the Speaker Ready Room 

to confirm speaker attendance and receive any 

late-breaking announcements. 

AAPS Speaker Website 

Speakers should visit, http://abstracts. 

aapspharmaceutica.com/aaps2009, and use 

previously assigned password, supplied by AAPS, 

for session information and other announcements. 

Speaker Questions 

Contact: Ms. Megan E. Reese 

Phone: +1 877-998-AAPS 

AAPS Expocard 

Funded by a grant from 

Expocard is your key to product information and 

the Message Center. As an electronic business 

card, Expocard is a fast and easy way to provide 

exhibitors with your name and address. Carry your 

Expocard with you to leave and retrieve messages 

at the Message Center located at the Los Angeles 

Convention Center. You will also be able to send and 

receive your office and home email. 

Lost Badges and Expocards 

AAPS charges $25.00 on-site to replace any lost 

badge and/or Expocard. This charge is necessary 

since AAPS is charged for each badge and 

Expocard printed. 

Photography 

Photography is not permitted in the meeting rooms, 

poster sessions or exhibit hall. Contact show 

management for further clarification. 

Electronic Devices 

As a courtesy to meeting attendees, electronic 

devices must be operated in silent/vibrate mode 

during all educational sessions; devices that 

beep, ring, etc. are prohibited. We ask that you 

please do not conduct cell phone conversations 

while in attendance at educational sessions. Your 

cooperation is appreciated.

99 



Recycling 

Your badge holder and Expocard are recyclable. 

Please help AAPS run a greener convention by 

recycling your badge holder and Expocard at the 

end of the meeting. Receptacle boxes for the badge 

holders and Expocards will be located in various 

places in the Los Angeles Convention Center. 

AAPS Message Center 

Located at the Los Angeles Convention Center, AAPS 

will provide an Electronic Message Center with full 

Internet access. Stay in touch with the office, home 

and fellow registrants while in Los Angeles. To access 

your office or home email, you will need your mail 

server address, your login name and your password. 

The Message Center also gives you access to the My 

Annual Meeting Itinerary and the Online Expo. 

Business Center 

For your everyday office needs, the Los Angeles 

Convention Center operates one full service Business 

Center conveniently located in the Concourse 

walkway, between the South and West buildings, 

on the first floor. 

It offers the following office services and 

business supplies: 

• Small package handling and shipping inbound 

and outbound (UPS and FedEx) 

• Black/white copy services 

• Office supplies/shipping supplies 

• Facsimile services 

• Computer and Internet access 

For more information, please contact the Business 

Service Center at +1 (213) 741-1151, Ext. 5520, 

Fax: +1 (213) 765-4446. 

Notice for all Attendees 

Before you leave for this year’s meeting, please 

provide your company and family with your hotel 

name and contact information while attending the 

meeting. AAPS staff is unable to forward messages 

to attendees. 

Smoking Policy 

By AAPS policy, smoking is prohibited in the meeting 

rooms and the exhibit hall. 

What to Wear 

Casual business attire is the standard dress code. 

In November temperatures average around 

69°F/20°C during the day and 55°F/12°C at night. 

AAPS Central 

AAPS invites you to stop by AAPS Central (booth 

#1147) in the AAPS Exposition Hall and enjoy a cup 

of coffee. AAPS will be providing strong pick-me-up’s 

to fuel your expo experience. You will also be able to 

review a new e-learning CD-ROM, webcasts, webinar 

replays, and the latest offerings from AAPS Press. 

As always, AAPS Staff will be on hand to answer your 

questions and fulfill your requests. 

AAPS Central will also be configured to facilitate 

conversation, in a relaxed atmosphere, with your 

fellow Section Members. All AAPS Sections are 

represented at the AAPS Booth: Analysis and 

Pharmaceutical Quality (APQ), Biotechnology 

(BIOTEC), Clinical Pharmacology and Translational 

Research (CPTR), Drug Design and Discovery 

(DDD), Formulation Design & Development (FDD), 

Manufacturing Science & Engineering (MSE), 

Physical Pharmacy & Biopharmaceutics (PPB), 

Pharmacokinetics, Pharmacodynamics, and Drug 

Metabolism (PPDM), and Regulatory Sciences (RS). 

FREE Give-aways 

It’s a surprise, so be sure to pick up your free gift 

at AAPS Central while supplies last. 

AAPS Fun Booth 


Stop by the AAPS Fun Booth (#1624) and prove 

to everyone that you could be the next 

“Masters Champion”! 

The 2009 AAPS Fun Booth guarantees to get those 

competitive juices flowing and will test your golfing 

prowess under pressure. 

Closest to the Pin Competition: Combine all of your 

golf skills and see who can cozy it up right next to 

the hole. A shot in between a clearing in the trees 

and over water will require a lengthy and on-themark 

shot. Bring your ‘A’ game! 

Get ROCK’d at the Annual Meeting! 

Look out for AAPS Staff presenting 2009 Annual 

Meeting and Exposition attendees with “Random 

Offers of Conference Kindness.” AAPS hopes 

to provide you with a meeting experience that 

will ROCK! 


The International Lounge can be used by 

international attendees as a meeting place, 

a place to meet new friends and see old ones. 

The International Lounge is open 

Monday, November 9 9:00 am – 5:00 pm 

Tuesday, November 10 7:00 am – 5:00 pm 

Wednesday, November 11 7:00 am – 5:00 pm 


Funded by a grant from 

Back by popular demand! AAPS is thrilled to 

announce the return of the AAPS Student Lounge. 

Once again, AAPS is pleased to provide this lounge 

with exclusive privileges to the AAPS Student 

Members. The lounge is a great place to network, 

relax, and will feature 

• Complimentary Wireless Internet 

• Light Refreshments 

The lounge is open 




Thursday, November 12 7:00 am – 12:00 pm 

Press Room 

AAPS welcomes professional journalists and science 

writers to attend the 2009 AAPS Annual Meeting 

and Exposition. The AAPS Press Room is provided 

for members of the press to research and draft 

articles, review publications and materials, and 

conduct interviews. Registration packets, news 

releases, AAPS background information, notices 

of meeting briefings and newsworthy events, press 

kits and information from exhibiting companies 

are provided. Visit the AAPS Press Room online at 

www.aapspharmaceutica.com/ampressroom for 

Annual Meeting and Exposition updates. The AAPS 

Press Room is located in the Los Angeles Convention 

Center and the hours of operation will be 

Sunday, November 8 8:00 am – 5:00 pm 




Thursday, November 12 7:00 am – 12:00 pm 

For press registration information, contact: 

AAPS Communications Specialist 

Phone: +1 (703) 248-4744 

Email: MayS@aaps.org

100 


Membership Information 

Join AAPS Today and Save on Registration Fees! 

Save up to 56% percent on registration fees! Become an AAPS Member and register using 

the discounted member rates. Please use the AAPS Annual Meeting registration website 

to join or renew your AAPS Membership. Do NOT mail the membership form separately. 

AAPS Members always pay the lowest prices for registration when attending the AAPS 

Annual Meeting and Exposition and all other AAPS Meetings. Not only will you pay the 

lowest registration prices, membership will also provide you with access to the following 

benefits and more: 

• Access to research on emerging science and technology — found within the pages 

of the AAPS Newsmagazine, journals, books, and online journals; 

• Numerous options in learning — when you participate in AAPS conferences, 

workshops, and e-learning programs; 

• Recognition and rewards — available in the form of fellowships, grants, awards, 

and travelships to members only; and 

• Limitless resources — from other members within your specific discipline and 

throughout the industry. 

As a member your savings for the 2009 AAPS Annual Meeting and Exposition could be 

$ 880.00 Non-Member — Early Registration 

- $ 565.00 Member — Early Registration 

$ 315.00 

- $ 145.00 Annual Membership fee 

$ 170.00 Savings for you! Join today! 

Questions? 

Email: membership@aaps.org 

Upcoming AAPS Annual Events 

2010 National Biotechnology Conference 

May 16–19, 2010 

Hilton San Francisco 

San Francisco, CA 

FIP Pharmaceutical Sciences World Congress 

in association with the 2010 AAPS Annual 

Meeting and Exposition 

November 14–18, 2010 

Ernest N. Morial Convention Center 

New Orleans, LA 


October 23–27, 2011 

Washington Convention Center 

Washington, DC 


November 11–15, 2012 

McCormick Place 

Chicago, IL 


November 10–14, 2013 

Henry B. Gonzalez Convention Center 

San Antonio, TX 


November 2–6, 2014 

San Diego Convention Center 

San Diego, CA 


October 25–29, 2015 

Orlando Convention Center 

Orlando, FL 

Register 

Today

101 


AAPS Tour Descriptions 

Click here to register for tours on-line. 

AAPS is pleased to offer the following tours. All arrangements must be made directly with RDS Productions using the 

Tour Registration Form. RDS Productions must receive tour registration forms by September 26, 2009. 

Once pre-registered, you can claim your tickets at the AAPS Tour Desk in the Los Angeles Convention Center. 

On-site tour registrations are available on a space-available basis. 

Tour Desk hours are 

Sunday, November 8 

8:00 am – 5:00 pm 

Monday, November 9 

8:30 am – 5:00 pm 


8:00 am – 5:00pm 

Wednesday, November 11 

8:00 am – 5:00pm 

Thursday, November 12 

8:00 am – 5:00pm 

Cancellations received by October 15, 2009 will receive a refund less a $5.00 per tour administrative fee. Cancellations received 

after October 15, 2009 will not receive a refund. Should a catastrophic event occur that adversely affects AAPS, a refund will be 

issued subject to a $5.00 administrative fee. Cancellation requests must be made in writing and addressed to: 

RDS PRODUCTIONS, AAPS, 3010 Bell Street, New Orleans, LA USA 70119 

Fax: +1 (504) 285-0775 

Refunds will be made via check following the conference. 

SUNDAY, NOVEMBER 8, 2009 

10:00 am – 3:00 pm 

$35.00 

GETTY MUSEUM TOUR 

The J. Paul Getty Museum, a program of the J. Paul 

Getty Trust, is an art museum. The museum at the 

Getty Center contains “Western art from the Middle 

Ages to the present”; its estimated 1.3 million 

visitors annually makes it one of the most visited 

museums in the United States. The Getty Museum 

is famous for its architecture, gardens and, of 

course its world class art collection! Exhibits change 

regularly and will be announced later this year for 

the AAPS time frame. 

MONDAY, NOVEMBER 9, 2009 

9:00 am – 12:00 pm 

$55.00 

STAR HOMES TOUR 

One of Hollywood’s most popular tours — includes 

a journey through Beverly Hills, Holmby Hills and 

Bel Air and a brief stop on Rodeo Drive. Discover the 

most famous places of Los Angeles: Beverly Hills 

and Bel-Air, Rodeo Drive, Sunset strip the Hollywood 

signs; contemplate the amazing mansions of some 

of the world’s most famous celebrities, including 

Tom Cruise, Ozzie Ozbourne, Madonna, Jackie Chan, 

Nicolas Cage, Dr. Phil, Sean Connery, Angelina Jolie, 

Peter Falk, Ronald Reagan, and former estates of 

such legends as Elvis Presley, Marilyn Monroe, 

Frank Sinatra, Lucille Ball, Gregory Peck, Jack Benny, 

Judy Garland, Humphrey Bogart, Lauren Bacall and 

dozens more. Tour is conducted on 13 seat mini 

coaches as mandated by the City of Beverly Hills. 

MONDAY, NOVEMBER 9, 2009 

1:00 pm – 4:30 pm 

$35.00 

HOLLYWOOD BEHIND THE SCENES 

A must see for anyone who wants to really 

see Hollywood! This 75 minute walking 

tour of Hollywood Blvd. covers only 2 

city blocks so it’s easy to walk. The tour 

includes commentary on the Chinese Theatre 

(hand and foot prints), Kodak Theatre Complex 

(home of the Oscars), Hollywood Sign, Walk of 

Fame, El Capitan Theatre (Disney Premiere Theatre), 

Egyptian Theatre (birthplace of the Hollywood 

premiere) …and much, much more! 

TUESDAY, NOVEMBER 10, 2009 

9:30 am – 12:30 pm 

$45.00 

A JOURNEY THROUGH TIME: 

WALKING/DRIVING TOUR OF DOWNTOWN 

LOS ANGELES 

This eye popping 3 hour tour is part walking and 

part driving and includes visits to landmarks 

in the Historic District (Grand Central Market, 

Angel’s Flight, Bradbury building) as well as the 

modern district (Walt Disney Concert Hall, Museum 

of Contemporary Art, L.A. Live). Unbelievably, 

Downtown Los Angeles Historic District is the 

largest in the United States that ironically is often a 

stand-in for turn-of-the-century New York or Chicago 

in movies. Pritzker Prize winning architects Frank 

Gehry, Thom Mayne, Raphael Moneo, Cesar Pelli 

and IM Pie’s have created iconic landmarks for 

Downtown L.A. that set the pace of 21st century 

cities around the world!

102 


AAPS Custom Tour Order Form 

Registration Form for Social Program Activities 

Type or print clearly. Please photocopy the completed form for your records. You can also register online! 

Last Name 

First Name 

Organization 

Street 

City 

State/Province Country Zip/Postal Code 

Home Phone ( ) Work Phone ( ) 

Fax ( ) Email 

Name of Hotel in L.A. 

Dietary requirements/allergies 

Return this form with appropriate fee(s) to: 

RDS Productions, Attn: AAPS Tour Registration — Production Coordinator, 

3010 Bell Street, New Orleans, LA 70119 

m Please check here if you require any special assistance 

Wheelchair/Other 

Fax: +1 (504) 285-0775, Telephone: +1 (504) 218-9665 Laura Swann 

See reverse page for Refund/Cancellation policy. All tour prices are in US dollars 

and are inclusive of all taxes, gratuities, entrance fees, etc. 

Tours Hours # Cost Total 

Getty Museum Tour 

Star Homes 

Hollywood Behind The Scenes 

A Journey Through Time: Walking/Driving Tour of Downtown Los Angeles 

Airport Shuttle: One-way Shuttles will depart the L.A. Convention Center to the Airport operating 

every hour on the hour between 12:00 pm – 5:00 pm on Wednesday and 9:00 am – 5:00 pm on Thursday 

(November 11 – 12, 2009). Passes may also be purchased on-site by AAPS attendees at the Tour/Airport 

Shuttle Desk. The motor coaches will run on the hour ever hour to LAX. We suggest booking the motor 

coach at least 2½ hours prior to flight. Please list your required departure time to LAX:_____________ 


10:00 am – 3:00 pm 

$35.00 


9:00 am – 12:00 pm 

$55.00 


1:00 pm – 4:30 pm 

$35.00 


9:30 am – 12:30 pm 

$45.00 

Wednesday and Thursday, November 11–12, 2009 

Wednesday (11/11/09) 

12:00 pm – 5:00 pm 

$15.00 

Thursday (11/12/09) 

9:00 am – 5:00 pm 

$15.00 

Total Amount Enclosed $ 

Credit card orders will be charged to your account upon receipt of your tour registration form. m VISA m MasterCard m American Express 

Credit Card Number 

Exp. Date 

Name on Card 

Signature (required) 

Forms can be FAXED with Credit Card Information to: +1 (504) 285-0775. Attn: RDS Productions Operations Department — Laura Swann (lswann@rdsconcepts.com) 

Email Address 

Hotel in which you are staying during the AAPS Annual Meeting 

Social Program Registration Policy 

Registration deadline: September 26, 2009 

RDS Productions is the social activities operating company 

for the AAPS Conference and will operate social program 

registration at the Los Angeles Convention Center during 

the regular conference registration hours from Sunday, 

November 8, 2009 (8:00 am – 5:00 pm) through Tuesday, 

November 10, (7:00 am – 9:30 am). 

RDS PRODUCTIONS: 

AAPS Tour Registration — Production Coordinator 


Phone: +1 (504) 218-9665 Fax: +1 (504) 285-0775 

You will receive notification from RDS confirming 

availability of the activities/tours you have selected. 

All prices are inclusive of taxes, gratuities and entry fees 

as stated. 

Registration 

Your Kit of materials may be picked up at the Los Angeles 

Convention Center at the Social Program Registration Desk. 

Refund/Cancellation Policy 

Cancellations received by October 15, 2009 will receive 

a refund less a $5.00 per tour administrative fee. 

Cancellations received after October 15, 2009 will not 

receive a refund. Should a catastrophic event occur that 

adversely affects AAPS for a refund subject to a $5.00 

administrative fee. 

Cancellation requests must be made in writing and 

addressed to: RDS PRODUCTIONS, AAPS 


Fax: +1 (504) 285-0775. 

Refunds will be made via check following the conference. 

Social Program Information 

Tickets will be distributed at the Social Program 

registration desk at the Los Angeles Convention Center 

for all guests that have pre-registered. Early registration 

is recommended in order to guarantee your space for 

the activity. RDS has the right to cancel any tours if the 

minimum number of attendees is not met. If a tour is 

cancelled due to lack of minimum attendance as listed 

in the brochure, registrant will be notified by RDS after 

the registration deadline of September 26, 2009 and the 

registration fee refunded in full, unless an alternate choice 

is selected by registrant. 

Deadline: September 26, 2009 

Online Registration: CLICK HERE!

103 


Short Course Application Form 

For For Graduate Graduate Students Students and and Postdoctoral Postdoctoral Fellows Fellows Only Only 

The first five applicants per short course will be selected to purchase short course registration for the reduced rate of $50. Reduced fees are available 

on a space-available basis. Please print or type. Incomplete forms will not be considered. Reduced fees are not applicable after October 2, 2009. 

APS091 

Please print or type. Incomplete forms will not be considered. 

First Name 

Last (Family) Name 

AAPS Member ID (required) 

Institution 

Address 

City 

State/Province 

Postal Code 

Country 

Day Phone 

Evening Phone 

Fax 

Email 

Are you a member of an AAPS Student Chapter? 

m Yes m No 

If so, which one? 

Short Course Selections 

My top three choices are (rank in order with #1 as your first choice): 


8:30 am – 4:00 pm 

SC #1: RNA-targeting Therapeutics: Issues and Advances 

SC #2: Learning the Drug Discovery and Delivery Interface Process 

SC #3: Developing Biorelevant Dissolution Test Methods with 

an Emphasis on QbD 

SC #4: Recent Advances in Oral Drug Delivery 

SC #5: Transporter Mediated Drug-drug Interactions: 

Possible Criteria that Warrant In Vivo Transporter-mediated 


SC #6: Rational Design and Development of Solid Dispersions 

with Amorphous Drug for Improving Oral Absorption 

Up to five applicants will be selected for each Short Course 

on a first-come, first-served basis. 

m I am also registered for the 2009 AAPS Annual Meeting and Exposition. 

m I want to purchase Continuing Education Credits for the Short Course. 

A reduced registration fee of $50 will be requested upon notification of 

acceptance. If you also request Continuing Education Credits, an additional 

$50 fee will apply. Applications are not transferable. 

The signature of your Dean or Department Chair is required to certify your 

full-time status to be eligible for this fee. 

Signature 

Date 

m If I am not accepted for a reduced fee, charge me for the full rate for 

the Short Course selected. 

Payment Method 

AAPS does not accept government training forms nor purchase orders. Federal Tax ID #521444968 

m Check # 

Payable to AAPS-09AM 

(U.S. dollars drawn on a U.S. bank) 

m Charge 

m Visa m MasterCard m American Express m Discover 

Card Number 

Exp. Date 

Card Holder’s Name 

Authorized Signature 

Amount to Charge 

Register! 

Mail or fax this form to: 

2009 Short Course Application Form 

AAPS 

Attn: Kate McHugh 

2107 Wilson Blvd., Suite 700 

Arlington, VA 22201-3042 

Fax: (703) 243-5582 

Questions? 

Phone: (703) 248-4793 


Deadline: October 2, 2009

104 


Registration Form 

APS091 123456 

First Name 

Middle Initial 


Nickname for Badge 

Job Title 

Organization 

Address 

City State/Province Postal Code 

Country Phone ( ) 

Fax ( ) Email Mobile 

Emergency Contact Name Phone ( ) 

Instructions 

• Type or print all information. 

• Credit card payments are 

available online only at 

www.aaps.com/annualmeeting 

• Payment must accompany your form 

for registration to be processed. 

• Keep a copy of your completed 

registration form for your records. 

• Group and combo registration 

are available online only at 

www.aaps.com/annualmeeting 

• All information must be completed 

in full to receive a badge. 

m The information above has changed. 

m I require special services in 

accordance with the Americans 

with Disabilities Act. 

m Check this box if you do not wish to be included 

in promotional mailings or faxes from AAPS 

exhibitors sent prior to the 2009 AAPS 

Annual Meeting and Exposition. 

m New Member 

m Member Renewal 

Applied or renewed separately for 

AAPS Membership: 

Date Sent 

AAPS Section (new members must select one section) 

m A APQ – Analysis and Pharmaceutical Quality 

m B BIOTEC – Biotechnology 

m C CPTR – Clinical Pharmacology and Translational Research 

m D DDD – Drug Design and Discovery 

m E FDD – Formulation Design and Development 

m F MSE – Manufacturing Science and Engineering 

m G PPB – Physical Pharmacy and Biopharmaceutics 

m H PPDM – PK/PD and Drug Metabolism 

m I RS – Regulatory Science 

Business Information 

Primary Job Function (Check one) 

m A Academic 

m B Consultant 

m C Corporate Management 

m D Engineer 

m E Marketing/Sales 

m F Media 

m G Production/Planning 

m H Purchasing 

m I QA/QC 

m J R&D 

m K Regulatory Sciences 

m L Other 

Primary Business/Industry (Check one) 

m A Academia 

m B Analytical Testing Lab 

m C Association 

m D Biotechnology 

m E Contract/Clinical Research 

m F Cosmetics 

m G Foods 

m H Government 

m I Manufacturing 

m J Materials Manufacturing 

m K Medical Devices/Diagnostics 

m L Publications 

m M Other 

Purchasing Authority 

m A Authorize 

m B Purchase 

m C Recommend 

m D Specify 

m E No Purchasing Authority 

Area of Interest 

(Check all that apply) 

m A Analytical Services 

m B Chemicals 

m C Chromatography 

m D Contract/Clinical Services 

m E Dissolution Test Equipment 

m F Drug Delivery Systems 

m G Excipients 

m H Ingredients 

m I Packaging 

m J Pumps 

m K Raw Materials 

m L Software 

m M Spectroscopy 

m N Tablet Presses 

m O Test Equipment 

m P Other 

AAPS Cancellation Policy 


and Exposition 

All requests for refunds must be 

submitted in writing and emailed 

to registration@aaps.org or faxed to 

(703) 243-5582. Registration refunds will 

be issued for all requests received by 

October 16, 2009, less an administrative 

fee ($100 for members and nonmembers/$30 

for student registrants). 

Refunds will not be issued for requests 

received after October 16, 2009. 

Registration substitutions from the same 

company may be submitted in writing 

at any time without penalty. If the membership 

status of the substitute differs 

from that of the original registrant, 

a refund or additional charge may apply. 

Combination Registration — Available Online Only! 

Register for a workshop, a Short Course, and the AAPS Annual 

Meeting and Exposition and receive a 15% discount. Combo 

registration available ONLINE ONLY at www.aaps.com/annualmeeting. 

Short Course Registration (Additional fee required) 

If registering for a Short Course, check the course in which you wish 

to enroll and circle the appropriate fee below. Course registration 

is limited and accepted on a first-come, first-served basis. 

Join AAPS Today and Save 

on Registration Fees! 

Sunday, November 8, 2009, 8:30 am – 4:00 pm 

m SC #1: RNA-targeting Therapeutics: Issues 

and Advances 

m SC #2: Learning the Drug Discovery and 

Delivery Interface Process 

m SC #3: Developing Biorelevant Dissolution 

Test Methods with an Emphasis on QbD 

m SC #4: Recent Advances in Oral Drug Delivery 

AAPS 2009 Membership Fees 

m Regular Member $145.00 (RM) 

m Full-time Graduate Student/Undergraduate Student $30.00 (ST) 

m SC #5: Transporter Mediated Drug-drug 

Interactions: Possible Criteria that 

Warrant In Vivo Transporter-mediated 


m SC #6: Rational Design and Development 

of Solid Dispersions with Amorphous 

Drug for Improving Oral Absorption 

m Postdoctoral Fellow $30.00 (PD) 

m Retired Member $50.00 (RT)

105 


Registration Form 

First Name 

Please check Registration Type and circle the dollar amount. 

Registration 

CRS/AAPS Workshop on Development and Regulatory Challenges for Controlled Release Formulations 

Early Registration 

Received on or before 





On-Site Registration 

Received on September 12, 

2009 – on-site 

m AAPS Member (M) $565 $820 

m Non-member (N) $880 $1,135 

m AAPS Member, Graduate Student/Postdoctoral Fellow* (S) Are you a member of an AAPS Student Chapter? m Yes m No $140 $165 

m Government (GM) $565 $565 

m 1 Day AAPS Member (M1) (circle day(s) attending) Monday Tuesday Wednesday Thursday $325 $415 

m 1 Day Non-member (N1) (circle day(s) attending) Monday Tuesday Wednesday Thursday $540 $685 

m 1 Day AAPS Graduate Student/Postdoctoral Fellow* (S1) Are you a member of an AAPS Student Chapter? m Yes m No $65 $90 

Special Events 

(an additional fee is required to attend these sessions) 







m Short Course AAPS Member (SM) SC1, SC2, SC3, SC4, SC5, SC6 $665 $775 

m Short Course Non-member (SN) SC1, SC2, SC3, SC4, SC5, SC6 $915 $990 

m Open Forum (OF) (circle one) APQ BIOTEC PPDM RS BIOTEC/RS $75 $100 

m CPTR Open Forum $175 $200 

Open Forum 

Titles: 


Thursday, November 12, 2009 1:30 pm – 5:30 pm APQ: Analytical Challenges in Detecting & Preventing Counterfeits in Global Environment 

Thursday, November 12, 2009 1:30 pm – 5:00 pm BIOTEC/RS: Biosimilars – Development Considerations and Future Directions 

Tuesday, November 10, 2009 7:00 pm – 9:00 pm CPTR: Adequacy of PK/PD Model Validation and Simulation 

Thursday, November 12, 2009 1:30 pm – 5:00 pm PPDM: An Evolution or Revolution in Drug Metabolism: When, Where, Why, What & How? 

Thursday, November 12, 2009 1:30 pm – 5:00 pm RS: Regulatory Challenges for Genotoxic Impurities 




m AAPS Member /CRS Member $1,140 $1,330 

m Non-member $1,510 $1,650 

m Government $450 $525 

m Student $70 $80 

AAPS Workshop on Special Dosage Forms — What’s New with In Vitro Drug Release? 

m AAPS Member $1,035 $1,225 

m Non-member $1,405 $1,545 



AAPS Workshop on Quantitative Model-Based Drug Development in Drug Discovery and Translational Research (QMBDD) 

m AAPS Member $930 $1,125 

m Non-member $1,330 $1,440 



Additional Fees 




m Guest Guest Name $35 $35 




m CE Short Course (CES) $50 $50 

m CE Annual Meeting (CE) $50 $50 

m CE Workshop (CEW) $50 $50 

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Total Fees 

AAPS Membership $ 

AAPS Annual Meeting and Exposition $ 

Combination $ 

Special Events 

CRS/AAPS Workshop on Development & Regulatory Challenges for Controlled Release Formulations $ 

AAPS Workshop on Quantitative Model-Based Drug Development in Drug Discovery & Translational Research (QMBDD) $ 

AAPS Workshop on Special Dosage Forms – What’s New with In Vitro Drug Release? $ 

Short Course $ 

Open Forum $ 

Additional Fees $ 

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Preliminary Program - American Association of Pharmaceutical ...

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