PHTD 2012 Spring Meeting - units.sla.org

Photos courtesy of Visit Baltimore and Hilton Baltimore. 

2012 Spring Meeting 

March 18-20, 2012 

Baltimore, MD 

“The Ever Changing Landscape” 

Meeting Book prepared by BizInt Solutions Inc., a proud sponsor of the 2012 PHTD Spring Meeting

PHTD 2012 Spring Meeting 

Sunday, March 18 th , 2012 

9:00 am 1:00 pm CE Course: Applying text mining techniques for scientific literature and patent search and analysis: 

A Hands-On Workshop. Instructor: Dr. David Milward, Chief Technical Officer, Linguamatics 

Peale 

11:00 am 4:00 pm Exhibitor Registration and Setup Holiday 1-5 

2:00 pm 4:00 pm PHTD Board Meeting (open to all; refreshments provided) Peale 

2:00 pm 5:30 pm Attendee Registration Holiday Foyer 

6:00 pm 9:30 pm Dinner Reception & Exhibits Holiday 1-5 

Monday, March 19 th , 2012 

8:00 am 9:00 am Registration, Breakfast & Exhibits Holiday 1-5 

9:00 am 9:15 am Welcome from the PHTD Chair Holiday 6 

9:15 am 10:30 am Keynote: The US Pharmaceutical Market: Trends, Issues and Outlook. 

Doug Long, Vice President, Industry Relations, IMS Health, Inc. 

10:30 am 11:00 am Break & Exhibits Holiday 1-5 

11:00 am 11:45 am Practical steps to reinvent the Corporate Information Center and demonstrate value. 

Blanca Chou and Eric Stubbs, Otsuka Pharmaceuticals 

Holiday 6 

11:45 am 12:30 pm Managing data and providing competitive insights from clinical trials databases. 

using BizInt Smart Charts. Diane Webb (BizInt Solutions) and Jennifer Friend-Huizer (Janssen/J&J) 

12:30 pm 2:00 pm Lunch & Exhibits Holiday 1-5 

2:00 pm 

2:45 pm 


Hilton Baltimore 

Baltimore, MD 

Mobile Devices & the Information Professional – where do I fit in? Andrew Clark, UCB 

Holiday 6 

2:45 pm 3:30 pm Librarians as internal consultants. Josh Duberman, Partner, Pivotalinfo LLC 

3:30 pm 4:00 pm Break & Exhibits Holiday 1-5 

4:00 pm 4:45 pm KOLs – who are they, where are they, and how do you find them? 

Marc Engelsgjerd, M.D., Wolters Kluwer InThought 

Holiday 6 

4:45 pm 5:15 pm Big projects need big solutions – Utilizing OvidSP and QUOSA for AdComm Prep. 

Natalie Rainford, Astellas Pharma Global Development 

6:30 pm 10:00 pm Social Event – National Aquarium, Baltimore 

6:00 pm: meet in Hilton 

Sponsored by Wolters Kluwer Health (Ovid) & Adis 

Tuesday, March 20 

lobby for shuttle buses 

th , 2012 

8:00 am 9:00 am Registration, Breakfast & Exhibits Holiday 1-5 

9:00 am 9:15 am Remarks from the PHTD Chair Holiday 6 

9:15 am 10:30 am The Rise of China: Implications for Pharma and Pharma Librarians. 

Josh Berlin, Elsevier Business Intelligence 

10:30 am 11:00 am Break & Exhibits Holiday 1-5 

11:00 am 11:45 am Biosimilars and biopharmaceuticals. Ronald A. Rader, Biotechnology Information Institute Holiday 6 

11:45 am 12:45 pm Vendor Panel – Discovery Services. EBSCO, Ex Libris, and Serials Solutions. 

Moderator: Karin Ross, AstraZeneca 

12:45 pm 2:00 pm Lunch and Exhibits Holiday 1-5 

2:00 pm 3:00 pm Breakout sessions 

1. Challenges of globalizing contracts II. Moderator: Robyn Smith, Takeda Pharmaceuticals 

2. Managing of copyright – reactive/responsive use. Moderator: John Chu, Gilead 

3. Should I know what cloud computing is? 

4. What was your library’s role in the BRIC expansion? 

5. Pharmacovigilance - managing the right product literature database 

Holiday 6 

Calloway A 

Calloway B 

Poe 

Holiday 6 

3:15 pm 3:35 pm Break Out Sessions: Summaries Holiday 6 

3:35 pm 3:50 pm Closing Remarks and Meeting Adjournment — See you in Chicago 14-17 July! Holiday 6

SLA Pharmaceutical & Health Technology Division 

2012 Spring Meeting 

“The Ever Changing Landscape” 



Baltimore, Maryland 

Meeting Book prepared by BizInt Solutions, Inc., a proud sponsor of the PHTD 2012 Spring Meeting 

1

PHTD 2012 Spring Meeting, Baltimore MD 

2 

Welcome to Baltimore for the 

2012 PHTD Spring Meeting! 

Welcome to beautiful Baltimore, the site of our 2012 Spring Meeting! We’re so glad you have 

made time to join us for three days of quality time, focused on you, your career, and our future! 

And for those of you for whom this is your first time, a special welcome to you! (Thanks for 

coming and please do stop me and say hi!) 

This meeting is about all of us –pharmaceutical & life sciences information professionals and 

suppliers supporting industry professionals – taking a few days in our already hectic lives 

to focus on what’s important for us as life science professionals: education to keep us at the 

leading edge, in both tools and techniques, networking to learn best practices and to better 

market ourselves, and dare-I-say-it strategic planning to make sure that we’re anticipating the 

future and collectively doing the right things to continue to show our value in the companies 

we serve. 

Last year, the theme for SLA was Future Ready. This year, the theme is Future Now. I can’t 

help but think that it is appropriate given the current economic environment. Yes, times are 

tough and we are being squeezed, asked to do more than ever. But it’s also a great opportunity 

to take on new responsibilities, strategically thinking on behalf of our companies, positioning 

ourselves, and best leveraging the tools that we have to make a measurable impact. Please - 

take advantage of this time to listen to the sessions, network with colleagues, and plan for what 

changes you can make in your organization (or in your career)! 

Nothing in this division, especially at the Spring Meeting, happens without the help of 

Division members. We’re grateful for so many Division members who have stepped up to take 

significant responsibility by filling key roles for this meeting. Mega-thanks to Robyn Smith, 

the planner for this meeting, and Margaret Basket, past-chair, for the countless hours of work 

overseeing this meeting! Thanks also to Patrice Costa, Karen Mirabile, Sandra Baker, Sidney 

McNab, Praveena Raman, Diane Webb, Magan Stephens, Rick Raske, and Janet Weiss, who 

have spent countless hours planning sessions, coordinating hotels, managing registrations, and 

sending invoices, among other thankless tasks (if you see them, give them a hearty pat on the 

back – or two!). 

Last but certainly not least, a huge thank-you (THANK YOU!) to our awesome sponsors! They 

are here exhibiting to connect with their most valued clients (and potential clients), so please 

take advantage of having them all in one place in this intimate setting to visit with them and 

learn about their most recent innovations. And don’t forget to thank them for their continued 

support of the Division. Without the support of our sponsors, this meeting would not be 

possible. 

Thanks again for coming - I look forward to spending the next three days alongside you! 

And feel free to stop me at any time with comments, thoughts, questions, or if you want to help out with 

Division activities! 

Alexander Feng, PHT Division Chair

Contents 

Table of Contents 

Agenda inside front cover 

A Special Message to Conference Participants 2 

Sunday, March 18 - CE Course 4 

Monday, March 19 - Speakers 6 

Tuesday, March 20 - Speakers 20 

Sponsors & Exhibitors 30 

Diamond & Platinum Sponsors - Ads 46 

Attendees (sorted by Name) 72 

Attendees (sorted by Company) 74 

Sponsor Attendees 75 

Monday Social Event (National Aquarium) 75 

PHTD Officers & Hotel Map inside back cover 

3


4 

Sunday, March 18 (CE Course) 

9 am - 1 pm Applying text mining techniques for scientific literature 

and patent search and analysis: A Hands-On Workshop 

Instructors: 

Dr. David Milward, Chief Technology Officer, Linguamatics 

Dr Jeff Nauss, Senior Application Specialist, Linguamatics 

This course is for those interested in learning more about text mining, natural 

language processing and how it is applies to drug discovery. Our goal is to 

educate attendees on how to deal with the vast amounts of information available 

from the literature, and how text mining can get them to answers more quickly. 

Existing experience with text mining is not required. 

Biographies 

David Milward has 20 years experience of product development, consultancy and research 

in natural language processing. David is a founder of Linguamatics and pioneer of interactive 

text mining. He has been involved in applying text mining to applications in the life sciences 

for over 10 years, initially as a Senior Computer Scientist at SRI International. David has a 

PhD from the University of Cambridge, and was a researcher and lecturer at the University of 

Edinburgh. He is widely published in the areas of information extraction, spoken dialogue, 

parsing, syntax and semantics. 

Jeff Nauss is an Applications Specialist with Linguamatics based in Boston, MA. Prior to 

joining Linguamatics, Jeff served in the US Army, attaining the rank of major, and has held 

positions as the Director of Molecular Modeling Services at the University of Cincinnati and as 

the Lead Training Scientist for Accelrys. He has a Bachelor of Science degree in microbiology 

and a Master of Science degree in biochemistry, both from Texas A&M University. His PhD is 

from Rutgers University in physical chemistry. 

F F F

Applying text mining techniques for scientific literature and patent search 

and analysis: A Hands-On Workshop 

Dr. David Milward, Chief Technical Officer, Linguamatics 

Dr Jeff Nauss, Senior Application Specialist, Linguamatics 

Sunday CE Course 

5


6 

Monday, March 19 (Morning) 

9:15 – 10:30 am Opening Keynote: 

The US Pharmaceutical Market: Trends, Issues and Outlook 


Doug Long is Vice President of Industry Relations at IMS HEALTH, the world’s largest 

pharmaceutical information company. IMS HEALTH provides consulting services and an 

extensive product portfolio to the pharmaceutical industry in over 101 countries around the 

globe. 

Doug has been with IMS HEALTH since 1989. Doug has, and continues to be, a key component 

in the successful implementation of data Health databases. In addition, Doug continues to 

forge important manufacturer and association relationships, along with product development 

for data partners. Subsequently, he has attained considerable experience with, and a unique 

perspective on, the changing U.S. and global healthcare marketplace and pharmaceutical 

distribution. 

Most notably, the heart of Doug Long’s Industry Year in Review, are the trends and forecasts 

in the US market. Presenting up-to-the-minute market news and pharmaceutical innovation 

including customization with a specific focus on the topics most pertinent to each unique 

audience, leaves him a uniquely sought after expert in the field. Mergers and acquisitions, 

tiered co-pay, generics, biologics, PBM, and other emerging channels, along with patient 

privacy are topics that Doug has developed a detailed and in-depth knowledge base. 

Wholesalers, retailers, manufacturers, and multiple trade associations continually look to 

Doug for guidance and direction as an industry healthcare expert. 

Doug is also a frequent Industry speaker for the following groups: Health Distribution 

Management Association, National Association of Chain Drug Stores, Food Marketing 

Institute, National Council of Prescription Drug Programs, Pharmaceutical Care Management 

Association, National Community Pharmacist Association, International Federation of 

Pharmaceutical Wholesalers, Generics Pharmaceutical Association, BIO, AMCP, HIGPA and 

many others. Doug is a permanent member of the Editorial Advisory Board of HealthCare 

Distributor magazine. His honors include the 2004 HDMA NEXUS Award for Lifetime 

Achievement and IMS’ prestigious Summit Award in 2003. 

Prior to IMS HEALTH, Doug was at Nielsen Market Research for sixteen years in various 

sales and marketing capacities. A native of Illinois, Doug received a BA degree from DePauw 

University in Greencastle, Indiana, and an MBA in Management from Fairleigh Dickinson 

University in New Jersey. 

F F F

Opening Keynote: The US Pharmaceutical Market: Trends, Issues and Outlook 


Monday AM Keynote 

7


8 


11:00 – 11:45 am Practical steps to reinvent the Corporate Information Center 

and demonstrate value 


The decisions we make are framed by our perceptions, base assumptions and opinions. 

Many companies have struggled with the economic uncertainty of the past few years, and the 

pace of restructuring and outsourcing has grown as they try to cope with change. Corporate 

information centers often suffer downsizing or closure during these upheavals, but it does not 

have to be this way! In fact, they can survive and thrive in challenging times. 

Biographies 

Blanca Chou is a Senior Manager of Information Resource Center at Otsuka America 

Pharmaceuticals in Rockville, Maryland. She has worked in the pharmaceutical industry for 

13 years. Prior to the pharmaceutical industry, Blanca had worked at the EPA Toxic Chemicals 

Library, American Chiropractic Association and the Rural Health Information Center at the 

National Agricultural Library. She has won SLA Diversity Leadership Development Program 

award and has been a speaker for several events of SLA DC chapter and PHTD. She is also a 

very active leader in a local biopharma information professional network which she initiated 

in Maryland in 2008. 

Eric Stubbs is an Information Specialist in the Information Resource Center at Otsuka 

America Pharmaceutical, Inc., in Rockville, Maryland. He is responsible for competitive 

intelligence, biomedical and regulatory research/analysis and is also charge of electronic 

resources/systems evaluation, implementation, and content management. Eric has nearly 

5 years of pharmaceutical industry experience and holds an MLS from Catholic University 

in Washington, D.C., as well as an MA in International Affairs from George Washington 

University. 

F F F

Practical steps to reinvent the Corporate Information Center 


Monday AM Speakers 

9


10 


11:45 – 12:30 pm Managing data and providing competitive insights 

from clinical trials databases using BizInt Smart Charts 

Jennifer Friend-Huizer, Johnson & Johnson, & Diane Webb, BizInt Solutions 

In the pharmaceutical ndustry, clinical trial databases are used as a competitive tool to: 

• determine key competitor drug trial endpoints 

• determine when trials may be ending to predict potential product launches 

• monitor additional indications being sought 

• determine in which countries trials are being run and for which indications 

• evaluate dosing and delivery options 

We conducted a case study using three clinical trials databases: Adis Clinical Trials Insight, 

Citeline TrialTrove and the U.S. National Institutes of Health ClinicalTrials.gov. We searched 

for two drugs across each of the trials databases -- a marketed product that would yield a high 

volume of trials for a thorough comparison and a phase III candidate which has a smaller 

pool of trials. We also searched for all phase III drugs for a particular indication. The search 

results were combined using BizInt Smart Charts and the Common Trials ID tool was used 

to compare trials across databases and to evaluate the strengths and capabilities of each 

database. 

Biographies 

Jennifer Friend-Huizer is a Manager in Global Commercial Analytics Operations at Janssen 

Global Services, A Johnson & Johnson Company. In this new role, she supports the area of 

secondary market research analytics across all global groups and is administrator of the 

Global Business Intelligence Portal. 

Jennifer began her career with the Johnson & Johnson Family of Companies in 1997 as 

a Scientific Information Specialist for Janssen Research Foundation. Over the past 13 

years, Jennifer has been searching in pipeline and clinical trials databases and compiling 

results using BizInt Smart Charts. Though her role as an Information Specialist to Business 

Intelligence Manager has changed over the years, her use of Smart Charts has only grown. 

Jennifer earned an undergraduate degree in Human Ecology/Environmental Public Policy 

from Cook College, Rutgers University and an MLS degree from the School of Communication, 

Information and Library Sciences, Rutgers University. Jennifer resides in Trenton, NJ with 

her husband and two children. Her favorite hobbies include reading, working out, cooking, 

Geocaching, doing mission work in Haiti and going on vacation – preferably to a beach. 

Diane Webb is President and co-founder of BizInt Solutions, Inc. She received her A.B. in 1983 

in Physics and History of Science from Harvard University and her M.A. in 1985 in the History 

and Sociology of Science from the University of Pennsylvania. 

Diane has 20 years of experience managing the development of software tools for information 

analysis. In the early 1990’s, Diane managed several US Government projects to develop core 

technology used in BizInt Smart Charts. She directed the launch of the initial Smart Charts 

software at TRW, Inc. in 1993, and co-founded BizInt Solutions in 1996. Diane spends much of 

her time outside work training and competing with her longhaired dachshunds.

Managing data and providing competitive insights using BizInt Smart Charts 

Jennifer Friend-Huizer, Johnson & Johnson, and Diane Webb, BizInt Solutions 

Monday AM Speakers 

11


12 

Monday, March 19 (Afternoon) 

2:00 – 2:45 pm Mobile Devices & the Information Professional – Where Do I fit In? 

Andrew Clark, UCB 

With sales of mobile devices showing no sign of decrease and the need for instant access to 

information growing, where as an Information Professional do I fit in? How do I start? What 

are the challenges and opportunities? Mobile disaster or success? 

In this session learn first-hand practical steps to success with mobile devices, from knowing 

the landscape, understanding the user need, overcoming obstacles, to delivering an 

information strategy that adds value and raises the bar. This session aims to be fun and 

interactive! 

Biography 

Andrew Clark has more than 15 years’ experience in the information industry in both 

public and private sectors and is currently Head of Information Discovery at UCB, a global 

Biopharmaceutical company headquartered in Brussels, Belgium. A regular speaker at 

leading industry events in both Europe and the US, Andrew has recently been elected onto the 

Executive Board of the Pharma Documentation Ring (PDR) and is an active member of SLA 

Europe. 

In his spare time Andrew enjoys cooking, snowboarding and surfing not to mention spending 

time with his lovely wife. His philosophy is simple – inspire, engage, have fun and make a 

difference! 

F F F

Mobile Devices & the Information Professional – where do I fit in? 

Andrew Clark, UCB 

Monday PM Speakers 

13


14 


2:45 – 3:30 pm Librarians as internal consultants 

Josh Duberman, Partner, Pivotalinfo LLC 

Librarians’ roles have continued to evolve, from ‘rip and ship’ results provider, to information 

intermediary and subject expert; and now, to outreach specialist and research information 

consultant. Learn tips to add a consultant’s perspective to your repertoire, and brighten up your 

internal marketing and negotiation efforts. 

Presented by a long-time practitioner who has worked on all sides of the reference desk and the 

lab bench, this talk is an overview of what librarians can learn from consultants, including: 

• what outside consultants can do that librarians can’t 

• what librarians can do that consultants can’t and 

• how to get the best leverage from your in-house advantages. 

Biography 

Josh Duberman is a Partner at Pivotalinfo LLC, providing ‘information for solutions in 

business and technology’. He has more than 20 years of research information experience at 

Applied Biosystems, SRI International, and as a consultant. Previously, he was a scientist at 

Lawrence Berkeley National Laboratory and at Chevron Research Company. 

Mr. Duberman is a co-inventor of several patents, and has written numerous articles about the 

information industry, searching techniques and information resources. His areas of expertise 

include intellectual property, chemistry, biotechnology, pharmacology, toxicology, engineering, 

competitive intelligence, technology transfer/commercialization, and information retrieval 

issues. 

F F F

Librarians as internal consultants 

Josh Duberman, Partner, Pivotalinfo LLC 


15


16 


4:00 – 4:45 pm KOLs – who are they, where are they, and how do you find them? 


Dr. Engelsgjerd will introduce the best practices for finding medical experts around the world 

and conduct an audience discussion on various wrinkles that may come up. 

Biography 

Marc Engelsgjerd, M.D., oversees coverage of the oncology sector, including marketed 

products, drug development, clinical trial design, emerging molecular targets, diagnostics, 

and cancer genomics/personalized medicine. He joined Wolters Kluwer from Coleman 

Research Group where he was Director of Healthcare Research. Previously, Dr. Engelsgjerd 

spent five years analyzing the biopharma industry for the investment community at Bank of 

America Securities, UBS Securities, and Reuters Insight. Before coming to Wall Street, he was 

at Research Corporation Technologies, a $300M early-stage life sciences venture capital fund, 

where he vetted investment opportunities and helped to manage portfolio companies. Dr. 

Engelsgjerd has also served as Director of Clinical Affairs at Veritas Medicine, an eHealth startup 

company aimed at streamlining clinical trials recruitment. He completed a general surgery 

internship at the Barnes-Jewish Hospital (Washington University) and an anatomic pathology 

residency at the Brigham and Women’s Hospital. Dr. Engelsgjerd earned his Medical Degree 

at the University of California, San Francisco, where he received the Dean’s Research Award. 

He graduated summa cum laude from the University of Arizona with a Bachelor of Science with 

Honors in Molecular & Cellular Biology. 

F F F

KOLs – who are they, where are they, and how do you find them? 



17


18 


4:45 – 5:15 pm Big projects need big solutions – 

Utilizing OvidSP and QUOSA for AdComm Prep 


Those in the industry understand that a lot of work goes into every NDA submission. However, 

few may appreciate the post-submission events leading up to FDA action. Astellas decided to 

use this in-between time to do a major literature analysis in preparation for any concern an 

Advisory Committee might raise. Not wanting to leave any stones unturned, the ambitious 

goal was to review a significant segment of the biomedical literature. Starting from scratch, 

Natalie was integral in designing a workflow utilizing Ovid ( for searching) and QUOSA ( for 

retrieval, user tagging/annotating and storage/management). And while there were certainly 

bumps in the road, Natalie mitigated the challenges by being proactive and service-oriented. 

In her presentation, Natalie will cover the client-group’s wants and needs, the workflow 

implementation and a description of the final product. 

Biography 

While managing the Astellas Corporate Library since 2005, Natalie Rainford has been 

instrumental in providing a globally collaborative and innovative resource for employees 

throughout the organization. When she’s not busy keeping Astellas informed, Natalie enjoys 

spending time with her two daughters, CrossFitting and training for the Chicago triathlon. 

F F F

Utilizing OvidSP and QUOSA for AdComm Prep 



19


20 

Tuesday, March 20 (Morning) 

9:15 – 10:30 am The Rise of China: Implications for Pharma and Pharma Librarians 


Historically, Big Pharma has concentrated mostly on three key markets (the U.S., Europe and 

Japan), with China and other emerging markets given a lower priority. But in recent years, that 

mindset has changed as companies struggle with the patent cliff and related challenges and 

try to tap into rapidly growing emerging markets, particularly China. 

China has now become the third largest pharmaceutical market, and many experts predict 

it will overtake the U.S. in the next ten to 15 years to grab the top spot. On the back of 

massive government healthcare reforms, China has created the world’s largest single-payer 

system – representing 1.3 billion people – and the government has made funding of research 

and innovation a priority. Not surprisingly, Big Pharma has flocked to China, opening R&D 

facilities, rapidly expanding their commercial teams and incorporating China into global 

development plans. Many are also experimenting with new business and R&D models in 

response to huge unmet medical needs and affordability challenges. 

Given its strategic importance, it is imperative that pharma librarians have a working 

understanding of China and the unique content needs of the market. In this presentation, we 

will provide an overview of the China pharma market, including a closer look at China’s $124 

billion healthcare reforms, and also suggest helpful tips for librarians on how to find reliable 

sources about pharma-related issues in China. 

Biography 

Joshua Berlin is executive editor & director of business development for Elsevier Business 

Intelligence, a global publisher that provides analysis and insight on the biopharma and 

medical devices industries. At EBI, Mr. Berlin leads emerging markets, including PharmAsia 

News, a daily online publication that provides regulatory and business intelligence to 

life sciences executives doing business in China, India and other Asian markets; and the 

PharmAsia Summit, an annual strategic conference. He is also responsible for generating 

business and editorial opportunities for a suite of industry-leading publications, including “The 

Pink Sheet” and “IN VIVO.” EBI is a division of Elsevier, the world’s leading provider of science 

and health information. 

Prior to joining EBI, Mr. Berlin served as a manager in the life sciences practice at Ernst & 

Young LLP where he helped advise organizations on regulatory best practices. Before that, he 

served as a managing editor at Thompson Publishing Group in Washington, D.C., where he 

oversaw publications related to U.S. FDA compliance and enforcement. Mr. Berlin is a board 

member of the BioJudiciary Project, a 501(c)(3) organization with an educational mission 

to help judges better understand technical and legal issues related to biotechnology, and a 

member of the Loudoun County, Virginia, Science & Technology Cabinet. 

F F F

The Rise of China: Implications for Pharma and Pharma Librarians 


Tuesday AM Speakers 

21


22 


11:00 – 11:45 pm Biosimilars and biopharmaceuticals 

Ronald A. Rader, Biotechnology Information Institute 

Biography 

Ronald A. Rader has been President of his own publishing/consulting company, the 

Biotechnology Information Institute, since late 1990. Mr. Rader has a B.S. in Microbiology 

and M.L.S., both from the University of Maryland, and over 30 years experience as a 

pharmaceutical and biotechnology information specialist, author, publisher and consultant. 

His particular expertise is in biotechnology and pharmaceutical information, competitive 

intelligence, technology and market assessments, and information resources development. 

Mr. Rader is best known as the author and publisher of BIOPHARMA: Biopharmaceutical 

Products in the U.S. and European Markets, the only information resource or reference 

concerning biopharmaceutical products. For 15 years, he was the author and publisher of 

the Antiviral Agents Bulletin, the only periodical specializing in antiviral and HIV drug and 

vaccine development. Prior to starting his own company in 1991, Mr. Rader was Manager 

of Information Services, Porton International, then the world’s largest privately-held 

biotechnology company. Prior to that he served as a biomedical and chemical information 

specialist with companies including the Gillette Co., MITRE Corp., Biospherics, and Computer 

Sciences Corp. 

F F F

Biosimilars and biopharmaceuticals 

Ronald A. Rader, Biotechnology Information Institute 


23


24 


11:45 – 12:45 pm Vendor Panel – Discovery Services 

EBSCO, Ex Libris, and Serials Solutions 


Users are used to Google. They don’t want to use different search methods to explore different 

databases. They don’t even want to use different databases. Discovery services promise 

to enable all of a library’s material – print and ebooks, journal articles, streaming video, 

everything – to be uncovered through one search box. It’s different from the much-maligned 

federated search because instead of crawling through the catalog, then the databases, then 

the various ebook repositories, and so on, it compiles an enormous index of all of those things 

and searches it all at once. To date, it has been primarily academic libraries adopting this 

technology. Could it or would it work in a corporate library environment? 

Biographies 

Eddie Neuwirth, Serials Solutions, is the Senior Product Manager for Discovery Services for 

Serials Solutions, a ProQuest business. Eddie has been involved in the sales, marketing and 

development of the award-winning Summon Web-scale Discovery service since its inception. 

Eddie has more than 8 years of experience in developing groundbreaking discovery services 

with Serials Solutions and WebFeat (acquired by ProQuest in 2008). 

Ido Peled, ExLibris, holds a B.Sc. in Computer Science and Communication from the Tel 

Aviv University, Israel. Ido is currently the product manager of Primo, Ex Libris delivery and 

discovery solution. Prior to that Ido held the position of product manager for the Ex Libris 

digital preservation solution, Rosetta, as well as being part of the development teams of 

Rosetta and the Ex Libris digital asset management solution. 

Doug van der Zee, EBSCO Publishing, is the Directory of Corporate Sales, Mid West for 

EBSCO Publishing. He has been in the information/publishing industry for 20 years. In that 

time he has had the pleasure of working with all types of libraries and corporations. He is 

based out of Cincinnati, Ohio and manages a team of four sales representatives. 

F F F

Vendor Panel – Discovery Services with EBSCO, Ex Libris, and Serials Solutions 



25


26 

2:00 – 3:00 pm Breakout Sessions 

Tuesday, March 20 (Afternoon) 

1. Challenges of globalizing contracts II 

Moderator: Robyn Smith, Takeda Pharmaceuticals 

2. Managing of copyright – reactive/responsive use 

Moderator: John Chu, Gilead 


Moderator: Andrew Clark, UCB 


Moderator: Rya Ben-Shir, Shir Solutions 


Moderator: Tim Hoctor, Elsevier

Breakout Sessions 

Tuesday PM Speakers 

27


28 

Tuesday, March 20 (Afternoon) 

3:15 - 3:35 pm Breakout Sessions – Summaries 

1. Challenges of globalizing contracts II 

Moderator: Robyn Smith, Takeda Pharmaceuticals 

2. Managing of copyright – reactive/responsive use 

Moderator: John Chu, Gilead 


Moderator: Andrew Clark, UCB 


Moderator: Rya Ben-Shir, Shir Solutions 


Moderator: Tim Hoctor, Elsevier 

F F F

Breakout Sessions – Summaries 

Tuesday PM Speakers 

29


30 

Adis 

BizInt Solutions 

Please visit our sponsors in the Exhibit Hall during the Opening 

Reception and during breakfast, breaks and lunch on Monday and 

Tuesday. 

Diamond Sponsors 

Adis has a 40-year heritage of offering valuable information in 

pharmacology, therapeutics and disease management. Journals 

published by Adis cover all aspects of drug development from 

bench to bedside. Adis journals are a must-have resource for 

anyone working or studying in drug therapy and pharmacology. 

AdisInsight databases provide decision support tools that produce valuable insight into 

global drug development, clinical trials, and drug safety. Accurate, timely, and comprehensive 

information is the cornerstone on which AdisInsight databases are built. 

Adis R&D Insight is a leading drug pipeline database that tracks and evaluates drugs worldwide 

through the entire development process. It provides detail scientific review and forward looking 

commercial analysis for market and competitive analysis. 

Adis Clinical Trials Insight is the only clinical trials database to provide quick access to ongoing 

trials from internet trial registries as well as trial results presented at medical conferences 

and published in scientific journals. This approach provides complete information to assess 

competitor studies, identify treatment gaps, and make strategic decisions. 

Ask the Expert service provides you access to our editorial team to insure you get the insights 

you need. This service is included free with all AdisInsight database subscriptions. 

BizInt Solutions, Inc. is a small software company based in southern 

California. We develop, market and support the BizInt Smart Charts 

software products — including BizInt Smart Charts for Patents, 

BizInt Smart Charts for Drug Pipelines, and BizInt Smart Charts 

Reference Rows — which help information specialists create, 

customize, update and distribute tabular reports combining data 

from the leading patent and drug pipeline databases. Our customers 

include pharmaceutical, biotech, chemical, petroleum, and device 

manufacturing companies in North America and Europe. 

To learn about the latest features or to download a free, fully functional trial copy of our BizInt 

Smart Charts products visit our website: www.bizcharts.com.

Elsevier 

Elsevier Business Intelligence 

As the world’s leading provider of science and health information, Elsevier 

serves more than 30 million scientists, students and health and information 

professionals worldwide. We help customers advance science and health by 

providing world-class information and innovative tools that help them make 

critical decisions, enhance productivity and improve outcomes. In short, 

Elsevier’s information solutions increase the value of content and empower 

you to accelerate scientific research 

Elsevier Business Intelligence (EBI), a global 

leader in the field of healthcare industry 

information, provides business intelligence 

on regulatory, business and reimbursement 

issues that are vital to the healthcare 

industry. Through a range of products including publications, conferences, e-learning, 

databases and reports, Elsevier Business Intelligence places biopharma and medical device 

professionals, and those who focus on these industries, at the forefront of knowledge, by 

providing the perfect combination of news and information together with penetrating insight 

and analysis. 

EBI has amassed an unparalleled number of personal contacts at most companies in 

the pharmaceutical, biotech, medical device and diagnostic industries as well as in the 

investment banking, venture capital, consulting and other industry-support sectors. Our 

editorial and research staff leverages this extensive contact list in primary research, which 

we supplement with extensive scanning, an understanding and a use of company and 

SEC documents. But, whereas other information providers merely parrot back what they 

learn, EBI’s editors and writers use their extensive expertise in the industry to draw out the 

significance of the data, presenting not merely the facts but what we call the “so what” of 

trends, events, and strategies. Visit us at www.ElsevierBI.com. 

New England Journal of Medicine 

Diamond Sponsors 

The New England Journal of Medicine 

is pleased to offer corporate customers 

global, organization-wide access to its 

premier content. In addition to our 

standard license, which includes content back to 1990; we now offer access to the NEJM 

Archive. The NEJM Archive is available in two tiers: 1945-1989 and 1812-1944. Year after year, 

week after week, NEJM publishes groundbreaking research on the cutting edge of medicine. 

The NEJM corporate site license offers access via IP-authentication to enable your physician 

researchers, regulatory personnel, product managers, and sales staff seamless access to all 

NEJM content through your corporate network right from their desktops. 

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QUOSA 

WoltersKluwer Health – Ovid 

QUOSA, Inc., an Elsevier company, provides software 

solutions for literature management workflows and 

archives -- for full-text articles, patent documents, 

conference abstracts, and more. Our patented, automated copyright-compliant solutions are 

unique and can support all of your end-user literature workflows, plus enable in-workflow 

visibility of copyright permissions through-out. QUOSA systems support seamless integration 

with your document delivery ordering process for enterprise-wide ease-of-use and to drive 

savings. Our Fastest Path to PDF modules transform the efficiency of the end-user experience 

in accessing the full-text to which you subscribe. The QUOSA state-of-the-art Report Templates 

and Alerts platform provides major efficiencies for Information Professionals and end-users 

alike. My Journal Stats automates the collection and analysis of your journal usage, to identify 

savings opportunities for your evaluation. 

Professionals at leading pharmaceutical, biotechnology, and medical device companies use our 

solutions to increase efficiency, effectiveness, economy and copyright compliance across their 

organizations, including the Medical Affairs, R & D, Safety & Regulatory, Marketing and Business 

Development, Legal & Intellectual Property and Knowledge Management functions. Fully hosted 

or internally installed, access from desktops, laptops or tablets – QUOSA can fit your needs and 

environment. 

For more information, please visit us at the QUOSA display or www.quosa.com. 

Ovid (www.ovid.com), part of 

Wolters Kluwer Health, is a 

global information solutions provider offering medical, scientific, and academic communities 

customizable solutions of high-quality core and niche content fully integrated with their 

institutional holdings. Clinicians, professionals, students, and researchers benefit from Ovid’s 

best-in-class content, technology tools, and services. 

OvidSP, our industry-leading online search and discovery platform, continues to break barriers 

to transform the research community. OvidSP’s unique tools and features are designed to 

maximize search precision and efficiency, and simplify and speed analysis and workflow—all in a 

simple, integrated and easy-to-use system. 

Ovid is used by the world’s leading colleges and universities; medical schools; academic research 

libraries and library consortia; hospitals and healthcare systems; pharmaceutical, engineering 

and biotechnology companies; and HMOs and clinical practices. 

Ovid offers tremendous depth and breadth of content published by the world’s leading 

publishers, covering a wide range of core and niche scientific, medical, and healthcare 

disciplines: 

♦ More than 3,000 ebooks, 60 book collections, archive collections of critical historical material, 

publisher collections, and topical collections 

♦ Over 1,200 premium, peer-reviewed journals- with no embargoes! Plus 50 journal collections, 

archive collections and packages based on publisher or subject 

♦ Over 100 bibliographic and full-text databases

Platinum Sponsors 

BioCentury Publications 

Citeline 

Copyright Clearance Center 


Now entering its 20th year, BioCentury 

Publications, Inc. is internationally 

recognized as the leading provider of valueadded 

information, analysis and data for biotechnology and pharmaceutical companies, 

investors, academia and government on the strategic issues essential to the formation, 

development and sustainability of life science ventures. BioCentury employs a fully integrated 

multimedia platform — including publications, video, online data solutions and conferences 

— to provide its audience with authoritative and up-to-date intelligence about corporate 

strategy, partnering, emerging technology, clinical data, public policy and the financial 

markets. The company publishes the weekly industry journal BioCentury®, the Bernstein 

Report on BioBusiness and SciBX: Science Business eXchange, a weekly translational 

science journal published in collaboration with Nature Publishing Group. The company also 

markets its BCIQ data solutions product, and in 2010 launched its weekly biotech TV show, 

“BioCentury This Week,” a partnership with the Gannett-owned CBS affiliate in Washington, 

D.C. 

The world’s leading authority on pharmaceutical clinical 

trials 

Citeline is the world’s most comprehensive source of real-time R&D intelligence for the 

pharmaceutical industry, featuring an unmatched data collection of global clinical trials, 

investigator profiles and drug development pipelines. Our data is drawn from over 20,000 

unique sources and analyzed by the industry’s largest team of expert analysts and editors, 

making Citeline the most trusted source of R&D intelligence in the market. The full suite of 

Citeline products has been developed to allow easy cross-navigation, allowing you to move 

seamlessly from pipeline analysis and drug trial records to 

profiles of trial investigators. 

Copyright Clearance Center (CCC), the rights licensing 

experts, is a global rights broker for the world’s most sought 

after materials, including in- and out-of-print books, journals, newspapers, magazines, 

movies, television shows, images, blogs and ebooks. Founded in 1978 as a not-for-profit 

organization, CCC provides smart solutions that simplify the licensing of content that lets 

businesses and academic institutions quickly get permission to use copyright-protected 

materials, while compensating publishers and content creators for the use of their works. 

For more information, visit www.copyright.com. 

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Dialog 

Dow Jones 

EBSCO 

Central to Innovative Research Around the World 

With more than 40 years of service, Dialog continues to be the world’s leading aggregator of 

scientific literature, intellectual property content and business information from the most 

renowned publishers in the industry. Our extensive collections of databases provide immediate, 

online access to the information you need to support your research with accuracy and precision. 

Now as part of ProQuest, a leader in the collection, organization and publishing of information, 

the all-new ProQuest Dialog service offers end-users an intuitive interface combined with a 

fresh approach to precision search based on relevancy, transparency, control and completeness 

— delivering critical information to decision makers in scientific, legal, government and business 

markets around the globe. 

Learn more at www.dialog.com and www.dialog.com/proquestdialog 

Dow Jones & Company is a global provider of news and 

business information and a developer of technology to 

deliver content to consumers and organizations across 

multiple platforms. Dow Jones produces newspapers, newswires, Web sites, apps, newsletters, 

magazines, proprietary databases, conferences, radio and video. Its premier brands include 

The Wall Street Journal, Dow Jones Newswires, Factiva, Barron’s, MarketWatch, SmartMoney 

and All Things D. Its information services combine technology with news and data to support 

business decision making. The company pioneered the first successful paid online news site 

and its industry leading innovation enables it to serve customers wherever they may be, via 

the Web, mobile devices and tablets. The Dow Jones Local Media Group publishes community 

newspapers, Web sites and other products in six U.S. states. Dow Jones & Company (www. 

dowjones.com) is a News Corporation company (NASDAQ: NWS, NWSA; ASX: NWS, NWSLV; 

www.newscorp.com). 

One of the largest private companies in the United States, EBSCO serves the 

information needs of more than 100,000 institutions, serving millions of end 

users from around the world through EBSCOhost®, the company’s proprietary 

platform and hosting service. Whether you’re looking for clinical information 

for drug discovery, resources for your research and development needs, 

chemical information for drug development, business development resources, or ways to 

drive users to your website, EBSCO can meet your research, business and medical information 

needs with our suite of resources. EBSCO also provides the necessary integration tools for 

making critical content available where and when you need it. Leveraging these tools to 

integrate premium content into the corporate workflow allows organizations to reduce timeconsuming 

and costly integration work while maximizing the value of investments made in 

corporate portals and applications. By bringing together content from top magazine and journal 

publishers, and the technology to facilitate access and integration, EBSCO continues to meet 

the complex information needs of pharmaceutical and biotechnology companies as the leading 

provider of pharmaceutical and biotechnology content.

EvaluatePharma 

FirstWord 

EvaluatePharma®, a 

leader in life science 

sector analysis, we deliver exclusive commercial, clinical and regulatory insight into industry 

performance globally. With 10+ years’ experience and investment in our services, we provide 

meaningful, value-added information, analysis and news that aids in competitive intelligence, 

target identification, strategic decision-making and risk mitigation. Our friendly and 

knowledgeable customer support staff are always ready to assist you. Our services include: 

uncoated 

EvaluatePharma® featuring Proprietary Data Standardization, Merge Company tool, Calendar 

of Events, Interactive NPV Analyzer, user friendly Data@FDA information, Sales by Indication 

and Consensus Forecasts to 2016 to give you the most accurate view of the global market. 

EP Clinical TrialsSM greatly simplifies data access and analysis of global clinical trials 

including cross-linked full records of ClinicalTrials.gov, EudraCT and a Japanese clinical trial 

data source. It provides data quality you can rely on and the time savings you need through 

easy access and share. 

EvaluatePharma® Partnering Services makes finding your next licensing partner easier, and 

features the latest assets available for partnering presented in their commercial context 

alongside our unique industry analysis. 

EPVantage® renowned news service provides mapped commentary and analysis that keeps 

470 coated 

you abreast of the latest sector developments relevant to you. 

FirstWord is a leader in the provision of 

fast, reliable, unbiased global news and 

intelligence to the pharmaceutical and 

medical technology industries. Over 180,000 

pharma and medical technology professionals rely on FirstWord to give them a competitive 

edge. 

FirstWord Pharma PLUS provides busy executives with daily global pharmaceutical industry 

news and business intelligence. Users have unlimited access to the FirstWord Pharma news 

service plus insights and analysis from the editorial team and industry experts to help them 

stay ahead. FirstWord Pharma PLUS also helps users save time by allowing them to filter 

in and filter out what is most relevant to them. This means users can really focus on the 

companies, conditions, products and markets that matter most to them. 

FirstWord Pharma PLUS. Your News. Your Way. www.firstwordpharma.com 

Now launched! FirstWord MedTech PLUS serves the medical technology industry with global 

news and business intelligence. Delivering the same benefits as FirstWord Pharma PLUS, the 

FirstWord MedTech PLUS service offers MedTech professionals a new, cost-effective option to 

keep updated on their competitors and markets. 

FirstWord MedTech PLUS. Your News. Your Way. www.firstwordmedtech.com 

FirstWord Dossier reports provide insight, analysis and the latest thinking on important 

trends and the most challenging issues affecting the pharmaceutical industry today. Highlyfocused, 

relevant, up-to-date reports for actionable intelligence, delivering information vital 

for competitive advantage. 

www.fwreports.com 


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FOI Services 

InfoDesk 

FOI Services specializes in delivering unpublished FDA documents acquired 

using the Freedom of Information Act. Over 85,000 documents are available for 

immediate delivery, including Establishment Inspection Reports, 483s, FDA 

investigator diaries, Warning Letters, 510(k)s, NDA reviews, supplemental drug reviews, FDA/ 

Industry correspondence, and much more. Search the database and read detailed document 

descriptions free at foiservices.com; pay only for the files you choose to download. Customized 

Drug Adverse Event searches are available on request; please call or email for details. In May 

2011, watch for the latest update of the book Drugs Under Patent. 

InfoDesk specializes in Information Management 

Solutions that help organizations integrate, optimize and 

share information resources more quickly, cost effectively and 

securely. 

Meeting a large organization’s shifting information needs and 

keeping pace with constantly changing technology is hard in any industry. But it is particularly 

true in the life science industry. 

InfoDesk offers Pharmaceutical, Biotech and Life Science companies custom information 

portals, advanced publishing tools, sophisticated email alerts, custom newsletters and other 

custom services to help deliver more targeted content to users faster and more efficiently. 

In addition, many InfoDesk pharmaceutical clients utilize our Editorial Services. Our highly 

experienced team of information professionals create custom news and media monitoring 

newsletters or daily briefings that meet the most exacting information demands. 

By combining InfoDesk’s state-of-the-art technology with a professional editor’s review, we 

provide a unique service that scans and filters thousands of news sources and delivers only the 

most relevant articles. Without redundancy. 

This spring, InfoDesk is unveiling its new Federated Drug Pipeline Solution. InfoDesk’s drug 

pipeline solution integrates drug pipeline data from multiple information sources, then applies 

real-time intelligence to generate a single integrated set of results. 

For more information about any of our products or services, visit www.infodesk.com or call us 

directly at 914.332.5940.

Infotrieve, Inc. 

Leadership Directories 

Infotrieve is the leader in cloud-based software 

solutions for information centers around the 

world. More than 350,000 researchers from nearly 

6,600 organizations in 80 countries rely on the award-winning Mobile Library platform for 

document delivery and instant access to all enterprise and personal e-resources including 

licensed e-content, corporate and personal libraries, along with the 50+ million citations 

in our pay-per-view store. Mobile Library makes enterprise e-content available anywhere, 

anytime through one secure, easy to use gateway from a desktop, laptop and iPad, and at the 

same time provides a secure social networking environment for employee collaboration. 

Additionally, Infotrieve provides many information management services including strategic 

content licensing and subscription management, research services, supplemental staffing, 

collection management, preparations for FDA submissions along with bulk reprint and eprint 

services and ordering solutions. 

Looking for decision-makers in healthcare? Leadership® Health Focus is the 

perfect solution. This accurate, up-to-date resource will help you identify and 

contact the leaders and organizations you need to reach in the growing world 

of health and healthcare. It includes the most important people in business, 

government, the healthcare system, non profits and associations, including: 

♦ C-level officers (including CIOs and CTOs) 

♦ Board Members and Trustees 

♦ Department Chairs 

♦ Medical School Staff 

♦ Government officials in healthcare departments and agencies (state, local, federal) 

♦ Nonprofit Executives 

♦ Medical Manufacturing and Pharmaceutical contacts...plus much more 


Leadership Directories goes beyond healthcare too. We research contact and biographical 

data for hundreds of thousands of thought leaders - with emails, phone numbers, addresses, 

background information and much more. We build web-based directories which include 

accurate contacts at companies, government agencies, Congressional offices, law firms, news 

media outlets, and nonprofits. Many of our online directories allow you to download data 

(including emails and phone numbers) for outreach, and track specific contacts as they move 

from job to job. 

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MaryAnn Liebert 

Pharmacircle 

Mary Ann Liebert, Inc.’s 

Biotech/Biomedical 

Research Collection of cutting-edge, peer-reviewed journals covers the full spectrum of research 

and development processes including translational research and clinical applications. Customize 

your journal collection by visiting us at our booth at the DPHT meeting or online at www. 

liebertpub.com/packages. 

Mary Ann Liebert, Inc. is a leading company in the Scientific, Technical, and Medical knowledge 

and information industry and is known for authoritative, peer-reviewed publications in many 

promising areas of science and biomedical research. Our publications play an active and 

important role in advancing critical research and facilitating collaboration throughout the world 

in academia, industry, and government, and are also highly respected resources for legislators, 

policy makers, and educators. Mary Ann Liebert, Inc. is committed to discovering more efficient 

and positive means to better the way science and knowledge is understood, shared, and 

published worldwide. The research we publish accelerates innovation and advances the way 

we communicate and share information to build industry opportunity and improve healthcare 

outcomes. As Knowledge Engineers, we are directly the impacting scientific advancements and 

applications of the future. 

PharmaCircle is an innovative knowledge 

management company specializing in 

the drug delivery, pharmaceutical and 

biotechnology fields. PharmaCircle gives 

you a one stop source for critical technical and business information and analysis. We provide 

detailed, comprehensive and up-to-date industry details that are essential for your whole team. 

Our cutting edge software features dynamic and interactive tables and charts that gives you the 

qualitative and quantitative data necessary to make informed technical and business decisions. 

The software is easy to use and is continuously updated and improved. Our prompt and effective 

customer support from industry veterans is always available to answer any of your needs. 

Radiological Society of North America (RSNA) 

The Radiological Society of North America (RSNA®) publishes Radiology 

and RadioGraphics, the top peer-reviewed journals in the field. With 

an impact factor of 6.066 and more than 44,700 citations last year, 

Radiology is the #1 cited diagnostic radiology journal. RadioGraphics, 

the journal of continuing medical education in radiology, is read by two out of three radiologists 

and has awarded more than 740,000 continuing education credits since 2000. RSNA Journals 

Online feature published-ahead-of-print articles, videos and podcasts, e-alerts, interactive 

images and datasets and the Radiology Legacy Collection, a searchable electronic archive of 

vintage Radiology issues from 1923 to 1998.

PMR 

SAGE 

PMR is a research, consulting and publications company 

providing high-quality market information and services 

to businesses interested in Central and Eastern Europe 

countries. 

Being present on the market since 1995, offering high international standards in projects and 

publications, as well as providing one of most frequently visited websites, PMR is one of the 

largest companies of its type in the region. 

PMR main areas of competence: 

♦ consumer and market research, 

♦ business consulting, 

♦ off the shelf market studies, reports, online services. 

PMR business publications present vital market information and in-depth analysis of the 

pharmaceutical sector (and other market sectors) including: pharmaceutical companies, 

distributors and producers, medical and healthcare market, medical insurance market, drugs 

and dietary supplements market, clinical trials and other subsectors. 

The reports by PMR Publications comprise a sophisticated analysis of the industry, 

making them a useful guide in formulating strategic decisions and development plans for 

organisations in pharmaceutical and healthcare markets. Additionally, they present the 

findings of PMR’s surveys, conducted among the management of the largest companies. 

PMR also runs popular business information portals on pharmaceutical market in Central 

and Eastern European countries : www.ceepharma.com, www.pharmapoland.com. 

Contact us: moreinfo@pmrcorporate.com, +48 12 618 90 30 

The academic and professional publisher of choice. SAGE 

is an independent international publisher of journals, books, 

and electronic media. Known for our commitment to quality and 

innovation, we are a world leader in our chosen scholarly, educational, and professional 

markets. Our highest priority is to make any contact you have with SAGE—whether as a 

book author, a journal editor, a contributor to one of our journals, a customer, or a reader—a 

pleasant and rewarding experience. 

SAGE’s publishing philosophy is based on three principles: 

♦ Relationships — We depend upon the experience and expertise of the authors, editors, 

learned societies, colleagues, and vendors with whom we work. 

♦ Vision — We focus on anticipating and delivering what our customers want. 

♦ Excellence — We are committed to quality in all that we publish and in all that we do. 

Innovative ideas and approaches consistently distinguish SAGE’s publishing, across all of our 

programs. Our products include: 

♦ Journals at the forefront of knowledge, contributing to the disciplines of the future, and 

delivered in varied electronic and print formats 

♦ Academic and reference books with breadth of vision and valued content 

♦ Innovative teaching texts for college courses 

♦ Professional books reflecting practical approaches to new perspectives and challenges 

Gold Sponsors 

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Springer 

Tarius 

Springer’s Pharmaceutical Collection includes a range of 

authoritative eBooks and eJournals covering current topics 

in pharmaceutical sciences across all major areas of the field 

including: biomedical engineering, cancer research, human genetics, human physiology 

& immunology, microbiology, molecular medicine, and virology as well as other areas of 

pharmaceutical sciences 

Global coverage – Human Drugs, Biologics, Medical Devices and IVD’s 

Tarius® web portals offer regulatory intelligence from more than 75 countries, 

regions and international organizations, including: North America, Latin 

America, South Africa, Middle East, Eastern and Western Europe, Asia and The Pacific Rim. 

Because this up-to-date intelligence is available from one single website, Tarius not only promises 

to minimize the amount of time spent on browsing and searching, it also helps assure that the 

quality of the information meets the high standards of the industry. 

By honoring values of credibility, responsibility, continuity and professionalism, Tarius has 

established a proven track record of serving our customers in long-lasting relationships. Our 

customers see us as reliable, responsive and competent partners who deliver information services 

tailored to their needs. www.tarius.com 

Thomson Reuters Healthcare & Reuters Health 

With Thomson Reuters Healthcare and Reuters 

Health you can stay on the cutting edge of 

health information. 

Thomson Reuters Healthcare brings you Micromedex 2.0. With over 15 separate databases all 

integrated into a single search, researchers can quickly find the information from foreign drug 

listings to FDA off label recommendations. With over 90 advanced degree editors reviewing over 

1,000 journals, you can trust that the content is relevant and current. 

Reuters Health provides daily breaking news coverage of the global pharmaceutical, medical 

and consumer health sectors. Timely and authoritative, Reuters Health is a must-have resource 

for those managing doctor and patient facing websites, healthcare-focused publications, 

pharmaceutical industry corporate intranets and health sector information services.

Wiley-Blackwell 

Gold Sponsors 

Wiley Online Library hosts the world’s broadest and deepest 

multidisciplinary collection of online resources covering life, 

health and physical sciences, social science, and the humanities. 

It delivers seamless integrated access to over 4 million articles from 1500 journals, more than 

10,000 online books, and hundreds of reference works, laboratory protocols and databases. 

From break-through discoveries and authoritative reference materials to cutting-edge 

scholarly research, Wiley Online Library connects you to the information you need, when and 

where you need it. wileyonlinelibrary.com 

American Association for the Advancement of Science 

Basch Subscriptions 

Science, published by the American Association for the Advancement 

of Science (AAAS), is the world’s leading weekly general scientific 

journal. Science, with an impact factor of 31, ranks highest for impact 

among all multidisciplinary science journals. 

Platinum & Gold Sponsors 

Additional e-resources published by AAAS include Science Classic, the digital archives 

of Science; Science Signaling, a weekly journal about cell signaling; Science Express, a 

collection of Science articles published ahead of print; and Science Translational Medicine, 

AAAS’s resource that links basic scientists and clinical researchers to improve patient care 

worldwide, and provides a unique forum for bringing laboratory research into practical 

patient cures and therapies. 

BSI and Prenax, Inc. provide responsive, 

customer-oriented print and electronic 

subscription management. BSI services and 

systems are shaped by the needs of medical, government, academic and public libraries; those 

of Prenax mesh with corporate fulfillment systems and the desk-top ordering and approval 

processes common among legal, financial, and industrial clients. 

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F1000 

General Biologic 

Information Express 

Faculty of 1000 is a post-publication peer review service that highlights 

important articles based on the opinions of global leaders in biology 

and medicine. F1000’s distinguished international Faculty of 10,000 

top researchers and clinicians select, rate, and evaluate key articles in 

these fields, and provide a short evaluation explaining why the article is important. More than 

115,000 evaluations are published on F1000.com covering essential and interesting research from 

3,500 journals. The service also includes F1000 Posters, an open access repository for posters and 

slide presentations across biology and medicine, and F1000 Reports, peer-reviewed reports on 

emerging themes in the life sciences.The service also now includes F1000 Posters, an open access 

repository of biomedical conference posters, reviewed and evaluated by the Faculty. The open 

access F1000 Reports journals provide unique, peer-reviewed perspectives from the world’s top 

scientists on emerging themes in biology and medicine. The Scientist - F1000’s magazine of the 

life sciences, provides compelling coverage of the latest developments in research, technology, 

business and careers. 

GBI is a leading information provider covering China’s pharmaceutical, 

biotechnology, and healthcare industries. GBI’s flagship data 

system, SOURCE, and industry newsletter, China Pharmaceutical & 

Biotechnology Review, have set a new standard for tracking and acting 

in China’s dynamic landscape. GBI provides the data, insights, and market transparency 

pharmaceutical and biotechnology companies need to capitalize on the opportunities available 

in China. 

GBI’s SOURCE data system provides unprecedented access to a wealth of critical news, data, and 

analytics on virtually every aspect of China’s pharmaceutical industry and healthcare market. 

Whether monitoring pipeline and deals activity, newly registered drugs and emerging local 

players, pricing and reimbursement, patents and trademarks, or hospital and physician profiles, 

SOURCE is essential. SOURCE provides customizable alerts and drug tracking capabilities and 

enables fast and easy retrieval of the latest industry developments and comparative market 

data. SOURCE’s powerful mapping, benchmarking and analytical tools help users make better 

forecasts and informed strategic decisions. 

This spring, GBI will be launching three new pharma intelligence products—INTELEX, METRIX, 

and SOURCE BRAZIL. 

To learn more or see a product demo, please stop by the GBI table, call our US office at (703) 938- 

0279, or visit our website: www.gbipharma.com. 

Founded in 1985, Information Express (IE) has become the leader in finding 

innovative, customized solutions for institutional document delivery needs. A 

full service company specializing in the fast, accurate and competitively priced 

delivery of published articles for all industries, IE is the document provider 

of choice for a host of U.S. Fortune 500 companies and major academic 

institutions.

Linguamatics 

Logicden 

Linguamatics enables organizations 

to maximize the value derived from 

information resources through effective deployment of innovative natural language 

processing (NLP)-based technology. The versatile semantic knowledge discovery system, I2E, 

helps organizations to do much more than simply cope with vast quantities of information. Its 

unique combination of search and text mining enables organizations to turn this information 

into a competitive advantage. From life sciences and healthcare to business intelligence, from 

media analysis to security, users mine large collections of documents, extracting, analyzing 

and synthesizing relevant facts, relationships and quantitative data from content such as 

scientific papers, news feeds, patents, or internal reports. Linguamatics has a rapidly growing 

user community with I2E deployed at 9 of the top-10 global pharma companies. 

Linguamatics partners and collaborates with companies, academic and governmental 

organizations to bring customers the right solution for their needs, and to develop next 

generation capabilities. Current partners include Oracle, Accelrys, ChemAxon, Selventa and 

Fairview. The company has also received project research funding from the European Union 

and won a number of awards. 

The company was founded in 2001, and is based in Cambridge, UK, and Boston, MA. 

Logicden software products allow managing and sharing information 

across the organization Our products are made available as SAAS 

(Software As A Service) or can be installed on-site. 

Products: 

1) Inquiry and Response Log: Because information professionals should spend more time on 

research and less on recordkeeping. Track incoming research requests and save strategies, 

sources andsearch results for future reference. 

2) Knowledge Indexing and Retrieval Archive: Retrieve the right information with minimum 

effort, at the time you need it. Store internal documents in a central location with easy-to-use 

search and retrieval for company staff worldwide. 

3) Current Information Aggregator and Publisher: Give your decision makers and researchers 

a competitive edge by providing quality current information ...while it’s still current. Gather 

and tag current information automatically from a variety of sources, then publish and 

disseminate to staff via web front-end, e-mail or newsletter. 

4) Dissemination of Medical Information: Provide top-notch medical information service 

to Health Care Professionals. Deliver your company’s medical information to health care 

professionals via a secure, self-serve website. 

Gold Sponsors 

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RightAnswer.com 

RightAnswer Knowledge Solutions offer current and accurate 

chemical, MSDS, regulatory, reproductive risk and toxicology 

data, all in one place, using integrated and simultaneous search 

capabilities through their ChemKnowledge and RegsKnowledge 

solutions. More information about each product line is provided 

below and can also be found at www.rightanswer.com. 

The ChemKnowledge® System, exclusively licensed by RightAnswer®, provides quick access to 

the environmental, hazard and medical information you need for safe management and handling 

of chemicals. The ChemKnowledge System includes: 

♦ TOMES® System 

♦ TOMES Plus® System 

♦ REPRORISK® System 

♦ MSDS Collection 

RegsKnowledge: By consolidating globally respected regulatory resources into a single, 

comprehensive reference tool, RegsKnowledge enables you to ensure regulatory compliance, 

prepare MSDSs, and protect both human health and the environment with confidence. Searches 

immediately deliver U.S. and international data from a large collection of advisory, regulatory, 

and inventory lists. The RegsKnowledge System, exclusively licensed by RightAnswer, includes: 

♦ RegsLink® state and federal regulatory compliance information 

♦ LOLI®: The Regulated Chemicals List of Lists helps you find the regulatory status of specific 

chemicals and chemical groups. The database contains hundreds of regulatory lists from around 

the world. 

♦ LOLI Global Inventories international inventory of lists. 

Thomson Reuters Life Sciences 

Thomson Reuters is the world’s leading source 

of intelligent information for businesses and 

professionals. They combine industry expertise 

with innovative technology to deliver critical information to leading decision makers in the 

financial, legal, tax and accounting, healthcare, science and media markets, powered by the 

world’s most trusted news organization. 

Thomson Reuters Life Sciences supports R&D productivity across the Pharma lifecycle with 

respected and comprehensive intelligence solutions. 

Offering unbiased scientific, competitive, regulatory, and generics information, analytics, and 

expertise for your organization, Thomson Reuters Life Sciences empowers and enables effective, 

evidence-based decision-making at every stage from discovery to launch and beyond. 

science.thomsonreuters.com/pharma

Technology & Patent Research International (TPRI) 

Timely Data Resources 

Silver Sponsor 

DrugPatentWatch 

It was true during our first search in 1995, and it’s true today. We’re 

here to make a real impact for our clients – one that empowers them 

to make smarter, more insightful business decisions. 

Gold & Silver Sponsors 

Technology & Patent Research, TPR International is a full service search firm specializing 

in searching pharmaceutical and biotechnology subject matter. Information research 

ranges from R&D, pipeline and competitive intelligence studies, clinical, regulatory, animal 

alternative, safety, medical and business searching, as well as intellectual property. TPR 

searchers are experienced in their profession, and work in a seamless manner to support 

busy information departments and libraries with reliable search and analysis when your 

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PROFILES See Opportunity The In Public IBS Policy Implications Chemotherapy And of A Potential New 

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M E D I C A L D E V I C E Q U A L I T Y C O N T R O L 

Founded 1996 Vol. 15, No. 11 

November 2011 

news this month Three Barriers To Device Quality And 

A new FDA report finds three 

major barriers to medical device 

quality: a misalignment between 

FDA investigator priorities and the factors 

that truly drive product quality; a lack of 

information on how products compare 

with one another in terms of quality; and 

manufacturers’ failure to use appropriate 

risk management tools at a time of 

increasing device complexity. The report, 

“Understanding Barriers to Medical Device 


What FDA, Industry Might $1,015 A Year Do About Them 

Shawn M. SchMitt sm.schmitt@elsevier.com 

DA is reassessing its facility inspection strategy after hearing that industry 

believes the agency places manufacturer adherence to the Quality System 

F Regulation ahead of product quality. ‘‘The Gold Sheet’’ 

Manufacturers’ perceptions that they must throw an exorbitant amount of resources 

at low-risk problems found during agency inspections is just one of three 

PHARMACEUTICAL & BIOTECHNOLOGY QUALITY CONTROL 

roadblocks to quality outlined in “Understanding Barriers to Medical Device Quality,” 

an FDA report released Oct. 31. 

November 2011 

“What FDA inspects for becomes important, and what’s important gets done [by 

PUbLISHeD 

moNTHLY 

Vol. 45, No. 11 

Quality,” lists possible solutions for FDA and manufacturers], so it’s critical that we are inspecting for the right things,” CDRH 

industry. “Identifying and addressing bar- Director Jeffrey Shuren said. 

news this issue Opportunities to Statistically Mine 

riers to medical device quality can improve 

“We want to make sure ... we’re not focusing on the minor stuff so we don’t divert 

public health outcomes while also improv- companies’ attention to those things that matter What less,” large he said. samples “Instead, could [we tell need FDA PAT Data for Release Testing Explored 

ing a company’s bottom line and allowing 


to] get them focused – and ourselves focused – on what matters most.” 

CDRH to better utilize its resources,” CDRH 

The streams PUbLISHeD 

of process analytical data that 

$1,935 A Year 

Joanne S. eglovitch J.eglovitch@elSevier.com 

Director Jeffrey Shuren said. A goal for FDA One way FDA might modify its inspectional approach drug makers is to instruct increasingly WeeKLY 

its investiga- produce could 

tors to place more emphasis on QSR requirements support that regulatory greatly affect compliance the quality by showing 

anufacturers, compendial authorities and FDA officials recently explored 

is to collaborate with industry to create a 

set of robust, commonly understood quality of devices – such as design controls and supplier that processes controls – are and validated less weight and batches on 

ways the pharmaceutical industry could use sophisticated statistical meth- 

practices ...........................Cover 

areas of the regulation that are not as quality-centered. releasable. A recent PQRI meeting explored M ods to unlock the regulatory compliance potential of vast amounts of pro- 

how to make it happen. ............................Cover cess analytical data it is generating. 

‘‘The Further, inspections could be structured to concentrate more on products with a 

FDA quality report Gray singles out Sheet’’ ® 

history of quality failures, such as infusion pumps. Inspections also should target Discussions at a recent Product Quality Research Institute workshop focused 

seven areas where manufacturers can 

known company-specific quality weaknesses, the A coming report out notes. party for China’s GMPs mainly on batch release testing for content uniformity. Manufacturers typically 

boost quality ...........................5 

m e d c a l d e v c e s a n d d a g n o s t c s China is sending inspectors abroad to see 

rely on a compendial end-product testing method that can demonstrate compli- 

The report is an attempt by CDRH to understand why device quality problems 

Warning Letters 

how the rest 

ance of a 10- to 30-tablet sample, but that does not address the likelihood that 

continue to occur. Offering a menu of action items, it is Vol. of 

intended 37, the No. world 50 complies with 

as a starting the sample actually represents the batch. 

December Respironics cited 12, for 2011 

its new GMPs so they can learn how to in- 

MDR violations in point for the agency and industry as they work to remove quality hurdles. 

spect that kind of quality into China’s do- They talked about alternatives for statistically analyzing these small-sample re- 

relation to its Trilogy Continuous Venti- 

Manufacturer use of any recommendations in mestic the quality industry. report What is will completely this mean for sults to gain greater batch-wide insights. 

lators; SterilMed was selling its Femo- voluntary; FDA has no authority to prescribe to multinational firms how to corporations? make their products. ...................... 8 

Stop Gold compression device without 

But the main focus of the Sept. 12-13 sample size workshop in Bethesda, Md., was 

top news CardioMEMS’ Heart Failure Monitor 

Continued > Page 3 

FDA approval ......................10 

on tapping the treasure trove of process analytical data that constitutes much 

Foiled At panel By FDA Inspection FDA deferring CMC changes ‘wish list’ larger and therefore more representative data sets. 

CMS pre-payment Close-Out reviews Letters ..................12 

In Their Words FDA explains why it’s setting aside industry’s 

The existing compendial approach under USP General Chapter 905, Uniformity 

Anxiety may be unfounded Findings Of Study Bias 

‘wish list’ as it focuses on clarifying draft 

News In Brief 

of Dosage Units (UDU), for tablets and capsules is also not relevant in the new 

Zach Miners guidance on downgrading CMC changes to 

The jury is still out on whether Medicare 

z.miners@elsevier.com 

This quality initiative will allow small firms to dedicate their 

quality-by-design manufacturing paradigm where in-process testing and control 

Former FDA Office of Compliance Direc- “ 

annually reportable. PhRMA complains the 

pre-payment reviews will significantly 

tor Tim Ulatowski joins Becker Consult- n FDA panel limited meeting resources last week on to CardioMEMS areas that Inc they .’s draft PMA know would for its are actually Champion priorities increase supplement to fil- is emphasized, they say. 

reduce procedure volumes and device 

ing, while former compliance office implantable FDA heart – and failure that monitor is as was beneficial dominated to not them ing by requirements..................................................12 

the as firm’s it is to clinical 

consumption, but hospital execs say 

firms like 

USP officials say that they are mulling over the possibility of creating a new chap- 

official Larry Spears jumps from Becker A data but by findings from FDA’s pre-market clinical-site inspections pointing 

that outcome is unlikely .10 

medtronic and Johnson & Johnson. 

ter addressing content uniformity of large samples. Meanwhile the European 

to Deloitte; AAMI continues to address to bias in that data FDA wants generics more equivalent Pharmacopeia issued a proposal this year outlining new requirements for large 

” 

“alarm fatigue” .....................14 

The result: CardioMEMS appears to be facing an uphill battle at best for ap- 

– Steven Silverman, director, CDRH Office of Compliance 

samples. 

Diagnostic patent or law of nature? 

proval That is a disappointing surprise not only for Atlanta-based 

No more holding 

CardioMEMS, 

your nose and trying to 

but also for St Jude Medical, which holds a 19% ownership 

choke 

stake 

down 

in the 

smelly, 

firm and 

bulky generics. FDA One approach pharmaceutical manufacturers are talking about is adopting the 

Mayo v. Prometheus case argued 

has touted the technology as a major opportunity for its business 

says it wants 

(See 

them 

“St Jude: 

the same size, taste and American National Standards Institute E2709 standard, otherwise known as the 

before Supreme Court 

CardioMEMS’ Heart Failure Data Reflects Major Opportunity” 

smell 

— “The 

as the 

Gray 

reference 

Sheet,” 

listed drugs. ............14 CUDAL method, which ASTM approved in 2009. 

The court To struggled sign up last for week FREE to map ONLINE Feb ACCESS, 14, 2011 .) go to: www.ElsevierBI.com/publications/The-Silver-Sheet Officials say that CUDAL is a highly effective method in identifying nonconform- 

out rules for the types of method 

ANDAs will need more stability data ing material for both large and small sample sizes. This method can be used to 

claims, particularly for diagnostic 

FDA is drafting guidance that will call for ge- assess the likelihood that particular sample results are representative of entire 

methods, that should be eligible for 

nerics firms to submit up to 12 months of sta- batches, and could play a role in process validation studies and in lot release. 

patent protection 12 

bility data with their ANDAs, instead of just the 

FDA officials also pointed to published simulation studies showing that the ASTM 

three months of data currently required. And 

E2709 method is superior to the USP 905 chapter for detecting batch defects. 

New on the mHealth scene 

industry has a lot of questions about it. ...........15 

Qualcomm launches wireless 

Other statistical approaches for handling large sample sizes discussed at the 

health business 

Telecommunications firm unveils Qualcomm 

Life, a new health care sub- 

What ICH Q1A means for generics 

conference included parametric tolerance interval test (PTIT) and nonparametric 

counting test methods. Both approaches can be used to ensure dose uniformity 

Current stability testing requirements vs. 

at lot release. 

what ICH Q1A requires. ......................................18 

sidiary The company’s first product, 

pictured below, is a platform that will 

CardioMEMS’ Champion heart failure sensor is implanted via catheter to continuously 

Continued > Page 3 

allow wireless medical devices to send 

take pulmonary artery pressure measurements. 

patient data from the home to a cloud- 

To sign up for FREE ONLINE ACCESS, go to: www.ElsevierBI.com/publications/The-Gold-Sheet 

based storage site .20 

FDA’s Circulatory System Devices panel voted 6-4 that the benefits of Champion 

do not outweigh its risk at the Dec 8 meeting in Gaithersburg, Md 

And in spite of the fact that the trial met its primary endpoint of reducing 

heart-failure hospitalizations, panel members voted 3-7 against device effectiveness 

due largely to a level of interaction between the sponsor and clinical site 

investigators that FDA said went beyond the protocol outlined in the firm’s PMA 

submission 

This “auxiliary management,” as panelists came to call it, included telephone 

calls and certain e-mails offering medical therapy advice from CardioMEMS nurses 

to study investigators Most panel members agreed they could not tease out the 

clinical benefits of the device from the benefits of the sponsor-generated therapy 

recommendations 

“There are confounding factors that make it impossible to know if the device alone 

can explain the benefit,” concluded David J Slotwiner, of Long Island Jewish Medical 

Table of Contents > page 3 

Story continues > Page 5 

To sign up for FREE ONLINE ACCESS, go to: www.ElsevierBI.com/publications/The-Gray-Sheet 


Photo: CardioMEMS top stories 

Table of Contents > 3 

P R E S C R I P T I O N P H A R M A C E U T I C A L S A N D B I O T E C H N O L O G Y 

January 2, 2012 

Research Policy 

NIH Repurposing Of Failed 

Compounds Could Begin Soon 

NIH’s National Center for Advancing 

Translational Science could launch its 

first project in early 2012 with an agreement 

with one or more drug companies 

to repurpose compounds that the firms 

have abandoned. Negotiations with industry 

are very close to bearing fruit, 

says Kathy Hudson, an NIH deputy director 

and NCATS’ acting deputy director. 

The repurposing project would the first 

uniquely NCATS program..........................11 

Manufacturing 

Ranbaxy’s $500 Million 

GMP Settlement Would Be 

Second Most Expensive For 

Rx Manufacturing Violations 

Ranbaxy Laboratories’ consent decree 

with FDA and agreement to set aside 

$500 million to settle a related Department 

of Justice investigation appears 

to put the Daiichi Sankyo subsidiary on 

pace to pay the second highest settlement 

for pharmaceutical good manufacturing 

practice violations, according to 

data compiled by “The Pink Sheet”.......25 

European Health 

Technology Assessment 

Grunenthal CEO Views German 

Reimbursement Hurdle As Fair, As Pain 

Drug Palexia Rolls Out Across Europe 

German reimbursement authority’s strong 

emphasis on drugs’ added benefit is logical, 

Grunenthal’s Harald Stock says, and all 

health care systems will eventually move 

the same way.....................................................8 

Looking AheAd To 2012: 

To sign up for FREE ONLINE ACCESS, go to: http://ThePinkSheet.ElsevierBI.com 

$2,450 A YEAR (print and online) 

Founded 1939 | Vol. 74, No. 1 

ACOs Get In Gear, Accelerating The Need to Prove 

Biopharma Products’ Overall Value In Health Care 

F 

Scott Steinke s.steinke@elsevier.com 

or any biopharma manufacturers standing on the sidelines as Medicare 

accountable care organizations take shape, the time has arrived to 

get involved. 

The first group of ACOs began operations Jan. 1, and from day one, their 

focus is on improving patient outcomes while also reducing the growth of 

health care costs. Manufacturers that connect with ACOs and convince them 

that their products contribute to both of those goals stand to gain share in 

what could be a very influential program. 

Improving outcomes while reducing costs is a familiar phrase in the health care 

world. But with the creation of ACOs under the Affordable Care Act, Medicare is aiming 

to put that phrase into practice by allowing all of the providers who interact with 

Medicare beneficiaries – from primary care and specialty physicians to hospitals and 

long-term care facilities – to organize into groups that will coordinate care. Through 

the associated Medicare Shared Savings Program, ACOs will share in the cost savings 

achieved or be penalized for cost over-runs based on a spending benchmark, all 

while having patient outcomes measured to ensure care is improving. 

Despite early reservations that the accountable care program would have few 

takers, 32 ACOs, which CMS is calling “Pioneer ACOs,” started up Jan. 1. Other 

Key Points 

Story continues > Page 4 

• ACO providers are responsible for overall patient outcomes and the related 

costs, so physicians must consider the overall value to patient care of the 

drugs they prescribe. 

• ACO P&T committees are likely to develop formularies and treatment guidelines 

for their physicians, so it will be essential to present the committees with good 

data on a product’s value to overall patient care. 

• Manufacturers should look for opportunities to partner with ACOs, both 

to ensure the overall success of the ACO model and to ensure expected 

outcomes for particular products are achieved, such as through working 

on patient adherence. 

• High-priced oncologics could be particularly vulnerable in ACOs to the need 

for high-quality data on value, since cost benchmarks cannot be adjusted to 

account for new therapies and cancer care is not a quality measure. 

• The Medicare ACO model could spill over into other health care settings, with 

successful ACOs potentially contracting to provide services to managed care 

organizations serving commercial or Medicaid plans.


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72 

Attendees (sorted by name) 

Name Company Email 

Abramowitz, Amanda Otsuka America Pharmaceutical amanda.tc-abramowitz@otsuka-us.com 

Alexander, Mauricia American Thoracic Society malexander@thoracic.org 

Barlow, Desmond FDANews dbarlow@fdanews.com 

Ben-Shir, Rya Shir Solutions Rya@shirsolutions.com 

Bosso, Katie Boston Scientific katherine.bosso@bsci.com 

Breiner, David Boehringer Ingelheim david.breiner@boehringer-ingelheim.com 

Brown, Melissa Bristol-Myers Squibb melissa.brown@bms.com 

Cahall, Molly The DD&P Group mcahall@ddp-g.com 

Campbell, Richard Novo Nordisk Inc rcam@novonordisk.com 

Chandler, Nena PPD nenachand@gmail.com 

Chin, Ernie Pubget echin@pubget.com 

Chou, Blanca Otsuka Pharmaceuticals blanca.cho@otsuka-us.com 

Chu, John Gilead Sciences, Inc. john.chu@gilead.com 

Chung, Hyun-Duck MaRS Discovery District hchung@marssdd.com 

Cirrito, Marianne Purdue Pharma L.P. marianne.cirrito@pharma.com 

Clark, Andrew UCB andrew.clark@ucb.com 

Cleland, Gary WilmerHale LLP gwcleland@crimson.us.edu 

Cochrell, Cary B Elan Pharmaceuticals cary.cochrell@elan.com 

Crane, Cindy Takeda Pharmaceuticals International, Inc. cindy.crane@takeda.com 

Cuca, Claudia cbc500@yahoo.com 

Darlington, Carol We Buy Books carol@webuybooks.net 

De La Calle, Val Astellas valeria.de.la.calle@us.astellas.com 

Di Nallo, Lou Ann BST America, LLC louann.dinallo@bstamerica.com 

Domke, Mark Prescott Medical Communications mdikmke@prescottmed.com 

Douglas, Jason Piribo North America/Reportbuyer.com jason.douglas@reportbuyer.com 

Duberman, Josh Pivotalinfo LLC pivotalinfo@usa.net 

Durant, William American Association for Cancer Research william.durant@aacr.org 

Erani, Karen kerani@pratt.edu 

Feng, Alexander dd+p group afeng@ddp-g.com 

Fisher, Jeanie Vantage Information Services jeanfisher2@verizon.net 

Fraser, Jeanie cacurlytop@mac.com 

Friend-Huizer, Jennifer Janssen Global Services jfriend1@its.jnj.com 

Gleckner, Susan Johnson & Johnson Consumer sgleckn@its.jnj.com 

Gray, Christian Reprints Desk, Inc. cgray@reprintsdesk.com 

Gutierrez, Tanya MedImmune gutierrezt@meidimmune.com 

Hacker, Jessica Warburg Pincus jessica.hacker@warburgpincus.com 

Hadley, Jessica Merck & Co. jemhadley@gmail.com 

Harrison, Lauren Roche lauren.harrison@roche.com 

Hauck, June UCB june.hauck@ucb.com 

Hendershot, Patrick Covidien Mallinckrodt patrick.hendershot@covidien.com 

Heyns, Nola Eli Lilly and Company nolah@lilly.com 

Hilberdink, Wendie Eli Lilly and Company whilberdink@lilly.com

Attendees (cont.) 

Name Company Email 

Hoffman, Kate L.E.K. Consulting katehoffman1@gmail.com 

Hohman, Helen hjhohman@verizon.net 

Kim, Sherry Abbott Laboratories sherry.kim@abbott.com 

LaFever, Sara BioMedTracker slafever@sagientresearch.com 

Maxwell, William Genericsweb w.maxwell@genericsweb.com 

McNab, Sidney L.E.K. Consulting s.mcnab@lek.com 

Merrill, Robin Elan Pharmaceuticals robin.merrill@elan.com 

Mozloom Goodling, Fran Shire Pharmaceuticals fmozloom@shire.com 

Norton, Candace United BioSource Corp candace.norton@unitedbiosource.com 

Olson, Chris Chris Olson & Associates chris@chrisolson.com 

O'Meara, Elizabeth Johnson & Johnson eomeara@its.jnj.com 

Otani, Patti Sanofi patti.otani@sanofi.com 

Peters, Sandra Tufts Center for the Study of Drug Dev. sandra.peters@tufts.edu 

Rainford, Natalie Astellas natalie.rainford@us.astellas.com 

Raske, Rick Baxter Healthcare Corporation rick_raske@baxter.com 

Ross, Karin AstraZeneca karin.ross@astrazeneca.com 

Sanfilippo, Pauline Johnson & Johnson psanfil3@its.jnj.com 

Sheaffer, Karalee Sanofi Pasteur karalee.sheaffer@sanofipasteur.com 

Siegelman, Lynn Sanofi lynn.siegelman@sanofi.com 

Smith, Laurie United BioSource Corp laurie.smith@unitedbiosource.com 

Smith, Lori Merial lori.smoth@merial.com 

Smith, Robyn Takeda Pharmaceuticals International, Inc. robyn.smith@takeda.com 

Speed, Melissa Appalachian College of Pharmacy mspeed@acpharm.org 

Spitalniak, Vicky Human Genome Sciences vicky_spitalniak@hgsi.com 

Stafford, Thomas tstaff1@gmail.com 

Stephens, Magan Gilead Sciences magan.stephens@gilead.com 

Stesis, Karen stesiskr@gmail.com 

Stoudt, Gen Shire Pharmaceuticals gstoudt@shire.com 

Stubbs, Eric Otsuka America Pharmaceutical eric.stubbs@otsuka-us.com 

Stultz, Shelia Merial shelia.stultz@merial.com 

Sullivan, Christina Covidien christina.sullivan@covidien.com 

Tavares, Sharlotte Onyx Pharmacueticals stavares@onyx-pharm.com 

Tetervin, Amy KNInformation amy@kninformation.com 

Walsh, Kathryn Purdue Pharma kathy.walsh@pharma.com 

Weiss, Janet Daiichi Sankyo Inc jweiss@dsi.com 

Williams, Julie Sanofi julie.williams@genzyme.com 

Young, Rosalind Otsuka America Pharmaceutical rosalind.young@otsuka-us.com 

Zalenski, Susan Teva szalenski@cephalon.com 

Ziegler, Paul Merck & Co., Inc paul.ziegler@merck.com 

Attendees (By Name) 

73


74 

Attendees (sorted by company) 

Company Name 

Abbott Laboratories Sherry Kim 

American Assoc Cancer Research William Durant 

American Thoracic Society Mauricia Alexander 

Appalachian College of Pharmacy Melissa Speed 

Astellas Val De La Calle 

Astellas Natalie Rainford 

AstraZeneca Karin Ross 

Baxter Healthcare Rick Raske 

BioMedTracker Sara LaFever 

Boehringer Ingelheim David Breiner 

Boston Scientific Katie Bosso 

Bristol-Myers Squibb Melissa Brown 

BST America, LLC Lou Ann Di Nallo 

Chris Olson & Associates Chris Olson 

Covidien Mallinckrodt Patrick Hendershot 

Covidien Mallinckrodt Christina Sullivan 

Daiichi Sankyo Inc Janet Weiss 

dd+p group Alexander Feng 

Elan Pharmaceuticals Cary B Cochrell 

Elan Pharmaceuticals Robin Merrill 

Eli Lilly and Company Nola Heyns 

Eli Lilly and Company Wendie Hilberdink 

FDANews Desmond Barlow 

Genericsweb William Maxwell 

Gilead Sciences John Chu 

Gilead Sciences Magan Stephens 

Human Genome Sciences Vicky Spitalniak 

Janssen Global Services Jennifer Friend-Huizer 

Johnson & Johnson Elizabeth O'Meara 

Johnson & Johnson Pauline Sanfilippo 

Johnson & Johnson Consumer Susan Gleckner 

KNInformation Amy Tetervin 

L.E.K. Consulting Kate Hoffman 

L.E.K. Consulting Sidney McNab 

MaRS Discovery District Hyun-Duck Chung 

MedImmune Tanya Gutierrez 

Merck & Co. Jessica Hadley 

Merck & Co. Paul Ziegler 

Merial Lori Smith 

Merial Shelia Stultz 

Novo Nordisk Inc Richard Campbell 

Company Name 

Onyx Pharmacueticals Sharlotte Tavares 

Otsuka Pharmaceuticals Amanda Abramowitz 

Otsuka Pharmaceuticals Blanca Chou 

Otsuka Pharmaceuticals Eric Stubbs 

Otsuka Pharmaceuticals Rosalind Young 

Piribo NA/Reportbuyer.com Jason Douglas 

Pivotalinfo LLC Josh Duberman 

PPD Nena Chandler 

Prescott Medical Comm Mark Domke 

Pubget Ernie Chin 

Purdue Pharma Marianne Cirrito 

Purdue Pharma Kathryn Walsh 

Reprints Desk, Inc. Christian Gray 

Roche Lauren Harrison 

Sanofi Patti Otani 

Sanofi Lynn Siegelman 

Sanofi Julie Williams 

Sanofi Pasteur Karalee Sheaffer 

Shir Solutions Rya Ben-Shir 

Shire Pharmaceuticals Fran Mozloom Goodling 

Shire Pharmaceuticals Gen Stoudt 

Takeda Pharmaceuticals Cindy Crane 

Takeda Pharmaceuticals Robyn Smith 

Teva Susan Zalenski 

The DD&P Group Molly Cahall 

Tufts Center Sandra Peters 

UCB Andrew Clark 

UCB June Hauck 

United BioSource Corp Candace Norton 

United BioSource Corp Laurie Smith 

Vantage Information Services Jeanie Fisher 

Warburg Pincus Jessica Hacker 

We Buy Books Carol Darlington 

WilmerHale LLP Gary Cleland 

Claudia Cuca 

Karen Erani 

Jeanie Fraser 

Helen Hohman 

Thomas Stafford 

Karen Stesis

Sponsor Attendees (sorted by company) 

Company Name 

AAAS/Science Catherine Holland 

Adis Gail Kohler 

Adis Beth Yavne 

Adis John Knapp 

Adis Jeff Southwood 

Basch Laurie Schwed 

Bio Century Pub Michelle Ortega 

Bio Century Pub Orlando Abello 

BizInt Solutions Diane Webb 

BizInt Solutions John Willmore 

Citeline Shannon Fisher 

Citeline Tim Daley 

Copyright Clearance Center Troy Baker 

Copyright Clearance Center Katherine Bonnar 

Dialog Amy Barlet 

Dialog Penny Doane-Setzer 

Dialog Melissa Schaufler 

Dialog Jody Burton 

Dow Jones Andrew Eberle 

Dow Jones Jennifer Hayek 

Drug Patent Watch no attendee 

EBSCO Greg DiDonato 

EBSCO Doug van der Zee 

EBSCO Mike Lucarelli 

Elsevier Kristopher Patterson 

Elsevier Darrell White 

Elsevier Cheryl Hackos 

Elsevier James Phimister 

Elsevier Tim Hoctor 

Elsevier Katherine Quinlan 

Elsevier Neal Katz 

Elsevier Manisha Murthy 

Elsevier Judy Olson 

Elsevier Business Int Deanna Flanick 

Elsevier Business Int John Lucas 

Elsevier Business Int Elissa Langer 

Elsevier Business Int Amanda Micklus 

Elsevier Business Int Gerry Stoia 

Elsevier Business Int Andrea Mancini 

Elsevier Business Int Mike Fergus 

Elsevier Business Int Ken May 

Company Name 

Elsevier Business Int Alicia McNiven 

Attendees (By Company) 

Evaluate Pharma Margaret Nelson 

Evaluate Pharma Tom Moore 

Faculty of 1000 Patrick Brown 

Faculty of 1000 Jim Jacketti 

First Word Dwayne Bowie 

First Word Christian Bisaillon 

FOI Services Marlene Bobka 

FOI Services John Carey 

FOI Services Eva Gonsalves 

FOI Services John Scappini 

GBI Tom DePaul 

InfoDesk Maria Barlev 

InfoDesk Lynn Epstein 

Information Express Neema Naficy 

InfoTrieve, Inc. Lynn Schlesinger 

InfoTrieve, Inc. Tim Rozanski 

InfoTrieve, Inc. Brian Pouliot 

Leadership Directories Jim Marcus 

Leadership Directories Tessa Blanchfield 

Linguamatics Tony Scheffer 

Linguamatics Jeff Nauss 

Linguamatics David Milward 

Linguamatics Scott Pestana 

Logicden LaVerne Coan 

MaryAnn Liebert Geoff Worton 

MaryAnn Liebert Marianne Russell 

MaryAnn Liebert Bobbi Sokhey 

NEJM Patrice Costa 

NEJM Sandy Wellman 

NEJM Eileen Welch 

PharmaCircle Tugrul Kararli 

PharmaCircle Joseph Bosart 

PMR Mark Hamson 

PMR Monika Obiezierska 

QUOSA Malcolm MacKenzie 

QUOSA Hal Avery 

QUOSA Robin Fogel 

QUOSA Margaret Basket 

Right Answer.com, Inc. Scarlett Crawford 

RSNA Ashley Day 

75


76 

Sponsor Attendees (Continued) 

Company Name 

RSNA Nathan Wicks 

SAGE Bob Schufreider 

SAGE Elisabeth Lutanie 

Springer James DeFalco 

Springer Stacey Bowers 

Tarius Eva Lis Petersen 

Tarius Nina Lindholst 

Thomson Reuters Tad Crawford 

Thomson Reuters Jeremy Snelling 

Thomson Reuters Steve Love 

Timely Data Stephen DuPraw 

Monday Social Event: 

National Aquarium, Baltimore 

We will be spending the evening at the National Aquarium in Baltimore (www.aqua.org) from 6:30 

p.m. to 10:00 p.m. 

For the first hour you will have the opportunity to stroll through the Animal Planet Australia: Wild 

Extremes Exhibit. You will then make your way over to the first floor of the Main Building where 

we will start our strolling supper with wonderful hors d’oeuvres and an open bar. 

The fun then continues with a special demonstration as you make your way up the next 3 floors 

where you will end up on Level 4 for a wonderful dinner. You will end up back on the first floor 

where dessert and coffee will be served. 

During this time the lovely Gift Shop will also be open for you to enjoy! 

Please meet in the Hilton lobby at 6:00 p.m. I have arranged for transportation to take us to the 

Aquarium. We will be shuttling people in groups of 27 (I have 2 - 27 passenger buses). 

The shuttles will start leaving the Aquarium at 9:30 p.m. for anyone who doesn’t want to stay until 

10:00 p.m. The last shuttle will leave the Aquarium for the hotel at 10:00 p.m. 

Thank you to Wolters Kluwer Health (Ovid Technologies) and Adis for their generous 

sponsorship of this special event. Please stop by their booths in the exhibit hall and thank them 

for sponsoring our event! 

Note: Pre-registration and tickets are required for this event. 

Photos courtesy of National Aquarium, Baltimore. 

Company Name 

TPR Melissa Schneider 

Wiley Blackwell Zita Doktor 

Wiley Blackwell Patricia Ryan 

Wolters Kluwer/Ovid Karen Mirabile 

Wolters Kluwer/Ovid Fred Short 

Wolters Kluwer/Ovid Sara Schmitt 

Wolters Kluwer/Ovid Ben Beit-Zuri 

Wolters Kluwer/Ovid Keith Neumeyer 

Wolters Kluwer/Ovid Rachel Mante 

Wolters Kluwer/Ovid Phuong Tran 

Wolters Kluwer/Ovid Michelle Brewer 

F F F

2012 Officers and Board Members 

Chair Alex Feng 

Chair-Elect Mary Chitty 

Past Chair Margaret Basket 

Secretary Sidney McNab 

Treasurer Rick Raske 

Advertising Manager Janet Cooper Weiss 

Awards Chair Margaret Basket 

CapLits Editor Praveena Raman 

CapLits Production Editor Mark Domke 

Division Archivist Paul Ziegler 

Employment Relations Chair Natalie Rainford 

First Floor 

Second Floor 


401 West Pratt St. 

Baltimore, MD 21201 

(443) 573-8700 

Fundraising Chair Sandra Baker 

List Administrator Julia Parker 

Membership Chair Bonnie Snow 

Networking Chair Bonnie Snow 

Nominating Committee Chair Christine Geluk 

Past Treasurer Barbara Wetzel 

Professional Development Chair Megan Stephens 

Prog Planning I (annual 2012) Richard Campbell 

Prog Planning II (spring 2012) Robyn Smith 

Prog Planning III (annual 2013) Jeanie Fraser 

Public Relations Chair Sean Smith 

Web Master Paul Ziegler 

Tweet this meeting using Twitter tag 

#slapht 

Presentation handouts will be posted 

after the meeting on the 

Division Web site and the Blog: 

Web site: units.sla.org/division/dpht/ 

Blog: phtd.wordpress.com

“Remy” photo by Dog Gone Digital, March 2009 

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