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Event Guide<br />
May 12-15, 2013 • Hynes Convention Center • Boston, MA, USA<br />
Event Guide Sponsor:<br />
What's Inside...<br />
Agenda Overview........................................... 3<br />
Event Sponsors................................................ 4<br />
Conference Agenda<br />
Sunday Courses .......................................... 6-7<br />
Monday Sessions............................................ 8<br />
Tuesday Sessions................................... 10-13<br />
Wednesday Sessions............................ 14-16<br />
Exhibition Hours and Information<br />
Poster Presentations..................Addendum<br />
Meeting and Exhibit Room Map.............18<br />
Exhibitor List and Hall Map.......................20<br />
Platinum Sponsor<br />
Gold Sponsors<br />
Silver Sponsors<br />
Bronze Sponsors
Sunday, May 12, 2013<br />
Course #1: Application of Current FDA and<br />
10:00 am -<br />
ICH Guidelines to <strong>the</strong> Manufacturing and<br />
5:00 pm<br />
Analysis of Oligonucleotides (Room 202)<br />
Monday, May 13, 2013<br />
8:45 am -<br />
12:50 pm<br />
Agenda Overview with Room Assignments<br />
Course #2: Business and Operational<br />
Strategies for Successful Peptide<br />
Development (Room 204)<br />
Mipomersen: A Novel Second Generation Antisense<br />
Oligonucleotide for Treatment of <strong>the</strong> Rare Genetic Disorder,<br />
Homozygous Familial Hypercholesterolemia<br />
Mary P. McGowan, M.D., Senior Medical Director, Clinical Research,<br />
Genzyme, a Sanofi Company<br />
The State of Venture Capital, Startups, and Funding in<br />
Oligo and Peptide Therapeutics<br />
Bruce Booth, D.Phil., Partner, <strong>Life</strong> <strong>Sciences</strong>, Atlas Venture<br />
Keynote Session (Room 302/304)<br />
Course #3: Peptide and Oligonucleotide<br />
Conjugation Strategies (Room 203)<br />
Course #4: Physicochemical<br />
Characterization of Oligonucleotides<br />
and Peptides (Room 205)<br />
Poster and Exhibit Hall Hours: 3:15 pm – 6:45 pm<br />
Spherical Nucleic Acids (SNAs)<br />
Chad A. Mirkin, Ph.D., Professor, Chemistry, Northwestern University<br />
The Role of Drug Delivery and Device Technologies for Peptide Products<br />
William J. Lambert, Ph.D., Fellow, Drug Delivery and Device Development, MedImmune, Inc.<br />
Epitope Targeted, Protein Catalyzed Capture Agents Generated by In Situ<br />
Click Chemistry for Human Health Applications<br />
James R. Heath, Ph.D., Professor, Chemistry and Chemical Engineering,<br />
California Institute of Technology<br />
1:40 pm -<br />
5:30 pm Plenary Session: Updates on Commercialization of Therapeutic Candidates (Room 302/304)<br />
3:15 pm -<br />
4:30 pm Grand Opening of Poster and Exhibit Hall with Networking Refreshment Break (Exhibit Hall D)<br />
1:40 pm -<br />
5:30 pm Plenary Session (continued) (Room 302/304)<br />
5:30 pm -<br />
6:45 pm Networking, Wine and Cheese Reception in Poster and Exhibit Hall Sponsored by AIC Tedia (Exhibit Hall D)<br />
Tuesday, May 14, 2013<br />
Poster and Exhibit Hall Hours: 10:30 am – 6:15 pm<br />
8:00 am -<br />
11:15 am<br />
11:15 am -<br />
12:45 pm<br />
Oligonucleotide and Peptide Manufacturing, Technology<br />
and Product Development<br />
CMC Challenges and<br />
Solutions – Strategic Approaches<br />
Session Sponsored by Cepia Sanofi (Room 302)<br />
Strategy Discussion Forum<br />
Specifications for Oligonucleotide<br />
and Peptide Active<br />
Pharmaceutical Ingredients<br />
(Room 313)<br />
Emerging Technologies Showcase:<br />
Spotlight Presentations (Room 302)<br />
Sponsored by Tandem Labs and<br />
ST Pharm Co. Ltd. (former<br />
Samchully Pharm), Korea<br />
Oligonucleotide<br />
Therapeutics Discovery<br />
Peptide Discovery<br />
and Development<br />
Nucleic Acids Technologies<br />
for Molecular Diagnostics<br />
Room 311 Room 309 Room 310<br />
Single Stranded RNAs as<br />
Novel Active Compounds<br />
Novel Chemistries and<br />
PK/PD Modulation<br />
Oligonucleotide Delivery:<br />
Mechanisms and<br />
Emerging Strategies<br />
12:45 pm Networking Luncheon in Poster and Exhibit Hall (Exhibit Hall D)<br />
2:00 pm -<br />
4:15 pm<br />
4:15 pm -<br />
5:15 pm<br />
CMC and Analytical<br />
Challenges and Solutions –<br />
Oligonucleotide Case Studies<br />
(Room 302)<br />
Strategy Discussion Forum:<br />
Manufacturing: What Scale,<br />
When? (Room 308)<br />
CMC Challenges and Solutions<br />
– Peptide Case Studies and<br />
Strategies (Room 304)<br />
Session Sponsored by Bachem<br />
Emerging Technologies Showcase:<br />
Spotlight Presentations<br />
Sponsored by<br />
ChemGenes/<br />
Prime Syn<strong>the</strong>sis<br />
and aptaIT GmbH<br />
(Room 302)<br />
Sponsored by<br />
Lonza and<br />
Sekisui<br />
(Room 304)<br />
Technologies for Cell and<br />
Tissue Targeting or<br />
Improved Delivery<br />
Panel Discussion: What<br />
Does it Take to Bring an<br />
Oligonucleotide to Market?<br />
Novel Syn<strong>the</strong>tic Approaches<br />
to Modify Peptides and<br />
Improve Drug-like Properties<br />
Structure-based Design of<br />
Novel Peptides<br />
Molecular Diversity and<br />
Novel Peptide Macrocycles<br />
Panel Discussion: Emerging<br />
Strategies for Novel Peptide<br />
Drug Discovery<br />
Regulatory, Manufacturing and<br />
Business Considerations<br />
Keynote Presentation:<br />
Industry Perspective on Evolving<br />
Regulatory Environment for IVDs<br />
Karen S. Long, Division Vice President,<br />
Medical, Regulatory and Clinical<br />
Affairs, Abbott Molecular, Inc.<br />
Audience Interactive Panel<br />
Discussion: Regulatory Support<br />
of Innovation: Navigating<br />
FDA’s Pathways while Developing<br />
Novel Technologies<br />
Strategy Discussion Forum:<br />
Specifications for Oligonucleotide<br />
and Peptide Active<br />
Pharmaceutical Ingredients<br />
(Room 313)<br />
New Technologies<br />
Panel Discussion: The Oligo<br />
Supply Chain for Diagnostics –<br />
Raw Materials for Oligo Syn<strong>the</strong>sis<br />
– Selecting <strong>the</strong> Right Fluorophore/<br />
Reporter Pair and Chemistry<br />
5:15 pm -<br />
6:15 pm Networking, Wine and Cheese Reception in Poster and Exhibit Hall Sponsored by Lonza (Exhibit Hall D)<br />
Wednesday, May 15, 2013<br />
Poster and Exhibit Hall Hours: 10:30 am – 2:00 pm<br />
8:00 am -<br />
8:30 am<br />
8:30 am -<br />
11:15 am<br />
11:15 am -<br />
12:45 pm<br />
Oligonucleotide and Peptide Manufacturing, Technology<br />
and Product Development<br />
Oligonucleotide<br />
Therapeutics Discovery<br />
Peptide Discovery<br />
and Development<br />
Nucleic Acids Technologies<br />
for Molecular Diagnostics<br />
Room 311 Room 309 Room 310<br />
Featured Presentation: Steven F. Dowdy, Ph.D., UCSD School of Medicine (Room 311)<br />
Strategies for Oligonucleotide<br />
Process Design and Optimization<br />
(Room 302)<br />
Spotlight Presentation<br />
Sponsored by OctoPlus<br />
(Room 302)<br />
(ends 11:45)<br />
Conjugated Oligonucleotide and<br />
Peptide Therapeutics (Room 304)<br />
Strategy Discussion Forum:<br />
Conjugation: Extending <strong>the</strong><br />
Therapeutic Potential of<br />
Oligonucleotides and Peptides<br />
(Room 308)<br />
Discovery and Preclinical<br />
Strategies<br />
12:45 pm Networking Luncheon in Poster and Exhibit Hall (Exhibit Hall D)<br />
1:55 pm -<br />
5:15 pm<br />
Formulation and Delivery (Room 302)<br />
Clinical Progress of<br />
Oligonucleotide Therapeutics<br />
Intracellular Delivery<br />
of Peptides<br />
Preclinical Strategies to Exploit<br />
Novel Targets and Optimize<br />
Properties of Peptides<br />
Peptides in Early Development and<br />
New Frontiers in Peptide R&D<br />
MicroRNA for Diagnostics<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/TIDES 3
Event Sponsors<br />
Platinum Sponsor<br />
Gold Sponsors<br />
Silver Sponsors<br />
Bronze Sponsors<br />
Session Sponsors<br />
Spotlight Presentation Sponsors<br />
Corporate Suite Sponsors<br />
Badge/Lanyard Sponsor<br />
Totebag Sponsor<br />
Networking Reception Sponsors<br />
(Monday)<br />
(Tuesday)<br />
Event Guide Sponsor<br />
Literature Sponsors<br />
4 TIDES® Conference & Exhibition
Sunday, May 12, 2013 • Courses<br />
9:00 Registration and Coffee<br />
Course #1:<br />
Application of Current FDA and ICH<br />
Guidelines to <strong>the</strong> Manufacturing<br />
and Analysis of Oligonucleotides<br />
Room 202<br />
Course Leaders:<br />
Doug Brooks, Ph.D., Executive Director, Chemistry, Regado Biosciences<br />
G. Susan Srivatsa, Ph.D., President, ElixinPharma<br />
Fran Wincott, Ph.D., Wincott and Associates<br />
10:00 Overview: Application of Existing FDA/ICH Quality Guidelines to<br />
<strong>the</strong> Development of Oligonucleotides<br />
Doug Brooks, Ph.D., Executive Director, Chemistry, Regado Biosciences<br />
Fran Wincott, Ph.D., Wincott and Associates<br />
10:30 Control Strategy for Raw Materials of Oligonucleotide<br />
Drug Substances: Application of ICHQ11<br />
Claus Rentel, Ph.D., Executive Director, Analytical Development,<br />
Isis Pharmaceuticals, Inc.<br />
11:10 Acceptance Criteria and Thresholds for Impurities in<br />
Oligonucleotide Drug Substances and Drug Products<br />
James V. McArdle, Ph.D., President, McArdle & Associates<br />
11:50 Report from IQ Consortium Working Group<br />
Shiranthi Jayawickreme, Ph.D., Associate Director Technical Development,<br />
Biogen Idec<br />
12:30 Lunch on your own<br />
2:00 Application of Statistical Principles in ICHQ1 to Shelf <strong>Life</strong><br />
Assignment of Oligonucleotides with Limited Number of Batches<br />
Matthias Kretschmer, Ph.D., Director, Analytical <strong>Sciences</strong>,<br />
Alnylam Pharmaceuticals, Inc.<br />
2:40 Case Study Pulling it all Toge<strong>the</strong>r – Effectively Applying <strong>the</strong><br />
Current ICH Guidelines for Method Validation, Impurities, and<br />
Specifications to Advance your Programs to Phase III<br />
Doug Brooks, Ph.D., Executive Director, Chemistry, Regado Biosciences<br />
3:20 Networking Refreshment Break (Boylston Hallway- 2nd Floor)<br />
3:40 ICH Q11: Application of QBD Principles to <strong>the</strong> Validation of<br />
Oligonucleotide Manufacturing Processes: Does Q11 Allow for<br />
Platform Validation?<br />
Mark C. Guzman, Ph.D., Principal, MG Consulting<br />
4:20 PAT Applications for Oligonucleotide Syn<strong>the</strong>sis and Purification<br />
Peter McDonnell, Ph.D., Senior Technical Director, Genzyme<br />
5:00 Audience Interactive Panel Discussion<br />
5:30 Close of Course<br />
Course #2:<br />
Business and Operational Strategies for<br />
Successful Peptide Development<br />
Room 204<br />
Course Leaders:<br />
Bruce H. Morimoto, Ph.D., Vice President, Drug Development,<br />
Allon Therapeutics Inc., Canada<br />
Gary F. Musso, Ph.D., President, Musso and Associates LLC<br />
10:00 Course Introduction: Strategies for Management of Manufacturing<br />
and Quality Control during Early Stage Development<br />
Michael Verlander, D.Phil., President, PolyPeptide Group (San Diego)<br />
10:30 Strategies for Manufacturing Success: Managing Intellectual<br />
Property and Know-How Challenges<br />
Firoz Antia, Ph.D., CMC Team Director, Pharmaceutical Operations and<br />
Technology, Biogen Idec<br />
11:10 Business Considerations for <strong>the</strong> Management of Contract<br />
Manufacturing to Support Multiple Development Programs;<br />
a Strategic Blend of DIY and Renting<br />
Bruce H. Morimoto, Ph.D., Vice President, Drug Development,<br />
Allon Therapeutics Inc., Canada<br />
11:50 What Does it Really Take to Scale Up Peptide Syn<strong>the</strong>sis to<br />
50 kg Batches?<br />
Brad Dehoff, Ph.D., Director, R&D, Corden Pharma<br />
12:30 Lunch on your own<br />
2:00 Bringing it All Toge<strong>the</strong>r for Development, Regulatory and<br />
Business Success<br />
Gary F. Musso, Ph.D., President, Musso and Associates LLC<br />
2:40 Networking Refreshment Break (Boylston Hallway- 2nd Floor)<br />
3:15 CMO-Sponsor Collaboration: Aligning <strong>the</strong> Manufacturing<br />
Approach with <strong>the</strong> Drug Development Stage<br />
Mimoun Ayoub, Ph.D., Vice President, Strategic Development,<br />
Peptisyntha, Member Of The Solvay Group, Belgium<br />
4:25 Follow Up Audience Interactive Panel Discussion<br />
5:00 Close of Course<br />
6 TIDES® Conference & Exhibition
Sunday, May 12, 2013 • Courses<br />
9:00 Registration and Coffee<br />
Course #3:<br />
Peptide and Oligonucleotide<br />
Conjugation Strategies<br />
Course #4:<br />
Physicochemical Characterization of<br />
Oligonucleotides and Peptides<br />
Room 203<br />
Course Leaders:<br />
Christopher P. Holmes, Ph.D., Executive Director, Chemistry, Affymax, Inc.<br />
Lubomir V. Nechev, Ph.D., Vice President, Process Chemistry,<br />
Alnylam Pharmaceuticals, Inc.<br />
10:00 Introduction: Why Do We Need to Conjugate Ligands<br />
to Oligonucleotides?<br />
Muthiah (Mano) Manoharan, Ph.D., Senior Vice President, Drug Discovery,<br />
Alnylam Pharmaceuticals, Inc.<br />
10:30 Linkers, Ligands, Linkages and Te<strong>the</strong>rs<br />
Kallanthotathil G. Rajeev, Director, Medicinal Chemistry,<br />
Alnylam Pharmaceuticals, Inc.<br />
11:00 Click Chemistry for Oligonucleotide Conjugates<br />
Jayaprakash (Jay) Nair, Principal Scientist, Medicinal Chemistry,<br />
Alnylam Pharmaceuticals, Inc.<br />
11:30 Application of Retro Diels Alder Chemistry to Cleavable<br />
Linker Technology<br />
Kenneth W. Hill, Ph.D., Principal Investigator, Agilent Technologies, Inc.<br />
12:00 Peptide Conjugated Oligonucleotides<br />
Scott Petersen, Ph.D., Chief Scientific Officer, Liposciences, Inc.<br />
12:30 Lunch on your Own<br />
2:00 Importance of Control Experiments to Support Product Approval<br />
of Conjugates<br />
Christopher P. Holmes, Ph.D., Executive Director, Chemistry, Affymax, Inc.<br />
2:30 Conjugation of Peptides: A CMOs Perspective<br />
Rodney Lax, Ph.D., Senior Director Business Development,<br />
PolyPeptide Group, North America<br />
3:00 Networking Refreshment Break (Boylston Hallway- 2nd Floor)<br />
3:30 Challenges of Analytical Characterization and Certification of<br />
Peptide Conjugates during Drug Substance Development<br />
Rainer Gast, Ph.D., Manager Analytical Development, PolyPeptide Group,<br />
North America<br />
4:00 Case Study Development of Enhanced PNA Delivery Systems via<br />
Conjugation Strategy<br />
Gang Shen, Ph.D., Research Scientist, Oligonucleotide Drug Development,<br />
OPKO Health<br />
4:30 Audience Interactive Panel Discussion<br />
5:00 Close of Course<br />
Room 205<br />
Course Leader: Andrew Dibble, Ph.D., Director,<br />
Pharmaceutical Development, Isis Pharmaceuticals, Inc.<br />
10:00 Overview: The Importance of Physicochemical Characterization as<br />
Part of <strong>the</strong> Development Process<br />
Andrew Dibble, Ph.D., Director, Pharmaceutical Development,<br />
Isis Pharmaceuticals, Inc.<br />
10:10 Routine Characterization (e.g., Buffering Capacity, pKa, Isoelectric<br />
Point, Zeta Potential, Moisture Sorption Iso<strong>the</strong>rm, T-Melt)<br />
Andrew Dibble, Ph.D., Director, Pharmaceutical Development,<br />
Isis Pharmaceuticals, Inc.<br />
10:35 The Application of DSC and ITC to <strong>the</strong> Characterization of<br />
Oligonucleotides and Peptides<br />
Hüseyin Aygün, Ph.D., Chief Scientific Officer, BioSpring GmbH, Germany<br />
11:05 Monitoring & Predicting Formulation Stability Using Non-Invasive<br />
Light Scattering<br />
Kevin Mattison, Ph.D., Principal Scientist – Bioanalytics, Malvern Biosciences<br />
11:50 Precipitation/Aggregation/Gelling/Turbidity<br />
Knut Langsetmo, Ph.D., Senior Scientist, Ipsen, Inc.<br />
Andrew Dibble, Ph.D., Director, Pharmaceutical Development,<br />
Isis Pharmaceuticals, Inc.<br />
12:05 Viscosity Considerations<br />
Andrew Dibble, Ph.D., Director, Pharmaceutical Development,<br />
Isis Pharmaceuticals, Inc.<br />
12:30 Lunch on your own<br />
1:50 The Application of NMR, CD, and FT-IR to <strong>the</strong> Characterization of<br />
Oligonucleotides and Peptides<br />
Michele DeRider, Ph.D., Lead Scientist, Catalent Pharma Solutions<br />
2:30 Considerations for Translation of Nanoparticle RNAi<br />
Therapeutic Candidates<br />
Martin C. Woodle, Ph.D., Co-Founder, CEO and CSO,<br />
Aparna Biosciences Corporation<br />
3:00 Networking Refreshment Break (Boylston Hallway- 2nd Floor)<br />
3:30 Case Study 1 Solubility in Therapeutic Peptide Candidate Selection<br />
Knut Langsetmo, Ph.D., Senior Scientist, Ipsen, Inc.<br />
4:00 Case Study 2 Mitigation of Viscosity and Turbidity in<br />
Oligonucleotide Solutions<br />
Andrew Dibble, Ph.D., Director, Pharmaceutical Development,<br />
Isis Pharmaceuticals, Inc.<br />
4:30 Audience Interactive Panel Discussion<br />
5:00 Close of Course<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/TIDES 7
Monday, May 13, 2013<br />
Keynote Session<br />
Room 302/304<br />
7:30 Registration and Coffee (Prefunction Hall D)<br />
8:45 Chairman’s Opening Remarks<br />
Christopher P. Holmes, Ph.D., Executive Director,<br />
Chemistry, Affymax, Inc.<br />
9:00 Mipomersen: A Novel Second<br />
Generation Antisense Oligonucleotide<br />
for Treatment of <strong>the</strong> Rare Genetic<br />
Disorder, Homozygous Familial<br />
Hypercholesterolemia <br />
Mary P. McGowan, M.D., Senior Medical Director,<br />
Clinical Research, Genzyme, a Sanofi Company<br />
9:40 The State of Venture Capital,<br />
Startups, and Funding in Oligo<br />
and Peptide Therapeutics<br />
Bruce Booth, D.Phil., Partner, <strong>Life</strong> <strong>Sciences</strong>,<br />
Atlas Venture<br />
10:20 Networking Refreshment Break<br />
(Level 3 Boylston Hallway)<br />
10:50 Spherical Nucleic Acids (SNAs)<br />
Chad A. Mirkin, Ph.D., Professor, Chemistry,<br />
Northwestern University <br />
11:30 The Role of Drug Delivery and<br />
Device Technologies for<br />
Peptide Products<br />
William J. Lambert, Ph.D., Fellow, Drug Delivery<br />
and Device Development, MedImmune, Inc.<br />
12:10 Epitope Targeted, Protein Catalyzed<br />
Capture Agents Generated by<br />
In Situ Click Chemistry for<br />
Human Health Applications <br />
James R. Heath, Ph.D., Professor,<br />
Chemistry and Chemical Engineering,<br />
California Institute of Technology<br />
12:50 Lunch on your own<br />
Plenary Session<br />
Room 302/304<br />
Updates on Commercialization of<br />
Therapeutic Candidates<br />
1:40 Chairman’s Remarks<br />
Bob D. Brown, Ph.D., CSO and Senior Vice President, Research,<br />
Dicerna Pharmaceuticals<br />
1:45 Plecanatide and SP-333, Guanylate<br />
Cyclase-C Agonists: A New Class of<br />
Drug Candidates for Treatment of<br />
Gastrointestinal Disorders and Diseases<br />
Kunwar Shailubhai, Ph.D., M.B.A., <br />
Chief Scientific Officer, Synergy Pharmaceuticals, Inc.<br />
2:15 Unpublished Data Development of Peptide<br />
Drug Candidates for Fast First Time in<br />
Man Dosing; A Biotech’s Perspective<br />
Torsten Malmström, Ph.D., Head of Pharmaceutical<br />
Development, Zealand Pharma A/S, Denmark<br />
2:45 Powered by KL4: A Better Treatment<br />
for Babies<br />
Russell G. Clayton Sr., D.O., Senior Vice President,<br />
R&D, Discovery Laboratories, Inc.<br />
3:15 Grand Opening of Poster and Exhibit Hall<br />
with Networking Refreshment Break<br />
(Exhibit Hall D)<br />
4:00 Antisense Development Portfolio Advances<br />
Richard S. Geary, Ph.D., Senior Vice President,<br />
Development, Isis Pharmaceuticals, Inc.<br />
4:30 Eteplirsen: One Small Step for Sarepta,<br />
One Giant Leap for DMD Treatment<br />
Jayant Aphale, Ph.D., MBA, RAC,<br />
Senior Vice President, Technical Operations,<br />
Sarepta Therapeutics <br />
<br />
5:00 Discovery and Development of GalNAc<br />
Conjugates for RNAi Therapeutics<br />
Muthiah (Mano) Manoharan, Ph.D.,<br />
Senior Vice President, Drug Discovery,<br />
Alnylam Pharmaceuticals, Inc. <br />
5:30 Networking, Wine and Cheese Reception<br />
in Poster and Exhibit Hall Sponsored by:<br />
8 TIDES® Conference & Exhibition<br />
Do you have your TIDES Passport Game Card in Hand?<br />
Pick up your Passport game cards at <strong>the</strong> entrance of <strong>the</strong> Exhibit Hall when <strong>the</strong> hall opens on Monday at 3:15 pm.<br />
If you complete your Passport game card, you will be enrolled in a drawing to win some amazing prizes.<br />
This is your chance to win!<br />
$200 Gift Card – Donated by Avecia at Booth 214<br />
Kindle Fire – Donated by Bachem at Booth 326<br />
$100 Visa Gift Card – Donated by Biotage at Booth 508<br />
Noise-cancelling Headphones– Donated by Biotechlogic, Inc. at Booth 229<br />
i-Home – Donated by CEPIA Sanofi at Booth 105<br />
MacBook Pro with Retina Display, Samsung 50” 1080p TV, Samsung 40” 1080 TV,<br />
iPad Mini, iPod Touch – Donated by CS Bio & ShengNuo Group at Booth 306/120<br />
Kindle Fire HD – Donated by NSF Pharmalytica at Booth 114<br />
i-Pad Mini – Donated by Pyamid Lab– Donated by Booth 524<br />
IPad mini WiFi-16GB ST Pharm – Donated by Booth 428<br />
How to Play:<br />
1. Visit each booth in <strong>the</strong> exhibit hall listed in your passport.<br />
Each booth will be labeled as a “Passport STOP”<br />
2. Have each exhibiting company initial <strong>the</strong>ir destination on<br />
your passport.<br />
3. Turn in your passport game card at <strong>the</strong> <strong>IBC</strong> Show<br />
Management Booth at <strong>the</strong> back of <strong>the</strong> hall by 1:30 pm<br />
on Wednesday.<br />
4. Winners will be announced Wednesday at 1:35 pm.<br />
The drawing will be held in <strong>the</strong> exhibit hall.<br />
You must be present to win!
Tuesday, May 14, 2013 • Main Conference<br />
Oligonucleotide and Peptide Manufacturing, Technology and Product Development<br />
Room 302<br />
7:15 Registration and Coffee (Prefunction Hall D)<br />
8:15 Chairman’s Remarks<br />
Bob Huang, Ph.D., Director, North American API Contract Manufacturing, Cepia Sanofi<br />
CMC Challenges and Solutions – Strategic Approaches Session Sponsored by<br />
8:30 Scale-up of Oligonucleotides: Principles and Pitfalls<br />
Peter McDonnell, Ph.D., Senior Technical Director, Genzyme, United Kingdom<br />
9:00 Continued Process Verification (CPV), What’s Changed in our Approach to Process Validation?<br />
Paul McCormac, Ph.D., Director, Biomanufacturing <strong>Sciences</strong> Group, Pfizer Global Supply<br />
9:30<br />
Unpublished Data Case Study Characterization of Oligonucleotide Bio<strong>the</strong>rapeutics by LC/MS/MS<br />
Olga V. Friese, Ph.D., Associate Research Fellow, Bio<strong>the</strong>rapeutics Analytical Research and Development, Pfizer<br />
10:00 Regulatory Expectations for <strong>the</strong> Quality of Oligonucleotide Products on Applications for Clinical Trials and Market Authorizations in <strong>the</strong> EU<br />
Axel Ståhlbom, Ph.D., Assessor Biotech, Department of Biotechnology and Pharmacy, Medical Products Agency, Sweden<br />
10:30 Networking Refreshment Break in Poster and Exhibit Hall<br />
Strategy Discussion Forum<br />
11:15 Room 313<br />
11:15 Spotlight Presentation (Room 302)<br />
Emerging Technologies Showcase<br />
Specifications for Oligonucleotide and Peptide<br />
Active Pharmaceutical Ingredients<br />
Moderator:<br />
Daniel C. Capaldi, Ph.D., Vice President, Analytical and<br />
Process Development, Isis Pharmaceuticals, Inc.<br />
Panelists:<br />
Pierre Boulas, Ph.D., Director, Analytical Development,<br />
Biogen Idec<br />
Doug Brooks, Ph.D., Executive Director, Chemistry,<br />
Regado Biosciences<br />
Christopher P. Holmes, Ph.D., Executive Director,<br />
Chemistry, Affymax, Inc.<br />
12:15<br />
Axel Ståhlbom, Ph.D., Assessor Biotech, Department of<br />
Biotechnology and Pharmacy, Medical Products Agency<br />
Aleksander Swietlow, Ph.D., Principal Scientist,<br />
Amgen Inc.<br />
12:15 Spotlight Presentation (Room 302)<br />
Sponsored by<br />
10 TIDES® Conference & Exhibition<br />
Sponsored by<br />
Advancements in <strong>the</strong> Bioanalyisis of Oligonucleotide Therapeutics:<br />
The Right Method for <strong>the</strong> Right Purpose<br />
Laixin Wang, Ph.D., Method Development Group Leader, Utah Facility, Tandem Labs<br />
11:45 11:45 Spotlight Presentation (Room 302)<br />
Sponsored by<br />
Advances and Applications of Blockmer Technology: Syn<strong>the</strong>sis of NUAAP siRNA Using<br />
Six Dimer Phosphoramidites<br />
Kyeong Eun Jung, Ph.D., Director, Oligo Division, ST Pharm Co. Ltd. (former Samchully Pharm), Korea<br />
Selected Innovations in Peptide-based Therapeutics in <strong>the</strong> 500-5000 Da Gap<br />
Richard Pariza, Ph.D., President, C-NOF Pharmaceuticals, Inc.<br />
12:45 Networking Luncheon in Poster and Exhibit Hall
Oligonucleotide<br />
Therapeutics Discovery<br />
Peptide Discovery<br />
and Development<br />
Nucleic Acids Technologies<br />
for Molecular Diagnostics<br />
Room 311 Room 309 Room 310<br />
7:15 Registration and Coffee (Prefunction Hall D)<br />
8:15 Chairman’s Remarks<br />
Erich Koller, Ph.D., Assistant Director Core<br />
Research, Isis Pharmaceuticals, Inc.<br />
Single Stranded RNAs as<br />
Novel Active Compounds<br />
8:30 Chemically Modified Single Stranded RNA<br />
Activates RNA Interference in Animals<br />
Thazha P. Prakash, Ph.D., Senior Research Fellow,<br />
Isis Pharmaceuticals<br />
9:00 Targeting Long Non-coding RNA Interactions<br />
with PRC2 to Activate Single Gene Expression<br />
James Barsoum, Ph.D., Chief Scientific Officer,<br />
RaNA Therapeutics<br />
Tuesday, May 14, 2013 • Main Conference<br />
Chairman’s Remarks<br />
Tomi K. Sawyer, Ph.D., Chief Scientific Officer and<br />
Senior Vice President, Aileron Therapeutics Inc.<br />
Novel Syn<strong>the</strong>tic Approaches to<br />
Modify Peptides and Improve<br />
Drug-like Properties<br />
Chemoselective Approaches for Protein<br />
Syn<strong>the</strong>sis and Bioconjugation<br />
Philip Dawson, Ph.D., Associate Professor,<br />
Department of Chemistry and Associate Dean of<br />
Graduate Studies, The Scripps Research Institute<br />
Clicking into Peptide Staples via a<br />
Chemoselective Cysteine Arylation<br />
Brad L. Pentelute, Ph.D., Assistant Professor of<br />
Chemistry, Massachusetts Institute of Technology<br />
(8:25) Chairwoman’s Remarks<br />
B. Melina Cimler, Ph.D., Vice President, Quality and<br />
Regulatory, Illumina, Inc.<br />
Regulatory, Manufacturing<br />
and Business Considerations<br />
Keynote Presentation:<br />
Industry Perspective on Evolving Regulatory<br />
Environment for IVDs<br />
Karen S. Long, Division Vice President, Medical,<br />
Regulatory and Clinical Affairs, Abbott Molecular, Inc.<br />
Patenting Genes: A Review of Myriad in <strong>the</strong><br />
Shadow of Prome<strong>the</strong>us<br />
Peter G. Carroll, Ph.D., J.D., Founding Partner,<br />
Medlen and Carroll<br />
Novel Chemistries and<br />
PK/PD Modulation<br />
9:30 Automated Parallel Solid-phase Syn<strong>the</strong>sis<br />
of 5’-triphosphate and 5’-diphosphate<br />
Oligonucleotides – Useful Tools for<br />
Therapeutics and Diagnostics Applications<br />
Ivan Zlatev, Ph.D., Scientist, Ontorii Inc. (This<br />
presentation will be based on work performed at Alnylam Pharmaceuticals)<br />
Oligonucleotide Delivery:<br />
Mechanisms and Emerging Strategies<br />
10:00 Physical Characterization of Lipid<br />
Nanoparticles for Efficient Delivery of Dicer<br />
Substrate siRNAs to Tumors<br />
Bob D. Brown, Ph.D., Chief Scientific Officer<br />
and Senior Vice President, Research,<br />
Dicerna Pharmaceuticals<br />
Structure-based Design of<br />
Novel Peptides<br />
Interfering Peptides Targeting<br />
Protein-protein Interactions<br />
Katja Arndt, Ph.D., Professor of Molecular<br />
Biotechnology, Institute for Biochemistry and<br />
Biology, University of Potsdam, Germany<br />
The Design of Cell-penetrating Peptides with<br />
Intrinsic Biological Activity<br />
Francesca Milletti, Ph.D., Head, Cheminformatics<br />
and Statistics, Hoffmann-La Roche<br />
Development and Validation of an<br />
Automated NGS LDT for Determining<br />
HIV Coreceptor Status<br />
A.J. Chmura, Ph.D., Staff Scientist,<br />
Siemens Healthcare Diagnostics<br />
Audience Interactive<br />
Panel Discussion<br />
Regulatory Support of Innovation:<br />
Navigating FDA’s Pathways while<br />
Developing Novel Technologies<br />
Moderator:<br />
B. Melina Cimler, Ph.D., Vice President, Quality and<br />
Regulatory Affairs, Illumina, Inc.<br />
Panelists: All morning speakers<br />
10:30 Networking Refreshment Break in Poster and Exhibit Hall<br />
Oligonucleotide Delivery:<br />
Mechanisms and Emerging<br />
Strategies (continued)<br />
11:15 Delivering on <strong>the</strong> Promise of Therapeutic<br />
Oligos: An ADME Perspective<br />
Steve Hood, Ph.D., Director, GSK Oligonucleotide<br />
Delivery (GOLD) Team, GlaxoSmithKline,<br />
United Kingdom<br />
11:45 Mechanisms of Single-stranded<br />
Phosphorothioate Modified<br />
Antisense Oligonucleotide<br />
Accumulation in Hepatocytes<br />
Erich Koller, Ph.D., Assistant Director Core<br />
Research, Isis Pharmaceuticals, Inc.<br />
12:15 RNAi Therapeutics as Personalized Medicine for<br />
<strong>the</strong> Treatment of Hepatocellular Carcinoma<br />
Mary Prieve, Ph.D., Director of Biology, PhaseRx, Inc.<br />
Structure-based Design of<br />
Novel Peptides<br />
(continued)<br />
Structure-based Discovery of ATSP-7041, a<br />
Dual MDM2 and MDMX Targeting Stapled<br />
α-Helical Peptide Exhibiting Potency In Vitro<br />
and In Vivo Efficacy in Xenograft Models of<br />
Human Cancer<br />
Vincent Guerlavais, Ph.D., Senior Principal Scientist,<br />
Aileron Therapeutics, Inc.<br />
Identification of Cell-permeable Peptides<br />
Targeting <strong>the</strong> Wnt-pathway – Functional<br />
Characterization and Activity In Vivo<br />
Hanjo Hennemann, Ph.D., Chief Scientific Officer,<br />
Nexigen GmbH, Germany<br />
The Alphabody: At <strong>the</strong> Crossroads of<br />
Constrained Peptides and Small Proteins<br />
Ignace Lasters, Ph.D., Chief Scientific Officer,<br />
Complix NV, Belgium<br />
Strategy Discussion Forum<br />
(Room 313)<br />
Specifications for Oligonucleotide and Peptide<br />
Active Pharmaceutical Ingredients<br />
Moderator:<br />
Daniel C. Capaldi, Ph.D., Vice President, Analytical<br />
and Process Development, Isis Pharmaceuticals, Inc.<br />
Panelists:<br />
Doug Brooks, Ph.D., Executive Director, Chemistry,<br />
Regado Biosciences<br />
Christopher P. Holmes, Ph.D., Executive Director,<br />
Chemistry, Affymax, Inc.<br />
Axel Ståhlbom, Ph.D., Assessor Biotech,<br />
Department of Biotechnology and Pharmacy,<br />
Medical Products Agency<br />
Aleksander Swietlow, Ph.D., Principal Scientist,<br />
Amgen Inc.<br />
12:45 Networking Luncheon in Poster and Exhibit Hall<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/TIDES 11
Tuesday, May 14, 2013 • Main Conference<br />
Oligonucleotide and Peptide Manufacturing, Technology and Product Development<br />
Room 302 Room 304<br />
1:55 Chairman’s Remarks<br />
Edward Huber, Ph.D., Director, Quality Control and Analytical Development,<br />
Avecia<br />
CMC and Analytical Challenges and Solutions –<br />
Oligonucleotide Case Studies<br />
2:00 Rapid 2-D UHPLC for In-process Control of<br />
Oligonucleotide Impurities<br />
Todd B. Kreutzian, Director, Analytical Development, Agilent Technologies, Inc.<br />
Chairman’s Remarks<br />
Brian Gregg, MBA, General Manager, Bachem Americas, Inc.<br />
CMC Challenges and Solutions –<br />
Peptide Case Studies and Strategies<br />
Session Sponsored by<br />
Featured Presentation:<br />
Regulatory Considerations for Peptide Cancer Vaccines<br />
Michail A. Alterman, Ph.D., Senior Investigator, Tumor Vaccines and<br />
Biotechnology Branch, Division of Cellular and Gene Therapies, Center for<br />
Biologics Evaluation and Research, US FDA<br />
2:30 Active Statistical Process Control of <strong>the</strong> AV7909<br />
Production Process<br />
Richard W. Welch, Ph.D., Vice President, Process and Analytical Development,<br />
BioDefense Division, Emergent BioSolutions<br />
BLP25 – A MUC1 Peptide Used in Development of an<br />
Immuno<strong>the</strong>rapy for Non-Small Cell Lung Cancer<br />
Christian Schröter, Ph.D., Site Director, EMD Serono, a Division of EMD Inc.,<br />
Canada<br />
3:00 Advantages and Disadvantages Related to Use of Quantitative<br />
LC/MS Methods for Routine QC Testing<br />
Edward Huber, Ph.D., Director, Quality Control and Analytical Development,<br />
Avecia<br />
Syn<strong>the</strong>tic Manufacturing of Glucagon<br />
Thomas Meier, Ph.D., Vice President, Production, Bachem AG, Switzerland<br />
3:30 Networking Refreshment Break in Poster and Exhibit Hall<br />
Strategy Discussion Forum<br />
(Room 308)<br />
4:15 Manufacturing: What Scale, When?<br />
Moderator:<br />
Rodney Lax, Ph.D., Senior Director, Business<br />
Development, PolyPeptide Group (Torrance)<br />
4:15 Spotlight Presentation (Room 302)<br />
Sponsored by<br />
Panelists:<br />
HybCPG- A New Solid Phase<br />
Oligosyn<strong>the</strong>sis Support<br />
Angelika Fretzen, Ph.D., Vice President,<br />
Marc Rothstein, President, Prime Syn<strong>the</strong>sis, Inc.<br />
Pharmaceutical Chemistry and Development,<br />
Suresh C. Srivastava, Ph.D., President,<br />
Ironwood Pharmaceuticals, Inc.<br />
ChemGenes Corp.<br />
4:45<br />
Paul McCormac, Ph.D., Director, Biomanufacturing<br />
<strong>Sciences</strong> Group, Pfizer Global Supply<br />
Christian Schröter, Ph.D., Site Director,<br />
EMD Serono, a Division of EMD Inc., Canada<br />
4:45 Spotlight Presentation (Room 302)<br />
Sponsored by<br />
Bringing Light into <strong>the</strong> Black Box of in vitro<br />
Brant Zell, Vice President and Global Director, Selection Experiments: Early and Improved<br />
Quality, PolyPeptide Group<br />
Identification of Ligands by in silico Analysis<br />
Kevin Fettes, Ph.D., Director, Manufacturing and of Next-Generation Sequencing Data<br />
CMC, Galena Biopharma<br />
Michael Blank, Ph.D., Chief Scientific Officer,<br />
aptaIT GmbH, Germany<br />
Emerging Technologies Showcase<br />
4:15 Unpublished Data Case Study (Room 304)<br />
Recent Developments in Liquid Phase Peptide<br />
Syn<strong>the</strong>sis: Application to Large Scale Production<br />
El Djouhar Rekaï, Upstream Process Group Leader,<br />
Operations, Lonza, Belgium<br />
4:45 Spotlight Presentation (Room 304)<br />
Sponsored by<br />
Molecular Hiving Technology: New LPPS<br />
Technology TM for cGMP Manufacturing<br />
Barry O’Connor, Ph.D., R&D Group, Iwate Research<br />
& Development Center, Pharmaceuticals & Fine<br />
Chemicals Division, Pharma & Research Business,<br />
Sekisui, Japan<br />
5:15 Networking, Wine and Cheese Reception in Poster and Exhibit Hall Sponsored by<br />
Dedicated Poster Viewing – Poster presenters will be at <strong>the</strong>ir posters to discuss results with you.<br />
12 TIDES® Conference & Exhibition
Oligonucleotide<br />
Therapeutics Discovery<br />
Tuesday, May 14, 2013 • Main Conference<br />
Peptide Discovery<br />
and Development<br />
Nucleic Acids Technologies<br />
for Molecular Diagnostics<br />
Room 311 Room 309 Room 310<br />
1:55 Chairman’s Remarks<br />
Martin Maier, Ph.D., Senior Director, RNA<br />
Syn<strong>the</strong>sis, Alnylam Pharmaceuticals<br />
Technologies for Cell and Tissue<br />
Targeting or Improved Delivery<br />
(continued)<br />
2:00 Lipid Nanoparticle siRNA Systems:<br />
Gene Silencing in Non-liver Tissues<br />
Pieter R. Cullis, Professor and Director,<br />
Nanomedicines Research Group, Department of<br />
Biochemistry and Molecular Biology, University of<br />
British Columbia, Canada<br />
2:30 Combinatorial Development of<br />
Syn<strong>the</strong>tic siRNA Delivery Systems<br />
Daniel G. Anderson, Ph.D., Associate Professor<br />
Chemical Engineering, Koch Institute,<br />
Massachusetts Institute of Technology<br />
3:00 Development of DPC Technology for<br />
Therapeutic siRNA Delivery<br />
David Lewis, Ph.D., Vice President, Biology,<br />
Arrowhead Research Corporation<br />
Chairman’s Remarks<br />
Tomi K. Sawyer, Ph.D., Chief Scientific Officer and<br />
Senior Vice President, Aileron Therapeutics Inc.<br />
Molecular Diversity and<br />
Novel Peptide Macrocycles<br />
Plant-based Production of Orally Active<br />
Macrocyclic Peptides<br />
David Craik, Ph.D., Professor of Biomolecular<br />
Structure, Institute for Molecular Bioscience<br />
University of Queensland, Australia<br />
New Strategies for Peptide Macrocyclization<br />
Andrei Yudin, Ph.D., Founder, Encycle Therapeutics<br />
and Professor of Chemistry, University of Toronto,<br />
Canada<br />
Macrocycles for Drug Discovery –<br />
Identification of Small Molecule Syn<strong>the</strong>tic<br />
Macrocycle Antagonists of Human IL17A<br />
Nick Terrett, PhD., Chief Scientific Officer,<br />
Ensemble Therapeutics Corp.<br />
3:30 Networking Refreshment Break in Poster and Exhibit Hall<br />
Panel Discussion<br />
4:15 What Does it Take to Bring an<br />
Oligonucleotide to Market?<br />
Moderator:<br />
Arthur A. Levin, Ph.D., Executive Vice President,<br />
R&D, Miragen Therapeutics<br />
Panelists:<br />
Ian MacLachlan, Ph.D., Executive Vice President<br />
and Chief Scientific Officer,<br />
Tekmira Pharmaceuticals Corp.<br />
Rachel Meyers, Ph.D., Vice President Research and<br />
RNAi Lead Development, Alnylam Pharmaceuticals<br />
Hans-Peter Vornlocher, Ph.D., Managing Director<br />
Research, Axolabs GmbH, Germany<br />
Molecular Diversity and Novel<br />
Peptide Macrocycles (continued)<br />
Bi-cyclic Peptides to Target Protein-protein<br />
Interactions<br />
Christophe Bonny, Ph.D., Chief Scientific Officer,<br />
Bicycle Therapeutics, United Kingdom<br />
Panel Discussion<br />
4:45 Emerging Strategies for Novel Peptide<br />
Drug Discovery<br />
Moderator:<br />
Tomi K. Sawyer, Ph.D., Chief Scientific Officer and<br />
Senior Vice President, Aileron Therapeutics Inc.<br />
Panelists:<br />
David Craik, Ph.D., Professor of Biomolecular<br />
Structure, Institute for Molecular Bioscience,<br />
University of Queensland, Australia<br />
Hanjo Hennemann, Ph.D., Chief Scientific Officer,<br />
Nexigen GmbH, Germany<br />
Francesca Milletti, Ph.D., Head, Cheminformatics<br />
and Statistics, Hoffmann-La Roche<br />
Nick Terrett, Ph.D., Chief Scientific Officer,<br />
Ensemble Therapeutics Corp.<br />
5:15 Networking, Wine and Cheese Reception in Poster and Exhibit Hall Sponsored by<br />
Dedicated Poster Viewing – Poster presenters will be at <strong>the</strong>ir posters to discuss results with you.<br />
Chairman’s Remarks<br />
Thomas Battersby, Ph.D., Senior Manager,<br />
Siemens Healthcare Diagnostics<br />
New Technologies<br />
Unpublished Data Single Molecule<br />
Electronic DNA Sequencing by Syn<strong>the</strong>sis<br />
Jingyue Ju, Ph.D., Samuel Ruben-Peter G. Viele<br />
Professor of Engineering Professor of Pharmacology<br />
and Chemical Engineering; Director, Center for<br />
Genome Technology and Biomolecular Engineering,<br />
Columbia University<br />
Sensitive Detection and Profiling of Cancer<br />
Cells Using Oligonucleotide-barcode Magnetic<br />
Nanoparticles and microNMR Sensors<br />
Hakho Lee, Ph.D., Assistant Professor,<br />
Biomedical Engineering, Center for Systems Biology,<br />
Harvard Medical School<br />
Unpublished Data Novel High-Affinity DNA<br />
Aptamers by in vitro Selection Using an<br />
Unnatural Base Pair System<br />
Ichiro Hirao, Ph.D., Team Leader/CEO,<br />
RIKEN / TagCyx Biotechnologies, Japan<br />
Audience Interactive<br />
Panel Discussion<br />
The Oligo Supply Chain for Diagnostics -<br />
Raw Materials for Oligo Syn<strong>the</strong>sis –<br />
Selecting <strong>the</strong> Right Fluorophore/Reporter<br />
Pair and Chemistry<br />
Moderator:<br />
Dick Keys, Ph.D., President, Advanced Biotectonics<br />
Consulting<br />
Panelists:<br />
Jessica Alexander, VP Specialty Manufacturing,<br />
Integrated DNA Technologies<br />
Chad Gerber, Director, GMP Manufacturing and<br />
Commercial Services, Biosearch Technologies, Inc.<br />
Andrei Laikhter, Ph.D., Chief Scientific Officer,<br />
ChemGenes Corporation<br />
Ca<strong>the</strong>rine McKeen, Ph.D., Technical Manager,<br />
Link Technologies Ltd., United Kingdom<br />
Premier Publication:<br />
Media Partners:<br />
Event Partner:<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/TIDES 13
Wednesday, May 15, 2013 • Main Conference<br />
Oligonucleotide and Peptide Manufacturing, Technology and Product Development<br />
7:30 Coffee (Prefunction Hall D)<br />
8:00 Featured Presentation (Room 311): Unpublished Data Tackling RNAi Delivery with Bioreversible PhosphoTriester siRNN Prodrugs<br />
Steven F. Dowdy, Ph.D., UCSD School of Medicine<br />
8:25 Chairman’s Remarks<br />
John DeMattei, Ph.D., Director of Chemical Development, Nucleic Acid Solutions<br />
Division, Agilent Technologies, Inc.<br />
Strategies for Oligonucleotide<br />
Process Design and Optimization (Room 302)<br />
8:30 Design Space Understanding to Lock Process for a Late Phase<br />
RNA Molecule<br />
Satya Kuchimanchi, Ph.D., Associate Director, RNAi Lead Development,<br />
Alnylam Pharmaceuticals, Inc.<br />
Chairman’s Remarks<br />
Lubomir V. Nechev, Ph.D., Vice President, Process Chemistry,<br />
Alnylam Pharmaceuticals, Inc.<br />
Conjugated Oligonucleotide<br />
and Peptide Therapeutics (Room 304)<br />
Understanding <strong>the</strong> Objectives: Why Do We Conjugate?<br />
Rory F. Finn, Principal Scientist, Bioprocess R&D, Bio<strong>the</strong>rapeutics<br />
Pharmaceutical <strong>Sciences</strong>, Pfizer Inc.<br />
9:00 Spotlight Presentation<br />
Sponsored by<br />
QbD: Building Quality into Oligo Processes at <strong>the</strong> Early<br />
Development Stage<br />
John DeMattei, Ph.D., Director of Chemical Development, Nucleic Acid Solutions<br />
Division, Agilent Technologies, Inc.<br />
9:30<br />
Unpublished Data Case Study<br />
Manufacturing Scale-Up Considerations for <strong>the</strong> REG1 System<br />
Doug Brooks, Ph.D., Executive Director Chemistry, Regado Biosciences<br />
Peptide Conjugation: A Novel Platform for Intracellular Delivery<br />
Paolo Botti, CEO and CSO, ArisGen, Switzerland<br />
Developing Process for Manufacture of GalNAc<br />
Conjugated Oligonucleotides<br />
Ligang Zhang, Principal Scientist, Process Chemistry, Alnylam Pharmaceuticals<br />
10:00 OligoFrag 1.0 - A Software for Rapid Impurity Profiling – Enabling<br />
Faster Process Development and Understanding<br />
Susann Rosmus, Ph.D., Head of Quality Management, BioSpring GmbH,<br />
Germany<br />
10:30 Networking Refreshment Break in Poster and Exhibit Hall<br />
11:15<br />
Spotlight Presentations<br />
Sponsored by (11:15-11:45)<br />
Development of Scalable Processes for Lipid Nano-particulates<br />
at OctoPlus (Room 302)<br />
Gert-Jan Ottjes, Senior Engineer Formulation and Process Development,<br />
OctoPlus N.V., The Ne<strong>the</strong>rlands<br />
Unpublished Data Co-injection of a Targeted, Reversibly Masked<br />
Endosomolytic Polymer Dramatically Improves <strong>the</strong> Efficacy of<br />
Small Interfering<br />
RNA-Conjugates In Vivo<br />
David B. Rozema, Ph.D., Vice President, Chemistry,<br />
Arrowhead Research Corporation<br />
Strategy Discussion Forum<br />
Conjugation: Extending <strong>the</strong> Therapeutic Potential<br />
of Oligonucleotides and Peptides (Room 308)<br />
Moderators:<br />
Rory F. Finn, Principal Scientist, Bioprocess R&D, Bio<strong>the</strong>rapeutics<br />
Pharmaceutical <strong>Sciences</strong>, Pfizer Inc.<br />
Lubomir V. Nechev, Ph.D., Vice President, Process Chemistry,<br />
Alnylam Pharmaceuticals, Inc.<br />
Panelists:<br />
Christopher P. Holmes, Ph.D., Executive Director, Chemistry, Affymax, Inc.<br />
Martin Maier, Ph.D., Senior Director, RNA Syn<strong>the</strong>sis, Alnylam Pharmaceuticals<br />
Muthiah (Mano) Manoharan, Ph.D., Senior Vice President, Drug Discovery,<br />
Alnylam Pharmaceuticals<br />
12:45 Networking Luncheon in Poster and Exhibit Hall<br />
14 TIDES® Conference & Exhibition
Oligonucleotide<br />
Therapeutics Discovery<br />
Peptide Discovery<br />
and Development<br />
Nucleic Acids Technologies<br />
for Molecular Diagnostics<br />
Room 311 Room 309 Room 310<br />
7:30 Coffee (Prefunction Hall D)<br />
8:00 Featured Presentation (Room 311): Unpublished Data Tackling RNAi Delivery with Bioreversible PhosphoTriester siRNN Prodrugs<br />
Steven F. Dowdy, Ph.D., UCSD School of Medicine<br />
8:25 Chairman’s Remarks<br />
Troels Koch, Ph.D., Vice President, Research and<br />
CTO, Santaris Pharma A/S, Denmark<br />
Discovery and<br />
Preclinical Strategies<br />
8:30 Novel Chemical Modifications for siRNAs<br />
Martin Maier, Ph.D., Senior Director, RNA<br />
Syn<strong>the</strong>sis, Alnylam Pharmaceuticals<br />
9:00 Efficacy, PK and Tox Data Supporting <strong>the</strong><br />
Move to IND for Mirna Therapeutics<br />
David Brown, Ph.D., Director of Discovery,<br />
Mirna Therapeutics<br />
9:30 Nucleic Acid Polymers and Their Application<br />
in Hepatitis B Infection (HBV): Efficacy<br />
and Safety<br />
Andrew Vaillant, Ph.D., Vice President and Chief<br />
Scientific Officer, REPLICor Inc., Canada<br />
10:00 Therapeutic Opportunities for Interferon<br />
Regulatory Factor 5 (IRF5) Antisense<br />
Inhibitors in Systemic Lupus<br />
Ery<strong>the</strong>matosus (SLE)<br />
Alexey Revenko, Ph.D., Senior Scientist,<br />
Isis Pharmaceuticals<br />
Wednesday, May 15, 2013 • Main Conference<br />
Chairman’s Remarks<br />
Jesse Z. Dong, Ph.D., Vice President,<br />
Compound Discovery, IPSEN<br />
Intracellular Delivery of Peptides<br />
Intracellular Delivery of Peptides – An<br />
Overview from <strong>the</strong> Perspectives of Pharma<br />
Thomas Vorherr Ph.D., Director Peptide Discovery,<br />
Novartis Pharma AG, Switzerland<br />
(9:10) Cellular Peptide Delivery – Exploration<br />
of Structure Space<br />
Roland Brock, Ph.D., Head, Department of Biochemstry,<br />
Nijmegen Centre for Molecular <strong>Life</strong> <strong>Sciences</strong>, Radboud<br />
University Nijmegen Medical Centre, The Ne<strong>the</strong>rlands<br />
Preclinical Strategies to Exploit<br />
Novel Targets and Optimize<br />
Properties of Peptides<br />
(9:50) Exploiting Disulfide-rich Peptides in<br />
Drug Discovery<br />
Mark Smy<strong>the</strong>, Ph.D., Founder,<br />
Protagonist Therapeutics<br />
10:30 Networking Refreshment Break in Poster and Exhibit Hall<br />
MicroRNA for Diagnostics<br />
(8:55) Chairman’s Remarks<br />
Thomas Battersby, Ph.D., Senior Manager,<br />
Siemens Healthcare Diagnostics<br />
Unpublished Data Development and<br />
Characterization of a Rapid Pathogen<br />
Capture System for Direct Isolation of<br />
Microorganisms from Blood<br />
Sergey A. Dryga, Ph.D., MBA, Vice President,<br />
Immunochemistry, NanoMR, Inc.<br />
Automated microRNA Assays for Tissue-based<br />
Diagnostics<br />
Lorenzo F. Sempere, Ph.D., Research Assistant<br />
Professor of Medicine, Geisel School of Medicine<br />
at Dartmouth<br />
MicroRNA in Biofluids: Robust Biomarkers<br />
for Disease<br />
Peter Mouritzen, M.Sc., Ph.D., VP Research and<br />
Development, Exiqon A/S, Denmark<br />
11:15 Structure Activity Determinants of Locked<br />
Nucleic Acids: Platform, Discovery, Clinic<br />
Troels Koch, Ph.D., Vice President, Research and<br />
CTO, Santaris Pharma A/S, Denmark<br />
Phenotypic Screening of Phylomer Libraries<br />
to Discover and Validate Targets Using<br />
“Protein Interference”<br />
Paul Watt, Ph.D., Non-Executive Director,<br />
Phenomica; CEO, Phylogica, Australia<br />
Plasma microRNAs Serve as Biomarkers of<br />
Therapeutic Efficacy and Disease Progression<br />
in Hypertension-Induced Heart Failure<br />
Brent A. Dickinson, Research Scientist, Biology,<br />
miRagen Therapeutics, Inc.<br />
11:45 Intervening in Complex Disease Biology with<br />
microRNA Targeting Therapeutics<br />
William S. Marshall, Ph.D., President and Chief<br />
Executive Officer, miRagen Therapeutics<br />
12:15 Targeting microRNAs and Biological<br />
Networks: An Innovative Approach to<br />
Treat Disease<br />
Neil Gibson, Ph.D., Chief Scientific Officer,<br />
Regulus Therapeutics<br />
(11:50) Peptide Lead Optimization using<br />
Solid-phase Peptide Arrays<br />
Peter Timmerman, Ph.D., Chief Technology Officer,<br />
Pepscan Therapeutics, The Ne<strong>the</strong>rlands<br />
microRNA-Associated Progression Pathways<br />
and Potential Therapeutic Targets Identified<br />
by Integrated mRNA and microRNA<br />
Expression Profiling in Breast Cancer<br />
Ioannis (Jiannis) Ragoussis, Ph.D., Head of<br />
Genome <strong>Sciences</strong>, Associate Professor in Human<br />
Genetics, McGill University and Génome Québec<br />
Innovation Centre, Canada<br />
Circulating miRNA Biomarkers:<br />
An Industrial Perspective<br />
Pavan Kumar, Ph.D., Senior Scientist, Biomarkers<br />
and Personalized Medicine, Eisai Inc.<br />
12:45 Networking Luncheon in Poster and Exhibit Hall<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/TIDES 15
Oligonucleotide and Peptide<br />
Manufacturing, Technology<br />
and Product Development<br />
Oligonucleotide<br />
Therapeutics Discovery<br />
Peptide Discovery<br />
and Development<br />
Room 302 Room 311 Room 309<br />
1:55 Chairman’s Remarks: Overcoming<br />
Challenges in Formulation and Delivery<br />
Ved Srivastava, Ph.D., Head, Peptide Chemistry,<br />
GlaxoSmithKline<br />
Wednesday, May 15, 2013 • Main Conference<br />
Chairman’s Remarks<br />
Bo Rode Hansen, Vice President, Santaris Pharma<br />
A/S, Denmark<br />
Chairman’s Remarks<br />
Thomas Vorherr Ph.D., Director Peptide Discovery,<br />
Novartis Pharma AG, Switzerland<br />
Formulation and Delivery<br />
Clinical Progress of<br />
Oligonucleotide Therapeutics<br />
Peptides in Early Development and<br />
New Frontiers in Peptide R&D<br />
2:15<br />
2:45<br />
Unpublished Data<br />
Techniques for Assessing Aggregation of<br />
Peptides and Nucleic Acids<br />
John Philo, Ph.D., Vice President,<br />
Alliance Protein Laboratories, Inc.<br />
Unpublished Data Case Study Prospects in<br />
Developing Injectable Peptide Drug Products<br />
Farooq Z. Qureshi, Ph.D., Senior Principal Scientist,<br />
Research Leader, Pharmaceutical and Analytical<br />
R&D, Hoffmann-La Roche Inc.<br />
Update on Alnylam Clinical Programs<br />
Akshay Vaishnaw, M.D., Ph.D.,<br />
Executive Vice President, Chief Medical Officer,<br />
Alnylam Pharmaceuticals<br />
Inhibition of Toll-like Receptors as a Strategy<br />
for Treating Autoimmune Diseases<br />
Sudhir Agrawal, CEO, Idera Pharmaceuticals, Inc.<br />
3:15 Networking Refreshment Break (Level 3 Boylston Hallway)<br />
First Non-hormonal Therapeutic Candidate<br />
for Endometriosis<br />
Vinay K. Singh, Ph.D., Assistant Professor,<br />
Department of Biomedical and Molecular <strong>Sciences</strong>,<br />
Queen’s University, Canada<br />
ShK-186 from Discovery to<br />
Clinical Development<br />
Michael Pennington, Ph.D., President and COO,<br />
Peptides International<br />
3:45<br />
Unpublished Data Case Study Update on<br />
State of <strong>the</strong> Art: Lipid-Based Delivery for<br />
Oligonucleotide-Based Therapeutics<br />
Ian MacLachlan, Ph.D., Executive Vice President and<br />
Chief Scientific Officer, Tekmira Pharmaceuticals<br />
Corp., Canada<br />
Clinical Development of RXI-109 to<br />
Reduce Dermal Scarring<br />
Pamela Pavco, Ph.D., Chief Development Officer,<br />
RXi Pharmaceuticals<br />
From Discovery to <strong>the</strong> Clinic:<br />
Applications of Protein Epitope Mimetics<br />
Daniel Obrecht, Ph.D., Chief Scientific Officer,<br />
Polyphor, Switzerland<br />
4:15<br />
Unpublished Data Case Study<br />
Scale-up of Lipid-based Delivery Systems for<br />
Oligonucleotides<br />
Violetta Akopian, Ph.D., Director, Quality<br />
Management, Nitto Denko Technical Corp.<br />
First Clinical Phase IIa Data of <strong>the</strong> Mirror-<br />
Image RNA Oligonucleotide NOX-A12<br />
Sven Klussmann, Ph.D., Chief Scientific Officer,<br />
NOXXON Pharma AG, Germany<br />
Accurate In Vivo Cancer Identification Using<br />
Protease-triggered Fluorescent Peptides<br />
Jesus “Tito” Gonzalez, Ph.D., Chief Scientific<br />
Officer, Avelas Biosciences<br />
4:45<br />
Unpublished Data<br />
Peptide Delivery: What’s <strong>the</strong> Present Status<br />
and What Does <strong>the</strong> Future Hold?<br />
Joel Richard, Ph.D., Vice President, Peptides CMC<br />
and Engineering, Ipsen, France<br />
A Syn<strong>the</strong>tic, Chemically Modified siRNA<br />
Targeting Caspase-2 as a Therapeutic Agent<br />
for Ocular Neuroprotection<br />
Elena Feinstein, M.D., Ph.D., Chief Scientific<br />
Officer, Quark Pharmaceuticals, Israel<br />
Peptides for Diagnostic Imaging<br />
and Targeted Radionuclide Therapy:<br />
A Theranostic Approach<br />
Ulrich Reineke, Ph.D., CEO and Co-Founder,<br />
3B Pharmaceuticals, Germany<br />
5:15 Close of TIDES Safety, Pharmacokinetics and<br />
Pharmacodynamics of PNT2258<br />
(An anti-BCL2 DNA Targeted Drug) in<br />
Patients with Advanced Solid Tumors<br />
Wendi V. Rodrigueza, Ph.D., CSO and VP,<br />
Product Development, ProNAi Therapeutics, Inc.<br />
5:45 Close of TIDES<br />
Close of TIDES<br />
Private Meeting Rooms/Receptions (by invitation only)<br />
Peptisyntha ...................................Room 201<br />
Senn Chemicals Private Reception .............Room 202<br />
Thermo Scientific. .............................Room 203<br />
Cepia Sanofi. ..................................Room 204<br />
ChemGenes ...................................Room 205<br />
Agilent Technologies Inc. ................ Rooms 206, 301<br />
Avecia. ........................................Room 209<br />
SAFC ..........................................Room 307<br />
Bachem’s Private<br />
Reception .....Independence Ballroom 2F, Sheraton Hotel<br />
16 TIDES® Conference & Exhibition
See You Next Year!<br />
May 12-15, 2014<br />
Rhode Island Convention Center • Providence, RI<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/TIDES 17
Meeting and Exhibit Room Map<br />
2nd Level<br />
Exhibit<br />
Hall D<br />
Conference and Exhibit Registration<br />
Session Rooms<br />
207 208 209 210<br />
201 202 203 204 205 W<br />
M 206<br />
Courses/Private Meeting Rooms/Receptions<br />
Boylston Hallway<br />
3rd Level<br />
302 304 306 309<br />
Oligonucleotide<br />
Manufacturing, Technology<br />
and Product Development<br />
Peptide Manufacturing,<br />
Technology and<br />
Product Development<br />
Session Rooms<br />
Peptide<br />
Discovery and<br />
Development<br />
310 311<br />
Nucleic Acids<br />
Technologies for<br />
Molecular<br />
Diagnostics<br />
Oligonucleotide<br />
Therapeutics Discovery<br />
312<br />
301 303 305 307<br />
308 313<br />
Strategy<br />
Discussion<br />
Forums<br />
W<br />
M<br />
Strategy<br />
Discussion<br />
Forums<br />
Private Meeting Rooms/Receptions<br />
Boylston Hallway<br />
18 TIDES® Conference & Exhibition
Poster and Exhibit Hall Hours<br />
Monday, May 13 • 3:15 pm - 6:45 pm<br />
Tuesday, May 14 •10:30 am - 6:15 pm<br />
Wednesday, May 15 • 10:30 am - 2:00 pm<br />
Exhibit Hall<br />
O : Oligo-Focused<br />
P : Peptide-Focused<br />
D : Diagnostics-Focused<br />
AAPPTEC LLC ...................... 109 P<br />
Advanced ChemTech<br />
(A Division of CreoSalus) ........... 526 P<br />
Agilent Technologies, Inc............. 314 O<br />
AIC/Tedia .......................... 330 O<br />
Ajinomoto Co., Inc. ................. 221 P<br />
Almac.............................. 226 P<br />
AmbioPharm ....................... 429 P<br />
American Peptide Company, Inc. . . . 325 P<br />
Asahi Kasei Bio Process .............. 409 O P<br />
Avecia ............................. 214 O<br />
Bachem............................ 326 P<br />
BCN Peptides........................ 520 P<br />
Berry & Associates.................. 426 O<br />
Bioautomation Inc. .................. 406 O<br />
BiOptix............................. 228 O D<br />
Biosearch Technologies. ............. 206 O D<br />
BioSpring GmbH .................... 421 O<br />
Biotage ............................ 508 P<br />
Biotechlogic, Inc. ................... 229 O<br />
Boston Open Labs ................. 514 O P<br />
Buchiglas USA Corp ................ 119 O P<br />
Carbosynth ........................ 430 P D<br />
CBL Bio Pharma .................... 510 P<br />
CEM Corporation ................... 230 P<br />
CEPIA Sanofi ....................... 105 O P<br />
ChemGenes........................ 220 O D<br />
Corden Pharma International ...... 205 P<br />
CPC Scientific Inc................... 210 P<br />
CS Bio Co........................... 306 P<br />
Exiqon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 O<br />
GE Healthcare <strong>Life</strong> <strong>Sciences</strong> ........ 519 O<br />
GeneDesign, Inc. ................... 110 O<br />
Glen Research...................... 407 O<br />
Grace Discovery <strong>Sciences</strong> .......... 525 P<br />
Honeywell Burdick & Jackson ...... 225 O<br />
Hongene Biotechnology Ltd........ 227 O<br />
Hybio Pharmaceutical............... 327 P<br />
Intavis, Inc. ......................... 513 O P<br />
Irvine Pharmaceutical Services, Inc . 505 O P D<br />
JenKem Technology................ 232 O P D<br />
Kinovate <strong>Life</strong> <strong>Sciences</strong>.............. 208 O<br />
Lonza .............................. 320 O P<br />
Mallinckrodt Pharmaceuticals ...... 213 O P<br />
Medimetrics ....................... 515 P D<br />
121<br />
119<br />
111<br />
109<br />
107<br />
105<br />
231<br />
229<br />
227<br />
225<br />
232<br />
230<br />
228<br />
226<br />
120<br />
221<br />
220<br />
219<br />
116<br />
114<br />
110<br />
108<br />
106<br />
329<br />
327<br />
325<br />
328<br />
326<br />
Entrance<br />
330 431<br />
429<br />
322<br />
320<br />
213 214 314<br />
209<br />
205<br />
210<br />
208<br />
206<br />
309<br />
305<br />
Metkinen Chemistry ............... 425 O<br />
NOF Corporation................... 432 O P D<br />
Novasep, Inc ....................... 209 P<br />
NSF Pharmalytica,<br />
Part of NSF Health <strong>Sciences</strong> ........ 114 O<br />
PCAS BioMatrix Inc. ................ 410 P<br />
Peptisyntha S.A..................... 329 P<br />
Phenomenex ...................... 405 O P D<br />
PolyPeptide Group ................. 305 P<br />
PPD................................ 111 O P D<br />
Prime Syn<strong>the</strong>sis, Inc. ............... 310 O<br />
Protein Technologies, Inc........... 427 O P<br />
PYRAMID Laboratories, inc.......... 524 O P<br />
310<br />
306<br />
427<br />
425<br />
421<br />
419<br />
409<br />
407<br />
405<br />
432<br />
430<br />
428<br />
426<br />
<strong>IBC</strong><br />
Show<br />
Mgt.<br />
527<br />
420 519<br />
416<br />
414<br />
410<br />
406<br />
525 526<br />
515<br />
513<br />
509<br />
507<br />
505<br />
524<br />
522<br />
520<br />
516<br />
514<br />
512<br />
510<br />
508<br />
Quanta BioDesign, Ltd.............. 509 P D<br />
SAFC............................... 309 O D<br />
Scino Pharm Taiwan, Ltd. ........... 328 P<br />
Sekisui ............................. 516 P<br />
Shanghai SoHo-Yiming<br />
Pharmaceuticals Co., Ltd............ 322 P<br />
Shengnuo Peptide ................. 120 P<br />
ST Pharm Co., Ltd. .................. 428 O<br />
Sussex Research Laboratory, Inc. ... 219 O P D<br />
Thermo Scientific ..............414, 416 O<br />
Tosoh Bioscience................... 420 O<br />
TriLink BioTechnologies, Inc......... 512 O<br />
Waters Corporation ................ 419 O P D<br />
20 TIDES® Conference & Exhibition
2013 Scientific Advisory Committees<br />
Oligonucleotide and Peptide Manufacturing, Technology and Product Development<br />
Kathryn L. Ackley, Ph.D., Senior Director<br />
Cincinnati Operations, Avecia<br />
Firoz Antia, Ph.D., CMC Team Director,<br />
Pharmaceutical Operations and Technology,<br />
Biogen Idec<br />
Mimoun Ayoub, Ph.D., Vice President,<br />
Global Business, Sales and Strategic Development,<br />
Peptisyntha, Member Of The Solvay Group,<br />
Belgium<br />
Neil H. Baine, Ph.D., Executive Director,<br />
Scinovo, Preclinical Development,<br />
GlaxoSmithKline Pharmaceuticals<br />
Doug Brooks, Ph.D., Executive Director,<br />
Chemistry, Regado Biosciences<br />
Bob D. Brown, Ph.D., Senior Vice President,<br />
Research, Dicerna Pharmaceuticals<br />
Uditha deAlwis, Senior Director,<br />
Analytical <strong>Sciences</strong>, Avecia<br />
Andrew Dibble, Ph.D., Director, Pharmaceutical<br />
Development, Isis Pharmaceuticals, Inc.<br />
Alex Fässler, Ph.D., President and COO, Bachem<br />
Americas Inc.<br />
Thomas Forman, Advisor Project Management,<br />
Project Management, Eli Lilly and Co.<br />
Mark Francis, MRSC, CChem, Csi, Director,<br />
Formulation Process and Analysis, UK,<br />
GlaxoSmithKline, United Kingdom<br />
Peter Hoffmann, Ph.D.<br />
Christopher P. Holmes, Ph.D., Executive Director,<br />
Chemistry, Affymax, Inc.<br />
Troels Koch, Ph.D., Vice President and CTO,<br />
Santaris Pharma A/S, Denmark<br />
Rodney Lax, Ph.D., Senior Director, Business<br />
Development, PolyPeptide Group (Torrance)<br />
Zhen Li, Ph.D., Director, Chemistry,<br />
Merck Research Laboratories<br />
David Litzinger, Ph.D., Director, Formulations<br />
Development, Allergan, Inc.<br />
Derek Maclean, Process Engineer, Amgen<br />
Bing Mao, Ph.D., Associate Director, Process<br />
Research, Merck & Co., Inc.<br />
John P. Mayer, Ph.D., Senior Research Scientist,<br />
Department of Chemistry, Indiana University<br />
Paul McCormac, Ph.D., Director,<br />
Biomanufacturing <strong>Sciences</strong> Group,<br />
Pfizer Global Supply<br />
Michael McGinley, Bioseparations Product<br />
Manager, Phenomenex<br />
Paul Metz, Senior Director, Manufacturing<br />
Operations, Agilent Technologies, Inc.<br />
Bruce H. Morimoto, Ph.D., Vice President,<br />
Drug Development, Allon Therapeutics Inc.,<br />
Canada<br />
Gary F. Musso, Ph.D., President,<br />
Musso and Associates LLC<br />
Lubomir V. Nechev, Ph.D., Vice President,<br />
Process Chemistry, Alnylam Pharmaceuticals, Inc.<br />
Rodney Parsons, Ph.D., Group Director,<br />
Chemical Development, Bristol-Myers Squibb<br />
El Djouhar Rekai, Ph.D., Upstream Group Leader,<br />
Lonza, Belgium<br />
Claus Rentel, Ph.D., Executive Director,<br />
Analytical Development Quality Control, Isis<br />
Pharmaceuticals<br />
Christopher A. Rhodes, Ph.D., President,<br />
Christopher A Rhodes & Associates LLC<br />
G. Susan Srivatsa, Ph.D., President, ElixinPharma<br />
James D. Thompson, Ph.D., Vice President,<br />
Pharmaceutical Development,<br />
Quark Pharmaceuticals, Inc.<br />
David Tumelty, Ph.D., Associate Director,<br />
Chemistry, BioTherapeutics R&D, Pfizer Inc.<br />
Fran Wincott, Ph.D., President,<br />
Wincott & Associates, LLC<br />
Oligonucleotide<br />
Therapeutics Discovery<br />
David Brown, Ph.D., Director of Discovery,<br />
Mirna Therapeutics<br />
Elena Feinstein, M.D., Ph.D., Chief Scientific<br />
Officer, Quark Pharmaceuticals, Inc., Israel<br />
Troels Koch, Ph.D., Vice President,<br />
Research and Chief Technology Officer,<br />
Santaris Pharma, Denmark<br />
Satya Kuchimanchi, Ph.D.,<br />
Associate Director, RNAi Lead Development,<br />
Alnylam Pharmaceuticals, Inc.<br />
Muthiah (Mano) Manoharan, Ph.D.,<br />
Senior Vice President, Drug Discovery,<br />
Alnylam Pharmaceuticals, Inc.<br />
Pamela Pavco, Ph.D., Chief Development<br />
Officer, RXi Pharmaceuticals<br />
Dmitry Samarsky, Ph.D.,<br />
Executive Vice President, Technology<br />
Development, Guangzhou RiboBio Co. Ltd,<br />
China<br />
Peptide Discovery and<br />
Development<br />
Jesse Z. Dong, Ph.D., Vice President,<br />
Compound Discovery, IPSEN<br />
Hanjo Hennemann, Ph.D., Chief Scientific<br />
Officer, Nexigen GmbH, Germany<br />
Derek Maclean, Ph.D., Director,<br />
Process Engineering, Amgen<br />
Tomi K. Sawyer, Ph.D.,<br />
Chief Scientific Officer and Senior Vice<br />
President, Aileron Therapeutics Inc.<br />
Peter Timmerman, Ph.D., Chief Technology<br />
Officer, Pepscan Therapeutics, The Ne<strong>the</strong>rlands<br />
David Tumelty, Ph.D., Associate Director<br />
Chemistry, BioTherapeutics R&D, CovX, Pfizer<br />
Thomas Vorherr, Ph.D., Director, Peptide<br />
Discovery, Novartis Pharma AG, Switzerland<br />
Paul Watt, Ph.D., CEO, Phylogica, Ltd,<br />
Australia<br />
Nucleic Acids Technologies<br />
for Molecular Diagnostics<br />
Thomas Battersby, Ph.D., Senior Manager,<br />
Siemens Healthcare Diagnostics<br />
B. Melina Cimler, Ph.D., Vice President,<br />
Quality and Regulatory, Illumina, Inc.<br />
Dick Keys, Ph.D., President,<br />
Advanced Biotectonics Consulting<br />
Michael McGinley, Bioseparations Product<br />
Manager, Phenomenex<br />
22 TIDES® Conference & Exhibition
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/TIDES 23
2013/2014 <strong>Life</strong> Science Events<br />
May 2013<br />
Cell Line Development & Engineering<br />
May 20-22, 2013<br />
Hyatt Regency La Jolla at Aventine • La Jolla, CA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/CellLine<br />
Medicaid Managed Care Congress<br />
May 20-22, 2013 • Baltimore Marriott Inner Harbor at<br />
Camden Yards • Baltimore, MD<br />
www.MMCCongress.com<br />
June 2013<br />
Single-Use Applications<br />
for Biopharmaceutical Manufacturing<br />
June 3-5, 2013 • Durham Convention Center • Durham, NC<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/SingleUse<br />
Vaccine Development<br />
& Production Summit<br />
June 3-5, 2013 • Durham Convention Center • Durham, NC<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/Vaccines<br />
Applications for Enzyme Technologies<br />
June 17-18, 2013<br />
Hotel Nikko San Francisco • San Francisco, CA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/Enzyme<br />
Bioprocess Training Academy<br />
June 12-13, 2013<br />
Le Méridien Cambridge-MIT • Cambridge, MA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/Courses<br />
Pharmaceutical Manufacturer’s<br />
Gross-to-Net Accounting Forum<br />
June 17-18, 2013 • Hyatt Harbor Side • Boston, MA<br />
www.grosstonetforum.com<br />
Oncology Management Summit<br />
June 17-18, 2013 • The Wit Hotel • Chicago, IL<br />
www.oncologymanagementsummit.com<br />
Next Generation<br />
Protein Therapeutics Summit<br />
June 26-28, 2013 • Hotel del Coronado • Coronado, CA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/ProteinSummit<br />
Bioconjugates: from Targets to<br />
Therapeutics<br />
June 26-28, 2013 • Hotel del Coronado • Coronado, CA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/Bioconjugates<br />
August 2013<br />
BioProcess International<br />
Conference & Exhibition CHINA<br />
August 20-21, 2013<br />
Grand Hyatt Shanghai • Shanghai, China<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/BPIChina<br />
September 2013<br />
Medicaid Drug Rebate Programs Summit<br />
September 9-11, 2013<br />
Chicago Marriott Downtown • Chicago, IL<br />
www.medicaiddrugrebates.com<br />
BioProcess International<br />
Conference & Exhibition<br />
September 16-19, 2013<br />
Hynes Convention Center • Boston, MA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/BPI<br />
Formulation and Delivery Strategies for<br />
Biologics and Protein Therapeutics<br />
September 17-19, 2013<br />
Hynes Convention Center • Boston, MA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/Formulation<br />
ePharma Summit West<br />
September 16-18, 2013 • Hyatt Regency • San Francisco, CA<br />
www.epharmawest.com<br />
Clinical Collaboration Congress<br />
September 25-27, 2013<br />
Seaport World Trade Center • Boston, MA<br />
www.clinicalcollaborationcongress.com<br />
Biorepositories & Sample<br />
Management Conference<br />
September 25-27, 2013<br />
Seaport World Trade Center • Boston, MA<br />
www.biorepositories<strong>event</strong>.com<br />
Business of Biosimilars & Generic Drugs<br />
September 2013 • Boston, MA<br />
www.biosimilars<strong>event</strong>.com<br />
24 TIDES® Conference & Exhibition
2013/2014 <strong>Life</strong> Science Events<br />
October 2013<br />
Bioassays and Bioanalytical<br />
Method Development<br />
October, 2013 • The Wigwam • Phoenix, AZ<br />
www.bioassays<strong>event</strong>.com<br />
Well Characterized Biologicals<br />
October 21-23, 2013 • L’Enfant Plaza Hotel • Washington DC<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/WCB<br />
Product and Process Variants & Impurities<br />
Oct 21-22, 2013 • L’Enfant Plaza Hotel • Washington DC<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/Variants<br />
Cell Therapy Bioprocessing<br />
Co-Located with <strong>IBC</strong>’s Inaugural Conference on:<br />
Gene Therapy Bioprocessing<br />
October 21-22, 2013 • Be<strong>the</strong>sda Marriott • Be<strong>the</strong>sda, MD<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/CTB<br />
November/December 2013<br />
Antibody Engineering & Therapeutics<br />
December 8-12, 2013<br />
Hyatt Regency Huntington Beach Resort & Spa<br />
Huntington Beach, CA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/AntibodyEng<br />
January/February/March 2014<br />
Drug Delivery Partnerships<br />
January 27-29, 2014 • Boca Raton, FL<br />
www.drugdeliverypartnerships.com<br />
Flexible Facilities<br />
February 20-21, 2014 • Claremont Resort and Spa • Berkeley, CA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/Facilities<br />
Biopharmaceutical Development<br />
& Production Week<br />
March 24-28 2014 • The Hilton Bayfront Hotel • San Diego, CA<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/BDPWeek<br />
Organized by:<br />
Plus: The Only Event in Japan with Comprehensive Coverage of<br />
Oligonucleotides and Peptides<br />
<strong>IBC</strong>’s 6th Annual<br />
February 25-27, 2014<br />
Sheraton Miyako Hotel<br />
Tokyo, Japan<br />
www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/TIDES 25
Ranked <strong>the</strong> #1 BioProcessing Event by <strong>the</strong> Industry for 10 Years Running<br />
Featuring 200+ Speakers, 150+ Exhibitors and 1500+ Attendees Providing You More<br />
Content, Networking and Business Opportunities than Any O<strong>the</strong>r Event on <strong>the</strong> Market<br />
Conference: September 16-19, 2013<br />
Exhibition: September 17-19, 2013<br />
Hynes Convention Center • Boston, MA<br />
Where Industry Connects to Share Technical, Scientific and<br />
Strategic Solutions Across All Phases of Bioprocess Development<br />
Upstream<br />
Processing<br />
Downstream<br />
Processing<br />
Formulation<br />
& Delivery<br />
Manufacturing<br />
Clinical &<br />
Commercial<br />
Analytical<br />
& Quality<br />
Lowest Rates Available Until May 31 u visit www.<strong>IBC</strong><strong>Life</strong><strong>Sciences</strong>.com/BPI<br />
26 TIDES® Conference & Exhibition