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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

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