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Washington Court Hotel

Sep 25, 2013 8:00 AM - Sep 27, 2013 5:00 PM

525 New Jersey Avenue NW, Washington, DC 20001

DIA/FDA Oligonucleotide-based Therapeutics Conference

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Session 6: Pharma/FDA Case Study

Session Chair(s)

David H. Schubert

David H. Schubert

DH Schubert Regulatory Solutions LLC, United States

Oligonucleotide therapeutic development presents various challenges to CMC, Pharm/Tox, Clinical Pharm., and Clinical disciplines at early-, middle-, and late-stage development. This session will include three real and hypothetical case studies that identify challenges faced by these disciplines across the development cycle. Case study presenters will engage the audience in discussions about development issues, decision-making, and lessons learned based on prior experience.

Speaker(s)

A Case Study of Challenges Faced during Early Stage Oligo Development

Doug Kornbrust, PhD

Preclinsight, United States

President

Decisions During Mid-Stage Development

Akshay K. Vaishnaw, MD, PhD

Alnylam Pharmaceuticals, Inc., United States

Chief Medical Officer

Late Phase Development Issues

Mike L. Webb

GlaxoSmithKline, United Kingdom

Vice President, API Chemistry & Analysis

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