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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

Session 9: Conference Highlights

Session Chair(s)

Session  Chair Invited

Session Chair Invited

United States

This panel discussion is meant to highlight the challenges and issues with the development of oligonucleotide-based products in general and as brought forth at this conference. The intention is to transform this discussion into action-oriented objectives to address the regulatory and industry issues and challenges affecting us all.

Speaker(s)

Scott  Henry, PHD

Discussant and Panelist: Nonclinical Track

Scott Henry, PHD

Ionis Pharmaceuticals, Inc., United States

Senior Vice President, Nonclinical Development

Arthur A. Levin, PHD

Discussant and Panelist: Nonclinical Track

Arthur A. Levin, PHD

Avidity Biosciences, United States

Distinguished Scientist

Daniel  Capaldi, PHD

Discussant and Panelist: CMC Track

Daniel Capaldi, PHD

Ionis Pharmaceuticals, Inc, United States

Vice President, Analytical and Process Development

René  Thürmer, PHD

Discussant and Panelist: CMC Track

René Thürmer, PHD

Federal Institute for Drugs and Medical Devices, Germany

Quality Assessor

James D. Thompson, PHD

Discussant and Panelist: Clinical Track

James D. Thompson, PHD

Quark Pharmaceuticals Inc., United States

Vice President, Pharmaceutical Development

Saraswathy V. Nochur, PHD, MSC

Discussant and Panelist: Clinical Track

Saraswathy V. Nochur, PHD, MSC

Alnylam Pharmaceuticals, United States

Chief Regulatory Officer

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