Agenda

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Time Description
2:00 – 2:45pm Registration
2:45 – 3:00pm Welcome and Introductions
3:00 – 3:45pm

Keynote:

Opportunities in Integrating Biologic Drug Structure and In Vivo PTM Data into Clinical Program Design and Analysis—An FDA Perspective


Steve Kozlowski
, MD, Director, Office of Biotechnology Products, US Food and Drug Administration

 

3:45 – 4:30pm

Keynote:

Opportunities in Integrating Biologic Drug Structure and In Vivo PTM Data into Clinical Program Design and Analysis—A Pharma Perspective


Wassim Nashabeh, PhD, Vice President, Regulatory Policy and International Operations, Roche Pharmaceutical Group

4:30 – 4:45pm Break
4:45 – 5:45pm

Panel Discussion With Keynote Speakers

Patrick Swann, PhD, Vice President, Quality Science and Technology, Amgen; Former Vice President, CMC Regulatory Affairs, Biogen and Deputy Director, Division of Monoclonal Antibodies, US Food and Drug Administration

Katy Stein, PhD, Principal, Kathryn Stein Consulting; Former Director, Division of Monoclonal Antibodies, US Food and Drug Administration and Senior Vice President, Product Development and Regulatory Affairs, Macrogenics

Pamela M. Klein, MD, Principal, PMK BioResearch; Former Chief Medical Officer, Intellikine (acquired by Millennium/Takeda) and Vice President, Development, Genentech

5:45 – 6:30pm Closing Cocktail Reception