Our 2018 Agenda
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
|
3:45 – 4:30pm |
Keynote:Opportunities in Integrating Biologic Drug Structure and In Vivo PTM Data into Clinical Program Design and Analysis—A Pharma PerspectiveWassim 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 SpeakersPatrick 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 |