2:00 - 3:00pmRegistration
3:00 - 3:30pm


Steve Kozlowski, MD, Director, Office of Biotechnology Products, US Food and Drug Administration
3:30 - 4:00pm


Wassim Nashabeh, PhD, Vice President, Regulatory Policy and International Operations, Roche Pharmaceutical Group
4:00 - 5:00pm

Panel Discussion

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 Monocolonal 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

5:00 - 6:00pmClosing Reception with Cocktails