Global Regulatory Summit

The SITC 2015 Presentation Archive is supported through a generous contribution from AstraZeneca/MedImmune.

Access slide decks and video via the links in the schedule below.

= PDF of slides is available

= Presentation video is available

Program Schedule

Wednesday, November 4, 2015

8:00 a.m. – 8:15 a.m.	Welcome and Introductions Ke Liu, MD, PhD – U.S. Food and Drug Administration Patrick Celis, PhD – European Medicines Agency
General Introductions: Novel Science on Cancer Immunotherapies
8:15 a.m. – 8:45 a.m.	Evolution and Future Predictions Part I     Ke Liu, MD, PhD – U.S. Food and Drug Administration
8:45 a.m. – 9:15 a.m.	Evolution and Future Predictions Part II     Björn Carlsson, PhD – Medical Products Agency- Sweden
United States & Europe: Regulatory Considerations in Cancer Immunotherapy Product Development
9:15 a.m. – 9:45 a.m.	U.S. Food and Drug Administration Perspectives Peter Bross, MD – U.S. Food and Drug Administration
9:45 a.m. – 10:15 a.m.	European Medicines Agency Perspectives     Patrick Celis, PhD – European Medicines Agency
10:15 a.m. – 10:30 a.m.	Break
Asia: Regulatory Considerations in Cancer Immunotherapy Product Development
10:30 a.m. – 10:45 a.m.	Japan Perspective     Sumimasa Nagai, MD, PhD - Pharmaceuticals and Medical Devices Agency, Japan
10:45 a.m. – 11 a.m.	India Perspectives   Geeta Jotwani, PhD – Indian Council of Medical Research
11 a.m. – 11:15 a.m.	Korea Perspectives Gi Hyun Kim, PharmD – Ministry of Food and Drug Safety
11:15 a.m. – Noon	Lunch
Panel Discussion
Noon – 1 p.m.	Moderators: Ke Liu, MD, PhD – U.S. Food and Drug Administration Patrick Celis, PhD – European Medicines Agency Panelists: Geeta Jotwani, PhD – Indian Council of Medical Research Sumimasa Nagai, MD, PhD – Pharmaceuticals and Medical Devices Agency, Japan Peter Bross, MD – U.S. Food and Drug Administration Allen Wensky, PhD – U.S. Food and Drug Administration Björn Carlsson, PhD – Medical Products Agency - Sweden
1 p.m.	Closing Remarks Patrick Celis, PhD – European Medicines Agency