Global Regulatory Considerations in the Development of Oncology Biologics Products for the Treatment of Cancer

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October 29, 2008
Westin Gaslamp Quarter Hotel
San Diego, CA

Presentation Slides & Schedule
Slides for select presentations below have been provided by the corresponding speaker for your convenience.
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Wednesday, October 29, 2008
11:00 am - 7:00 pm	Registration Open
1:00 pm - 1:20 pm	Welcome and Introductions
	Ulrich Kalinke, PhD - Paul-Ehrlich-Institut, Germany  Raj K. Puri, MD, PhD - U.S. Food and Drug Administration, CBER
United States: Regulatory Considerations in Oncology Biologics Product Development
1:20 pm - 1:50 pm	FDA: Chemistry, Manufacturing and Controls (CMC) Issues for Investigational New Drugs (IND)  Keith Wonnacott, PhD - Food and Drug Administration
1:50 pm - 2:20 pm	FDA: Perspective on the Preclinical Evaluation of Biological Therapies for Cancer  Yongjie Zhou, MD, PhD - Food and Drug Administration, CBER
2:20 pm - 2:50 pm	Introduction to FDA Drugs and Biological Review Process  Ke Liu, MD, PhD - Food and Drug Administration, CBER
2:50 pm - 3:15 pm	Break
Europe: Regulatory Considerations in Oncology Biologics Product Development
3:15 pm - 3:50 pm	European Medicines Agency: New Regulations for Advanced Therapies including Oncology Biological Products  Patrick Celis, PhD - European Medicines Agency
3:50 pm - 4:25 pm	Paul-Ehrlich-Institut: Considerations in Product Development with Advanced Therapies and Cancer Vaccines  Thomas Hinz, PhD - Paul-Ehrlich-Institut, Germany
Japan: Regulatory Considerations in Oncology Biologics Product Development
4:25 pm - 5:00 pm	Cancer Vaccines and Immunotherapy Regulation  Masatoshi Narita - Pharmaceuticals and Medical Devices Agency, Japan
Global Regulatory Considerations in Oncology Biologics Product Development
5:00 pm - 5:30 pm	Gina Coleman, MD - Health Canada  Bindu Dey, PhD - Department of Biotechnology, Government of India  Jianhui Luo, MD - Center for Drug Evaluation, SFDA, P.R.China  Andreas Marti, PD, PhD - Swissmedic, Swiss Agency for Therapeutic Products
Roundtable Discussion
5:30 pm - 6:30 pm	Moderators: Ulrich Kalinke, PhD - Paul-Ehrlich-Institut, Germany Raj K. Puri, MD, PhD - U.S. Food and Drug Administration, CBER Panelists: Ashok M. Batra, MD - U.S. Food and Drug Administration, CBER Patrick Celis, PhD - European Medicines Agency Gina Coleman, MD - Health Canada Bindu Dey, PhD - Department of Biotechnology, Government of India Thomas Hinz, PhD - Paul-Ehrlich-Institut, Germany Jianhu Luo, MD - Center for Drug Evaluation, SFDA, P.R. China Koji Kawakami, MD, PhD - Japan Science and Technology Agency Ke Liu, MD, PhD - U.S. Food and Drug Administration, CBER Andreas Marti, PD, PhD - Swissmedic, Swiss Agency for Therapeutic Products Masatoshi Narita - Pharmaceuticals and Medical Devices Agency, Japan Keith Wonnacott, PhD - U.S. Food and Drug Administration, CBER Yongjie Zhou, MD, PhD - U.S. Food and Drug Administration, CBER
Reception
6:30 pm - 8:00 pm	Open to registered attendees for the Global Regulatory Summit

All presentations are licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.