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

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

Schedule at a Glance

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: Pre-Clinical Issues Yongjie Zhou, MD, PhD – Food and Drug Administration, CBER
2:20 pm – 2:50 pm	FDA: Clinical issues 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 Katsutoshi Tanaka - Pharmaceuticals and Medical Devices, 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 Luo Jianhui, MD – Center for Drug Evaluation, SFDA, P.R.China Andreas Marti, PD, PhD – Swissmedic, Swiss Agency for Therapeutic Products Samir Khleif, MD - National Cancer Institute

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 Katsutoshi Tanaka – Pharmaceuticals and Medical Devices, Japan 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 Luo Jianhu, MD – Center for Drug Evaluation, SFDA, P.R. China Koji Kawakami, MD, PhD – Japan Science and Technology Agency Samir Khleif, MD - National Cancer Institute Ke Liu, MD, PhD – U.S. Food and Drug Administration, CBER Andreas Marti, PD, PhD – Swissmedic, Swiss Agency for Therapeutic Products 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