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

Raj K. Puri, MD, PhD
U.S. Food and Drug Administration, CBER

Ulrich Kalinke, PhD
Paul-Ehrlich-Institut, Germany

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 Jianhui, MD
Center for Drug Evaluation, SFDA, P.R. China

Ulrich Kalinke, PhD
Paul-Ehrlich-Institut, Germany

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

Raj K. Puri, MD, PhD
U.S. Food and Drug Administration, CBER

Katsutoshi Tanaka
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