Milwaukee, WI ---The International Society for Biological Therapy of Cancer (iSBTc) convened international regulatory leaders for a Global Regulatory Summit entitled, “Global Regulatory Considerations in the Development of Oncology Biologics Products for the Treatment of Cancer” on Wednesday, October 29, 2008 in San Diego, CA. The Summit marked the opening of iSBTc’s 23rd Annual Meeting and Associated Programs which took place at the Westin Gaslamp Quarter Hotel from October 29 - November 2, 2008.
Organized by Raj K. Puri, MD, PhD of the US Food and Drug Administration and Ulrich Kalinke, PhD of the Paul-Ehrlich-
* US Food and Drug Administration (FDA)
* European Medicines Agency
* Japan Science and Technology Agency
* Pharmaceuticals and Medical Devices Agency, Japan
* Center for Drug Evaluation, SFDA, P.R. China
* Paul-Ehrlich-
* Department of Biotechnology, Government of India
* Health Canada
* Swissmedic, Swiss Agency for Therapeutic Products
After highlighting the individual regulatory requirements of their perspective agency, faculty members reconvened as a panel to discuss and address audience questions on the current guidelines for product development within these different regions, including successes and challenges within pre-clinical and clinical trial designs. The panel addressed issues such as:
* Key regulatory challenges for first-in-human oncology biologics trials?
* Immunological endpoints in pre-clinical and clinical studies and why they are important for cancer vaccines
* Requirements for accelerated approval or conditional marketing authorization for promising new biologics?
The Global Regulatory Summit details, including the presentations as presented are available online at www.isbtc.org.
