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Press Release

For more information, contact:

MelissaKaye Shekoski
International Society for Biological Therapy of Cancer
555 E Wells St, Suite 1100, Milwaukee, WI 53202
Phone: 414-271-2456 • Fax: 414-276-3349
Email: mshekoski@isbtc.org
Website: www.isbtc.org

For Immediate Release

GLOBAL REGULATORY SUMMIT FOCUSES ON ONCOLOGY BIOLOGICS PRODUCT DEVELOPMENT

San Diego, CA ---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-Institut in Germany, the Global Regulatory Summit gave a global perspective on regulatory considerations and requirements within the development of oncology biologic products for the treatment of cancer. Key discussions regarding the evolving regulatory policies and guidelines were led by a faculty comprised of representatives from regulatory agencies from around the world, including:

  • 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-Institut, Germany
  • 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 was videotaped and details will be made available online at www.isbtc.org in the upcoming weeks.

Founded in 1984, the International Society for Biological Therapy of Cancer is a not-for-profit organization of clinicians, researchers, students, post-doctoral fellows, and allied health professionals dedicated to improving cancer patient outcomes by advancing the development and application of biological therapy through interaction, innovation and leadership.

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