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Press Release

Contact:

MelissaKaye Shekoski, Administrative Coordinator
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

Members of the media are encouraged to attend a Summit on "Global Regulatory Considerations in the Development of Oncology Biologics Products for the Treatment of Cancer" free of charge by presenting their press credentials at the iSBTc registration desk.

For Immediate Release

iSBTc TO HOST GLOBAL REGULATORY SUMMIT ON ONCOLOGY BIOLOGICS PRODUCT DEVELOPMENT

Milwaukee, WI --- The International Society for Biological Therapy of Cancer (iSBTc) is proud to host a summit of global regulatory bodies at a program 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 will mark the opening of iSBTc's 23rd Annual Meeting and Associated Programs taking place at the Westin Gaslamp Quarter Hotel from October 29 - November 2, 2008. p

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 will give a global perspective on regulatory considerations and requirements within the development of oncology biologics products for the treatment of cancer. This iSBTc sponsored program will bring together regulatory representatives from around the world to discuss current regulatory requirements and guidance for product development within these different regions in addition to shared successes and challenges within pre-clinical and clinical trial design and analysis for oncology biologics. Regulatory agencies represented at the Summit will include:

  • 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
  • For attendees, the interaction with representatives from various global regulatory agencies and the National Cancer Institute will provide an opportunity to learn new and existing regulatory policies and guidelines, as well as explore strategic international partnerships between clinicians, regulatory personnel, and translational and basic scientists from academia, government and industry. In addition to scheduled presentations, the program will feature a panel discussion during which representatives will be prepared to address such key questions as:
  • What are the key regulatory challenges for first-in-human oncology biologics trials?
  • Why immunological endpoints in pre-clinical and clinical studies are important for cancer vaccines?
  • What are the requirements for accelerated approval or conditional marketing authorization for promising new biologics?

Details and a complete schedule for the Global Regulatory Summit can be found at iSBTc's website at www.isbtc.org. Registration to attend this event is still open.

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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