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iSBTc NewsPress ReleaseFor Immediate Release For more information, contact: iSBTc Primer Provides Guidance on Regulatory Expectations, Strategies for Oncology Biologics Development in the US, EU and Japan Milwaukee---The International Society for Biological Therapy of Cancer (iSBTc) recently held the Oncology Biologics Development Primer (OBDP) in Gaithersburg, MD from February 28-29, 2008. This program was a key forum for the exploration of best practices for worldwide biologics development. Thirty expert speakers from the oncology biologics and regulatory affairs arena covered topic areas such as regulatory expectations and strategies for oncology biologics development in the US, EU and Japan; an in-depth analysis of Good Clinical Practice (GCP) standards; pre-clinical and clinical design and regulatory strategies; and in-licensing and out-licensing expectations and opportunities for academia and industry. There is a continuing need to have new agents that are more effective and less toxic than current treatments for many oncology indications and biological therapies in many instances appear to address those goals. The OBDP successfully created an environment to facilitate dialogue between key stakeholders in academia, industry and regulatory agencies. These discussions helped to provide an understanding of effective strategies for oncology biologics development, as well as the pre-clinical and clinical regulatory expectations to address these continuing needs. The collaborative and interactive environment at the OBDP facilitated productive dialogue among clinicians, researchers, pharmaceutical biotech companies, academia and regulatory representatives. "The high quality of the educational sessions and case studies was matched by excellent panel discussions and audience participation," said Robert J. Zimmerman, SD, one of the program's four co-organizers. "The synergies between these groups helped all of us to see new ways to achieve the overall goal of moving promising therapies from research and pre-clinical testing into clinical development as quickly and efficiently as possible." "The conference provided an excellent opportunity to first introduce data from a newly completed study in patients with melanoma receiving ipilimumab", said Rachel W. Humphrey, MD, a member of the iSBTc Board of Directors and ipilimumab Development Leader at Bristol Myers-Squibb, "We look forward to using this venue in the future to release, review and discuss additional data as they become available". Reference materials from the meeting including biologics development resources, as well as speaker presentations are available for public viewing on the iSBTc web site at www.isbtc.org. Founded in 1984, the International Society for Biological Therapy of Cancer (iSBTc) is a non-profit organization of medical professionals. Membership includes over 500 clinicians, researchers, students, post-doctoral fellows and allied health professionals in academia, industry and regulatory agencies dedicated to improving cancer patient outcomes by advancing the development and application of biological therapy through interaction, innovation and leadership. ### |
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