The Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) and Friends of Cancer Research (Friends) are convening a high-level group of stakeholders to discuss current obstacles halting co-development of two or more experimental drugs for the treatment of cancer.
In December 2010, the U.S. Food and Drug Administration (FDA) released a Guidance Document addressing the protocol researchers should follow when deciding if co-developing drugs is appropriate. However, barriers found outside of clinics and labs, such as business, legal, liability and intellectual property issues were not examined in detail.
The objective of the Cancer Drug Development Roundtable is to develop a set of recommendations for the FDA to be revealed later this year, addressing industry hurdles currently halting co-development, with the ultimate goal of easing the process and bringing revolutionary cancer treatments to patients faster and with more efficiency.
Prior to the closed working session occurring later in the day, Roundtable participants will hold an open public session for researchers, advocates, patients and media that would like to learn more about the issue and ask questions. Panel participants include:
- Michael Caligiuri, M.D. - Director of The Ohio State Comprehensive Cancer Center and CEO of the James Cancer Hospital and Solove Research Institute
- Jim Doroshow, M.D. - Director of the Division of Cancer Treatment and Diagnosis at the National Cancer Institute
- Eric Rubin, M.D. - Vice President, Oncology Clinical Research, Merck
- Ellen Sigal, Ph.D. - Chair and Founder, Friends of Cancer Research
- Janet Woodcock, M.D. - Director, Center for Drug Evaluation and Research, FDA
WHERE: The Ohio State University, Biomedical Research Tower, Room 115, 460 W. 12th Avenue, Columbus, OH 43210
WHEN: Wednesday, May 4, 2011
10:00 - 11:00 a.m.
WHO: Hosted by Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) and Friends of Cancer Research (Friends)