The National Cancer Policy Forum convened a public workshop to address the promises and challenges involved in the development of combination investigational cancer therapies. Advances in biomedical research have increased our understanding of the complex nature of disease and the interaction of multiple molecular pathways involved in cancer. Combining investigational products early in their development is thought to be a promising strategy for identifying effective therapies, especially when a combination targets multiple pathways, or more than one step in a pathway, conferring greater benefit than a therapy directed at a single target.
This approach to drug development presents several unique challenges, and the purpose of the workshop was to identify barriers that may be preventing the development of combination investigational cancer therapies and offer potential solutions for greater collaboration. Workshop presentations and discussions addressed scientific challenges and opportunities in the codevelopment of investigational therapies (both preclinical and clinical); the regulatory environment for codevelopment, including the recent FDA draft guidance on this topic; and organizational culture and legal issues that may be influencing collaboration.
Speakers and Panelists
Jeff Allen, Friends of Cancer Research
Sherry Ansher, Cancer Therapy Evaluation Program, NCI
Kurtis Bachman, GlaxoSmithKline
Michael Barrett, Translational Genomics Research Institute
Donald Berry, MD Anderson Cancer Center
Samuel Blackman, GlaxoSmithKline
Wesley Blakeslee, Johns Hopkins University
Lewis Cantley, Beth Israel Hospital
Helen Chen, National Cancer Institute
Jason Cristofaro, National Cancer Institute
Ramzi Dagher, Pfizer
Carl Dieffenbach, National Institute of Allergy and Infectious Diseases
James Doroshow, National Cancer Institute
Jeffrey Engelman, Massachusetts General Hospital
Keith Flaherty, Massachusetts General Hospital Cancer Center
Roy Herbst, Yale Cancer Center
Robert Iannone, Merck Research Laboratories
Carl June, University of Pennsylvania
Robert Leibenluft, Hogan Lovells
Nils Lonberg, Bristol-Myers Squibb
Patricia LoRusso, Barbara Ann Karmanos Cancer Institute
Stuart Lutzker, Genentech
Lydia McNally, Novartis Pharmaceuticals
Bernard Munos, InnoThink Center for Research in Biomedical Innovation
Gary Nabel, National Institute of Allergy and Infectious Diseases
Vassiliki Papadimitrakopoulou, MD Anderson Cancer Center
Jane Perlmutter, Gemini Group
Philip Porter, Hogan Lovells
Larry Rubinstein, NCI Biometric Research Branch
Haleh Saber, Food and Drug Administration
Jeffrey Schlom, National Cancer Institute
Rachel Sherman, Food and Drug Administration
David Stern, Yale Cancer Center
Robert Temple, FDA Center for Drug Evaluation and Research
David Wholley, Foundation for the National Institutes of Health
Planning Committee
John Hohneker, Novartis Pharmaceuticals (Chair)
Renzo Canetta, Bristol-Myers Squibb
Michaele Chamblee Christian
Roy Herbst, Yale Cancer Center
Patricia LoRusso, Barbara Ann Karmanos Cancer Institute
Frank McCormick, UCSF Helen Diller Family Comprehensive Cancer Center
Richard Pazdur, Food and Drug Administration
Philip Porter, Hogan Lovells
Ellen Sigal, Friends of Cancer Research
John Wagner, Merck
James Zwiebel, National Cancer Institute