Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary (2012)

Welcome from the IOM National Cancer Policy Forum
John Mendelsohn, MD Anderson Cancer Center, and Chair, National Cancer Policy Forum

Session 1: Workshop Introduction
Moderator: John Hohneker, Novartis Pharmaceuticals, Workshop Planning Chair

Rationale for Developing Combination Targeted Cancer Therapies
• Jeffrey Engelman, Massachusetts General Hospital

Application of Genomic Tools to Assist in Combination Therapy Development
• Michael Barrett, TGen

Patient Advocate Perspective
• Jane Perlmutter, Gemini Group

Panel Discussion (30 minutes)

Session 2: Scientific Challenges and Opportunities: Preclinical Issues in Codevelopment
Moderator: James Zwiebel, National Cancer Institute

Perspectives from the National Cancer Institute
• James Doroshow, National Cancer Institute

Perspectives from Academia
• David Stern, Yale University
• Carl June, University of Pennsylvania

Perspectives from Industry
• Kurt Bachman, GlaxoSmithKline

Panel Discussion (60 minutes) Includes speakers and
• Haleh Saber, Food and Drug Administration
• Robert Iannone, Merck
• Michael Caligiuri, OSU Comprehensive Cancer Center

Session 3: Scientific Challenges and Opportunities: Clinical Issues in Codevelopment
Moderator: Roy Herbst, Yale Cancer Center

Perspectives from the National Cancer Institute
• Helen Chen, National Cancer Institute

Perspectives from Academia
• Patricia LoRusso, Barbara Ann Karmanos Cancer Institute

Perspectives from Industry
• Stuart Lutzker, Genentech

Perspectives on Trial Design and Statistical Issues
• Donald Berry, MD Anderson Cancer Center
• Larry Rubinstein, National Cancer Institute

Panel Discussion (45 minutes) Includes speakers and
• Samuel Blackman, GlaxoSmithKline

Session 4: The Regulatory Environment for Codevelopment
Moderator: Richard Pazdur, Food and Drug Administration

FDA Presentation on Draft Guidance
• Rachel Sherman, CDER, Food and Drug Administration

Brookings/Friends of Cancer Research Perspective on FDA Submission
• Jeff Allen, Friends of Cancer Research

Industry Perspective
• Ramzi Dagher, Pfizer

Panel Discussion (40 minutes) Includes speakers and
• Robert Temple, CDER, Food and Drug Administration
• Ellen Sigal, Friends of Cancer Research

June 14, 2011

Welcoming Remarks
John Hohneker, Novartis Pharmaceuticals, Workshop Planning Chair

Session 5: Codevelopment in Vaccines, Biologics, and Other Therapeutic Areas
Moderator: Renzo Canetta, Bristol-Myers Squibb

Experiences from HIV Drug and Vaccine Development
• Carl Dieffenbach, National Institute of Allergy and Infectious Diseases
• Gary Nabel, National Institute of Allergy and Infectious Diseases

Preclinical Issues
• Nils Lonberg, Bristol-Myers Squibb

Clinical Issues
• Jeffrey Schlom, National Cancer Institute

Multimodality Combination Therapies
• Keith Flaherty, Massachusetts General Hospital

Panel Discussion (45 minutes)

Session 6: Pharmaceutical and Biotechnology Industry Collaboration to Codevelop Therapies
Moderator: Michaele Christian

Organizational Culture in Pharmaceutical and Biotechnology Companies
• Bernard Munos, InnoThink

Legal Issues
Overview of Antitrust Issues
• Robert Leibenluft, Hogan Lovells
Overview of Intellectual Property Issues
• Anishiya Abrol, Hogan Lovells
Overview of NCI’s CRADA Intellectual Property Language
• Jason Cristofaro, National Cancer Institute

Panel Discussion: Perspectives on Intellectual Property Issues in Collaboration (30 minutes)
Industry perspective
• Lydia McNally, Novartis
Research institution/technology transfer perspective
• Wesley Blakeslee, Johns Hopkins
National Cancer Institute perspective
• Jason Cristofaro, National Cancer Institute
• Sherry Ansher, National Cancer Institute

Practical Examples and Possible Models of Collaboration Collaborations to Develop Drugs Targeting PI3K
• Lewis Cantley, Beth Israel Hospital/Harvard
BATTLE 1 and 2 Trials
• Roy Herbst, Yale Cancer Center
I-SPY 2 TRIAL
• David Wholley, Biomarkers Consortium

Panel Discussion (45 minutes)
Includes speakers and
• Vassiliki Papadimitrakopoulou, MD Anderson Cancer Center

Closing Comments/Wrap-Up
John Hohneker, Novartis Pharmaceuticals