Appendix B

Workshop Agenda

June 13 and 14, 2011
The Keck Center of the National Academies, Room 100
500 Fifth Street, NW Washington, DC 20001

June 13, 2011

7:30 am Breakfast and Registration
 
8:00 am

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

 
8:05 am

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)



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Appendix B Workshop Agenda June 13 and 14, 2011 The Keck Center of the National Academies, Room 100 500 Fifth Street, NW Washington, DC 20001 June 13, 2011 7:30 am Breakfast and Registration 8:00 am Welcome from the IOM National Cancer Policy Forum John Mendelsohn, MD Anderson Cancer Center, and Chair, National Cancer Policy Forum 8:05 am Session 1: Workshop Introduction Moderator: John Hohneker, Novartis Pharmaceuticals, Workshop Planning Chair Rationale for Developing Combination Targeted Cancer Therapies • effrey Engelman, Massachusetts General Hospital J Application of Genomic Tools to Assist in Combination Therapy Development • Michael Barrett, TGen Patient Advocate Perspective • Jane Perlmutter, Gemini Group Panel Discussion (30 minutes) 91

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92 COLLABORATIONS TO DEVELOP COMBINATION CANCER THERAPIES 9:35 am 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 12:00 pm Lunch 1:00 pm 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 • atricia LoRusso, Barbara Ann Karmanos Cancer P 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

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93 APPENDIX B Panel Discussion (45 minutes) Includes speakers and • Samuel Blackman, GlaxoSmithKline 3:20 pm Break 3:30 pm 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 5:30 pm Adjourn, Day 1 June 14, 2011 7:30 am Breakfast and Registration 8:00 am Welcoming Remarks John Hohneker, Novartis Pharmaceuticals, Workshop Planning Chair 8:10 am Session 5: Codevelopment in Vaccines, Biologics, and Other Therapeutic Areas Moderator: Renzo Canetta, Bristol-Myers Squibb Experiences from HIV Drug and Vaccine Development • arl Dieffenbach, National Institute of Allergy and C Infectious Diseases • ary Nabel, National Institute of Allergy and Infectious G Diseases

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94 COLLABORATIONS TO DEVELOP COMBINATION CANCER THERAPIES 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) 10:10 am 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 • ydia McNally, Novartis L Research institution/technology transfer perspective • esley Blakeslee, Johns Hopkins W National Cancer Institute perspective • ason Cristofaro, National Cancer Institute J • herry Ansher, National Cancer Institute S 11:55 am Break: Please pick up boxed lunch and return to workshop 12:15 pm Session 6 (Continued)

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95 APPENDIX B 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 • assiliki Papadimitrakopoulou, MD Anderson Cancer V Center 1:50 pm Closing Comments/Wrap-Up John Hohneker, Novartis Pharmaceuticals 2:00 pm Adjourn

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