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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FDA Presentation on Draft Guidance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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