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

Chapter: Appendix B: Workshop Agenda

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Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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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
• 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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Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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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
• 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
Page 93 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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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
• Carl Dieffenbach, National Institute of Allergy and Infectious Diseases
• Gary Nabel, National Institute of Allergy and Infectious Diseases
Page 94 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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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
• 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
   
11:55 am Break: Please pick up boxed lunch and return to workshop
   
12:15 pm Session 6 (Continued)
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Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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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
   
1:50 pm

Closing Comments/Wrap-Up
John Hohneker, Novartis Pharmaceuticals
   
2:00 pm Adjourn
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Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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Page 94 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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Page 95 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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Page 96 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." Institute of Medicine. 2012. Facilitating Collaborations to Develop Combination Investigational Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13262.
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