Session Objectives:
  • Identify potential approaches to facilitate coordination of activities under CAN with FDA regulatory science initiatives and activities.
  • Discuss existing activities in multiple sectors and address ways to maximize CAN impact in the drug development ecosystem.
  • Explore promising models for public–private collaborations that could be strengthened or facilitated by activities under CAN. Discuss barriers to such collaborations and identify opportunities and potential solutions for moving past the identified barriers.
8:30 a.m.Background and Session Objectives
Margaret Anderson, Session Chair
Executive Director
FasterCures
8:35 a.m.FDA Presentations: Intersection of CAN with FDA Regulatory Science Initiatives and Activities
Jesse Goodman
Chief Scientist
Food and Drug Administration
ShaAvhrée Buckman-Garner
Director, Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
9:05 a.m.Roundtable Discussion: Identification and Discussion of Regulatory Science Priorities That Are Important for Drug Development
Panelists
ShaAvhrée Buckman-Garner
Director, Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
Elizabeth Mansfield
Director, Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Food and Drug Administration
Thomas Kalil
Deputy Director for Policy
Office of Science and Technology Policy
Executive Office of the President
Carolyn Compton
President and Chief Executive Officer
Critical Path Institute
Garry Neil
Corporate Vice President, Science and Technology
Johnson & Johnson
Panel Moderator:
Margaret Anderson
Executive Director
FasterCures
9:45 a.m.Roundtable Discussion: Role of CAN in Advancing Cross-Sector and Other Collaborative Translational Science Activities
Panelists
Ellen Sigal
Founder and Chair
Friends of Cancer Research
David Wholley
Director, Biomarkers Consortium
Foundation for the NIH
Jane Reese-Coulbourne
Executive Director
Reagan-Udall Foundation for the FDA
Freda Lewis-Hall
Chief Medical Officer
Pfizer Inc.
Doug Throckmorton
Deputy Director
Center for Drug Evaluation and Research
Panel Moderator:
Myrl Weinberg
President
National Health Council
Issues for Discussion:
  • Coordination of efforts across funding agencies/sources (e.g., HHS, DoD, NGOs, industry) and with other established partners in translational research activities (e.g., FNIH, Reagan-Udall Foundation, C-Path), and reduction of duplication.
  • Implications of CAN for academic translational science—career paths, funding opportunities, etc.
10:30 a.m.BREAK

From: Appendix A, Workshop Agenda

Cover of Accelerating the Development of New Drugs and Diagnostics
Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary.
Institute of Medicine (US).
Washington (DC): National Academies Press (US); 2012.
Copyright © 2012, National Academy of Sciences.

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