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Appendix A: Workshop Agenda
Pages 73-86

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From page 73...
... New paradigms for discovering and developing drugs are being sought to bridge the ever-widening gap between scientific discoveries and translation of those discoveries into life-changing medications. New collaborative approaches within the federal agencies, academia, and industry are directing focused attention 73
From page 74...
... In addition to providing suggestions to NCATS, the workshop is, in part, in response to congressional interest in CAN expressed in the FY 2012 appropriations act conference report. The workshop will inform NIH/NCATS in its efforts to implement CAN and advance translational sciences, and will also inform the public, policy community, and other stakeholders as all of these parties continue to work to enhance the development and testing of therapies and diagnostics to patients.
From page 75...
... 8:40 a.m. Background and Session Objectives Sudip Parikh, Session Chair Vice President, Health Policy Managing Director Centers for Public Health Research and Evaluation Battelle Health and Life Sciences 8:45 a.m.Keynote Address: Introduction to NCATS and Overview of Translational Science Initiatives and CAN Tom Insel Acting Director National Center for Advancing Translational Sciences National Institutes of Health
From page 76...
... 9:45 a.m. Background and Session Objectives Bill Chin, Session Chair Executive Dean for Research Harvard Medical School
From page 77...
... BREAK 10:45 a.m.Brief Presentations: Product Development/ Commercialization Efforts James Bradner Assistant Professor, Harvard Medical School Instructor in Medicine, Dana-Farber Cancer Institute Stephen Seiler Founder and Chief Executive Officer AesRx Louis DeGennaro Executive Vice President and Chief Mission Officer The Leukemia & Lymphoma Society 11:25 a.m. Discussion with Speakers and Audience: · What are the translational science needs?
From page 78...
... 12:35 p.m. Background and Session Objectives Nancy Sung Senior Program Officer Burroughs Wellcome Fund 12:40 p.m.Series of Brief Presentations: Application of "Matching" or Similar Authority Michael Weingarten Director, SBIR Development Center National Cancer Institute National Institutes of Health Kristen Doyle General Counsel Cancer Prevention and Research Institute of Texas Ellen Feigal Senior Vice President, Research & Development California Institute for Regenerative Medicine 1:25 p.m.
From page 79...
... 2:50 p.m. Background and Session Objectives William Warren, Session Chair Vice President, VaxDesign Campus Sanofi Pasteur
From page 80...
... Department of Energy 4:15 p.m.Panel Discussion with Speakers, Discussants, and Audience: Comparing Flexible Research Authority to Existing NIH Authorities Discussants: Dan Wattendorf Program Manager, Defense Sciences Office Defense Advanced Research Projects Agency Robi Blumenstein President CHDI Management Issues for Discussion: · How can the other transaction authority (OTA) be most effectively applied in the biomedical/life sciences space?
From page 81...
... Welcome and Introductions Workshop Co-Chairs Carolyn Compton President and Chief Executive Officer Critical Path Institute Louis DeGennaro Executive Vice President and Chief Mission Officer The Leukemia & Lymphoma Society
From page 82...
... 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
From page 83...
... APPENDIX A 83 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
From page 84...
... Carolyn Compton President and Chief Executive Officer Critical Path Institute
From page 85...
... APPENDIX A 85 Louis DeGennaro Executive Vice President and Chief Mission Officer The Leukemia & Lymphoma Society 10:50 a.m.Presentation of Key Themes/Suggested Paths from Workshop Session Chairs Sudip Parikh, Session I Chair Vice President, Health Policy Battelle Memorial Institute Bill Chin, Session II Chair Executive Dean for Research Harvard Medical School Nancy Sung, Session III Chair Senior Program Officer Burroughs Wellcome Fund Dan Wattendorf, Session IV Rapporteur Program Manager, Defense Sciences Office Defense Advanced Research Projects Agency Margaret Anderson, Session V Chair Executive Director FasterCures 11:40 a.m.Reflecting on Potential Approaches to Maximize the Goals of CAN: Panel Discussion with Session Chairs, Panelists, and Audience Discussants Joshua Boger Founder, Vertex Pharmaceuticals Kathy Hudson Acting Deputy Director, NCATS Deputy Director for Science, Outreach, and Policy, NIH Office of the Director National Institutes of Health
From page 86...
... 86 MAXIMIZING THE IMPACT OF THE CURES ACCELERATION NETWORK Carol Mimura Assistant Vice Chancellor for Intellectual Property and Industry Research Alliances University of California, Berkeley Robert O'Neill Senior Statistical Advisor Center for Drug Evaluation and Research Food and Drug Administration 12:20 p.m. Closing Observations from NCATS Kathy Hudson Acting Deputy Director, NCATS Deputy Director for Science, Outreach, and Policy, NIH Office of the Director National Institutes of Health 12:30 p.m.


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