Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders Workshop Summary (2015) / Chapter Skim
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Appendix B: Workshop Agenda
Appendix B: Workshop Agenda
Pages 65-78
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From page 65... ...
. Although there have been recent international initiatives to better understand the human brain in order to develop new therapeutics, several large pharmaceutical companies have decreased investment or even withdrawn from their neuroscience research programs.
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From page 66... ...
Presentations and discussions will be designed to: • Examine opportunities and barriers to increasing investments for the development of novel therapeutics to support unmet medical needs for nervous system disorders. o Discuss specific considerations for combination therapies and disease-modifying treatments that may require extensive long-term prevention trials.
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From page 67... ...
Overview of Unmet Medical Needs for Nervous System Disorders STEVEN HYMAN Professor of Stem Cell and Regenerative Biology Director, Stanley Center for Psychiatric Research Broad Institute, MIT and Harvard University 9:15 a.m. Policy-Based "Pull" Incentives for Creating Break through CNS Drugs: Background Neuron Paper DENNIS CHOI, Workshop Co-Chair Professor and Chair, Department of Neurology, School of Medicine Director, Neurosciences Institute Stony Brook University 9:45 a.m.
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10:45 a.m. Overview of Current Intellectual Property Protections: Patents and Data Package Protection ROBERT ARMITAGE, Session Chair IP Strategy and Policy Consultant Former Senior Vice President & General Counsel, Eli Lilly and Company 11:05 a.m.
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From page 69... ...
? Panelists: • Marc Boutin, Executive Vice President and Chief Operating Officer, National Health Council
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Engelberg, Trustee, The Engelberg Foundation • William (Terry) Fisher, Wilmer Hale Professor of Intellectual Property Law, Faculty Director, Berkman Center for Internet and Society, Harvard Law School • Nicholas Manetto, Director, FaegreBD Consulting • Bonnie Weiss McLeod, Partner, Cooley, LLP • Steven Paul, Chief Executive Officer and Board Member, Voyager Therapeutics; Weill Cornell Medical College • Arti Rai, Professor of Law and Co-Director, Duke Law Center for Innovation Policy • Kiran Reddy, Senior Director, Corporate Strategy, Biogen Idec 2:45 p.m.
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From page 71... ...
The Promise and Pitfalls of Changing Regulatory Standards to Spur CNS Drug Discovery AARON KESSELHEIM Associate Professor of Medicine Harvard Medical School and Brigham and Women's Hospital 3:25 p.m. Six Opportunities for Improving Pathways to Market: A Global Perspective RAJ LONG Senior Regulatory Officer-Integrated Development, Global Health The Bill & Melinda Gates Foundation 3:40 p.m.
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From page 72... ...
• Explore innovations in clinical trials that could help reduce time, cost, and risk to expedite pathway to market. Panelists: • Jeff Allen, Executive Director, Friends of Cancer Research • Lauren Chiarello, Senior Director, Federal Government Relations at National Multiple Sclerosis Society • Jeffrey Jonas, Chief Executive Officer, SAGE Therapeutics • Aaron Kesselheim, Harvard Medical School and Brigham and Women's Hospital • Alex London, Professor of Philosophy and Director, The Center for Ethics and Policy, Carnegie Mellon University • Raj Long, The Bill & Melinda Gates Foundation 4:20 p.m.
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From page 73... ...
Potential Impact of New Treatments on Health Care Costs Defining Value for Innovative Therapeutics to Meet Unmet Medical Needs for Nervous System Disorders ROGER LONGMAN Chief Executive Officer Real Endpoints Economic Cost and Impact of Nervous System Disorder Prevention and Treatment Strategies ADELINA COMAS-HERRERA Research Fellow London School of Economics and Political Science 9:10 a.m. Balancing Access, Value, and CNS Drug Risks:
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• Discuss the role of each stakeholder (patients, academic societies, and the private sector) in helping to implement potential policy changes to incentivize CNS drug discovery and development.
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• What actions are needed to advance CNS drug dis covery and development at a policy level? ROBERT ARMITAGE IP Strategy and Policy Consultant Former Senior Vice President & General Counsel, Eli Lilly and Company JANET WOODCOCK Director, Center for Drug Evaluation and Research Food and Drug Administration GEORGE VRADENBURG Chairman, Founding Board Member USAgainstAlzheimer's 11:55 a.m.
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Dana Foundation • Katie Sale, Executive Director, American Brain Coalition • Paul Summergrad, President, American Psychiatric Association; Tufts University School of Medicine 2:00 p.m. Next Steps: The Potential Role of Patient or Disease Advocacy Groups to Advance Policy-Based Incen tives for CNS Drug Discovery and Development Moderator: Margaret Anderson, Executive Director, FasterCures Panelists: • Brian Fiske, Vice President, Research Programs, The Michael J
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From page 77... ...
Closing Remarks DENNIS CHOI, Workshop Co-Chair Professor and Chair, Department of Neurology, School of Medicine Director, Neurosciences Institute Stony Brook University TIMOTHY COETZEE, Workshop Co-Chair Chief Advocacy, Services, and Research Officer National Multiple Sclerosis Society 4:45 p.m.
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