Breakthrough Business Models Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary (2009) / Chapter Skim
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Appendix A: Agenda
Appendix A: Agenda
Pages 106-112
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From page 106... ...
• Discuss new models for funding translational research and new technologies and consider their impact on the process. • Examine regulatory, legislative, and institutional policy tools cur rently in place to help advance therapeutic development for rare or neglected diseases and individualized therapies, and discuss whether these tools are adequate or whether new ones are needed in light of these new funding models.
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From page 107... ...
• Are federal regulatory policies adequate for helping speed develop ment and approval of drugs for rare diseases? Moderator: imothy Coetzee T Executive Director Fast Forward, LLC 9:10 OneWorld Health: A Not-for-Profit Pharmaceutical Company Victoria Hale Founder and Chair of the Board of Directors Institute for OneWorld Health 9:25 Cystic Fibrosis Foundation Therapeutics' Pipeline Approach to CFTR Drug Discovery and Development Diana Wetmore Vice President of Alliance Management Cystic Fibrosis Foundation Therapeutics
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From page 108... ...
Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases Eli Lilly and Company Marlene Haffner (Drug Forum Member) Executive Director, Global Regulatory Intelligence and Policy Amgen Mark Batshaw Chief Academic Officer Children's National Medical Center Chaitan Khosla Professor, Departments of Chemistry, Chemical Engineering, and Biochemistry Stanford University Doug Onsi Venture Partner HealthCare Ventures Q&A 11:15 Break
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From page 109... ...
• Are federal regulatory policies adequate for helping speed develop ment and approval of drugs for rare diseases? Moderator: argaret Anderson M Chief Operating Officer FasterCures 11:35 Agreements for Research and Materials Sharing Michael Mowatt Director, Office of Technology Development National Institute of Allergy and Infectious Diseases, NIH 11:50 The Alzheimer's Disease Neuroimaging Initiative (ADNI)
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From page 110... ...
• Which novel strategies have been implemented in recent years to manage intellectual property in light of new funding models? Moderator: nthony So A Professor of the Practice of Public Policy Studies Director, Program in Global Health and Technology Access Terry Sanford Institute of Public Policy, Duke University 1:45 Creating an Enabling Intellectual Property Environment for Neglected and Rare Diseases Anthony So 2:05 Innovation in Alliances and Licensing: Transforming Now for the Future Craig Sorensen Senior Director, Strategic Research Alliances Vertex Pharmaceuticals Incorporated 2:25 Accelerating Intellectual Property Sharing to Facilitate Translation Rusty Bromley Chief Operating Officer Myelin Repair Foundation
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From page 111... ...
Moderator: tephen Groft (Drug Forum Member) S Director, Office of Rare Disease Research National Institutes of Health 4:05 FDA Review and Regulation of Small Clinical Trials: Successes, Barriers, and Directions for the Future Anne Pariser Medical Team Leader, Inborn Errors of Metabolism Team Division of Gastroenterology Products Center for Drug Evaluation and Research U.S.
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From page 112... ...
112 BREAKTHROUGH BUSINESS MODELS 4:35 Maximizing Your Assets in Clinical Trials: Economies of Scale and Standardization Sharon Hesterlee Vice President, Translational Research Muscular Dystrophy Foundation Q&A 5:15 Session 5: Recap of Key Points Made Throughout the Day Enriqueta Bond President Burroughs Wellcome Fund 5:30 Adjourn
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