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Breakthrough Business Models - Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary (Paperback, New)
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Breakthrough Business Models - Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary (Paperback, New)
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The process for developing new drug and biologic products is
extraordinarily expensive and time-consuming. Although large
pharmaceutical companies may be able to afford the cost of
development because they can expect a large return on investment,
organizations developing drugs to treat rare and neglected diseases
are unable to rely on such returns. On June 23, 2008, the Institute
of Medicine's Forum on Drug Discovery, Development, and Translation
held a public workshop, "Breakthrough Business Models: Drug
Development for Rare and Neglected Diseases and Individualized
Therapies," which sought to explore new and innovative strategies
for developing drugs for rare and neglected diseases. Table of
Contents Front Matter 1 Introduction and Overview 2 Current Model
for Financing Drug Development: From Concept Through Approval 3 The
Food and Drug Administration's Orphan Drug Program 4 Diverse
Funding Models 5 Strategies for Facilitating Sharing of Research
Materials and Data 6 Strategies for Navigating Intellectual
Property 7 Strategies for Facilitating Clinical Trials 8 Summary
References Appendix A: Agenda Appendix B: Speaker Biographies
Appendix C: Resources
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