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.
Institute of Medicine. 2009. Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary. Washington, DC: The National Academies Press. https://doi.org/10.17226/12219.
|1 Introduction and Overview||1-6|
|2 Current Model for Financing Drug Development: From Concept Through Approval||7-11|
|3 The Food and Drug Administration's Orphan Drug Program||12-18|
|4 Diverse Funding Models||19-41|
|5 Strategies for Facilitating Sharing of Research Materials and Data||42-54|
|6 Strategies for Navigating Intellectual Property||55-81|
|7 Strategies for Facilitating Clinical Trials||82-97|
|Appendix A: Agenda||106-112|
|Appendix B: Speaker Biographies||113-127|
|Appendix C: Resources||128-132|
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