Breakthrough Business Models:

Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary

Status: Available Now

Size: 150 pages, 6 x 9

Publication Year:2008

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PAPERBACK ISBN-10: 0-309-12088-8 ISBN-13: 978-0-309-12088-3	$36.00	Add to Cart

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Authors:
Theresa Wizemann, Sally Robinson, and Robert Giffin, Forum on Drug Discovery, Development, and Translation, Institute of Medicine
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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 ...
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Table of Contents
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Front Matter	i-xviii
1 Introduction and Overview	1-6	(skim)
2 Current Model for Financing Drug Development: From Concept Through Approval	7-11	(skim)
3 The Food and Drug Administration's Orphan Drug Program	12-18	(skim)
4 Diverse Funding Models	19-41	(skim)
5 Strategies for Facilitating Sharing of Research Materials and Data	42-54	(skim)
6 Strategies for Navigating Intellectual Property	55-81	(skim)
7 Strategies for Facilitating Clinical Trials	82-97	(skim)
8 Summary	98-103	(skim)
References	104-105	(skim)
Appendix A: Agenda	106-112	(skim)
Appendix B: Speaker Biographies	113-127	(skim)
Appendix C: Resources	128-132	(skim)

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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.

Breakthrough Business Models:

Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary

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