Breakthrough Business Models

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

Sally Robinson author Institute of Medicine author Board on Health Sciences Policy author Forum on Drug Discovery, Development, and Translation author Theresa Wizemann author Robert Giffin author

Format:Paperback

Publisher:National Academies Press

Published:17th Mar '09

Currently unavailable, and unfortunately no date known when it will be back

Breakthrough Business Models cover

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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ISBN: 9780309120883

Dimensions: unknown

Weight: unknown

150 pages