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E-raamat: Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop

  • Formaat: 102 pages
  • Ilmumisaeg: 27-Jan-2020
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309498517
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  • Formaat: 102 pages
  • Ilmumisaeg: 27-Jan-2020
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309498517

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To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24-25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Table of Contents



Front Matter Proceedings of a Workshop Appendix A: Statement of Task Appendix B: Workshop Agenda
Acronyms And Abbreviations xv
Proceedings Of A Workshop
1(1)
Overview Of The Workshop
1(2)
The Translational Research Landscape
3(16)
Bridging the Valley of Death
8(1)
Eroom's Law
9(5)
Translational Science: Increasing Efficiency, Decreasing Failure
14(2)
NCATS Rare Disease Research Programs
16(1)
Models for Drug Discovery
17(1)
Moving Forward
18(1)
Federal Biomedical Research Funding And New Drug Development
19(12)
Perspectives on the Federal Role in Advancing Drug Development Innovation
19(3)
Accounting for Public Funding in Drug Pricing
22(1)
Direct and Indirect Effects of Public-Sector Funding on Drug Development
23(3)
Gauging the Returns on Federally Funded Basic Research
26(2)
Quantifying the Impact of Targeted, Disease-Specific NIH Extramural Funding
28(2)
Improving Data Resources
30(1)
Reforming the Patent System
30(1)
Impact Of Patent And Technology Transfer Policies On Nih-Funded Innovation
31(11)
Patent-Eligible Subject Matter in Biomedical Research and Development
33(2)
Technology Transfer at U.S. Academic Institutions
35(1)
March-In Rights
36(2)
Stakeholder Feedback on the Technology Transfer Process
38(2)
Interpreting the Bayh-Dole Act
40(2)
Standardizing the Licensing Process
42(1)
The Economics Of Drug Pricing
42(15)
Pricing and Reimbursement of Pharmaceuticals in the United States
43(5)
Consumer Perspective on Prescription Drug Price Trends
48(2)
Providing Access and Value for Low-Income Persons with Complex Medical Needs
50(2)
Financing Antibacterial Drug Discovery and Development
52(5)
Strategies And Policies To Facilitate Translation
57(9)
Reducing Risks and Costs and Improving Returns in Drug Development
58(1)
Meeting U.S. Department of Defense Medical Support Needs
59(1)
C-Path: Collaborating to Accelerate Medical Product Development
60(1)
Repurposing Compounds for New Therapeutic Uses
61(1)
Infrastructure for Drug Development Innovation
62(1)
Partnering for Translational Research Success
63(3)
Additional Strategies to Facilitate Translation
66(1)
Potential Policies To Ensure Affordable Access
66(10)
Pricing of Taxpayer-Funded Drugs
67(3)
Improving System Performance and Supporting Emerging Innovative Companies
70(6)
References 76(3)
Appendix A Statement Of Task 79(2)
Appendix B Workshop Agenda 81