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E-raamat: Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders: Workshop Summary

  • Formaat: 128 pages
  • Ilmumisaeg: 22-Oct-2015
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309373241
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  • Formaat: 128 pages
  • Ilmumisaeg: 22-Oct-2015
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309373241
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The Institute of Medicine (IOM) Forum on Neuroscience and Nervous System Disorders, in collaboration with the IOM Forum on Drug Discovery, Development, and Translation, convened a workshop on January 20-21, 2015, to explore policy changes that might increase private sector investment in research and development innovation that fills unmet medical needs for central nervous system (CNS) disorders. Workshop participants strategized about how to incentivize companies to fortify their CNS drug development programs, shrinking obstacles that currently deter ventures. Representatives from academia, government agencies, patient groups, and industry gathered to share information and viewpoints, and to brainstorm about budget-neutral policy changes that could help widen the pipeline toward drugs that address unmet needs for CNS disorders. This report summarizes the presentations and discussion of the workshop.

Table of Contents



Front Matter 1 Introduction and Overview 2 Improving Market Protection 3 Strengthening the Regulatory Pathway 4 Patient Benefit and Engagement Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees Appendix D: Participant Biographies
1 Introduction and Overview
1(12)
Workshop Objectives
2(3)
Organization of the Report
5(1)
Unmet Medical Needs in Nervous System Disorders
5(5)
Topics Highlighted During Presentations and Discussions
10(3)
2 Improving Market Protection
13(18)
How Companies Make Decisions
14(4)
Business Implications of the Stagnant R&D Climate for CNS Drugs
18(1)
Overview of the Current Intellectual Property (IP) Environment for the Private Sector
18(2)
Legislation Establishing Market Protection Periods
20(4)
Potential New Approaches to Extending Market Protection
24(4)
Opportunities to Incentivize R&D Through Improved Market Protection
28(3)
3 Strengthening the Regulatory Pathway
31(20)
Drug Development: A Regulatory Viewpoint
32(3)
Regulatory Challenges Specific to CNS Disorders
35(3)
Potential Mechanisms to Address Regulatory Challenges
38(4)
Clarity of Regulatory Processes and Decisions
42(4)
Reimbursement: The Decision-Making Process
46(2)
Opportunities to Incentivize R&D by Strengthening Regulatory Pathways
48(3)
4 Patient Benefit and Engagement
51(10)
Patient Involvement: Understanding Risks and Benefits
52(2)
Determining Value to Patients
54(4)
Creatively Engaging Public-Private Partnerships, Advocacy Groups, and Nonprofit Health Organizations
58(1)
Opportunities to Encourage Patient Involvement in the Drug Development Process
59(2)
APPENDIXES
A References
61(4)
B Workshop Agenda
65(14)
C Registered Attendees
79(8)
D Participant Biographies
87