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.

Contents

• THE NATIONAL ACADEMIES
• PLANNING COMMITTEE ON FINANCIAL INCENTIVES TO SUPPORT UNMET MEDICAL NEEDS FOR NERVOUS SYSTEM DISORDERS
• FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS
• FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
• Reviewers
• 1. Introduction and Overview
  • WORKSHOP OBJECTIVES
  • ORGANIZATION OF THE REPORT
  • UNMET MEDICAL NEEDS IN NERVOUS SYSTEM DISORDERS
  • TOPICS HIGHLIGHTED DURING PRESENTATIONS AND DISCUSSIONS
• 2. Improving Market Protection
  • HOW COMPANIES MAKE DECISIONS
  • BUSINESS IMPLICATIONS OF THE STAGNANT R&D CLIMATE FOR CNS DRUGS
  • OVERVIEW OF THE CURRENT INTELLECTUAL PROPERTY (IP) ENVIRONMENT FOR THE PRIVATE SECTOR
  • LEGISLATION ESTABLISHING MARKET PROTECTION PERIODS
  • POTENTIAL NEW APPROACHES TO EXTENDING MARKET PROTECTION
  • OPPORTUNITIES TO INCENTIVIZE R&D THROUGH IMPROVED MARKET PROTECTION
• 3. Strengthening the Regulatory Pathway
  • DRUG DEVELOPMENT: A REGULATORY VIEWPOINT
  • REGULATORY CHALLENGES SPECIFIC TO CNS DISORDERS
  • POTENTIAL MECHANISMS TO ADDRESS REGULATORY CHALLENGES
  • CLARITY OF REGULATORY PROCESSES AND DECISIONS
  • REIMBURSEMENT: THE DECISION-MAKING PROCESS
  • OPPORTUNITIES TO INCENTIVIZE R&D BY STRENGTHENING REGULATORY PATHWAYS
• 4. Patient Benefit and Engagement
  • PATIENT INVOLVEMENT: UNDERSTANDING RISKS AND BENEFITS
  • DETERMINING VALUE TO PATIENTS
  • CREATIVELY ENGAGING PUBLIC−PRIVATE PARTNERSHIPS, ADVOCACY GROUPS, AND NONPROFIT HEALTH ORGANIZATIONS
  • OPPORTUNITIES TO ENCOURAGE PATIENT INVOLVEMENT IN THE DRUG DEVELOPMENT PROCESS
• APPENDIXES
  • A References
  • B Workshop Agenda
  • C Registered Attendees
  • D Participant Biographies

Rapporteurs: Sheena M. Posey Norris, Evelyn Strauss, Christopher DeFeo, and Clare Stroud.

This project was supported by contracts between the National Academy of Sciences and AbbVie; the Alzheimer's Association; American Diabetes Association; American Society of Microbiology; Amgen Inc. (Contract No. GHCCOPS-CSARF-63987); Association of American Medical Colleges; AstraZeneca; Baxter BioScience; Brain Canada Foundation; Burroughs Wellcome Fund (Contract No. 1015149); Critical Path Institute; the Department of Health and Human Services' Food and Drug Administration (Contract No. 1R13FD005154-01) and National Institutes of Health (NIH, Contract Nos. HHSN26300026 and HHSN263201200074I, Task Order HHSN26300023 [Under Master Base #DHHS-10001292]) through the National Cancer Institute, National Center for Advancing Translational Sciences, National Center for Complementary and Integrative Health, National Eye Institute, National Institute of Allergy and Infectious Disease, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and NIH Blueprint for Neuroscience Research; Department of Veterans Affairs (VA240-14-C-0057); Doris Duke Charitable Foundation (Contract No. 2015103); Eli Lilly and Company; FasterCures; Foundation for the National Institutes of Health; Friends of Cancer Research; the Gatsby Charitable Foundation; GlaxoSmithKline, Inc. (Contract No. 005319); Johnson & Johnson Pharmaceutical Research and Development, LLC; Lundbeck Research USA; Merck & Co., Inc. (Contract No. CMO-141224-000649); The Michael J. Fox Foundation for Parkinson's Research; the National Multiple Sclerosis Society; the National Science Foundation (Contract No. BCS-1064270); New England Journal of Medicine; One Mind for Research; Orion Bionetworks; Pfizer Inc.; Pharmaceutical Product Development, LLC; Sanofi; the Society for Neuroscience; Takeda Pharmaceutical Company Limited (Contract No. 53108); and Wellcome Trust. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for this project.

Suggested citation:

IOM (Institute of Medicine). 2015. Financial incentives to encourage development of therapies that address unmet medical needs for nervous system disorders: Workshop summary. Washington, DC: The National Academies Press.

NOTICE: The workshop that is the subject of this workshop summary was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.