Excerpt

This public workshop considered options and opportunities to maximize the usefulness and impact of the Cures Acceleration Network (CAN) program in order to advance translational sciences. The workshop objectives were to:

• Identify and catalog potential tools, methods, and approaches that hold promise for accelerating translational science.

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  Consideration of such promising approaches will draw from the experiences of existing activities at other federal agencies related to the goals of CAN—for example, FDA, the U.S. Centers for Disease Control and Prevention (CDC), and the Agency for Healthcare Research and Quality (AHRQ).

• Discuss the authorities conferred to CAN and identify strategies for effectively using those authorities.

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  Consideration of the CAN authorities will specifically explore the flexible research, or “other transaction,” authority and will reference existing efforts in which such authority is currently applied across other federal agencies—for example, DARPA, the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA).

• Explore promising models for public–private collaborations that could be strengthened or facilitated by activities under CAN.

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  Discuss barriers to such collaborations and identify opportunities and potential solutions for moving past the identified barriers.

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  Discuss the respective roles of multiple sectors, including, for example, the pharmaceutical and biotechnology industries, venture capital and private equity, and patient advocacy groups.

• Identify barriers and potential solutions to facilitate coordination of activities under CAN with the FDA regulatory review process and timelines.

Contents

• THE NATIONAL ACADEMIES
• PLANNING COMMITTEE FOR THE WORKSHOP ON MAXIMIZING THE GOALS OF THE CURES ACCELERATION NETWORK TO ACCELERATE THE DEVELOPMENT OF NEW DRUGS AND DIAGNOSTICS
• FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
• Reviewers
• Acronyms
• 1. Introduction
  • THE HISTORY AND GOALS OF CAN
  • The History of CAN
  • OVERVIEW OF THE THEMES OF THE WORKSHOP
• 2. Approaches to Accelerating Translational Science
  • CYSTIC FIBROSIS AND THE NEED FOR PARTNERSHIPS
  • ALZHEIMER’S DISEASE AND THE DRUG DEVELOPMENT ECOSYSTEM
  • NUT MIDLINE CARCINOMA AND OPEN INNOVATION
  • SICKLE CELL ANEMIA AND THE NEED FOR HEDGEHOGS
  • LEUKEMIA AND LYMPHOMA AND THE NEED FOR PARTNERSHIPS
  • CROSS-CUTTING ISSUES
• 3. Application of Matching Authority
  • THE SMALL BUSINESS INNOVATION RESEARCH PROGRAM AT THE NATIONAL CANCER INSTITUTE
  • THE MATCHING REQUIREMENT AT THE CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS
  • THE MATCHING REQUIREMENT AT THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE
  • PERSPECTIVES OF MATCHERS
• 4. Application of Flexible Research Authority
  • OTA AT DARPA
  • ARPA-E AT THE DEPARTMENT OF ENERGY
  • PROMOTING AN EFFECTIVE MEDICAL COUNTERMEASURES ENTERPRISE AT BARDA
  • OTA AT DTRA
  • COLLABORATION AT THE CHDI FOUNDATION
• 5. Situating CAN Within the Drug Development Ecosystem
  • FDA
  • THE OFFICE OF SCIENCE AND TECHNOLOGY POLICY
  • THE PHARMACEUTICAL INDUSTRY
  • PUBLIC–PRIVATE PARTNERSHIPS
  • TOOLS AND CURES
• 6. Final Reflections on Ways to Maximize the Goals of CAN
  • RESPONDING TO FRUSTRATION
  • A RALLYING CRY
  • MASTERING THE DETAILS
  • BEYOND ROCKET SCIENCE
  • CHANGING THE CULTURE AND SHOWING DELIVERABLES
  • “THE STATUS QUO IS NOT ACCEPTABLE”
• References
• APPENDIXES
  • Appendix A Workshop Agenda
  • Appendix B Public Health Service Act, Title IV—National Institutes of Health
  • Appendix C Participant Biographies

Rapporteurs: Steve Olson, Anne B. Claiborne

This study was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and HHSF223001003T), Abbott Pharmaceuticals, American Diabetes Association, American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly & Co., FasterCures, Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Janssen Research & Development, LLC, March of Dimes Foundation, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, and Pfizer Inc.

Suggested citation:

IOM (Institute of Medicine). 2012. Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary. Washington, DC: The National Academies Press.

The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the project.

NOTICE: The project that is the subject of this report 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.