Stimulating Medical Innovation HHS Task Force

1
Stimulating Medical InnovationHHS Task Force

• Larry Kessler, Sc.D.
• Task Force Executive Director
• Director, Office of Science and Engineering
  Laboratories,
• CDRH, FDA

2
Task Force Goals

• Weigh new ideas and promote new solutions to
  encourage innovation in health care and to speed
  the development of effective new medical
  technologies, such as drug and biological
  products and medical devices
• Will issue a report this year on appropriate
  steps that can be taken across the department to
  speed the development and availability of new
  medical technologies

3
Task Force Members

• Chair Lester M. Crawford, D.V.M., Ph.D.,
  Commissioner of Food Drugs (Actg)
• Principal Members
• Elias Zerhouni, M.D., Director, National
  Institutes of Health
• Mark B. McClellan, M.D., Ph.D., Director, Centers
  for Medicaid Services
• Julie Gerberding, M.D., Director, Centers for
  Disease Control Prevention
• Andrew Von Eschenbach, M.D., Director, National
  Cancer Institute, NIH

4
Task Force Workers

• Larry Kessler, Sc.D., FDA, Executive Director
• Nancy Stanisic, FDA, Project Manager
• Howard Zucker, OS, Point of Contact
• Tom Kuchenberg, OS
• Daniel Sullivan, NCI/NIH
• Vadim Lubarsky, CMS
• Shana Christrup, CDC
• Elise Berliner, AHRQ
• Angela Hight-Walker, NIST

5
Two Approaches

• Find ways in which HHS Agencies can better
  coordinate efforts to speed technology from
  discovery to delivery these should complement
  the FDA Critical Path, NIH Roadmap, other
  initiatives
• Locate other non-HHS Agencies that play a
  significant role in the development of cutting
  edge medical technology and improve collaboration
  with HHS

6
Selected Ideas from the Docket

• Facilitating biomarker development
• More informative development programs and data
• Streamlining HHS involvement in technology
  (replicate ICBIO model)
• Facilitate In Vitro Diagnostic Development
• Facilitate Antibiotic Development
• Cross Training Technology Transfer in HHS

7
Organizations for Collaboration

• National Institute on Standards and Technology
  (NIST)
• Defense Science Office (DARPA)
• Telemedicine and Advanced Techonlogy Research
  Center (TATRC)
• National Science Foundation (NSF)
• National Institute on Disability and
  Rehabilitation Research (NIDRR Dept Ed)
• Veterans Administration (VA)