Fostering Innovation – The Role of the Federal Government/NIH in our Future

1. Fostering Innovation –The Role of the Federal Government/NIH in our Future BME – Innovation, Design, and Entrepreneurship Alliance Meeting September 28, 2005 Roderic I. Pettigrew, Ph.D., M.D. Director National Institute of Biomedical Imaging and Bioengineering

2. Fostering Innovation at NIH • Majority of applications received by NIH are investigator-initiated applications • Investigator-initiated grants are the cornerstone of NIH research – many great ideas come from the investigators • Research can be focused on an area of interest / opportunity through NIH initiatives

3. Fostering Innovation at NIH • Majority of applications received by NIH are investigator-initiated applications • Investigator-initiated grants are the cornerstone of NIH research – many great ideas come from the investigators • Research can be focused on an area of interest / opportunity through NIH initiatives

4. Fostering Innovation at NIH Review criteria for NIH study sections includes: • Significance -Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? • Approach -Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? • Innovation - Is the project original and innovative, e.g., does it challenge existing paradigms or clinical practice or address an innovative hypothesis or critical barrier to progress in the field? Does it develop or use novel concepts? • Investigator -Are the investigators appropriately trained and well suited to carry out this work? Is the work appropriate to the experience level of the PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project, if applicable? • Environment -Does the scientific environment in which the work will be done contribute to the probability of success? Do the studies benefit from unique features of the scientific environment or subject populations or include useful collaborative arrangements? Is there evidence of institutional support?

5. Fostering Innovation at NIH • Majority of applications received by NIH are investigator-initiated applications • Investigator-initiated grants are the cornerstone of NIH research – many great ideas come from the investigators • Research can be focused on an area of interest / opportunity through NIH initiatives

6. HHMI – NIBIB Interface Initiative for Interdisciplinary Graduate Research Training January 10, 2005 Illustration: Randy Lyhus Channel image: Courtesy of Rapoport Laboratory

7. Fostering Innovation Training at the Interface GOALS: • Attracting quantitative scientists to careers in biomedical research • Interfacing clinicians and basic researchers in quantitative sciences • To speed translation from basic technology to clinic

8. HHMI-NIBIB Interfaces Initiative For Interdisciplinary Graduate Research Training HHMI NIBIB Phase I Phase II ~10 Awards Tomorrow’s Program Development Student Support Scientist 3 yr 5 yr Other Institutions

9. Illustration: Randy Lyhus Channel image: Courtesy of Rapoport Laboratory

10. NIH Roadmap for Medical Research ACCELERATING MEDICAL DISCOVERY TO IMPROVE HEALTH www.nihroadmap.nih.gov

11. NIH Roadmap Goals • Accelerate basic research discoveries and speed translation of those discoveries into clinical practice • Explicitly address roadblocks that slow the pace of medical research in improving the health of the American people

12. New Pathways to Discovery Re-engineering the Clinical Research Enterprise Research Teams of the Future NIH RoadmapThree Themes

13. NIH RoadmapNIH Director’s Pioneer Award Goals: • Encourage highly innovative biomedical research with the great potential to lead to significant advances in human health • Complement NIH’s traditional, investigator-initiated grant programs • Support highly creative and pioneering people Criteria: • Evidence of scientific innovation and creativity • Testimony of intrinsic motivation, enthusiasm and intellectual energy • Potential for scientific leadership and evidence of, or potential for, effective communication skills

14. NIH RoadmapMolecular Libraries and Imaging RFA: Innovation in Molecular Imaging Probes • Encourages the development of new probes that will achieve one or two orders of magnitude (i.e., a factor of 10 to 100) improvement in the ability to detect and imaging specific molecular events in vivo • Potential for clinical applications • Solicits pilot and feasibility studies that explore novel and untested “high-risk” approaches • Encourages a team approach

15. Fostering InnovationNIBIBQuantum Projects • Definition – Highly-focused, collaborative research and development projects that require technological approaches and will result in significant (quantum) improvements in healthcare in 7-10 years. • Phase 1 – Exploratory Grants - Make 5-7 three-year exploratory grants to (l) assemble team, (2) develop research plan and infrastructure, (3) prepare detailed proposal, and (4) demonstrate capabilities. RFA in late 2005, awards in late 2006. • Phase 2 – Establishment Grants – Make large-scale grants to conduct focused research and development projects. Awards in late 2009. • Strategy – Investigators identify focus areas, collaborations with appropriate NIH IC’s, Industry

16. Fostering InnovationNew Investigators - NIH NIH K22/R22 Career Transition Program • Problem: Increasing gap between Postdoc training to fully independent research.* • Strategies: (a) facilitate ability to receive first R01, and (b) maintain a healthy cohort of “new investigators” • Plan: Standardized transition program across NIH: 1-2 years of mentored support, followed by 1-3 years of independent support contingent on securing an independent research position * Recent reports: (1) NRC Report, "Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research" (2005), and (2) NRC Report, "Advancing the Nation's Health Needs: NIH Research Training Programs (2005).

17. Fostering InnovationNew Investigators NIBIB Activities • Funding of New Investigators with priority scores within 5 percentile points of the stated pay line in any given year • Grant Writing Workshops at various meetings and as separate activity

18. NIBIB FY 2005 R01 Pay Line* NIBIB Pay Line for FY 2005 at the 20th Percentile New Investigator Pay Line for FY2005 at the 25th Percentile Policy Impact - Total Number of Awards to New Investigators: 17 new investigators funded at 20th Percentile 5 new investigators funded between 20th and 25th Percentile *Estimate as of September 14, 2005

20. NIH RoadmapNIH Director’s Pioneer Award Criteria: • Evidence of scientific innovation and creativity • Testimony of intrinsic motivation, enthusiasm and intellectual energy • Potential for scientific leadership and evidence of, or potential for, effective communication skills

21. Fostering InnovationTraining at the Interface • Phase I: FY 2005-08 (funded by HHMI): • Facilitate the design, initiation & development of new interdisciplinary programs • Can support current or new faculty salary, administrative staff,building modifications, recruitment of new students, student stipends, tuition, health insurance, and travel • Up to a total of 10 awards in years 1 and 2 • Review to be coordinated with NIBIB • One award per institution, 3 years non-renewable • Phase II FY 2008-12 (funded by NIBIB): • Sustain the programs via traditional T32 grants • Limited competition RFA for recipients of Phase I awards • Up to 10 training programs, each supporting 8-10 students per year • Consistency of review panel members for phase I and II • One award per institution, 5 years renewable

22. Fostering InnovationResidency Supplements NIBIB Research Supplements to Promote Clinical Resident Research Experiences - PAR-04-140, August 2004 • 1-2 year period of research experience for physicians in a residency program through supplements to existing NIBIB grants • PIs holding an active R01, R37, P01, P41, or P50 from the NIBIB may apply for this program • A candidate must have a health professional degree (M.D. or equivalent) and be currently enrolled in an accredited clinical residency or fellowship training program in the U.S. • Additional Receipt Dates: NOT-EB-05-006, May 2005. October 21, 2005, and February 21, 2006

23. Fostering InnovationTraining at the Interface HHMI-NIBIB InterdisciplinaryResearch Training Program Partnership Purpose: Support the creation and development of new graduate training programs that integrate biomedical sciences with the physical and computational sciences or mathematical disciplines Goal: Develop a cadre of Ph.D. scientists who are trained to conduct interdisciplinary research at the boundaries between the biomedical and physical, computational, and mathematical disciplines

24. NIH Mission Science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability

25. Mission Improve human health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. Vision We will profoundly change health care. NIBIB will push the frontiers of technology to make the possible a reality.