NIH Career Development Awards Workshop

1. NIH Career Development Awards Workshop NIH Career Transition Awards: Enabling Your Success Joan M. Lakoski, Ph.D.University of Pittsburgh Vanderbilt University Medical Center November 16, 2006

2. NIH Career Transition Awards GOAL: • To provide guidance on applications for NIH career development (“K”) awards of relevance to basic scientists, including the NIH Pathway to Independence (K99/R00) Award

3. Workshop Objectives By the completion of this session, participants should be able to • Choose the appropriate type of K Award for their career stage & situation. • Complete an application for a NIH career transition award. • Submit an application using strategies for a successful grant proposal.

4. Workshop Overview • Navigating NIH • Inside the Study Section Process • Anatomy of an Application • 15 Steps to the Payline • Questions & Discussion

5. NIH Career Transition Awards Understanding NIH http://www.nih.gov/about/maps.html

6. Navigating NIH • Structure of NIH • Grant reviews • The Study Section Poster by L. Azzinarohttp://www.nih.gov/od/museum/exhibits/history/

7. National Institutes of Health (NIH) • Agency of the US Public Health Service • Mission: research, training, education • 19 Institutes + other components • Director: Elias Zahouni, M.D. • Budget (FY06) = $28,845 million

8. National Institutes of Health (NIH) Functional Divisions: Intramural Research Program • research within NIH Institutes: ~10% budget • administration & support: ~9% budget Extramural Research Program • external research & training: ~81% budget

9. NINDS — a typical Institute National Institute of Neurological Diseases & Stroke (NINDS) Advisory Council: • oversees institute Division of Intramural Research: • NINDS research labs in Bethesda Division of Extramural Research: • grants & contracts for external research

10. NINDS — a typical Institute Division of Extramural Research: • organized into Programs • each responsible for an area of research • Program Officers: • administer funded grants in their area Cultivating the interest and support of program officers is essential!

11. NIH — Extramural Support Research Project Grants (~50% budget): R01: single investigator P01: Program Project Other Types: Center Grants: 9% budget Contracts: 9% budget

12. NIH — Career Development Awards K Awards: • support for career development • ~ 2% budget: $624 million (FY06) • wide range of types: • currently 14 (K01-K99) • for clinicians & basic scientists • for junior & senior faculty

13. NIH: grant/career timeline post doc resident juniorfaculty seniorfaculty student training: F31 F32 K Awards (career dev) research: R01 P01

14. K Awards Why should you be interested? • K awards: • foster basic, clinical & patient-oriented research • provide partial funding for salaries

15. K Awards Success Rates: all K awards

16. K Awards For mentored career development: • clinicians: K08, K23, K24 • basic scientists: K01 For career transition: • basic scientists: K02, K22 • Pathway to Independence: K99/R00

17. NIH Grants: Information General: http://www.nih.gov/grants/guide/index.html • search on mechanism of interest and applicable institute K Awards: “K kiosk” http://grants1.nih.gov/training/careerdevelopmentawards.htm

18. NIH Grants: Information Distribution of K Awards by NIH Institute Contact the appropriate Program Officer first!

19. K Awards Mentored career development: • development of junior faculty • dedicated mentor is essential for • successful application • successful outcome • clinicians & basic scientists

20. Mentored Research Scientist Award K01 IndependentScientist Award Career Transition Award K02 K22 K Awards: for basic scientists Independentinvestigator Faculty —> Postdoc. Ph.D.

21. potential for productive independent research mentor with extensive research experience 75% effort over 3-5 years differences among Institutes K Awards for basic scientists K01: Mentored Research Scientist Award — career development in a new area of research images © 2002 www.arttoday.com

22. salary support for newly independent scientists must have peer-reviewed research support 75% effort for 5 years K Awards for basic scientists K02: Independent Scientist Award — develop career of funded scientists images © 2002 www.arttoday.com

23. potential for productive independent research differences among Institutes: may involve training in intramural NIH programs K Awards for basic scientists K22: Career Transition Award — support for postdoctoral fellows in transition to faculty positions images © 2002 www.arttoday.com

24. K Awards for basic scientists Success rates:

25. NIH Career Transition Awards NIH Pathway to Independence (PI) Award Program (PA-06-133)K99/R00 (Kangaroo) Award Designed to facilitate receiving an R01 award earlier in an investigator’s research career

26. First Major Independent Research Support Occurs at an Ever-Later Age Average Age of Initial Type 1 R01/R23/R29 Award for Different Degrees Held 45 44 44 43 42 42 M.D.-Ph.D. 41 M.D. Average age 40 40 Ph.D. 39 38 38 37 37 36 35 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 Fiscal Year For more information, see http://grants.nih.gov/grants/20040712_New_Investigator_Talk.ppt

27. Developing a Successful K99/R00 Application Overall Goal of Initiative To facilitate a new investigator’s ability to transition from a postdoctoral status to an independent scientist capable of applying for an receiving their first R01 and securing a stable research position

28. Facilitating the grant/career timeline post doc resident juniorfaculty seniorfaculty student training: F31 F32 K Awards (career dev) Combining the K and R research: R01 P01

30. K99/R00 Award • Provides up to five years of support consisting of two phases: • Initial 1-2 years of mentored support for highly promising postdoctoral research scientists (K99 Phase) • Followed by up to 3 years of independent support contingent on securing an independent research position (R00 Phase)

31. Mentored (K99) Phase • Will provide 1-2 years for mentored support for highly promising postdoctoral research scientists who have terminal clinical or research doctorates • Total cost per year up to $90,000 • This phase may be submitted on behalf of candidate by wide range, but not foreign institutions • U.S. citizens and non-U.S. citizens eligible

32. Independent Investigator (R00) Phase • Transition from K99 to R00 (years 3-5) is to be continuous in time • Activation of R00 Phase requires offer and acceptance of a tenure-track, full time assistant professor position (or equivalent) • Transition is subject to administrative review of progress and evaluation of research plan

33. Independent Investigator (R00) Phase • Application may be submitted on behalf of PI by universities etc but not Federal and foreign institutions • Total cost for independent investigator phase may not exceed $249,000 per year • Institution must demonstrate commitment to candidate (minimum 75% effort, space, etc.) • PI expected to apply for independent research grant support

34. Current Status of NIH Pathway to Independence Awards* • Number of applications received • April 7 = 445 • June 1 = 229 • Number of Awards Anticipated = 177 • Success rate = 40% * Excludes data from October 1 2006 submission deadline

35. Review Criteria:Mentored (K99) Phase • Candidate • Career development plan • Research plan • Mentor • Environment & Institutional Commitment to the Candidate • Training in Responsible Conduct of Research • Letters of Reference and Mentor(s) statements 8. Plans to Evaluate Progress

36. Comparison of K22 and K99/R00 Awards

38. Know Your K: Navigating NIH • Structure of NIH • Grant reviews • The Study Section http://www.csr.nih.gov/about/about.htm

39. 6 4 5 3 1 2 Council Program NIH Institute The Grant Triangle Investigator application funding Home Institution StudySection NIH 1. an application is initiated & prepared by an investigator 2. application is submitted to NIH through the investigator’s home institution 3. a NIH study section reviews the proposal & the score is sent to a NIH Institute 4. the Institute Council decides whether to fund the grant 5. an Institute Program sends funding for the grant to the home institution 6. the home institution administers the grant for the investigator

40. The Grant Review Process Important Concepts: • applications must be submitted from a recognized institution • each application has two independent reviews within NIH: “Dual Review” • funding goes to the investigator’s home institution not the investigator

41. The Grant Review Process Dual Review: • Study Section: • scientific merit • written review & score • Institute Council: • significance, programmatic merit • approval for funding

42. The Grant Review Process Center for Scientific Review (CSR): • independent unit within NIH • separate from Institutes • administers review panels (Study Sections) • receives & assigns applications: • to Study Sections for review • to Institutes for funding http://www.csr.nih.gov/welcome.htm

44. Know Your K: Navigating NIH • Structure of NIH • Grant reviews • The Study Section images © 2002 www.arttoday.com • http://www.csr.nih.gov/welcome.htm

45. The Study Section Members: • working scientists (~15-20) • one member serves as Chair Scientific Review Administrator (SRA) • NIH (CSR) staff person • assigns grants to reviewers, collates reviews Meetings: • 1-2 days, 3 times per year

46. The Study Section Assignments: • primary & secondary: written reviews • tertiary (“reader”): read & comment Review Criteria • defined for each application type Priority Scores: • scale: 100 (best) to 500 (worst)

47. Sequence of Review • moderated by Chair • reviewers indicate enthusiasm • primary & secondary reviewers present • tertiary reviewer comments • open discussion • members score application • SRA writes summary of discussion

48. Review Criteria:Mentored (K99) Phase • Candidate • Career development plan • Research plan • Mentor • Environment & Institutional Commitment to the Candidate • Training in Responsible Conduct of Research • Letters of Reference and Mentor(s) statements 8. Plans to Evaluate Progress

49. The Next Steps Reviews: • collated by SRA & sent to Program Officer, who sends to applicant (“pink sheets”) Payline: • determined by funding available to Institute Council: • sets payline, approves grants for funding Funding: • Notice of Award sent to applicant