1. Career Development Grants American College of Epidemiology Annual Meeting September 17, 2007 Faith Davis, PhD, University of Illinois at Chicago Jennifer Peel, PhD, Colorado State University

2. Career Development Awards This presentation will focus on NIH awards This presentation will focus on NIH awards Many other organizations have similar awards, e.g., Many other organizations have similar awards, e.g., American Cancer Society American Cancer Society American Lung Association American Lung Association American Heart Association American Heart Association Centers for Disease Control and Prevention Centers for Disease Control and Prevention And likely many more… And likely many more…

3. 28 th Annual American College of Epidemiology Meeting Marriott Harbor Beach Resort Ft. Lauderdale, FL. September 17, 2007 NIH Support For Research Training And Career Development in Epidemiology NCI Cancer Training Branch Lester S. Gorelic, Ph.D. Program Director, Clinical/Prevention Sciences gorelicl@mail.nih.gov

4. Interim Branch Chief: J. Carl Oberholtzer oberholtzerc@mail.nih.gov Program Directors: Lester Gorelic gorelicl@mail.nih.gov Sonia Jakowlewjakowles@mail.nih.gov Shannon Lemrowlemrows@mail.nih.gov Nancy Lohrey lohreyn@mail.nih.gov Dorkina Myrick myrickd@mail.nih.gov National Cancer Institute Cancer Training Branch (CTB) * *: cancer.gov/researchandfunding/trainin g

5. Learning Objectives Where to find information  Where to find information  What is available  What is provided  How to choose the support that best meets your needs meets your needs

6. Organization Of Presentation  Overview  Institutional programs  Individual awards  Administrative supplements  Putting it all together

7. Conventions  NIH funding mechanisms used in place of program names  Blue: NCI-specific programs  Red: Clinicians only  Caveat: Will discuss only those programs that conceivably can be used for training and CD in epidemiology. To be sure, contact the component NIH institute

8. Overview

9. Where To Find Information  Office of Extramural Research: Funding: http://grants.nih.gov/training/index.htm  Extramural (Outside of NIH):  Ruth L. Kirchstein National Research Service Awards (NRSA)  Career Development (K) Awards  Relevant links http://grants.nih.gov/training/extramural.htm http://grants.nih.gov/training/nrsa.htm http://grants.nih.gov/training/careerdevelopmenta wards.htm

10. Where To Find Information, cont’d  Office of Extramural Research: Funding:  Extramural, cont’d:  Selected programs for special populations: Research supplements to promote diversity in health-related research: http://grants.nih.gov/grants/guide/pa-files/PA-05- 015.html  Intramural (within NIH) http://www.training.nih.gov/  Individual NIH institute websites

11. Where To Find Information, cont’d  NIH Wide Initiatives: Roadmap for Biomedical Research  Provides a framework of the priorities the NIH must address in order to optimize its entire research portfolio  Focus:  New pathways to discovery  Research teams of the future  Re-engineering the clinical research enterprise  Relevant link: http://nihroadmap.nih.gov/

12. Where To Find Information, cont’d  NIH Wide Initiatives: Roadmap for Biomedical Research, cont’d  Multidisciplinary Clinical Research Career Development programs  Training an Interdisciplinary Workforce  Relevant links http://nihroadmap.nih.gov/ http://nihroadmap.nih.gov/clinicalresearch/clinicaltrainin g/futureleaders.asp http://grants.nih.gov/training/T_Table.htm

13. Institutional Programs

14. Institutional Programs Institutional Programs  Generally for individuals with a limited number of publications (if consistent with program selection criteria) or unable to obtain a strong institutional commitment to career development (pre, postdoc)  Individuals apply to an ongoing program for a “slot”  Prepares an individual to apply for an individual research career (K) award; if appointed as a predoc, a postdoc fellowship (F32); or an R-grant  Provides a training experience in biomedical research

15. Institutional Programs, cont’d Institutional Programs, cont’d  NRSA T32 & T90  Training experience in biomedical research (T32) or interdisciplinary research (T90)  NCI supports ca. 170 T32 programs, 11 focus specifically on epidemiology  K12 programs  “Physician scientist” career development programs  Roadmap initiative  NCI R25T programs  NCI supports 40 R25T programs  4 of the R25T’s specifically focus on epidemiology

16. Institutional Programs Basic provisions & requirements

17. T32 & T90 Programs  PI is an established investigator  Trainees (predoc, postdoc) must be US citizens or permanent residents (not for an NIH T90)  Requires full-time (40 hr/week) commitment

18. T32 & T90 Programs, cont’d  Up to 5 years of predoc, 3 years postdoc support is possible  Legislated stipend levels  No support for research  Institutional allowance for training expenses

19.  Two types: Clinicians only. Clinicians & postdoctoral Ph.D.’s  Provides salary and research support  Requires ≥ 75% effort commitment  May have core didactic requirements  May require multiple mentors  May have a specific research focus §  Must contact sponsoring NIH institute for specifics K12Programs K12 Programs

20. The NCI R25T Program  Curriculum-based predoc/postdoc/Jr. faculty program with required didactic and “laboratory” requirements  Requires multiple mentors for each appointee  Does not require 75% percent or full-time effort commitment  Support for curriculum development, implementation, evaluation, PI salary  Salary and research support for appointees

21. Individual Awards

22.  Fellowships (F’s) and Career Awards (K’s)  Mentored ((K01, K08), K07, K23, F31, F32)  “Transitioning” or “Cross” (K99/R00, K22’s) award  Unmentored K’s (New (K22’s) & Established)

23. Individual (K&F) Awards Individual (K&F) Awards  Not R grants  K & F’ s are for individuals who can demonstrate the need for additional training/career development before they are fully independent  R grants are for independent investigators  K & F’s focus on training or career development  R-grant focus is on research

24. Individual (K&F) Awards Individual (K&F) Awards  Not R grants, cont’d  Multiple interconnected elements  PI, sponsor (mentor), mentor’s statement §, training/career development plan (K’s), research plan, institutional commitment, environment  R grants: PI, research, environment  K’s generally reviewed at the institute level (not F’s)  Unsolicited R-grants (and F’s) are reviewed at CSR §

25. Individual Awards Individual Awards  Support a research career development experience (K’s) or research training experience (F’s)  Prepare an F32 awardee to apply for a K-award/R-grant or a K-awardee to apply for an R-grant

26. Fellowships  F’s can be used to support up to 3 years of mentored postdoc (F32) or up to 5 years (F31) of mentored predoc research training  Generally applicable to any area of biomedical research  Purpose of the F-program could be to increase the diversity of the biomedical research work force (NCI F31)

27. K-Awards  Can be used to support up to 5 years of mentored research career development leading to independent investigator status (K01, NCI K07; K08, K23)  Can be used to provide protected (unmentored) time to “new” investigators to initiate their first independent research program (K22)

28. K-Awards, cont’d  Can be used to support a mentored research experience followed by a transition to and support during an independent position (K99/R00, K22)  Individual K’s generally applicable to a specific aspect of biomedical research (viz., basic science, patient-oriented research) and research career stage

29. Individual Awards Basic Provisions & Requirements

30. Mentored Individual Awards  Fellowships: F31,F32  Need a sponsor  Need publications (not an F31)  Do not need institutional commitment  K-Awards: K01,K07, K08, K23  Postdoctoral (fellows) to junior faculty  Need a mentor  Need publications  Need strong institutional commitment

31. Mentored Individual Awards, General Provisions  Three (F32) to five year (F31, K’s) non- renewable  US Citizen or permanent resident  Require full-time (F31, F32) or at least 75% effort commitments (K’s)  Mentors  Provide stipends (F31, F32) or salaries (K’s)  Provide research support (K’s)

32. “Cross” Or “Transitioning”Awards  K22’s  Pathway to Independence Award (K99/R00)* http://grants.nih.gov/grants/new_investigators/pathway_indep endence.htm; http://grants.nih.gov/grants/guide/pa-files/PA-07-297.html  Facilitate a “seamless” transition of individuals from postdoc to independent investigator  Supports up to 1-2 years of mentored postdoctoral training (K99) followed by  Support of up to 3 years for protected time as an independent investigator to initiate first independent research program (R00) *NCI limits use to basic science research in human cancer

33. Individual Awards: Independent  NCI Transition Career Development Awards (K22)  Provides protected time (up to 3 years) to newly independent* investigators to initiate their first independent research program  NCI limits award to POR, CPCBPS;and basic science PhD’s (working in human cancer systems) in Federal intramural settings  Do not need a sponsoring institution at the time of application *: Moving from a postdoc position including a mentored K-grant to a first independent research position or ≤ 2 yrs in 1 st independent position

34. Administrative Supplements To Enhance Diversity In Biomedical Research  NIH:  Supplements to research project grants (RPG’s)  All stages in career development  Supplements to T32 grants  NCI: CURE program  NCI:  Supplements to R25T programs (CURE program)  Candidates contact the grant/program PI

35. Putting it all together

36. Continuum Of Opportunities Predoc Post/Fellow Jr.Faculty Predoc Post/Fellow Jr.Faculty Newly Independent Mentored T32 T90/R00 R25T F31 T32 T90/R00 R25T K12 F32 K07 R25T K12 K01 K07 K08 K23 K22

37. Continuum Of Opportunities Predoc Post/Fellow Jr.Faculty Predoc Post/Fellow Jr.Faculty Newly Independent Mentored T32 T90/R00 R25T F31 T32 T90/R00 R25T K12 F32 K07 R25T K12 K01 K07 K08 K23 K22

38. Continuum Of Opportunities Predoc Post/Fellow Jr.Faculty Predoc Post/Fellow Jr.Faculty Newly Independent Mentored T32 T90/R00 R25T F31 T32 T90/R00 K22 K99R00

39. Resources For Success Rates T32’s : 1996-2006: http://grants.nih.gov/grants/award/training/tra in9606.htm K-awards: up to 2005: http://grant.nih.gov/training/data/rcpsucc.xls

40. 28 th Annual American College of Epidemiology Meeting Marriott Harbor Beach Resort Ft. Lauderdale, FL. September 17, 2007 NIH Support For Research Training And Career Development in Epidemiology NCI Cancer Training Branch Lester S. Gorelic, Ph.D. Program Director, Clinical/Prevention Sciences gorelicl@mail.nih.gov

41. Training and Career Development Awards for Pre-Docs, Post-Docs and Junior Faculty Lynda Lisabeth University of Michigan Departments of Epidemiology and Neurology

42. Background PhD in Epidemiology (2003) PhD in Epidemiology (2003) Joined neurology faculty in 2003 Joined neurology faculty in 2003 K23 K23 National Institute for Neurologic Disorders and Stroke (NINDS) National Institute for Neurologic Disorders and Stroke (NINDS) September 2005 – May 2010 September 2005 – May 2010 Stroke population Stroke population In-person interviews In-person interviews Blood draws Blood draws

43. Feedback from Reviewers Piggy backed on R01 Piggy backed on R01 Mechanisms in place Mechanisms in place Clear mentoring plan (frequency of meetings, information on past trainees, etc.) Clear mentoring plan (frequency of meetings, information on past trainees, etc.) Multiple mentors Multiple mentors Commitment to other projects Commitment to other projects ≥75% effort ≥75% effort Overlap with ongoing studies – uniqueness Overlap with ongoing studies – uniqueness

44. Feedback from Reviewers Travel – on-site research, scientific meetings Travel – on-site research, scientific meetings Career development plan – mix theoretical, hands on experience and coursework Career development plan – mix theoretical, hands on experience and coursework Support from Department Chair Support from Department Chair Research space, start-up funds Research space, start-up funds

45. Lessons Learned High scientific interest, unique study population, need for well trained researchers High scientific interest, unique study population, need for well trained researchers Contact Project Officer Contact Project Officer Prior to submitting grant Prior to submitting grant Copy grant to PO at time of submission Copy grant to PO at time of submission Review successful K grant applications Review successful K grant applications Preliminary data Preliminary data Feasibility of proposed research Feasibility of proposed research

46. Lessons Learned Detailed career development plan Detailed career development plan Discuss Reviewer comments with PO (conference call), include mentor on call Discuss Reviewer comments with PO (conference call), include mentor on call Publication track record Publication track record Number of publications Number of publications Topic of K award Topic of K award

47. Training and Career Development Awards for Pre-Docs, Post-Docs and Junior Faculty Charlotte Joslin University of Illinois at Chicago Department Ophthalmology and Visual Science Division of Epidemiology, School of Public Health

48. Background K23 Award, National Eye Institute (NEI) –September 2004 – August 2009 Clinical research background –Mostly a clinician (70% time in clinic) –NEI-sponsored prospective cohort study: institution Co- Investigator –FDA clinical trials: institution PI and Co-Investigator –Industry sponsored research K23 Award –PhD in epidemiology –Determining corneal and intraocular lens power in post-LASIK eyes needing cataract surgery and intraocular lens implant

49. Feedback from Reviewers 1. Candidate and Career Development Plan –Demonstrate productivity and research potential: papers, collaborations, recent activity –Career goals – be specific! –Demonstrate aptitude and interest in goals –Provide specific details about plans: coursework, seminars, meetings, travel, etc.

50. Feedback from Reviewers 2. Mentors and Institutional Commitment –Highly qualified mentors with federal funding –Diverse mentor expertise –Meet training and research goals of project –Institutional commitment releasing time for research 3. Research Plan –“Appropriate to primary goal... a mentored research experience which she can accomplish within the proposed time period and that builds on her current expertise while allowing her to expand her skills in new areas.”

51. Feedback from Reviewers 3.Research Plan (continued) Well conceived Important clinical problem Include preliminary results Be aware that it may be reviewed as R01!!

52. Lessons Learned Career development proposal should build on current expertise and develop skills in new areas –Use caution too avoid research projects too similar to mentor’s existing research and interests –Demonstrate independence in proposal Mentor selection critical –Establish relationships –Mentors selected are usually local; however, commuting relationships allowed

53. Lessons Learned Review successful career development proposals Know and communicate with your project officer!!

54. Training and Career Development Awards for Pre-Docs, Post-Docs, and Junior Faculty Lisa Metsch, Ph.D. University of Miami Miller School of Medicine Department of Epidemiology and Public Health

55. Funding Background  HIV/AIDS Epidemiologic and Behavioral Research – Focus on HIV prevention and access to care issues  Received K01 award, National Institute on Drug Abuse, 1997 – 2004  Received grant from Robert Wood Johnson Foundation, 1998 - 2002  Received Large CDC awards, 1999 - 2004  Received Two R01 awards (NIDCR and NIDA), 2004 – 2009, 2005 – 2010  Served on NIH CSR HIV/AIDS IRG, 1999 – present  Reviewed K-awards

56. Top 10 List from a perspective of a reviewer #10: Sell yourself, but do not oversell -- Make reviewers think that this is the perfect time for you to have a K-award #9 Mentor Dilemma – Pick the right mentor and show that they will have time for you and they have been successful with mentoring others #8 Having more than one mentor should be considered

57. Top 10 List #7 Career Plan should address skills that you are lacking, should be complete and should make sense #6 Career Plan should include evaluation plan on how you will evaluate whether your careers goals have been met #5 Letters from Mentors and Department Chair/Dean are critical

58. Top 10 List #4 Research Project should be significant but feasible – sometimes “the more simple, the better.” #3 Background and significance should be comprehensive, tell a compelling story and close to perfect #2 Methods should be well-justified and rationale for all decisions should be provided

59. Top 10 List #1 Ideally, career plan and research project should provide foundation for you to be competitive to obtain R01 level funding

60. In Conclusion…  This top 10 list represents the views of one reviewer  Study sections will vary in how they evaluate K-awards  Review other successful K-awards  Give time to have your K-award reviewed by senior investigators before submission  Best of Luck!

61. Take Home Message Read the Institute websites Read the Institute websites Call the targeted institute contact Call the targeted institute contact Explore private organization alternatives Explore private organization alternatives Develop niche training/research plan Develop niche training/research plan Find appropriate mentors Find appropriate mentors Draft great letters Draft great letters Get approval for any exceptions/changes Get approval for any exceptions/changes Document all changes for audit purposes Document all changes for audit purposes