Career Development Grants

1. Daniel Kreisel MD PhD Washington University in St. Louis Career Development Grants

2. Obtain a position on the faculty of a progressive department Develop your research program Secure extramural funding Maintain clinical skills “The most important time in the career of a young surgical scientist is the first 5 years after completion of surgical training.” S.A. Wells, ASA Presid. Address 1996

3. “The development of the young surgical scientist is determined primarily by personal qualities (Investigator) and environment.” S.A. Wells, ASA Presid. Address 1996

4. Career Development Grants • Transition to an independent career as an investigator • Protect time to pursue research • Time lag for CT surgeons between “postdoctoral fellowship” as general surgery resident and first faculty appointment • Enhance “credibility” when applying for independent extramural funding

5. Career Development Grants • K08 – Mentored Clinical Scientist Research Career Development Award • Laboratory-based research • K23 – Mentored Patient-Oriented Research Career Development Award • Clinically oriented research • K99/R00 – Pathway to Independence Award • 2 years mentored – 3 years independent

6. K23 • Research conducted with human subjects or material of human origin in which the investigator interacts directly with human subjects • Mechanistic studies of human disease • Evaluation of therapies • Clinical trials • New technology

7. Eligibility • Principal investigator with a clinical degree (MD, DVM, DDS, DO, PharmD…) • Faculty position must include clinical duties • Follows completion of clinical specialty training • Applicants must have secured faculty position by the time award is made • Applicants are generally within the first 1-3 years of “tenure-track” faculty appointment

8. Personal Experience • 2002: PhD in Immunology as Surgery Resident • 9/2005: Submitted K08 application while CT Surgery Fellow • 2/2006: Joined faculty at Wash U • 4/2006: 5-year K08 with TSFRE matching funds started • 9/2009: R01 grant

9. Support • Up to $75,000 salary support / year + fringe benefits • Up to $25,000 support / year for research • Some additional funds from TSFRE (up to $150,000 total funding over five-year award from NHLBI or NCI)

10. Support • Adequate start-up package • Personnel • Supplies • Animal work is expensive • Access to surgical residents • Funding (i.e. training grants)

11. Requirements • Dedicated Scientific Mentor • Research Career Development Plan • Appropriate Research Plan for Training • Appropriate Time Commitment • (50-75% Effort for Duration of 3-5 Years)

12. Caveats • Loss of clinical productivity • Financial penalty for K awardees in Surgery Departments where pay is incentivized based on RVU’s • Economic pressures for societies that have provided matching funds

13. Critique Criteria • Candidate • Career Development Plan • Research Plan • Mentors / Co-Mentors • Environment

14. Candidate • Commitment to pursuing research career • Previous research experience • Previous publications • Potential to develop into independent investigator

15. Career Development • Likelihood that career development plan will contribute to the achievement of SCIENTIFIC INDEPENDENCE

16. Career Development • Scholarly course work • Address potential deficiencies before embarking on independent career • Consider formal degree (e.g. MPH) • Be specific about time commitment • Seminars, Conferences • Interactions with other scientists

17. Human Subjects • “Candidates must participate in courses such as data management, epidemiology, study design, hypothesis development, drug development as well as legal and ethical issues associated with research on human subjects.”

18. Career Development • How are clinical duties and research endeavors integrated? • How many days of clinic, how many days in the OR, call schedule, coverage, transplantation responsibilities? • Commitment from institution and department leadership • Other K awardees in recent past? Their track record?

19. Research Plan • Significance • Clinical relevance • Innovation • Conceptual • Technical • Approach / Experimental Design • Predicted outcomes • Alternatives • Pitfalls • Statistical considerations

20. Human Subjects • Tabulate number of human subjects expected • Women, children, minorities • Data safety plan • Monitoring plan • Ensures safety of participants and integrity of data (i.e. reporting of adverse events) • Investigator submits safety data to IRB annually • Data and safety monitoring board

21. Mentor/Mentors • History of research productivity • Stature in field • Adequate funds to support mentee’s project • NIH funding • Previous experience in fostering independent careers • Table with specifics

22. Mentor/Mentors • Usually not the clinical supervisor • Should be a basic scientist (K08) with qualifications in area of proposed research • Specifics about mentoring plan • Frequency of meetings • Milestones

23. Mentor – Advisory Committee • Co-Mentors (Clinical chief if he /she has history of independent research) or advisory committee can be helpful • Frequent meetings to evaluate progress

24. Environment • Resources • Institutional commitment to development of career as independent investigator • Balance research activity – clinical duties

25. Grant Submission • Simultaneous submission to NIH and TSFRE • Review by NIH study section • Secondary review by NIH council to determine funding • TSFRE provides funds to applicants, who receive funding from NIH

26. Funding Record K grants /TSFRE • 2012: K08 NCI • 2011: K23 NHLBI • 2010: K08 NHLBI x 2 • 2009: K08 NHLBI x 2, K23 NCI • 2008: K08 NCI x 2, K23 NCI • 2006: K08 NHLBI x 3 • 2005: K08 NHLBI, K23 NCI

27. Conclusions • K grants are an important mechanism to achieve status as independent investigator in cardiothoracic surgery • Key factors • Personal commitment • Suitable mentors • Institutional / departmental / divisional support