Multidisciplinary Clinical Research Career Development Program (MCRCDP) An Overview

1. Multidisciplinary Clinical Research Career Development Program (MCRCDP)An Overview Eugene P. Orringer, MD, Professor of Medicine & Executive Associate Dean for Faculty Affairs and Faculty Development UNC School of Medicine

2. UNC Multidisciplinary Clinical Research Career Development Program Leadership of the UNC Program • Eugene Orringer, MD Principal Investigator • Morris Weinberger, PhD Co-Principal Investigator • Susan Pusek, MPH Education Champion • Bill Miller, MD-PhD Curriculum Director • Rosalie Dominik, DrPh Director, Biostatistics Core • Tricia Byrns, MD Program Evaluation • Alison Regan Financial Manager • Lowell Goldsmith, MD Program Ombudsman

3. Multidisciplinary Clinical Research Career Development Program An NIH Roadmap Initiative

4. NIH Roadmap • Dr. Elias Zerhouni initiated the NIH Roadmap Program soon after he assumed the NIH Directorship in 2002 • The Roadmap was designed to identify opportunities and gaps in biomedical research that no single institute at NIH could tackle alone, but that the agency as a whole needed to address. • Dr. Zerhouni argued that NIH is uniquely positioned to catalyze the changes that must be made if we are to transform new scientific knowledge into tangible benefits for people.

5. NIH Roadmap UNC has been a major beneficiary of the Roadmap. Through the end of FY 2006, UNC had received more Roadmap awards than any other single institution. • 6 Roadmap Awards in 2004 • 8 Roadmap Awards in 2005 • 11 Roadmap Awards in 2006

6. NIH Roadmap Data

7. The NIH Roadmap New Pathways to Discovery Re-engineering the Clinical Research Enterprise Research Teams of the Future

8. Multidisciplinary Clinical Research Career Development Program • The MCRCDP was created as a key component of the NIH Roadmap. It was specifically designed to help Re-engineer the Clinical Research Enterprise Research Teams of the Future • The MCRCDP has been funded using the K12 mechanism

9. Multidisciplinary Clinical Research Career Development Program What is a K12 Award? • A K12 Award is a grant to an institution that is designed to provide protected time to a group of scientists committed to academic research careers. • A K12 Award is very much like a training grant (i.e., a T32), but one that is designed for more senior level post-doctoral fellows and especially for junior faculty

10. Number of Training Awards

11. UNC BIRCWH Program Building Interdisciplinary Research Careersin Women’s Health

12. UNC BIRCWH Program • UNC BIRCWH K12 Award began in September 2000 • This Grant brought us 5 years of NIH funding at $500,000/year • The vast majority of these $’s have been used to provide salary support to junior faculty members in exchange for 75% protected research time • Based on the success of our program, we were able to compete successfully for a renewal of the BIRCWH Award in September 2005

13. Multidisciplinary Clinical Research Career Development Program When was the MCRCDP first established? • The original RFA for this program was announced in late 2003 & a second RFA was published by the NIH in late 2004 • The initial group of awards was made in the summer of 2004 & the second group of awards was made in the summer of 2005

14. Programs funded in 2004 UCSF Mayo Clinic Case WR - Cleveland Clinic Johns Hopkins University of Washington University of Wisconsin University of Pittsburgh Programs funded in 2005 University of Minnesota Washington University UT - Southwestern University of Maryland UNC - Chapel Hill Multidisciplinary Clinical Research Career Development ProgramsWhat institutions were able to compete successfully for MCRCDPs?

15. Multidisciplinary Clinical Research Career Development Programs What has happened since the creation of the MCRCDPs? Establishment of the Clinical & Translational Science Awards (CTSA)

16. Primary Objective of the CTSA Program: Speed Discoveries that will Improve Patient Care • Develop a distinct discipline for clinical & translational science at institutions across the country • Provide opportunities and resources for original research on novel methods • Develop translational technologies & a knowledge base for the full spectrum of clinical and translational science • Synergize partnerships with industry, foundations, and community physicians • Train the multidisciplinary teams that will conduct the clinical and translational research of the future

17. Clinical and Translational Science Awards (CTSAs) • Lower barriers between disciplines • Encourage creative, innovative approaches in solving complex medical problems • Catalyze change: break silos, barriers, and conventions

18. NIH CTSA AwardsA Home for Clinical and Translational Science Trial Design Clinical Research Ethics NIH Advanced Degree-Granting Programs Biomedical Informatics CTSA HOME Industry Participant & Community Involvement Clinical Resources Biostatistics Regulatory Support Other Institutions

19. Multidisciplinary Clinical Research Career Development Programs • One of the key features of competing successfully for a CTSA award is the establishment of an Education, Training, & Career Development Program • A K12 Program like the one described here is essential if a CTSA is to be successful

20. Multidisciplinary Clinical Research Career Development Program How is the MCRCDP structured? • Each program includes: a) a well-designed, didactic, educational core component; b) a practical, hands-on, mentored clinical research component; and c) a shared clinical research support facility • Together, these three components are designed to provide CR Scholars with a broad experience in all aspects of the design, conduct, and analysis of clinical research

21. What is meant by Clinical Research? In this K12 Program, clinical research has been defined to include the following areas: • Patient oriented research: Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes: • Mechanisms of human disease • Therapeutic interventions • Clinical trials • Development of new technologies • Translational research • Epidemiologic and behavioral research • Health services and outcomes research

22. Multidisciplinary Clinical Research Career Development Program What is meant by multidisciplinary? Each program is expected to include representatives from multiple clinical disciplines and other professions. Examples include: • Clinical doctoral degrees such as M.D., D.O., D.D.S., D.M.D., D.V.M., O.D., D.C., Pharm.D., N.D. with various specialties and subspecialties • Non-clinical doctoral degrees such as DPH, Ph.D., Sc.D., EdD from a wide variety of disciplines.

23. How does multidisciplinary differ from interdisciplinary ? • A multidisciplinary approach brings together numerous experts from diverse disciplines to collectively address a complex problem, with each expert addressing the issues from the perspective of his or her own discipline. • An interdisciplinary approach results from the melding of two or more disciplines to create a new (i.e., interdisciplinary) science. Biostatistics, bioinformatics, bioengineering, and psychoneuroimmunology are but a few examples of existing interdisciplinary sciences.

24. Multidisciplinary Clinical Research Career Development Program What are the overall objectives of this Program? • Stimulate multidisciplinary clinical research training and education • Enhance career development of postdoctoral fellows and junior faculty from multiple disciplines, specialties and subspecialties • Establish a critical mass of national programs with a commitment to the development of a diverse, well- integrated, multidisciplinary workforce

25. Multidisciplinary Clinical Research Career Development ProgramThe UNC Program Based in all of the Schools on the Health Affairs Campus (Medicine, Public Health, Nursing, Dentistry, Pharmacy) Our Goals • Select as Scholars both senior fellows and junior faculty • Train these Scholars at a relatively early stage of research career • Have a minimum of 3 disciplines represented each year • Do our best to have all 5 schools represented within the program • Recruit both women and underrepresented minorities • Recruit both locally & nationally: Make the program a national resource

26. UNC Multidisciplinary Clinical Research Career Development Program Why was UNC selected receive this award? • Strong, well-established research programs based in each of the five schools on a single, contiguous Health Affairs campus • Long history of multidisciplinary collaboration • Great success with multidisciplinary Centers, Institutes, Programs • Excellent experience at UNC with the RWJ Clinical Scholars Program as well as with our K30 & several other NIH-funded K12 Programs • Well-established partnerships with public and private sector entities (e.g., Glaxo, Icagen, NIEHS, Quintiles, RTI) • Passionate commitment to the career development of junior investigators

27. UNC Multidisciplinary Clinical Research Career Development Program Leadership of the UNC Program • Eugene Orringer, MD Principal Investigator • Morris Weinberger, PhD Co-Principal Investigator • Susan Pusek, MPH Education Champion • Bill Miller, MD-PhD Curriculum Director • Rosalie Dominik, DrPh Director, Biostatistics Core • Tricia Byrns, MD Program Evaluation • Lowell Goldsmith, MD Program Ombudsman

28. UNC Multidisciplinary Clinical Research Career Development Program Multidisciplinary Advisory Committee (MAC) Made up of senior investigators from all five of the Schools on the Health Affairs campus (over 15 disciplines represented) Regular MAC Meetings - Responsibilities include: • Scholar selection • Review, monitor and recommend changes in curriculum • Monitoring and evaluation of the progress of each Scholar • Monitoring and evaluation of the effectiveness of the program

29. UNC Multidisciplinary Clinical Research Career Development Program What comes with support from the MCRCDP? • Support for salary: starting in 2007, this is 75% salary support up to $75,000 plus fringe benefits • Support for research activities, travel, tuition and fees, books: up to $25,000/year • Support for Mentors: $5,000/year for as many as two mentors per scholar • Support from the Shared Biostatistical Core Facility

30. UNC Multidisciplinary Clinical Research Career Development Program What are our overall recruitment efforts? • In July 2006 we recruited our first 6 Scholars • In July 2007 we recruited 5 more Scholars • In July 2008, we anticipate adding 5-6 additional Scholars • Our goal is to recruit both: • Junior Faculty Members • Senior Fellows (should be close to getting a faculty position) • We intend to recruit Scholars from UNC & from outside UNC • In all cases, there must be a commitment for a faculty position from the Chair of the relevant Department

31. UNC Multidisciplinary Clinical Research Career Development Program The website for the MCRCDP is: www.med.unc.edu/orfd/career-development-1/k12-roadmap The e-mail address for the MCRCDP is: Kprograms@med.unc.edu