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, MDPrincipal Investigator Morris Weinberger, PhDCo-Principal Investigator Susan Pusek, MPHEducation Champion Bill Miller, MD-PhDCurriculum Director Rosalie Dominik, DrPhDirector, Biostatistics Core Tricia Byrns, MDProgram Evaluation Alison ReganFinancial Manager Lowell Goldsmith, MDProgram 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 YEAR Total # of Roadmap Awards # Institutions Receiving Roadmap Awards # of States Receiving Roadmap Awards # of Roadmap Awards Received by UNC % of Roadmap Awards Made to UNC 2004193962963.1 2005186913084.3 200617810938116.2 Data for 2004-2006 55717740254.5

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

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 UniversityT32sK12s Michigan703 UNC-Chapel Hill536 1/2 UCSF505 Wisconsin434 Duke405 1/2 Wash U335 UAB273 Virginia241

11. UNC BIRCWH Program B uilding I nterdisciplinary R esearch C areers in W omen’s H ealth

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. Multidisciplinary Clinical Research Career Development Programs What institutions were able to compete successfully for MCRCDPs? 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

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 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 Awards A Home for Clinical and Translational Science Trial Design Advanced Degree-Granting Degree-GrantingPrograms Participant & Community Involvement RegulatorySupport Biostatistics ClinicalResources BiomedicalInformatics Clinical Research Ethics CTSAHOME NIH OtherInstitutions Industry

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: 1.Patient oriented research 1.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 2.Epidemiologic and behavioral research 3.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 ? multidisciplinary 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. interdisciplinary 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 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 Program The 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, MDPrincipal Investigator Morris Weinberger, PhDCo-Principal Investigator Susan Pusek, MPHEducation Champion Bill Miller, MD-PhDCurriculum Director Rosalie Dominik, DrPhDirector, Biostatistics Core Tricia Byrns, MDProgram Evaluation Lowell Goldsmith, MDProgram 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. 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 UNC Multidisciplinary Clinical Research Career Development Program

30. 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 UNC Multidisciplinary Clinical Research Career Development Program

31. 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