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Mentored Research

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Title: Mentored Research


1

New Career Opportunities for Clinician/Scientists

Mentored Research Professional
Development Eugene P. Orringer, MD April 14,
2003
2
Problems for Clinician-Scientists
  • The clinical investigator as an
  • endangered species
  • James Wyngaarden - NEJM, 1979

3
Problems for Clinician-Scientists
  • Crisis in Clinical Research
  • Ahrens Oxford Press, 1992

4
Problems for Clinician-Scientists
  • Investigator-initiated applications for
    patient oriented research (POR) are not reviewed
    equitably at the NIH
  • Williams et al. - JAMA, 1997.

5
Problems for Clinician-Scientists
  • The four Ps that are relevant to
    patient-oriented research include
  • Patience
  • Patients
  • Passion
  • Poverty
  • Brown Goldstein JCI 1997.

6
Problems for Clinician-Scientists
  • The number of first-time MD applicants
  • for NIH research support has plummeted
  • over the past few years
  • Rosenberg - Science, 1999

7
Problems for Clinician-Scientists
MDs
MD-PhDs
Rosenberg - Science, 1999.
8
Problems for Clinician-ScientistsReport from the
Clinical Research Roundtable
  • Four key challenges facing the US clinical
    research enterprise
  • Workforce training
  • Public participation
  • Information systems
  • Funding
  • Sung et al. - JAMA, 2003

9
Problems for Clinician-Scientists
  • Translating Biomedical Research to the Bedside
    A National Crisis a Call to Action
  • Rosenberg JAMA, 2003

10
  • The Promise of Basic Research
  • The Human Genome Project
  • Stem cell research
  • The procurement of suitable organs /or the
    development of artificial organs
  • Novel, target-based drugs
  • New vaccines

11
Delivering on the Promise Clinical Research could
. a) Be a powerful vehicle to deliver to the
public the promises of basic science or
alternatively it could . b) Emerge as the rate
limiting step in the translation of basic
science to benefit the greater public health

12
Problems for Clinician-Scientists
  • Is there truth to these various predictions of
    Gloom Doom?
  • Can something be learned from the career of a
    slightly graying clinican-scientist?
  • What has been/is being done to facilitate the
    efforts of todays young people?
  • How have we at UNC sought to take advantage of
    these new opportunities?

13
Eugene P. Orringer
  • My career provides evidence that
  • The right mentors /or role models are critically
    important to ones future success
  • It certainly pays to be at the right place at the
    right time

14
Eugene P. OrringerMentors Role Models
  • Medical School - Jack Myers
  • Fellowship - John C. Parker
  • Junior Faculty - Wendell Rosse
  • GCRC Director - Michael Thorner
  • MD-PhD Program - Sal Pizzo
  • Deans Office - Jeff Houpt

15
John C. Parker, MD 1935-1993
16
Eugene P. OrringerFellowship Training
  • Clinical Hematology
  • Red Cell Physiology
  • Membrane Transport
  • Volume Regulation
  • Metabolism

17
Eugene P. Orringer Initial NIH Funding
  • Co-I on Dr. John C. Parkers R01

18
Eugene P. Orringer Subsequent NIH Funding
  • PI RCDA from NHLBI
  • PI R01 from NHLBI

19
Eugene P. Orringer Evolution as a Clinical
Investigator
  • Realized that I was not a basic scientist
  • Looked for an opportunity to apply my
    understanding of RBC membrane transport to an
    important medical problem
  • Identified sickle cell disease as an ideal model
    of disordered RBC physiology
  • Recognized the institutional need for a clinical
    program that focused on patients with this
    genetic disorder

20
The UNC Sickle Cell Program
  • Identified those sickle cell patients who were
    receiving their care at UNC
  • Created an institutional program committed to the
    comprehensive care of children adults with
    sickle cell disease
  • Started a clinical research program, one that
    initially relied on industry-supported clinical
    trials
  • Used these studies to generate interest among the
    patients to recruit and fund the staff needed
    to begin to build a program

21
Wendell F. Rosse, MD
22
The UNC Sickle Cell Program
  • Began a long-standing collaboration with Wendell
    F. Rosse
  • The support encouragement of Dr. Rosse were
    instrumental in my long-term success as a
    clinical investigator

23
The UNC Sickle Cell Program
  • Developed a variety of joint efforts with Duke
  • Duke UNC helped to form and became key
    components of the North Carolina Sickle Cell
    Consortium
  • Built a Duke-UNC database which contains over
    1000 sickle cell patients

24
The UNC Sickle Cell Program
  • 1988 - Prepared our 1st joint Duke-UNC
    application received NIH funding for the
    Duke-UNC Comprehensive Sickle Cell Center

25
General Clinical Research Center
  • 1980s As a clinical investigator, I often used
    our NIH-funded GCRC
  • 1988 Invited to serve on the GCRC Study Section
  • 1989 Selected to serve as UNCs GCRC Program
    Director

26
General Clinical Research Center
  • As Program Director (1989-1999), I took a very
    institutional approach to the GCRC
  • Particular emphasis on junior faculty development
  • Training programs focused on both clinical
    research research ethics
  • Institutional clinical research fellowship
  • CAP M-CAP Programs
  • NIEHS Contract

27
UNC MD-PhD Program
  • In 1995, I agreed to assume the leadership of
    UNCs MD-PhD Program
  • At that time, this was a modest program
    recruiting 1-2 students per year without benefit
    of an MSTP grant
  • Based on the substantial support we received from
    UNC and on two excellent recruiting classes, we
    wrote a successful MSTP application in mid-1997
  • In early 1999, we were able to recruit our
    initial class of students as an NIH-funded MSTP
    Program

28
UNC MD-PhD Program1995 to the Present
29
UNC MD-PhD Program
  • The current year (2003) was an important one for
    UNCs MD-PhD Program
  • Wrote a renewal application for MSTP award
  • Eight of our current students will defend their
    PhDs
  • Four of our current students will graduate
  • 1 going to Stanford in Internal Medicine
  • 1 going to Baylor in Medical Genetics
  • 2 going to Yale in Dermatology

30
Institutional Philosophy - I
  • The best medical centers benefit from
    individuals with varying skills
  • Superb investigators
  • Excellent leaders
  • Effective administrators

31
Executive Associate Dean
  • In 1999, I agreed to give up the GCRC
    Directorship assume the role of Executive
    Associate Dean
  • My acceptance of this role was based, in part, on
    the opportunity to lead the recruitment of
    numerous chairs and center directors for our
    clinical and basic science departments

32
School of Medicine UNC-Chapel Hill
  • Over the past four years, we have recruited to
    UNC a cadre of new leaders who have together
    brought to the School of Medicine a vibrancy and
    a sense of excitement that is truly palpable

33
UNC School of Medicine New Chairs Center
Directors
  • CLINICAL LEADERS
  • Runge - Medicine
  • Stiles - Pediatrics
  • Meyer - Surgery
  • Diaz - Dermatology
  • Pillsbury - ENT
  • Longo - Neurology
  • Meredith - Ophthalmology
  • Newton - Family Medicine
  • Watkins - GCRC
  • BASIC SCIENCE LEADERS
  • Magnuson - Genetics
  • Snider - Neuroscience
  • Bankaitis - Cell Biology
  • Anderson - Physiology
  • Johnson - Pharmacology
  • Patel - Arthritis Center

34
Institutional Philosophy - II
  • At the end of the day, it is really the young
    people that are absolutely critical to the growth
    and the ultimate success of a School of Medicine

35
Executive Associate Dean
  • In 1999, I agreed to give up the GCRC
    Directorship assume the role of Executive
    Associate Dean
  • Based on my experiences with the GCRC and the
    MD-PhD Program, I realized how much I enjoyed
    helping young people succeed
  • I felt that this was a particularly good time for
    young people whose focus was clinical research

36
NIH Directors Panel(The Nathan Committee)
  • Key Recommendations
  • Creation of several new awards in the K
    series (see K Kiosk Website)
  • Re-evaluation of the NIH Review Process

37
Clinical Research Enhancement ActPublic Law
106-505
  • Statutory language for the GCRC Program
  • Infastructure support for clinical research
  • Loan forgiveness for clinical investigators
  • (http//lrp.info.nih.gov/extramural/FAQ_CRE.htm)

38
Eugene P. Orringer Executive Associate Dean
  • In negotiating for this position, I presented
    the Dean with the concept of developing a new
    office, the purpose of which would be to enhance
    the grant portfolio of the School of Medicine
  • Office of Research Faculty Development

39
UNC-CH School of Medicine Office of Research
Faculty Development
  • Using central resources, the School has created
    an Office of Research Faculty Development, the
    primary purpose of which is to assist our faculty
    and to enhance the grant portfolio in the School
    of Medicine

40
Office of Research Faculty Development
  • Since its inception, the focus of this office
    has been two-fold
  • Assist with proposals that are multidisciplinary,
    multi-school, and/or multi-institutional
  • Assist with junior faculty grant proposals

41
Office of Research Faculty Development
  • A few examples of the multidisciplinary and/or
    multi-institutional proposals include
  • Mutant Mouse Regional Resource Center
  • Two NCRR Renovation Grants
  • K30 Two K12 Awards (BIRCWH MCRSP)
  • Neonatal Research Network
  • Doris Duke Clinical Research Grant
  • Numerous Training Grants
  • Joint Duke-UNC Grant Proposals
  • Minority Center of Excellence Application

42
NIH Support UNC School of Medicine
Office of Research
43
Office of Research Faculty Development
  • Evidence of its success came in the spring of
    2002 when a re-engineering task force was asked
    by Dean Houpt to review all centrally-funded
    programs to recommend specific areas for budget
    cuts.
  • The Task Force suggested that the budget of this
    office should NOT be cut in fact, they suggested
    that it be increased!!!

44
Office of Research Faculty Development
  • Work with junior faculty to facilitate the
    submission of
  • K applications (K01, K08, K23)
  • Career applications to professional
    societies, foundations, and other non-
    governmental organizations (NGOs)

45
Office of Research Faculty Development
  • Over the past 3 Years, we have also created a
    grant library that has helped to coordinate
    facilitate the submission of numerous research
    grant applications, particularly those of young
    people

46
  • K23 - Patient-Oriented Research CDA
  • NIH Goal for K23 To fund at least 100 new
    awards/year

Independent Investigator
Medical School
Internship/Residency Specialty
Mentored Patient-Oriented Research CDA (K23)
47
Total of K23 Awards made by the NIH
48
NIH Support to UNC of K23 Awards
  • K23 Awards to junior faculty members at UNC
  • Year () ()
  • 1998 0 n/a
  • 1999 2 1.4
  • 2000 8 2.4
  • 2001 15 3.0
  • 2002 22 3.3

49
Total NIH Support to theExtramural Community
  • NIH Support to UNC
  • NIH s NIH s NIH
  • (Millions) () Ranking
  • 1999 131 1.02 17
  • 2000 144 0.98 15
  • 2001 170 1.08 15

50
UNC School of MedicineTotal NIH s vs K23 Awards
  •  
  • NIH Grants K23 Awards
  • () ()
  • 1999 1.02 1.4
  • 2000 0.98 2.4
  • 2001 1.08 3.0
  • 2002 n/a 3.3
  • Junior faculty at UNC also still hold 3 CAP
    awards, there are 6 people on the K12 (BIRCWH)
    award, 3 people on the K12 (Clinical Research),
    and 6 additional pending K23 applications at the
    NIH

51
Office of Research Faculty Development
  • Assumed a leadership role in a variety of
    institutional education training programs
  • Medical Student Research Programs
  • K30 Program
  • K12 BIRCWH Program
  • RWJ Clinical Scholars Program
  • K12 Mentored Clinical Research Program

52
UNC-Chapel HillMedical Student Research Programs
  • The School of Medicine at UNC-Chapel Hill enrolls
    160 students per year
  • Each year, over 50 of these students take part
    in some form of biomedical research

53
UNC-Chapel HillMedical Student Research
  • Short Term (3 month) Experiences
  • Holderness Foundation 10
  • Short Term Training Program (NIH) 35
  • Year-Long Experiences
  • Doris Duke Clinical Research Program
    5
  • Distinguished Medical Scholars Program 6
  • NIDDK Minority Fellowship Program (NIH) 3
  • Combined Degree Programs
  • MD-PhD (NIH MSTP award) 8
  • MD-MPH 23
  • TOTAL of Students / Year 90

54
Office of Research Faculty Development
  • Contributions to Medical Student Research
  • NIGMS Short Term Medical Student Training Program
  • Doris Duke Clinical Research Scholar Program
  • NIDDK Minority Medical Student Research Program
  • Individual (F30 F31) awards to MD-PhD students
  • NHLBI Minority Medical Student Short Term
    Training Program

55
Doris Duke Medical Student Clinical Research
Program
  • Five students per year
  • Full year of patient-oriented research (POR)
  • Solicit applications from student-mentor pairs
  • Require a GCRC-based project
  • Recruit both UNC external candidates
  • Emphasis on minority candidates

56
Office of Research Faculty Development
  • Contributions to Medical Student Research
  • NIGMS Short Term Medical Student Training Program
  • Doris Duke Clinical Research Scholar Program
  • NIDDK Minority Medical Student Research Program
  • Individual (F30 F31) awards to MD-PhD students
  • NHLBI Minority Medical Student Short Term
    Training Program

57
UNC-Chapel Hill
  • Career Development
  • for Clinician-Scientists

58
School of Medicine UNC-Chapel Hill
  • The School of Medicine at UNC has a passionate
    commitment to the development of its junior
    faculty, particularly those with a career focus
    on translational and patient-oriented research

59
UNC Seeks to Foster the Development of
Clinician-Scientists
  • Programs for Career Development
  • K30 Program
  • K12 Awards
  • Minority Cohort Program

60
K30 - Clinical Research Curriculum
  • K30 Award
  • UNC received funding as 1 of the initial cohort
    of 35
  • This grant provides funds for infrastructure
  • No funds for the trainees

61
K30 - Clinical Research Curriculum
  • Most K30 Programs placed emphasis on a new
    degree-granting program (e.g., MS or an MPH in
    Clinical Research or the equivalent)
  • Typical product of our K30 Program is not a
    degree, but rather a grant (e.g., K23 or the
    equivalent)

62
K30 - Clinical Research Curriculum
  • Broad-Based Program
  • Schools of Medicine, Pharmacy, Public Health
  • Two-year duration
  • Yr 01 didactics, design the research project,
    develop a grant proposal
  • Yr 02 Conduct of the research project
  • Submit a grant proposal

63
K30 - Clinical Research CurriculumStructure
  • Coursework
  • Seminar Series
  • Research Project
  • Work-in-Progress Presentations
  • Grant Preparation
  • Mock Study Section Reviews
  • Mentoring Panels

64
K30 - Clinical Research Curriculum Status of the
Trainees
  • Funding status of the K30 Trainees (n 13)
    who have enrolled between July 2000 the
    present
  • Funded Pending
  • K23 Awards 6 3
  • Note that 2 of these individuals are
    Professors on sabbatical. The others, fellows in
    their initial year of the K30 Program, are not
    yet ready to write a K23.

65
UNC Seeks to Foster the Development of
Clinician-Scientists
  • Programs for Career Development
  • K30 Program
  • K12 Awards
  • Minority Cohort Program

66
K12 Award
  • A K12 grant is an institutional award 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,
    but one that is designed for junior faculty
    rather than for post-doctoral fellows

67
The BIRCWH Program K12 Award
  • Building
  • Interdisciplinary
  • Research
  • Careers in
  • Womens
  • Health

68
UNC BIRCWH Program
  • The BIRCWH Award brought to UNC 5 years of
    support _at_ 500,000/year
  • Almost all s are available to support the
    salary of junior faculty, thereby providing them
    with 75 protected time for research
  • Our goal in the BIRCWH is to assist each Scholar
    obtain an NIH award (e.g., K23, K08, R01) thus
    achieve research independence within 2 years

69
UNC BIRCWH Program
  • Developed the concept that if funded, the UNC
    BIRCWH Program would have both
  • BIRCWH Scholars
  • BIRCWH Associates

70
BIRCWH Scholar
  • An individual who is receiving salary support
    from the BIRCWH grant

71
BIRCWH Associate
  • An individual who had previously received salary
    support from the BIRCWH grant but subsequently
    went on to compete successfully for his/ her own,
    independent grant support
  • - or -
  • An individual who would have been competitive
    for BIRCWH funding, but simply had too much
    independent funding

72
UNC BIRCWH Program
  • By developing this concept of both Scholars and
    Associates, the UNC BIRCWH Program has now grown
    substantially. Upon entering year - 03, we have
    a critical mass of approximately 15 young people
    with interests and backgrounds that are
    remarkably diverse.

73
K12 Awards
  • A very inexpensive way to fund the next
    generation of academic research
  • Example
  • Using the BIRCWH model, 5 Million supports 10
    programs 50 Trainees/year

74
K12 Awards
  • A K12 can have a big multiplier effect
  • Example
  • We have found that if they are used effectively,
    each K12 slot can be turned over 2-3 times in a 5
    year cycle

75
K12 BIRCWH ProgramStatus of the Trainees
  • Status of the BIRCWH Scholars Associates (n
    15) who have been a part of our Program between
    October 2000 the present
  • Funded Pending
  • K23 Awards 3
    -
  • K08 Awards 3 -
  • K01 Awards 1 -
  • R01 Awards 2 2
  • R03 Awards 3 -
  • Doris Duke Award 1 -
  • Pfizer Award 1
    -
  • Others 8 4

76
K12 - Mentored Clinical Research Scholars Program
(MCRSP)
  • A new K12 Program developed by NCRR
  • Designed to provide salary support for young
    people (including many K30 trainees)
  • The salary support will bring with it the
    protected time that is so important for the
    conduct of patient-oriented research
  • NCRR received 45 applications funded 11

77
K12 - Mentored Clinical Research Scholars Program
(MCRSP)
  • Structure of UNCs K12 Application
  • Close Linkage to the GCRC, to the K30 Program,
    to the Deans Office
  • Gene Orringer - Principal Investigator
  • Paul Watkins - Program Director

78
K12 - Mentored Clinical Research Scholars Program
(MCRSP)
  • Extremely pleased with the quality of the initial
    candiates
  • Initially selected three from a total of 15
    applicants
  • As with the BIRCWH
  • Each Scholar was promised 2 years of support
  • Require a minimum of 75 protected time
  • Too early to say how successful this program will
    be

79
Minority Cohort Program (MCP) Scholars
  • UNC is fully committed to having a faculty
    with as much ethnic and gender diversity as
    possible
  • The MCP was established in 1994 by then
    Dean Michael Simmons
  • Each faculty member selected as an MCP awardee
    receives up to 6 years of support

80
MCP Scholars
  • An Advisory Committee (3 department chairs)
    selects the awardees and provides guidance re.
    faculty development
  • Each Scholar is expected to
  • Be a visible and available role model
  • Exhibit progress along an academic path
  • Each Department Chair with a Scholar submits an
    annual report that reviews the Scholars progress
    and summarizes his/her career development
  • .

81
MCP Scholars
  • Total of awardees in the program 10
  • of awardees currently receiving support 6
  • 8 women and 2 men
  • 8 African-Americans and 2 Hispanics
  • Departments receiving support Family Medicine
    (1) Medicine (2) Nutrition (1) Pediatrics
    (4) Pharmacology (1) Social Medicine (1)
  • 16 of Schools URM faculty
  • 38 of Schools URM at the Assistant Professor
    Level
  • .

82
MCP Scholars
  • MCP has played a major role in increasing the
    diversity of our junior faculty
  • The MCP has had a major impact on the institution
    by helping to
  • Build new programs that further increase the
    diversity of the School
  • Provide protected time and thereby enhance the
    academic development and retention of our junior
    faculty

83
MCP ScholarsFunding Status of the Scholars
  • Independent funding status of the Scholars (n
    10) who have received support from the MCP
    between 1994 the present
  • Award Type Funded
  • RO1 Awards 3
  • K23 Awards 1
  • K01 Awards 1
  • P60 Project 1
  • NIH Minority Supplement 2
  • RWJ Minority Faculty Development Award 3
  • Other CDA 2
  • Co-I Research Grant 4
  • PI NIH T32 Award 1

84
Center of Excellence - HRSA
  • Awarded to UNC in the Fall of 2002
  • Among the criteria responsible for UNCs success
    in competing for this COE Grant
  • Rank 9th nationally in number of African-American
    physicians graduated
  • Rank 5th nationally in number of Native American
    physicians graduated
  • More than 15 of students are URM
  • More than 4 of faculty members are URM
  • The COE provides funds for two additional URM
    faculty members each year

85

New Career Opportunities for Clinician/Scientists
  • At UNC, we have developed a model that we believe
    has assisted our faculty and expanded the grant
    portfolio throughout the School of Medicine
  • We are convinced that this is actually a very
    good time for young people with a
    career-commitment to clinical patient-oriented
    research
  • Perhaps the most tangible benefit of this program
    has been a major increase the number of young
    people with extramural funding protected time

86
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