Mentored Research

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New Career Opportunities for Clinician/Scientists

Mentored Research Professional
Development Eugene P. Orringer, MD Scholars in
Clinical Science Advisory Board Meeting May 3,
2005
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Problems for Clinician-Scientists

• The clinical investigator as an
• endangered species
• James Wyngaarden - NEJM, 1979

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Problems for Clinician-Scientists

• Investigator-initiated applications for
  patient oriented research are not reviewed
  equitably at the NIH
• Williams et al. - JAMA, 1997.

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Problems for Clinician-Scientists

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

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Problems for Clinician-Scientists

• NIH review of clinical vs laboratory-based
  research applications from MDs favored the
  non-clinical applicants (1997 2002)
• Type N Priority Scores funded
• Clinical 7227 254
  23.9
• Lab-based 10209 244 28.1
• Ted Kotchen JAMA, 2004

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Problems for Clinician-Scientists

• Is there truth to these various predictions of
  Gloom Doom?
• What has been/is being done to facilitate the
  efforts of todays young clinician-scientists?
• How have we at UNC sought to take advantage of
  these new opportunities?

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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
• Biologics
• Vaccines
• etc. etc. etc. .

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

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A Dean ????

• In 1999, I was approached by Dean Jeff Houpt
  about my possible interest in moving to the
  Deans Office to help him develop the various
  academic aspects of our School

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Executive Associate Dean

• From 1989 to 1999, I had served as the Program
  Director of UNCs General Clinical Research
  Center (GCRC)
• From 1995 on, I also served as the Program
  Director for UNCs MD-PhD Program
• In 1999, Dean Houpt offered to me the role of
• Executive Associate Dean for Faculty Affairs

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Problems for Clinician-Scientists

• Based on my experiences with the GCRC, the CAP
  Program, and the MD-PhD Program, I realized how
  much I enjoyed working with young people and
  helping them to succeed
• Contrary to the Gloom Doom predictions, I
  actually felt that this was a good time for young
  people whose primary focus was clinical and
  translational research

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Institutional Philosophy

• At the end of the day, it is really the young
  people that are absolutely critical to the growth
  and the ultimate success of any School of Medicine

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Executive Associate Dean

• I told him that I would consider assuming the
  role of Executive Associate Dean for Faculty
  Affairs only if the role could be expanded to
  Executive Associate Dean for Faculty Affairs AND
  Faculty Development

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Executive Associate Dean

• In 1999, Dean Houpt and I agreed that I would
  keep the MD-PhD Program, but give up the GCRC
  Directorship as I assumed the role of Executive
  Associate Dean for Faculty Affairs Faculty
  Development

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Executive Associate Dean

• During my discussion with Dean Houpt, he
  listened to my ideas, and then ultimately agreed
  to support the creation of an office that we have
  since referred to as the
• Office of Research Faculty Development

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Office of Research Faculty Development

• When first established, this office had three
  specific purposes
• To assist faculty members with the preparation of
  large multi-disciplinary, multi-school, and/or
  multi-institutional proposals
• To develop write certain institutional grants
  (e.g., Renovation grants, K12 grants, Roadmap
  grants, etc.) that otherwise might never get
  written
• To support junior faculty members with the
  preparation of their individual grant proposals
  (e.g., K awards, etc.)

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Office of Research Faculty Development

• The cost of this office, which is approximately
  600K/year, has been stable for the past several
  years
• This includes a substantial percentage of my
  salary as well as that of the Associate Dean for
  Research
• We have developed this office in such a way that
  there is a significant incentive for us to obtain
  support for our salary from grants and contracts

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Office of Research Faculty Development

• Has this office been successful?

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Office of Research Faculty Development

• Additional evidence of success comes from a
  spring 2002 report from a School of Medicine
  re-engineering task force that stated
• The budget of this office should NOT be cut. In
  fact, its budget be increased!

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Office of Research Faculty Development

• Finally, we have recently hired a graduate
  student from the Department of Operations
  Research at UNC to conduct an independent
  evaluation of this Office.
• Specifically, we are trying to evaluate the
  Return on Investment (ROI) from the Office of
  Research Faculty Development that has been
  received by the SOM.

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Office of Research Faculty Development

• When first established, this office had three
  specific purposes
• To assist faculty members with the preparation of
  large multi-disciplinary, multi-school, and/or
  multi-institutional proposals
• To develop write certain institutional grants
  (e.g., Renovation grants, K12 grants, Roadmap
  grants, etc.) that otherwise might never get
  written
• To support junior faculty members with the
  preparation of their individual grant proposals
  (e.g., K awards, etc.)

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Office of Research Faculty Development
Representative Institutional Grants

• NCRR-funded Renovation Grants
• T35 Short Term Research Training Grant
• K30 Clinical Research Curriculum
• K12 BIRCWH Grant
• K12 Clinical Research Career Development
• Doris Duke Medical Student Training Grant
• RTRC several other NIH Roadmap Grants
• HRSA-funded Minority Center of Excellence
• etc, etc, etc.

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K30 - Clinical Research Curriculum UNC-Chapel
Hill

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

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K30 - Clinical Research Curriculum

• This Program has become the foundation upon
  which we have developed all aspects of our junior
  faculty development program

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K30 - Clinical Research Curriculum UNC-Chapel
Hill

• 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)

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Development of Clinician-Scientists UNC-Chapel
Hill

• Programs for Career Development
• K30 Program
• K12 Awards
• Minority Scholar Program

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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

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UNC BIRCWH Program

• Building
• Interdisciplinary
• Research
• Careers in
• Womens
• Health

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UNC BIRCWH Program

• The Office of Research on Womens Health (ORWH)
  advocated for ultimately created the BIRCWH
  Program
• ORWH employed the K12 funding mechanism to
  establish the BIRCWH Program
• The initial 12 BIRCWH awards (BIRCWH I) were
  announced and funded in September, 2000
• A second group of 12 awards (BIRCWH II) was
  made in September, 2002.

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UNC BIRCWH Program

• UNC BIRCWH Award began in September, 2000
• This Grant brought us 5 years of NIH support _at_
  500,000/year
• The vast majority of these s have
  provided salary support to junior faculty
  members in exchange for 75 protected research
  time
• Our goal has been to assure that within 2
  years, each BIRCWH Scholar writes an
  appropriate NIH grant (e.g., K23, K08, R01)

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UNC BIRCWH Program

• Developed the concept that the UNC BIRCWH
  Program would have both
• BIRCWH Scholars
• BIRCWH Associates

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UNC BIRCWH Program

• This concept (i.e., Scholars and Associates) has
  enabled us to grow the UNC BIRCWH Program
  substantially.
• By the end of year - 04, our BIRCWH Program had
  grown to a critical mass of 17 young people (9
  MDs, 6 PhDs, 1 PharmD, and 1 MD-PhD), who came to
  us with remarkably diverse interests and from
  very different backgrounds.

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UNC BIRCWH ProgramSuccess of the Scholars

• Status of the BIRCWH Associates (n 12) who
  were supported by the BIRCWH award between
  October 2000 June 2004 but are now no longer
  receiving support from the BIRCWH.
• Funded
• K23 Awards 4
• K08 Awards 3
• K01 Awards 2
• R01 Awards 5
• R03 Awards 3
• Doris Duke Award 1
• Pfizer Award 1
• Others 9

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UNC BIRCWH Program
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Development of Clinician-Scientists UNC-Chapel
Hill

• Programs for Career Development
• K30 Program
• K12 Awards
• Minority Scholar Program

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UNC Minority Scholar Program

• The School of Medicine at UNC has always been
  fully committed to having a faculty with as much
  ethnic and gender diversity as possible
• In 1995, the Dean set aside 375,000 in
  continuing state dollars to establish the UNC
  Minority Scholars Program (MSP)
• He then agreed to partner with any Chair who was
  successful in identifying an excellent minority
  candidate for the School of Medicine faculty

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UNC Minority Scholar Program

• Design of the Program
• Nominees would be solicited on a regular basis
  from each department in the School of Medicine
• Each candidate recommended for support by the MSP
  Advisory Committee would be granted an initial
  three years of support
• Scholars are expected to be visible and available
  role models
• Scholars are expected to exhibit progress along
  an academic path
• The activities of each scholar will be reviewed
  on an annual basis
• If the performance of an awardee is judged to be
  sufficiently meritorious, a second three year
  period could be awarded
• .

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UNC Minority Scholar Program

• MSP Advisory Committee
• The Advisory Committee meets 2-3 times per year
  to review each of the departmental nominees to
  select the new MSP Scholars
• The Advisory Committee also meets each spring
  with the Dean and with all of the Scholars and
  their Department Chairs to review their progress
  and to examine all aspects of their career
  development

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UNC Minority Scholar Program

• Institutional funding for the MSP was recently
  augmented by a Minority Center of Excellence
  (COE) Award that was funded by HRSA two years ago
• This COE grant brought with it support for two
  additional minority faculty members
• In the competitive renewal for our BIRCWH award,
  Dean Roper committed one additional minority
  scholar slot that would link together the BIRCWH
  the MSP Programs

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UNC Minority Scholar Program

• Status of the Program
• Total of MSP awardees 16
• Total of MSP Awardees currently at UNC 13
• Total of MSP Awardees currently supported 7
• Gender 12 women and 4 men
• Ethnicity 14 African-Americans and 2 Hispanics
• Primary departments of the Scholars
• Allied Health (1), Family Medicine (1),
  Medicine (4), Nutrition (2), Ob-Gyn (1),
  Pediatrics (5), Pharmacology (1), Social Medicine
  (1)

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UNC Minority Scholar Program Success of the
Scholars

• 12
• Current independent funding status of the
  Scholars (n 13) who have received support from
  the MSP includes
• Award Type Funded
• RO1 Awards 4
  
• K23 Awards 1
  
• K01 Awards 2
• P60 Project 1
• NIH Minority Supplement 3
• RWJ Minority Faculty Development Award 3
  
• Other CDA 2
  
• Co-I Research Grant 4
• PI NIH T32 Award 1
  

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UNC Minority Scholars Program
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UNC Minority Scholar Program
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UNC Minority Scholar Program

• The UNC School of Medicine currently has 1193
  full-time faculty members
• Of these, 66 (or 5.5) come from
  under-represented minority backgrounds
• The MSP has helped to recruit support a total
  of 16 young people, 13 of whom remain at UNC on
  the faculty
• These 13 individuals account for 19.7 of the
  total minority faculty members

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UNC Minority Scholar Program

• Very successful program
• Has become a valuable model
• Enabled UNC to recruit a number of outstanding
  young faculty members
• Has increased the ethnic diversity within the
  School of Medicine
• By demonstrating our commitment to ethnic
  diversity, the MSP has helped us to compete for a
  number of federal grants

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Development of Clinician-Scientists UNC-Chapel
Hill

• At UNC, we have chosen to place heavy emphasis
  on the individual K Award Mechanisms

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Why have we chosen to focus on the K Award
Mechanism

• A carefully crafted K Award assures that 75 of
  a young persons time will be carefully protected
  for both
• a) his/her research program and
• b) the training activities that are
  essential for his/her career
  development

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Development of Clinician-Scientists UNC-Chapel
Hill

• Use of the Individual K Award Mechanism by a
  number of our peer institutions

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K Award DataWho are our peers?

• Southeast Schools
• UNC
• A
• B
• C
• D
• E
• M

• 11-20 NIH Ranking
• UNC
• F
• G
• H
• I
• J
• E
• D
• K
• L

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K Award DataHow do our peers do?
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Junior Faculty Development

• How successful has UNC been using
• the Individual K Award Mechanism?

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How do we compare to our peers?
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Development of Clinician-Scientists UNC-Chapel
Hill

• To what do we attribute UNCs success in
  employing Individual K Award Mechanism?

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Success in Competing for Individual K Awards

• At UNC we have developed a centralized Office of
  Research Faculty Development
• This Office has enabled us to compete
  successfully for several institutional K Awards
  (K30, K12s)
• We have employed the K30 Program as a platform
  upon which to build a junior faculty career
  development program
• Unlike R01s, we have found that individual K
  Awards can easily be institutionalized (i.e.,
  there is considerable commonality between these
  applications)
• We have developed a library of successful
  individual K Awards that we share with potential
  new applicants

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Success in Competing for Individual K Awards

• We hold mock review sessions for new K
  applicants, from which the applicants receive
  written critiques
• We support a biostatistician who works with the
  applicant from the beginning of the process
• We assure that the selected mentor(s) are
  appropriate
• We provide Boiler Plate information re.
  resources, environment, training programs, etc.
• We provide carefully crafted institutional
  letters of support
• We make certain that the applications are sent to
  the proper institute request dual I/C
  assignment whenever possible

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NIH K08 Awards Success Rate by Institute or
Center
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NIH K23 Awards Success Rate by Institute or
Center
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Measuring the Success of Individual K Awardees

• A K Award assures that 75 of the time of a young
  person is protected for research
• It is our hypothesis that many of the K awardees
  will obtain RPGs and thus be more likely to
  succeed over the long term than non-K awardees
• However, it is important to remember that this
  remains an unproven hypothesis, particularly for
  clinical investigators with K23 awards

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Includes the following Awards K01, K07, K08,
K20, K21, K22, K23, K25
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Includes the following Awards K01, K07, K08,
K20, K21, K22, K23, K25
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Clinical Associate Physician (CAP) Program

• 137 CAP awardees
• 60.9 males and 39.1 females.
• Average duration of CAP funding was 3.77 yrs (SD
  1.2 yrs)

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CAP Program - Outcomes

• Two - five years after completing their awards,
  most CAPs are faculty members (Assistant or
  Associate Professors)
• Relatively few former CAPs have gone into
  practice or to industry

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Number of NIH Applications from Awards to
Former CAP Awardees
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CAP Program - Outcomes

• Many Former CAPs have received support either
  from Foundations or from the pharma-ceutical
  Industry

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CAP Program - Outcomes

• 42 former CAP awardees (31.6) have been able to
  obtain an NIH research grant (R, P, or U series)
• 42 former CAP awardees (31.6) applied for a
  subsequent NIH grant but were not funded.
• 49 former CAP awardees (36.8) never did apply
  for a subsequent NIH grant
• 67 of CAP former awardees continue to do human
  research
• An additional 9.1 of CAP former awardees are
  doing both human and animal research.

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Problems Facing Todays Clinical Research K
Awardees

• Clinical departments can no longer afford to
  support young people using clinical revenue as
  they try to obtain NIH grant support
• NIH budget limitations make for an increasingly
  competitive funding environment
• Clinical research applications still appear to
  face significant hurdles with NIH study sections
• Many institutional APT Committees remain focused
  on the old model of a single PI and a single R01

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Development of Clinician-Scientists UNC-Chapel
Hill

• At UNC, we have developed a model that we believe
  has assisted our faculty and expanded the grant
  portfolio throughout the School of Medicine
• Perhaps one of the most tangible benefits of this
  program has been the major increase in the number
  of young people with extramural funding
  (especially K Awards) the attendant protected
  time
• How many of these young people will be successful
  in converting their K awards to RPGs remains to
  be seen