Mentored Research

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New Career Opportunities for Clinician/Scientists

Mentored Research Professional
Development Eugene P. Orringer, MD April 14,
2003
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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

• Crisis in Clinical Research
• Ahrens Oxford Press, 1992

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Problems for Clinician-Scientists

• Investigator-initiated applications for
  patient oriented research (POR) 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

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

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Problems for Clinician-Scientists
MDs
MD-PhDs
Rosenberg - Science, 1999.
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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

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Problems for Clinician-Scientists

• Translating Biomedical Research to the Bedside
  A National Crisis a Call to Action
• Rosenberg JAMA, 2003

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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
• New vaccines

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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 it could . b) Emerge as the rate
limiting step in the translation of basic
science to benefit the greater public health

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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?

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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

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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

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John C. Parker, MD 1935-1993
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Eugene P. OrringerFellowship Training

• Clinical Hematology
• Red Cell Physiology
• Membrane Transport
• Volume Regulation
• Metabolism

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Eugene P. Orringer Initial NIH Funding

• Co-I on Dr. John C. Parkers R01

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Eugene P. Orringer Subsequent NIH Funding

• PI RCDA from NHLBI
• PI R01 from NHLBI

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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

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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

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Wendell F. Rosse, MD
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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

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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

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The UNC Sickle Cell Program

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

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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

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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

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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

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UNC MD-PhD Program1995 to the Present
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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

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Institutional Philosophy - I

• The best medical centers benefit from
  individuals with varying skills
• Superb investigators
• Excellent leaders
• Effective administrators

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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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

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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

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NIH Support UNC School of Medicine
Office of Research
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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!!!

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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)

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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

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• 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)
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Total of K23 Awards made by the NIH
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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

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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

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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

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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

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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

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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

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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

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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

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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

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UNC-Chapel Hill

• Career Development
• for Clinician-Scientists

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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

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UNC Seeks to Foster the Development of
Clinician-Scientists

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

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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

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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)

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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

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K30 - Clinical Research CurriculumStructure

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

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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.

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UNC Seeks to Foster the Development of
Clinician-Scientists

• Programs for Career Development
• K30 Program
• K12 Awards
• Minority Cohort 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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The BIRCWH Program K12 Award

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

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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

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UNC BIRCWH Program

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

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BIRCWH Scholar

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

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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
• .

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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
• .

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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

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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
  

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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

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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

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