Transcript Slide 1

New Career Opportunities for
Clinician/Scientists
Mentored Research &
Professional Development
Eugene P. Orringer, MD
April 14, 2003
Problems for Clinician-Scientists
“The clinical investigator as an
endangered species”
James Wyngaarden - NEJM, 1979
Problems for Clinician-Scientists
Crisis in Clinical Research
Ahrens: Oxford Press, 1992
Problems for Clinician-Scientists
“Investigator-initiated applications for
patient oriented research (POR) are not
reviewed equitably at the NIH………”
Williams et al. - JAMA, 1997.
Problems for Clinician-Scientists
“The four P’s that are relevant to patientoriented research include: ”
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Patience
Patients
Passion
Poverty
Brown & Goldstein – JCI 1997.
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
Problems for Clinician-Scientists
Number of First Time
Applicants to NIH
1000
800
600
400
200
MDs
MD-PhDs
0
1992 1994 1996 1998 2000 2002 2004 2006
Year
Rosenberg - Science, 1999.
Problems for Clinician-Scientists
Report from the Clinical Research Roundtable
Four key challenges facing the US
clinical research enterprise
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Workforce training
Public participation
Information systems
Funding
Sung et al. - JAMA, 2003
Problems for Clinician-Scientists
Translating Biomedical Research to
the Bedside: A National Crisis & a Call
to Action
Rosenberg – JAMA, 2003
The Promise of Basic Research
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The Human Genome Project
Stem cell research
The procurement of suitable organs
&/or the development of artificial organs
Novel, target-based drugs
New vaccines
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
Problems for Clinician-Scientists
Is there truth to these various
predictions of Gloom & Doom?
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Can something be learned from the career of a
slightly graying clinican-scientist?
What has been/is being done to facilitate the
efforts of today’s young people?
How have we at UNC sought to take advantage
of these new opportunities?
Eugene P. Orringer
My career – provides evidence that:
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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
Eugene P. Orringer
Mentors & Role Models
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Medical School
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Jack Myers
Fellowship
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John C. Parker
Junior Faculty
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Wendell Rosse
GCRC Director
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Michael Thorner
MD-PhD Program - Sal Pizzo
Dean’s Office
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Jeff Houpt
John C. Parker, MD: 1935-1993
Eugene P. Orringer
Fellowship Training
• Clinical Hematology
• Red Cell Physiology
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Membrane Transport
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Volume Regulation
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Metabolism
Eugene P. Orringer
Initial NIH Funding
Co-I on Dr. John C. Parker’s R01
Eugene P. Orringer
Subsequent NIH Funding
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PI: RCDA from NHLBI
PI: R01 from NHLBI
Eugene P. Orringer
Evolution as a Clinical Investigator
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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
The UNC Sickle Cell Program
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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
Wendell F. Rosse, MD
The UNC Sickle Cell Program
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Began a long-standing collaboration
with Wendell F. Rosse
The support & encouragement of Dr.
Rosse were instrumental in my longterm success as a clinical investigator
The UNC Sickle Cell Program
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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
The UNC Sickle Cell Program
1988 - Prepared our 1st joint Duke-UNC
application & received NIH funding for
the Duke-UNC Comprehensive Sickle
Cell Center
General Clinical Research Center
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1980’s: 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 UNC’s
GCRC Program Director
General Clinical Research Center
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As Program Director (1989-1999), I took a very
institutional approach to the GCRC
Particular emphasis on junior faculty
development
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Training programs focused on both clinical
research & research ethics
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Institutional clinical research fellowship
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CAP & M-CAP Programs
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NIEHS Contract
UNC MD-PhD Program
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In 1995, I agreed to assume the leadership of UNC’s
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
UNC MD-PhD Program
Students
1995 to the Present
50
45
40
35
30
25
20
15
10
5
0
1995 1996 1997
Year 1999 2000 2001 2002
UNC MD-PhD Program
The current year (2003) was an important
one for UNC’s MD-PhD Program
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Wrote a renewal application for MSTP award
Eight of our current students will defend their PhDs
Four of our current students will graduate
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1 going to Stanford in Internal Medicine
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1 going to Baylor in Medical Genetics
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2 going to Yale in Dermatology
Institutional Philosophy - I
The best medical centers benefit from
individuals with varying skills
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Superb investigators
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Excellent leaders
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Effective administrators
Executive Associate Dean
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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
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
UNC School of Medicine
New Chairs & Center Directors
CLINICAL LEADERS
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Runge - Medicine
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Stiles - Pediatrics
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Meyer - Surgery
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Diaz - Dermatology
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Pillsbury - ENT
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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
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
Executive Associate Dean
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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
NIH Directors Panel
(The Nathan Committee)
Key Recommendations
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Creation of several new awards in
the “K series” (see K Kiosk Website)
Re-evaluation of the NIH Review
Process
Clinical Research Enhancement Act
Public Law #106-505
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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)
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”
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
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
Office of Research &
Faculty Development
A few examples of the multidisciplinary
and/or multi-institutional proposals include:
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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
NIH Support
UNC School of Medicine
200
Dollars (Millions)
150
Office of Research
100
50
0
1970
1980
1990
Year
2000
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!!!
Office of Research &
Faculty Development
Work with junior faculty to facilitate the
submission of:
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K applications (K01, K08, K23)
Career applications to professional
societies, foundations, and other
non- governmental organizations (NGOs)
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
K23 - Patient-Oriented Research CDA
NIH Goal for K23: To fund at least 100 new awards/year
Medical
School
Internship/Residency
Specialty
Independent
Investigator
Mentored Patient-Oriented
Research CDA (K23)
Total # of K23 Awards made by the
NIH
700
600
500
400
300
200
100
0
1998
1999
2000
YEARS
2001
2002
NIH Support to UNC
# of K23 Awards
K23 Awards to junior
faculty members at UNC
Year
(#)
(%)
1998
1999
2000
2001
2002
0
2
8
15
22
n/a
1.4
2.4
3.0
3.3
700
600
500
400
300
200
100
0
1998
1999
2000
2001
2002
Total NIH Support to the
Extramural Community
NIH Support to UNC
$ (Billions)
NIH - Total Extramural Awards
20
15
10
5
0
1999
2000
Year
2001
NIH $’s NIH $’s NIH
(Millions) (%)
Ranking
1999
2000
2001
131
144
170
1.02
0.98
1.08
17
15
15
UNC School of Medicine
Total NIH $’s vs K23 Awards
1999
2000
2001
2002
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NIH Grants
(%)
K23 Awards *
(%)
1.02
0.98
1.08
n/a
1.4
2.4
3.0
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
Office of Research &
Faculty Development
Assumed a leadership role in a variety
of institutional education & training
programs:
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Medical Student Research Programs
K30 Program
K12: BIRCWH Program
RWJ Clinical Scholars Program
K12: Mentored Clinical Research Program
UNC-Chapel Hill
Medical Student Research Programs
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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
UNC-Chapel Hill
Medical Student Research
• Short Term (3 month) Experiences
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Holderness Foundation
Short Term Training Program (NIH)
• Year-Long Experiences
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Doris Duke Clinical Research Program
Distinguished Medical Scholars Program
NIDDK Minority Fellowship Program (NIH)
• Combined Degree Programs
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MD-PhD (NIH MSTP award)
MD-MPH
~ 10
~ 35
5
6
3
8
~ 23
TOTAL # of Students / Year ~ 90
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
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
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
UNC-Chapel Hill
Career Development
for Clinician-Scientists
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
UNC Seeks to Foster the
Development of Clinician-Scientists
Programs for Career Development
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K30 Program
K12 Awards
Minority Cohort Program
K30 - Clinical Research Curriculum
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K30 Award
UNC received funding as 1
of the initial cohort of 35
This grant provides funds
for infrastructure
No funds for the trainees
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)
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
K30 - Clinical Research Curriculum
Structure
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Coursework
Seminar Series
Research Project
Work-in-Progress Presentations
Grant Preparation
Mock Study Section Reviews
Mentoring Panels
K30 - Clinical Research Curriculum
Status of the Trainees
Funding status of the K30 Trainees (n = 13) *
who have enrolled between July 2000 & the
present
K23 Awards
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Funded
Pending
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.
UNC Seeks to Foster the
Development of Clinician-Scientists
Programs for Career Development
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K30 Program
K12 Awards
Minority Cohort Program
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
The BIRCWH Program
K12 Award
Building
Interdisciplinary
Research
Careers in
Women’s
Health
UNC BIRCWH Program
The BIRCWH Award brought to UNC 5 years of
support @ $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
UNC BIRCWH Program
Developed the concept that if funded, the
UNC BIRCWH Program would have both:
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BIRCWH Scholars
BIRCWH Associates
BIRCWH Scholar
An individual who is receiving salary
support from the BIRCWH grant
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
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.
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
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
K12 – BIRCWH Program
Status 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
K23 Awards
K08 Awards
K01 Awards
R01 Awards
R03 Awards
Doris Duke Award
Pfizer Award
Others
3
3
1
2
3
1
1
8
Pending
2
4
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
K12 - Mentored Clinical Research
Scholars Program (MCRSP)
Structure of UNC’s K12 Application
• Close Linkage to the GCRC, to the K30
Program, & to the Dean’s Office
• Gene Orringer - Principal Investigator
• Paul Watkins - Program Director
K12 - Mentored Clinical Research
Scholars Program (MCRSP)
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Extremely pleased with the quality of the initial
candiates
Initially selected three from a total of 15
applicants
As with the BIRCWH:
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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
Minority Cohort Program
(MCP) Scholars
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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
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 Scholar’s progress and
summarizes his/her career development
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MCP Scholars
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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 School’s URM faculty
38% of School’s URM at the Assistant Professor Level
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:
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Build new programs that further increase the
diversity of the School
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Provide protected time and thereby enhance the
academic development and retention of our junior
faculty
MCP Scholars
Funding 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
RO1 Awards
K23 Awards
K01 Awards
P60 Project
NIH Minority Supplement
RWJ Minority Faculty Development Award
Other CDA
Co-I Research Grant
PI: NIH T32 Award
Funded
3
1
1
1
2
3
2
4
1
Center of Excellence - HRSA
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Awarded to UNC in the Fall of 2002
Among the criteria responsible for UNC’s success in
competing for this COE Grant:
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Rank 9th nationally in number of African-American physicians
graduated
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Rank 5th nationally in number of Native American physicians
graduated
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More than 15% of students are URM
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More than 4% of faculty members are URM
The COE provides funds for two additional URM
faculty members each year
New Career Opportunities for
Clinician/Scientists
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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