| In establishing the
CRCA Program at Tulane University, two separate committees (Internal
Advisory and External Advisory) have been established. While
the make-up of these committees are different, the responsibilities
will be complementary and each will have an important role in
assessing both the Program itself as well as the progress of
trainees and the development of clinical research at Tulane
University.
Internal
Advisory Committee
The Internal Advisory Committee
is made up of faculty at Tulane University Medical Center,
Xavier University, and the Tulane Department of Biomedical
Engineering. This committee is comprised of senior faculty
members, all of whom have considerable experience in the training
of individuals for clinical research. During the selection
process, each candidate for the CRCA Training Program will
be interviewed by two members of the Internal Advisory Committee.
The Internal Advisory Committee will meet 3-4 times per year
during which time they will review each trainee's progress
as well as the status of the CRCA Program in general. Lastly,
the Internal Advisory Committee and Core Faculty are the governing
board to select trainees.
All the day-to-day operations
of the Program will be the responsibility of the Program Director,
the Associate Program Director and the Core Faculty, we will
take advantage of the meetings of the Internal Advisory Board
to solicit input and advice regarding all of the educational
components of the Program including core curriculum, seminar
series, mentoring process, and research projects. In addition
the Internal Advisory Committee will review the progress of
each trainee and of the Program itself on a yearly basis at
the retreat. All the members of the Internal Advisory Committee,
listed below, have established records of clinical research
training and funding.
Paul
Whelton, M.D. , M. Sc. - Dr. Whelton is the Senior
Vice-President for the Health Sciences at Tulane. He received
a M.B., B. Ch., and B.A.O. degrees with honors from the National
University of Ireland, University College Cork. He was recruited
to Tulane in 1999 from The Johns Hopkins University where
he was a Professor of Medicine and Biostatistics and Epidemiology.
He has published 207 papers and is on several journal editorial
boards and NIH committees. He is very familiar with the development
of clinical research training programs since he played a leadership
role in the development of what may have been the first masters
degree clinical research training program in the United States
while at Johns Hopkins. He also directed clinical research
training opportunities at the Johns Hopkins Medical Institutions
both as Director of the Welch Center for Prevention, Epidemiology
and Clinical Research, the NCRR-funded Outpatient GCRC, and
the Medical Institution's Program in Clinical Epidemiology.
While there, he has supervised 44 trainees in clinical research
areas. He also, as reviewed, leads a major program in clinical
hypertension research with over $3.5 million dollars in funding.
Roy
C. Orlando, M.D. - Dr. Orlando is Professor of Medicine
and Physiology and Chief of the Section of Gastroenterology
and Hepatology at Tulane University Medical Center. Dr. Orlando
received his M.D. degree from Georgetown University. There
are 12 clinical research projects ongoing in the Section including
studies of treatment for esophagitis, Crohn's disease, irritable
bowel syndrome, Hepatitis C infection, vomiting secondary
to chemotherapeutic agents and primate model of hepatocyte
regeneration. Dr. Orlando has also trained several clinical
investigators while at the University of North Carolina and
now at Tulane. He has $870,000 in NIH funding and is a NIH
MERIT awardee. He also has a VA Merit Review Grant.
Jeannette
Magnus, M.D., Ph.D. - Dr. Magnus is Clinical Professor
of Public Health and Head of the Maternal and Child Health
Section, Dept. of Community Health Sciences, TSPHTM. She received
her M.D. and Ph.D. degrees from the University of Tromso in
Norway. She is the Director and PI of the DHHS-funded Tulane/Xavier
National Center of Excellence in Women's Health ($185,000).
She is also Co-PI of a CDC grant to develop a community action
plan to reduce cardiovascular risk factors in African American
Women in New Orleans ($250,000). She has trained 9 MD clinical
investigators.
Gerald
Berenson, M.D. - Dr. Berenson is Professor of Medicine,
Pediatrics, Biochemistry and Epidemiology at Tulane University
Medical Center and Director of the Tulane Center for Cardiovascular
Health. He received his M.D. degree from Tulane University
where he was elected to AOA. He is best known as the developer
and long-time PI of the NIH-funded Bogalusa Heart Study. He
is internationally recognized for this clinical research program
on the early natural history of arteriosclerosis. He has over
690 publications. Dr. Berenson is also the PI of a newly funded
5-year NIH RO1 grant to study the evolution of cardiovascular
risk with normal aging. The total amount of funding to Dr.
Berenson is approximately $3.6 million.
Donald
Krogstad, M.D. - Dr. Krogstad is the Henderson Professor
and Chair, Department of Tropical Medicine, TSPHTM and Professor
of Medicine and Parasitology, Tulane School of Medicine. He
is the Director of the Tulane Center of Infectious Diseases.
He has many publications and is very experienced in both the
conduct and training of investigators in clinical research
of infectious diseases. For example, he is funded by several
grants from the NIH to link a cohort-based study of human
infection and disease to entomologic data in transmission,
to develop a cadre of sub-Saharan African health scientists
and to develop aminiquinoline antimalarials. He has trained
25 Ph.D.s and 150 MPHT over the past 5 years and has $1.8
million in research funding.
Wayne Harris, Ph.D.
- is Dean of the College of Pharmacy at Xavier University
of Louisiana. He received his Ph.D. degree from The University
of Kansas with a concentration in medicinal chemistry. As
pointed out in his letter of support, 10% of the graduating
class of the College of Pharmacy (100-110 students) continues
in postgraduate education and training. He is very enthusiastic
that both students and faculty at Xavier may utilize the CRCA
Program to further their education and training in clinical
research. Dr. Harris will coordinate the activities of the
CRCA Program at Xavier including the recruitment, selection
and monitoring CRCA trainees from Xavier. Also, as a member
of the Core Faculty, he will be involved in the direction
of the Program, serve as a Program co-mentor, and serve as
a consultant to the Program in the recruitment of trainees
from underserved populations.
Cyril
Y. Bowers, M.D. - Dr. Bowers received his M.D. degree
from the University of Oregon, Portland, OR. He is a Professor
of Medicine and Section Chief of Endocrinology and Metabolism
in the Tulane Department of Medicine. He has many publications
and is known throughout the world for his pioneering and ongoing
basic and clinical studies involving Growth Hormone Related
Peptides. Most of these studies are being performed in the
GCRC.
Jess
Thoene, M.D. - Dr. Thoene is the Director and Karen
Gore Chair of the Hayward Human Genetics Center and Professor
of Pediatrics at Tulane University Medical Center. He received
his M.D. from Johns Hopkins University. Dr. Thoene joined
the Tulane faculty this year. Previously, Dr. Thoene was Professor
and Director of the Section of Biochemical Genetics, Dept.
of Pediatrics and the Director of the Pediatric Clinical Trials
Center of the University of Michigan. In this capacity he
has trained five clinical research faculty and was involved
in clinical research in Pediatrics.
Richard
T. Hart, Ph.D. - Dr. Hart is the Professor and Chair
of the Department of Biomedical Engineering at Tulane University.
Dr. Hart's goal is to actively develop interdisciplinary relationships
with disease-centered investigations, e.g. as would be provided
by the CRCA Program. There are examples of present research
activities in the Department of Biomedical Engineering presently
that would accommodate the Ph.D. students to develop clinical
research careers including biomechanics of lung disease, neuroscience
and opthamology. Further evidence for the commitment of Dr.
Hart to pursue increases in clinical research activities is
his agreement to supply the CRCA with trainees.
Bernard
M. Jaffe, M.D. - Dr. Jaffe is Vice?Chairman of the
Department of Surgery and Chief of the Division of Surgical
Research at the Tulane University School of Medicine. He is
also the PI of the T-32 Training Grant from the NIH in Surgical
Oncology ($492,000) which funds 2 surgical oncology trainees
per year. He is Associate Director for Education of the TCC
and serves on its Executive, Steering, and Planning Committees.
He has been responsible for the scientific mentoring and training
of 7 basic scientists, 29 surgeons and surgical residents,
and many medical students. Dr. Jaffe was the Chair of Surgery
at the State University of New York Downstate Medical Center
prior to his recruitment to Tulane in 1992.
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External
Advisory Committee
An External Advisory Committee,
comprised of experts in clinical research training and recruitment
of investigators, has been created. The members of the committee
will make a two-day visit to New Orleans during the time of
the annual retreat to conduct a thorough review of all aspects
of the CRCA Program. During these visits, the External Advisory
Committee will first meet with the Program Director and Associate
Director and the members of the Core faculty to review all
aspects of the Tulane CRCA Program, since the last retreat.
The Program Director will also summarize all of the changes
made in the Program since the last visit of the External Advisory
Committee, emphasizing in particular, those changes that are
made in the response of the written recommendations. After
meeting with the Program faculty, the External Advisory Committee
will meet separately with the trainees. Holding these meetings
without the Program faculty will afford the External Advisors
an opportunity to hold a frank and open discussion with the
trainees to obtain comments that should provide them with
as much insight as possible in to all aspects of the CRCA
Program at Tulane. The External Advisory Committee will also
meet with the Internal Advisory Committee to obtain their
perspective on the CRCA Program, faculty and quality and progress
of trainees. At the end of the two day session, the External
Advisory Committee will also hold a wrap-up session with the
Program Director and Associate Director offering the Directors
a chance to respond to issues raised during their meetings.
Following the visit, the External Advisory Committee will
prepare and submit to the Program Director a written evaluation
of all aspects of the CRCA Program. The report will emphasize
the problems that the Committee was able to identify during
their visit. The report will also highlight recommendations
for change or modifications that the External Advisory Committee
feels might further strengthen the CRCA Program. The members
of the External Advisory Committee are:
Josef
Coresh, M.D., Ph.D. - Dr. Coresh is Associate Professor
at the Departments of Epidemiology, Medicine and Biostatistics
at the Johns Hopkins University School of Hygiene and Public
Health and the Johns Hopkins School of Medicine. Dr. Coresh
directs the Cardiovascular Epidemiology Training Program at
Johns Hopkins which includes five post-doctoral students as
well as four pre-doctoral students, directs clinical epidemiology
courses for the medical students which has encouraged a number
of students each year to pursue an MPH, MHH, MHS, or Ph.D
training in Epidemiology, the Cardiovascular Epidemiology
Course, as well as the GCRC Biostatistics, and Informatics
Core. As a member of the Welch Center for Prevention Epidemiology
and Clinical Research which was founded by Dr. Paul Whelton,
he is very experienced in multidisciplinary training in clinical
research and is affiliated with the present K30 CRCA Award
to Johns Hopkins University.
Eugene
P. Orringer, M.D. - Dr. Orringer is the Verne S. Caviness
Professor of Investigative Medicine and Executive Associate
Dean for Faculty Affairs at the University of North Carolina
at Chapel Hill School of Medicine. Dr. Orringer also directs
the M.D./Ph.D. Program at UNC and for ten years was the Program
Director of the GCRC at UNC. Dr. Orringer has a long career
in clinical research involving hematologic disorders, especially
in sickle cell disease, but he also has a long-term experience
with clinical research and training in his leadership roles
in the GCRC and M.D./Ph.D. programs.
David
R. Parkinson, M.D. - Dr. Parkinson is Vice-President,
Clinical Research and Development of Novartis Pharmaceuticals
Corporation. Dr. Parkinson has extensive experience in clinical
trial design and drug development which was gained during
his tenure at the NCI. He is leading a major industrial effort
in drug development in industry and brings to the external
advisory committee the perspective of industry which will
help focus and shape the curriculum on an ongoing basis.
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