 Jonathan
M. Fishbein, M.D. was appointed Director of
the newly created Office for Policy in Clinical
Research Operations (OPCRO), Division of AIDS,
National Institute for Allergy and Infectious
Diseases in July, 2003. OPCRO’s purpose
was to develop, standardize, implement and
execute policies, procedures and standards
of conduct for clinical research in support
of the DAIDS scientific agenda. The goal of
these activities would be the protection of
volunteer’s rights and the enforcement
of accountability, in order to achieve the
highest standard of scientific integrity in
the Division’s sponsored research.
Previously, Dr. Fishbein had served as
Vice President of North American Medical
Services at PAREXEL International Corporation
(Waltham, MA) from 1999 to 2003. Since 1997,
Dr. Fishbein’s responsibilities included
the financial, strategic, and operational
oversight for the North American medical
safety and consulting arm of one of the
world’s largest contract research
organization (CRO).
At PAREXEL, Dr. Fishbein’s accomplishments
included the expansion of his professional
staff four-fold to eighty employees, who
he placed in five offices throughout the
U.S. He recruited established clinical researchers
with a wide variety of therapeutic area
expertise from industry and academia to
increase the staff of physician clinical
trial specialists from five to fourteen.
He was responsible for improving safety
monitoring capabilities and establishing
new services such as DSMB creation and oversight,
pharmacovigilance, and medical telecommunications
center support for phase IV studies. He
maintained corporate relationships with
academic institutions, most notably McGill
University/Montreal General Hospital. Under
Dr. Fishbein’s leadership, North American
Medical Services grew its revenues substantially
and was a leader in corporate profitability.
As a Department Head, Dr. Fishbein continued
to maintain medical and safety oversight
on a number of trials, including a phase
III study of Riquent for La Jolla Pharmaceuticals.
Dr. Fishbein joined PAREXEL as an Associate
Medical Director in 1993. By 1997, Dr. Fishbein
was promoted to Senior Medical Director
where his responsibilities included providing
scientific and strategic guidance on medical
issues, clinical drug development, protocol
development, regulatory submissions, manuscript
development, safety monitoring and evaluation
of new technologies. Dr. Fishbein’s
business development activities focused
primarily on securing awards in the transplantation
field. As a result, PAREXEL became a leading
contractor for clinical trials in this therapeutic
area.
Dr. Fishbein was appointed a Medical Staff
Fellow at the Immunology Branch of the National
Cancer Institute in 1990. Under the mentorship
of David H. Sachs, M.D., Dr. Fishbein studied
mechanisms of transplantation tolerance
using inbred miniature swine. After a year,
Dr. Fishbein accompanied Dr. Sachs to Boston
to continue his work as a Research Fellow
in Surgery at the Harvard Medical School
and the Transplantation Biology Research
Center (TBRC) at the Massachusetts General
Hospital. In his research, Dr. Fishbein
studied the mechanism of tolerance using
a renal transplantation model in miniature
swine. He co-authored 14 publications relating
to this research in such journals as Transplantation,
Journal of Immunology, and Immunologic Reviews.
Dr. Fishbein trained in general surgery
for 2 years at Vanderbilt University Medical
Center and one year at the Michael Reese
Hospital and Medical Center in Chicago prior
to his fellowship. He is a 1987 graduate
of The Johns Hopkins University School of
Medicine and received his Bachelor's degree
from Lafayette College in 1983.
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