Genotoxicity and Carcinogenicity Testing of Pharmaceuticals (PDF)

Michael J.
Graziano, Ph.D., has more than 27 years of experience as a
toxicologist in the pharmaceutical industry. He is currently Vice President of
Drug Safety Evaluation at Bristol-Myers Squibb, where he is responsible for the
nonclinical safety testing for all drugs within the BMS portfolio. Within the
past 6 years, he has provided nonclinical support for 8 new drug approvals.
Prior to joining BMS in 2003, he was Director of Anticancer and Antibacterial
Toxicology Programs at Pfizer Pharmaceutical Research, in Ann Arbor, MI, and with
the Parke-Davis Pharmaceutical Research Division/Warner-Lambert Company. He is
the author or co-author of more than 90 scientific publications and abstracts,
many dealing with the nonclinical safety of new therapeutic agents. Dr.
Graziano is a member of the IQ DruSafe Leadership Group, the PhRMA Clinical and
Preclinical Development Committee, the EFPIA Preclinical Safety Development
Committee, and HESI. He is also the PhRMA Deputy Topic Leader for the current
ICH S1 Expert Working Group. Dr. Graziano received a B.S. in animal science
from Rutgers University, a M.S. in veterinary toxicology from Louisiana State
University, and a Ph.D. in toxicology from the University of Kentucky, and was
a Post-Graduate Research Toxicologist at the University of California,
Berkeley. He is also a Diplomate of the American Board of Toxicology.



David
Jacobson-Kram received his Ph.D. in embryology from the University of
Connecticut; he then went on to serve as a staff fellow at the National
Institute on Aging. After leaving the National Institutes of Health, Dr.
Jacobson-Kram joined the faculty of the George Washington University School of
Medicine and then later, Johns Hopkins University Oncology Center. During this
same period he served, on a part-time basis, as a geneticist in the Office of
Toxic Substances at the Environmental Protection Agency and as Acting Branch
Chief in the EPA's Office of Research and