Biopharmaceutics

Biography

Robert Makuch is a professor in the Department of Biostatistics at the Yale School of Public Health and Director of the Regulatory Affairs Track. A graduate of the University of Connecticut (BA), University of Washington (MA – mathematics), and Yale University (MPhil, PhD), Professor Makuch worked at the National Cancer Institute (NCI) and the World Health Organization’s International Agency for Research on Cancer early in his career. He also was heavily involved in HIV research from the mid 80's through the early-mid 90's. He participated on the data monitoring committee for the original AZT vs. placebo randomized clinical trial in AIDS patients, and served on numerous committees for the NCI and the National Institute of Allergy and Infectious Diseases. He returned to Yale in 1986, and has worked extensively on methodologic issues in clinical trials and large population-based studies since. Another area of interest involves detection of rare adverse drug events, especially in the post-marketing environment. These area of methodologic research evolved as a result of his continued interest (since the mid 80s) in regulatory affairs science. In addition, Makuch developed a regulatory affairs track at YSPH for its students, and over the past 4 years has been the leader of numerous training programs for senior delegations of the Chinese Food and Drug Agency. His areas of medical application include cancer, HIV, arthritis, and cardiovascular disease.

Research Interest