Center for the Study of Drug Development Records

The Center for the Study of Drug Development (CSDD) was founded by Dr. Louis Lasagna (1923-2003) in 1976 in Rochester, New York at the University of Rochester. Dr. Lasagna founded the CSDD to “provide objective analyses and add an academic voice to policy debates in biopharmaceutical innovation.” While in Rochester, the CSDD focused on researching the pharmaceutical industry and its regulation by the United States Food and Drug Administration. The first Director of the CSDD, Dr. William Wardell, led one of the earliest studies in the CSDD, which was an assessment of drug availability in the United States compared to the drug availability in the United Kingdom. The CSDD continued to work on several projects in Rochester, New York until 1984, when Dr. Lasagna was hired as the first Dean of the Sackler School of Graduate Biomedical Sciences at Tufts University. When Dr. Lasagna moved from the University of Rochester to Tufts University, he brought the CSDD with him, and it was renamed the Tufts Center for the Study of Drug Development (TCSDD) in 1988. As part of the Tufts University School of Medicine TCSDD had new opportunities to increase their research activities, focusing on economic, political, scientific, and legal issues impacting the pharmaceutical world.

Since the creation of the Center for the Study of Drug Development in 1976, the Center has done research in several fields surrounding the development of drugs. The TCSDD was the first organization to complete a comprehensive review of the cost of making a new drug and putting it on the market: $54 million in 1979, which had risen to $2.6 billion by 2014. These studies came under fire in 2016, when the TCSDD and their donors were the focus of protests as part of a global action campaign against high pharmaceutical prices led by ACT UP. Protesters demanded to know the names of donors funding the cost evaluation research conducted by Joseph DiMasi, but TSCDD director Kenneth Kaitin confirmed that no direct funding from any pharmaceutical companies was used in the drug development evaluations, and declined to release donor names, as it was against Center policy. The TCSDD continues to work in several fields related to the development of new drugs, including cost evaluation, biotechnology comparison, FDA policy review, drug effectiveness, regulation timeframes, drug withdrawals, and more.