Harvard-MIT Center for Regulatory Science

The goal of regulatory science is to innovate in the process of therapeutic development and evaluation to reduce the cost and increase the speed at which new therapeutics are brought to market. The US Food and Drug Administration has partnered with Harvard and MIT to create a forum in which to reimagine a new system that would ensure the safety and efficacy of new treatments without having to adhere to the process proscribed by law 50 years ago. The Harvard Program in Therapeutic Sciences (HiTS) is hosting the Center to create a neutral environment in which academia, industry and the FDA can jointly pursue new approaches to the evaluation and administration of drugs. This activity is a natural corollary to the modeling work at the Laboratory of Systems Pharmacology (LSP). The advancement of our understanding of beneficial and adverse responses to therapeutic molecules, devices and cells is necessary in order to take the critical next step and look at how those advances might be integrated into our regulatory system. New computational and measurement technologies could dramatically improve the practical business of developing and evaluating drugs including toxicology, clinical trial design and evaluation.