The Center for Cancer Systems Pharmacology

Harvard-MIT CRS responds to the COVID-19 Pandemic
READ MORE

Improving the Process of Therapeutic Development

Harvard, MIT, and the FDA have partnered to create a center focused on regulatory science, bringing together a range of scientific disciplines that are applied to assess the quality, safety and efficacy of medicinal products and inform regulatory decision-making throughout the lifecycle of a medicine. Working across academia, industry, and government institutions, the Center promotes regulatory science through research and education programs, uniting stakeholders under a common mission: promoting optimal patient health outcomes through biomedical innovation and the availability of safe and effective diagnostics and treatments.

More

Featured Publications

How Health Care AI Systems Are Changing Care Delivery
How Health Care AI Systems Are Changing Care Delivery
Sanders, Terwiesch, Gordon, and Stern. 2019.
Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations
Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations
Angus, Alexander, Berry, Buxton, Lewis, Paoloni, Webb, et al. 2019.
FDA and EMA Biosimilar Approvals
FDA and EMA Biosimilar Approvals
Jung, Sarpatwari, Kesselheim, and Sinha. 2019.
Promoting Pediatric Drug Research and Labeling – Outcomes of Legislation
Promoting Pediatric Drug Research and Labeling – Outcomes of Legislation
Bourgeois and Kesselheim. 2019.

The Regulatory Science Fellowship Program

Our fellowship program is affiliated with the FDA and focuses on training the next generation of regulatory science researchers. Learn more about the research our fellows are conducting or explore opportunities and how to get involved in our program.

MORE

News, Events, & Updates

Regulatory Science Forum: Fellows Showcase

Jan 24, 12pm-1:30pm

Harvard Medical School, Armenise 108

Regulatory Science Doctoral Student Symposium

Feb 3

Harvard Business School

Register

Partners