Paula (Gigi) Hirsch, MD

Executive Director of the Center for Biomedical System Design & NEWDIGS
Institute of Clinical Research and Health Policy Studies

Gigi Hirsch, MD serves as Executive Director of the Center for Biomedical System Design & NEWDIGS at the Institute of Clinical Research and Health Policy Studies (ICRHPS). She previous held the position of the Executive Director of the MIT Center for Biomedical Innovation (CBI) since 2007 where she focusesd the majority of her efforts leading the flagship New Drug Development Paradigms (NEWDIGS) Initiative. This systems engineering design lab focuses on advancing the capacity of the global innovation ecosystem to more reliably and sustainably deliver new, better, affordable therapeutics to the right patients faster. Collaborators include regulators from the US, EU, Canada, and Asia; payers and health technology assessment agencies; biopharmaceutical companies; providers and patients, among other key stakeholders. Work done by NEWDIGS helped to inspire the Adaptive Pathways pilot program launched by the European Medicines Agency (EMA) in March 2014. Under the ongoing leadership of Dr. Hirsch, NEWDIGS is continuing to advance Adaptive Biomedical Innovation principles through projects focused on new financing and reimbursement models; a framework for real world evidence “standards;” interactive design methods/tools for multi-stakeholder collaborative innovation; and, more broadly, advancing the “science of collaboration” in biomedical innovation.

Dr. Hirsch has held a number of leadership roles that leverage her broad clinical background (internal medicine, emergency medicine, and psychiatry) along with her passion for innovation, entrepreneurship, and improving clinical outcomes. Prior to joining CBI, she served as Director of Academic and Professional Relations at Millennium Pharmaceuticals, and was founder and CEO of a boutique entrepreneurial venture (MD IntelliNet) launched with seed funding from Boston’s Beth Israel Hospital. She held faculty appointments at Harvard Medical School (Internal Medicine and Psychiatry), Brown University (Internal Medicine), and served as an attending physician in the Emergency Department at Brigham and Women’s Hospital after receiving her medical degree at the University of Cincinnati.