Gigi Hirsch

Gigi
Hirsch
MD
Executive Director, Center for Biomedical Innovation, NEWDIGS

Dr. Hirsch is the Executive Director of the MIT Center for Biomedical Innovation (CBI), which focuses on improving global health by overcoming challenges to the development, diffusion and adoption of biomedical innovations. Her current efforts at CBI center on leading the New Drug Development Paradigms initiative (NEWDIGS), a multi-stakeholder “think and do tank” for biopharmaceutical and healthcare system innovation designed to drive more value faster to patients, in ways that work for all stakeholders.

NEWDIGS’ flagship project focused on “Adaptive Licensing,” which helped to lay the intellectual foundation for the successful Adaptive Pathways pilot led by the European Medicines Agency.  This project focused on enhancing the public health value of new drug therapies through new collaborative approaches to managing risk and reducing uncertainty. This project also led to Dr. Hirsch’s invited participation (2011-2012) on the Expert Advisory Committee of the President’s Council of Advisors on Science and Technology (PCAST) for a special report commissioned by President Obama on “Propelling Innovation in Drug Discovery, Development, and Evaluation.”

Under Dr. Hirsch’s leadership, NEWDIGS continues to advance other critical enablers of Adaptive Licensing.  Pilots focused on new “precision financing” models for durable cell and gene therapies in the US are now being planned (FoCUS Project).  In addition, NEWDIGS is now demonstrating a new collaborative systems approach to the planning, production, and use of real-world evidence, prototyped initially for Rheumatoid Arthritis, and now scaling to other diseases.

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 patient-centered system innovation. Prior to joining MIT, she worked in commercial strategy at Millennium Pharmaceuticals, and was founder and CEO of a boutique entrepreneurial venture, funded by Boston’s Beth Israel Hospital. She has held faculty appointments at the medical schools of Harvard, Brown, and Tufts.