Gigi Hirsch, MD, is the Executive Director of the Massachusetts Institute of Technology Center for Biomedical Innovation (CBI) which designs and leads collaborative research programs to overcome challenges to the development, diffusion and adoption of biomedical innovation.

Her current efforts at CBI largely center on leading the New Drug Development Paradigms initiative (NEWDIGS), a unique “think and do tank” focused on re-engineering key elements of the global biomedical innovation ecosystem to deliver new, better and affordable therapeutics to the right patients faster. 

NEWDIGS’ first program focused on aligning stakeholders around more adaptive approaches to the management of risk and uncertainty in pharmaceutical regulation, and helped to inspire the “adaptive pathways” pilot program launched by the European Medicines Agency (EMA) in March 2014.

NEWDIGS methodologies offer an emerging model for research-driven policy and process change, highlighted through Dr. Hirsch’s invited participation as an Expert Advisor to the US President’s Council of Advisors on Science & Technology (PCAST) in 2011-2012.

Dr. Hirsch has held a number of leadership roles that leverage her broad clinical background 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 Deaconess Medical Center. She has held faculty appointments at Harvard Medical School and Brown University. Dr. Hirsch received her medical degree at the University of Cincinnati.