Boaz Hirshberg, MD
MedImmune, Gaithersburg, Maryland

Boaz Hirshberg, MD is the Vice President, Clinical Therapeutic Area Head, Cardiovascular/Metabolic / renal Disease (CVMD) at MedImmune. He is accountable for all early clinical development plans and clinical trials within CVMD; chairing the CVMD Clinical Functional Review Committee (FRC) and Protocol Review Committee (PRC), respectively; and serving as a rotating member of the MedImmune Safety Review Board (MSRB).

Previously, Dr. Hirshberg was Medical science director (global clinical lead) for the saxagliptin (Onglyza) franchise. He is an endocrinologist and internist with over eight years of pharmaceutical small and large molecule clinical development and six years as academic / government physician scientist. He has over 70 peer reviewed papers and book chapters, been invited to speak in international meetings and is a member of scientific advisory boards. He has extensive documented experience ranging from phase 1 translational studies, proof of concept studies, phase 3 and life cycle management programs.

Dr. Hirshberg led multiple global clinical studies including a mega cardiovascular outcome study (SAVOR, 16,500 patients, 26 countries, ~$250MM). US, EMA, China SFDA and global regulatory experience, with numerous interactions including IND’s /BLA, preparation for and responses to regulatory interactions, participation in successful NDA and sNDA. He also has significant experience with evaluating and integrating licensing opportunities and collaborations with outside partners (academia, biotech and large pharmaceutical companies). He supported the US and global commercial organization marketing efforts. He has clinical development expertise in the fields of diabetes, transplantation and dyslipidemia.