Carmen Bozic, MD
Carmen Bozic, MD is Senior Vice President of Global Development at Biogen, accountable for developing, obtaining and maintaining regulatory approval of therapies in Biogen’s therapeutic focus areas of Multiple Sclerosis and Specialty Diseases, Neurodegeneration, and Rare Diseases. Dr. Bozic is an experienced drug development leader with 18 years of progressively increasing responsibilities in the biopharmaceutical industry. Her Global Development organization includes Regulatory Affairs, Safety and Benefit-Risk Management, Global Clinical Operations, Biometrics, R&D Compliance, Medical Writing, as well as Development Sciences in Japan.
Previously, she oversaw Clinical Development in the Neurology, Immunology and Hematology Therapeutic Areas as well as Preclinical Safety and was the former SVP and Global Head of Safety and Benefit-Risk Management at Biogen. In her leadership roles at Biogen, Dr. Bozic has overseen regulatory filings and approvals of multiple therapies, including TYSABRI (natalizumab), AVONEX (interferon beta-1a) pre-filled syringe and auto-injector, TECFIDERA (dimethyl fumarate) and PLEGRIDY (pegylated interferon beta-1a) for the treatment of multiple sclerosis, as well as ELOCTATE (Factor VIII Fc fusion protein) and ALPROLIX (Factor IX Fc fusion protein) for the treatment of severe Hemophilia A and B in multiple countries. In addition, in her role as SVP and Global Head of Safety and Benefit-Risk Management at Biogen for several years, she built a world-class organization accountable for patient safety and epidemiology in the pre and post-approval pipeline and addressed complex issues in safety and benefit-risk management. While in that role she led the development of the risk management plan for TYSABRIÒ (natalizumab) and presented on this topic at an FDA Advisory Committee, leading to the approval of TYSABRI for the treatment of multiple sclerosis. She has served as the industry representative to the FDA’s Risk Communication Advisory Committee and is a member of PhRMA’s Clinical and Preclinical Development Committee.
She is a member of the Board of Managers at BioMotiv. She received an MD degree and did her residency in internal medicine at McGill University in Montreal, Canada, completed a fellowship in Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital in Boston, and was an Associate Physician at Beth Israel Deaconess Medical Center and Harvard Medical School before joining the biopharmaceutical industry. Dr. Bozic is a frequent lecturer and speaker on benefit-risk and other drug development topics nationally and internationally.