Brian

Dr. Walter is the Head of Global Regulatory Affairs: Neuroscience at Takeda Pharmaceuticals, Cambridge, MA, United States, where his primary focus is on the strategic development and oversight of regulatory affairs for neuroscience and rare disease drug candidates.

Dr. Walter’s career spans over 30 years in the pharmaceutical industry, with a deep focus on Global Regulatory Affairs for the past two decades. His expertise has been pivotal in navigating the approval process for a multitude of pharmaceutical products, including small molecules, biologics, and gene therapies, across various therapeutic domains such as neurology, psychiatry, cardiovascular, pulmonary, immune-mediated, and rare diseases. His most significant product approvals include AMPYRA® ER tablets (a small synthetic molecule) in multiple sclerosis, PRALUENT® (a monoclonal antibody drug-device combination) to reduce low-density lipoprotein cholesterol (LDL-C) and the risk of myocardial infarction (MI), stroke, and unstable angina, and KEVZARA® (a monoclonal antibody) for the treatment of rheumatoid arthritis.

Before his current role at Takeda, Dr. Walter held several leadership positions in Regulatory Affairs and Quality at Magenta Therapeutics, Relmada Therapeutics, REGENXBIO Inc., and Acorda Therapeutics, as well as scientific positions in Drug Metabolism and Clinical Pharmacokinetics at Boehringer Ingelheim and Novartis. He holds a Ph.D. in Toxicology from the University of Kentucky, College of Pharmacy, with a focus on Drug Metabolism, and a B.S. in Biology from Denison University.