Amale Hawi, Ph.D.
Dr. Hawi is an independent consultant in the Pharmaceutical industry providing drug development, CMC and Regulatory consulting services across the development cycle. She has more than 20 years of hands-on experience in preformulation, formulation and manufacturing, preclinical and clinical PK from compound selection into registration and has developed innovator and repurposed drugs from concept to commercialization. Her primary interest is the development of an integrated CMC- biopharmaceutical approach to drug product development.
Most recently, Dr. Hawi has served as Senior Vice president of Pharmaceutical Development at Penwest Pharmaceuticals where she oversaw the CMC and DMPK of NCEs. Previously, Dr. Hawi spend 12 years at Boehringer Ingelheim Pharmaceuticals where she held several positions of increasing responsibilities in the Pharmaceutics Department and Drug Metabolism and Pharmacokinetics.
Prior to joining the pharmaceutical industry, she was a research assistant professor at the University of Kentucky, College of Pharmacy. She holds a Ph.D. in Organic Chemistry from the University of London, England.
Brian Walter, Ph.D.
Dr. Walter is currently VP of Regulatory Affairs at Acorda Therapeutics with primary responsibility for the global regulatory affairs strategy and operations.
Dr. Walter brings over 25 years of experience in the pharmaceutical industry, including 16 years in Global Regulatory Affairs. Dr. Walter has a successful track record in leading small molecule and biologics products from early development to approval in the fields of neurology, cardiovascular, pulmonary, and immune-based diseases guiding several orphan drug and priority review applications and recently the advisory committee for Ampyra (dalfampridine) ER tablets in multiple sclerosis securing its marketing approval.
Prior to joining Acorda, Dr. Walter held various positions of increasing responsibilities in Regulatory Affairs at Boehringer Ingelheim Pharmaceuticals and scientific positions in Drug Metabolism and Clinical Pharmacokinetics at Boehringer Ingelheim and Ciba Geigy (currently Novartis) . Dr. Walter has a Ph.D. in Toxicology with emphasis on drug metabolism from the College of Pharmacy at University of Kentucky, Lexington, KY and a B.S. in Biology from Denison University, Granville, OH.