Samuel Simon Dychter
Founding Strategic Advisor
Dr. Samuel Simon Dychter has over 10 years of extensive experience in clinical drug development, project team management, clinical research trial design and implementation, and safety/risk management. His experience spans all phases of clinical drug development; multinational clinical trials; new drug applications in both the U.S. (NDA) and Europe (MAA), including proven successes in the NDA and MAA approval for sunitinib malate (Sutent®), a novel tyrosine kinase inhibitor. Dr. Dychter has successfully led drug development efforts in multiple therapeutic areas, with most of his career focused on solid tumor and hematological malignancies.
Dr. Dychter is currently the Senior Medical Director at Halozyme Therapeutics. From 2005-2007, Dr. Dychter was the Safety and Risk Management Leader for the tyrosine kinase clinical program, which was focused on sunitinib malate (Sutent®). From 2002 to 2004, Dr. Dychter was Associate Medical Director at Chugai Pharma USA, LLC, a member of the Chugai-Roche group. His responsibilities included overseeing the early stage clinical trial programs for a monoclonal antibodies against parathyroid hormone related protein and IL-6, which is now approved under the trade name of Actemra®. From 2000 to 2002, Dr. Dychter was the global clinical project manager for the histamine dihydrochloride Phase III pivotal study in acute myeloid leukemia, which after the completion of ancillary studies, received MAA approval in 2008.
Dr. Dychter trained as a general medical practitioner and transitioned into the pharmaceutical industry in 1998 to work at ICON Clinical Research. He received his university and medical training at the National Autonomous University of Mexico. He completed his medical clerkships at the Mexican Institute for Social Security in Mexico City and practiced general medicine, having also worked as a clinical sub-investigator in several clinical trials.