Acer Therapeutics Appoints Benjamin Dewees as Vice President, Regulatory Affairs and Manufacturing
Acer Therapeutics Inc., a pharmaceutical company developing therapies for serious rare diseases with significant unmet medical need, appointed Benjamin Dewees as Vice President, Regulatory Affairs and Manufacturing. In this role, Mr. Dewees brings extensive experience in
regulatory processes for, and approvals of, therapies for rare diseases.
“Ben brings critically important expertise in regulatory affairs and manufacturing to Acer as we move forward with our programs in Maple Syrup Urine Disease, Urea Cycle Disorders and vascular Ehlers-Danlos Syndrome,” said Chris Schelling, COO and Founder of Acer Therapeutics. “We are looking forward to working closely with the FDA as we advance ACER-001 and ACER-002 through clinical studies to potentially bring the first approved therapies to patients suffering from these serious, rare diseases.”
Prior to Acer, Mr. Dewees spent 16 years at BioMarin and was instrumental in the approval of the first three products that BioMarin developed. He coordinated the Chemistry, Manufacturing and Controls portion of the Aldurazyme marketing applications in the US, EU, Japan, Canada, and various other countries. He led the approval process for Naglazyme in the EU, was the regulatory lead for the Kuvan program starting with the Phase 3 stage of development through marketing approval in the U.S., and continued to support Kuvan in the post-marketing setting including collaborating with corporate partners for approvals in the EU and ROW. Mr. Dewees’s initial experience in industry was at IDEC Pharmaceuticals, where he served in manufacturing with an emphasis on facility and process design start-up. He led key aspects of a clinical stage Good Manufacturing Practice (GMP) facility at IDEC and one clinical and one commercial scale GMP manufacturing facility at BioMarin.