Labrys Biologics has made key executive appointments to lead the development of RN-307, a Phase II anti-CGRP monoclonal antibody for the treatment of chronic migraine. Marcelo Bigal, M.D., Ph.D., joins the company as chief medical officer, Michael Chang, Ph.D., as vice president of project management, Michele Bronson, Ph.D., as vice president of regulatory and quality, Rafael Escandón, Ph.D., MPH, as vice president of clinical operations, and Henry Stern as executive director of CMC.
"The collective experience of this group of individuals is highly relevant to our focus at Labrys, where they bring incredibly deep and complementary expertise in neurology, biologics and clinical research including multiple migraine trials and biologics manufacturing processes," said Steven P. James, president and chief executive officer of Labrys Biologics. "It is a testament to the RN-307 program to be able to attract such a high caliber team."
Dr. Bigal is a neurologist and noted authority on migraine research. Most recently, Dr. Bigal was head of the Investigator Study Program at Merck, and before that was the global director for scientific affairs in neuropsychiatry at Merck, where he was directly involved with Merck's migraine development programs. Prior to Merck, he was the director of research at the New England Center for Headache, as well as a faculty member at Albert Einstein College of Medicine, and director of research at Montefiore Headache Center.
Dr. Chang is a founding member of the Labrys team and brings 20 years of pharmaceutical industry experience in managing R&D programs. Prior to joining the company, Dr. Chang was vice president of R&D at Limerick BioPharma and vice president of project management at CV Therapeutics, where he was responsible for managing the company's key partnership to commercialize Ranexa in Europe. Dr. Chang also managed the development and registration of Viracept at Agouron Pharmaceuticals.
Dr. Bronson has more than 15 years of regulatory and quality systems experience in start-up to medium sized biotech companies. Prior to joining the company, Dr. Bronson was the vice president of regulatory, quality and project management at Medivation, Inc., where she was responsible for managing, prioritizing and selecting molecules to bring into development, and serving on joint oversight committees for collaborations. Previously, Dr. Bronson served as the director of regulatory affairs at Chiron Corp. until its acquisition by Novartis in 2006.
Dr. Escandón has more than 20 years of experience in clinical research and operations. Most recently he was a consulting vice president of clinical outcome services at ICON, where he built a team of specialized project managers, nurses and programmers for an electronic adjudication, surveillance and reporting system for clinical outcomes to sponsors and regulatory agencies. Prior to ICON, Dr. Escandón was vice president of clinical operations at Cytokinetics and senior director, clinical operations at CV Therapeutics, where he headed clinical operations for the trials leading to the U.S. approvals of Ranexa and Lexiscan.
Mr. Stern has more than 30 years of biologics industry experience having held multiple leadership roles within Genentech's contract manufacturing, plant management, and technology/engineering functions. He worked extensively in both drug substance and drug product supply for commercial and clinical products. Mr. Stern was instrumental in gaining regulatory approval for the first multi-product biologics facilities and has been involved with multiple regulatory submissions and inspections.