Healthcare Industry News: CV Therapeutics
News Release - March 18, 2013
Labrys Biologics Announces Key Executive AppointmentsSAN FRANCISCO, March 18, 2013 -- (Healthcare Sales & Marketing Network) -- Labrys Biologics Inc., a company focused on treatments for chronic migraine, today announced key executive appointments to lead the development of RN-307, a Phase 2 ready anti-CGRP monoclonal antibody for the treatment of chronic migraine. Marcelo Bigal, M.D., Ph.D., joins Labrys as chief medical officer, along with Michael Chang, Ph.D., as vice president of project management; Michele Bronson, Ph.D., 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 CEO 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 and has spent most of his career advancing treatments for migraine and other neurological disorders, as well as researching the mechanisms and risk factors for the development of chronic migraine. Most recently, Dr. Bigal was the head of the Merck Investigator Study Program at Merck, Inc, and before that he was the global director for scientific affairs in neuropsychiatry at Merck, directly involved with Merck's migraine development programs. Prior to Merck, he was the director of research at the New England Center for Headache, a full time faculty member at Albert Einstein College of Medicine, and director of research at Montefiore Headache Center. He has authored and co-authored nearly 300 published papers in peer-reviewed journals, written six books and received numerous awards in the fields of pain and headache research, including the prestigious Wolff Award of the American Headache Society.
"Chronic migraine is a disease associated with severe disability and with tremendous unmet needs. Labrys has a unique opportunity to develop a potential breakthrough product capable of reducing frequency and severity of chronic migraine with a tolerable medication that is conveniently administered," said Dr. Bigal. "RN-307 represents a promising approach to using a humanized monoclonal antibody as a prophylactic against CGRP, which is a validated target for migraine, that may potentially reduce a chronic condition into episodic events."
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 Labrys, 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 and led functions involving manufacturing, project management, lifecycle planning, and portfolio analysis. Prior to joining CV Therapeutics, Dr. Chang managed the development and registration of Viracept® at Agouron Pharmaceuticals.
Dr. Bronson brings over 15 years of regulatory and quality systems experience in start-up to medium sized biotech companies. Prior to joining Labrys, 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. At Medivation, Dr. Bronson oversaw the approval of their lead molecule (MDV3100) from pre-IND stage through FDA approval. Before joining Medivation, Dr. Bronson served as the director of regulatory affairs at Chiron Corporation until its acquisition by Novartis in 2006.
Dr. Escandón has over 20 years of experience in clinical research and operations. He was most recently a consulting vice president of clinical outcome services at ICON, PLC where he built a team of specialized project managers, nurses and programmers for a novel electronic adjudication, surveillance and reporting system for clinical outcomes to sponsors and regulatory agencies. Prior to his time at ICON, Dr. Escandón was vice president of clinical operations at Cytokinetics, Inc. and senior director, clinical operations at CV Therapeutics where he headed clinical operations for the trials leading to the US approvals of Ranexa® and Lexiscan®.
Mr. Stern has worked in the biologics industry for over 30 years, holding multiple leadership roles within Genentech's contract manufacturing, plant management, and technology/engineering functions and working extensively in both drug substance and drug product supply for commercial and clinical products. During his tenure at Genentech, 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.
About Chronic Migraine
Chronic migraine, defined as fifteen or more headache days per month, is a serious and widespread condition that affects several million people, or approximately 1.5—2% of the U.S. population. Chronic migraineurs suffer from debilitating headaches frequently accompanied by nausea, vomiting, sensitivity to light and fatigue, and they often report periods of lost productivity. Migraines affect women over men by a ratio of three to one. There is a significant need for chronic migraine therapies with better efficacy and improved safety.
RN-307 is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a validated target in migraine. RN-307 has successfully completed Phase 1 trials in more than 74 patients. RN-307 was originally discovered and developed by Rinat Pharmaceuticals, which was acquired by Pfizer in 2006.
About Labrys Biologics
Labrys Biologics is a private, venture-financed development stage biotechnology company focused on treatments for chronic migraine. Labrys' lead candidate, RN-307, is an anti-CGRP monoclonal antibody for the treatment of chronic migraine which has completed Phase 1. Founded in late 2012, Labrys is backed by venBio, Canaan Partners, InterWest Partners and Sofinnova Ventures.
Source: Labrys Biologics
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