Pittsburgh, PA – Carmell Therapeutics announced today the appointment of Dr. James Hart as its new Chief Medical Officer (“CMO”).
“I am excited about the opportunity to join Carmell Therapeutics as its new Chief Medical Officer and am looking forward to bringing forth the company’s first BLA (biologic license application),” said Dr. Hart.
Before joining Carmell as its new CMO, Dr. James Hart, MD, FACS, FACC, FACCP has worked with small medical device companies to provide medical and clinical expertise, since his retirement from JNJ (Johnson & Johnson) in February, 2014. Dr. Hart was with J&J for over twelve years with multiple roles of increasing responsibility, being named VP Medical Operations in 2006, Worldwide VP, Evidence Based Medicine and Chief Medical Officer for ETHICON in 2011 and, finally, Chief Medical Officer and VP Medical Affairs for JNJ’s Global Surgery Group in 2012. Since 2006 to his departure, he was very active with the regulatory, clinical and evidence based medicine strategy and execution for Ethicon Biosurgery. The Biosurgery operating company had multiple successful regulatory submissions around the world, including new and novel BLA (Biologic License Application) technologies approved by CBER (Center for Biologics Evaluation & Research).
Prior to joining JNJ, Dr. Hart practiced Cardiovascular and Thoracic surgery for 20 years, during which time he was a pioneer in the early evolution of minimally invasive cardiac surgery.
“Dr. Hart brings significant senior executive experience and knowledge of the biologic-surgical device industry to the management team. This experience will be particularly important as we take the next steps with the FDA and executing the pivotal study for US approval” said Randy Hubbell President & Chief Executive Officer of Carmell Therapeutics.