February 18, 2016
Pittsburgh, PA – Carmell Therapeutics announced today the appointment of Randy Hubbell to President and Chief Executive Officer. Former CEO, Alan West, has successfully positioned Carmell Therapeutics towards initiation of pivotal study for FDA BLA (Biologics License Application) approval and will stay on as a Chief Operating Officer.
Mr. Hubbell is a highly experienced business leader with significant experience in commercialization of transformational medical devices as well as drug device combination products. Mr. Hubbell’s most recent leadership role was as Chief Commercial Officer for Cardiva Medical, which received PMA (pre-market approval) for the next generation vascular closure device in 2013. At Cardiva, Mr. Hubbell designed, implemented and executed against a successful go-to-market strategy. Prior to Cardiva, Mr. Hubbell spent 13 years as a member of various management boards at Johnson & Johnson (J&J); Ethicon Biosurgery, Pharmaceutical Group Strategic Marketing (PGSM) and Cordis. During those years, he was a key member of leadership teams that oversaw the development and commercialization of CYPHER®, the first drug-eluting stent, IONSYS®, a novel post-op pain drug (fentanyl) delivery device and EVARREST®, a transformational biologic hemostat. Before J&J, Mr. Hubbell worked at two start-ups (Enmed & VASCA/NxStage Medical), Boston Scientific and IBM. He holds a B.S. in Computer Science from Tulane University and an M.B.A. from Loyola University of the South.
“Carmell Therapeutics will benefit significantly from Mr. Hubbell’s experience and knowledge related to bringing transformational drug device combination products to market. Mr. Hubbell’s leadership experience at Ethicon Biosurgery, where he championed transformational projects through product development, FDA BLA regulatory approval and commercialization, will be especially relevant in driving the next phases of Carmell’s success,” said Bill Newlin, Carmell Board Chairman and General Partner, Newlin Investment Company.
Mr. Hubbell commented, “I believe Carmell has created a revolutionary technology that will enhance the healing process through the innovative delivery of naturally-derived active biologics. Carmell’s patented technology is unique in its ability to be delivered in various forms with predetermined (days, weeks or months) and controlled release of active biologics. Carmell’s technology is unlike anything on the market or in development today and I look forward to introducing this innovative and highly differentiated healing solution to physicians and patients.”