ProChon Biotech Ltd. hired of Brian Callahan for the role of executive vice president, regulatory and quality affairs.
Callahan’s last job was with EEC & Associates, a global compliance consulting firm for the medical device and pharmaceutical industries. At Prochon he’ll be the company’s liaison to regulatory agencies, including the Food & Drug Administration, European Medical Authorities and Israeli Ministry of Health, in addition to overseeing regulatory strategy, implementation and compliance.
ProChon is developing tissue regeneration technology for articular cartilage injuries of the knee and, eventually, other joints.
Prochon CEO Patrick O’Donnell said “Brian Callahan is an essential and timely addition to ProChon’s executive management team as we navigate through the completion of the BioCart Autologous Cartilage System Phase II clinical study and collaborate with the FDA and EMA in regards to the upcoming Phase III pivotal trial,” according to a prepared statement. ProChon said in March that it expected to release the results from the BioCart trials by June.
Last fall, O’Donnell told MassDevice that one of his company’s greatest concerns was the FDA’s regulatory process and the potential changes to its 510(k) pre-market approval system for medical devices.