Oliver Cácananta

Senior Director, Regulatory Affairs

Mr. Cacananta is a 25-year veteran of the biopharmaceutical industry, having worked broadly with biologics, combination medical devices, and small molecule drugs. He has extensive involvement in collaboration or leadership of approved marketing and investigational regulatory filings (BLAs, MAAs, PMA, CE Mark, 510(k), NDA, INDs/IDEs as well as CMC and other pre- and post-approval commitment submissions) and in organizing and participating in various agency interactions (e.g., PDUFA meetings and advisory panel). His global experience spans multiple therapeutic areas, including vaccines for influenza and biodefense medical countermeasures, diabetes and other metabolic disorders, endovascular disease, blood pathogen reduction technologies, and cell therapy for ophthalmology and medical aesthetics, and diverse geographies, working with partners and agencies across North America, Europe, Asia-Pacific (primarily China, Japan, and Australia), South America, and Middle East-North Africa.

Mr. Cacananta’s career and contributions to research and science are rooted in the intersections of the biotech and pharmaceutical industry and the quality and regulatory pathways by which treatment and technological innovations reach patients. As a regulatory professional, his impact comes from shepherding research products through the product lifecycle, from clinical trials to market approval, all the while ensuring that products are safe and efficacious and are within the regulatory parameters set forth by governing agencies.

Mr. Cacananta has worked at a variety of large and small biotechnology companies, including Lineage Cell Therapeutics, Cerus Corporation, Medtronic, Amgen, Emergent BioSolutions, BioMarin Pharmaceuticals, and Chiron Corporation. He received his BS in Biological Sciences from California State University, East Bay, and MBA in Global Management from the University of Phoenix.