Frank Shannon

Frank Shannon is a seasoned health technology strategist and independent consultant with three decades of experience spanning clinical and regulatory development, manufacturing, quality, medical affairs, health economics, and market access. His career encompasses pharma, biotech, and medtech, with deep expertise guiding complex programs from early-stage development through global market authorization.

As an independent consultant, Frank partners with early-stage companies to navigate the full spectrum of preclinical, clinical, and regulatory strategy – supporting programs from initial development planning through regulatory submissions, market authorizations, and strategic partnerships. Beyond advisory engagements, he is an active coach, mentor, and investor to emerging health technology ventures.

Frank most recently served as Senior Vice President, Clinical Development and Regulatory Affairs at Sernova Biotherapeutics, with prior executive roles at Ripple Therapeutics and Interface Biologics. Earlier in his career, he led regulatory affairs, quality assurance, and compliance at the Canadian affiliates of St. Jude Medical and Baxter Corporation. He also held senior leadership positions in Medical Affairs and R&D at Occulogix, Genentech, Roche, and Boehringer Ingelheim, overseeing the design, execution, analysis, and reporting of international clinical trials and real-world outcomes research.

Across his career, Frank has led and supported numerous successful regulatory submissions for drugs, devices, and combination products in jurisdictions around the world.