Global head of regulatory affairs for Q BioMed

Q BioMed Inc., a commercial-stage biotech company, appointed Geoff Fatzinger as the global head of regulatory affairs.

Fatzinger is responsible for providing strategic regulatory oversight to Q BioMed for product development and commercialization. Specifically, he is focused on developing the global regulatory approval strategy for the commercialization of Q BioMed’s lead product, the FDA-approved, non-opioid Strontium89 (Strontium Chloride Sr-89 Injection, USP). He is additionally contributing strategic regulatory insight and guidance to the company’s portfolio of earlier-stage assets.

“Q BioMed is taking on projects which are providing medical benefit to those with byproducts of illnesses which often go overlooked or minimized,” Fatzinger says. “Medicine is not about the ‘flavor of the month.’ I look forward to helping achieve these goals and bringing medicines to those who need it.”

Company management says Fatzinger brings more than 20 years of regulatory expertise, having been directly involved in all phases of product development with a demonstrated record of regulatory and business accomplishments covering the United States, Europe, Middle East, and Asia Pacific with in-depth experience in Japan, China, and Korea. His specialties include global product regulatory strategy development; market assessments; agency interactions; health economics outcomes research (HEOR) and regulatory economics; extensive global experience in drug and device development; clinical trials and approvals, including such areas as: biosimilar development and approval; nanotechnology, stem cell and gene therapy products, medical devices; in-licensing and divestitures; and regulatory due diligence.

“We are very happy to have Geoff join the team at Q BioMed,” says CEO Denis Corin. “His deep global regulatory expertise and strategic leadership is critical as we reach some important milestones, including our effort to globally commercialize Strontium89. We look forward to his contributions and are pleased with the strength we’ve continued to build in our leadership team.”

Q BioMed received FDA marketing approval to manufacture and distribute Strontium89 during November 2019. The company completed its initial commercial production run and shipment in February and has begun distribution in the United States, with distribution to the EU and the rest of the world expected later during 2020.