Catalyst Biosciences has announced the appointment of Charles Democko as Senior Vice President, Regulatory Affairs.
Democko brings over 20 years of regulatory affairs experience in the development of both biologics and small molecules ranging from pre-IND through commercial stage companies across several therapeutic areas. Democko will lead the regulatory efforts for the Company’s rare hematologic and systemic complement-mediated disorders portfolio.
“Catalyst has an expansive pipeline of differentiated product candidates. I am looking forward to leading the Company’s regulatory affairs efforts, which are growing and expanding in the organization,” Democko said.
Democko joins Catalyst from CytomX, where he led the Company’s regulatory affairs and quality. Prior to CytomX, he was a Vice President of Regulatory Affairs at Ascendis, KaloBios, Novacea, PharmacoFore, and Connetics. Earlier in his career, Democko held regulatory affairs positions at Theravance, Elan and Genentech. Democko oversaw successful marketing applications for Activase (ischemic stroke), Myobloc (cervical dystonia), Olux (whole-body psoriasis) and Evoclin (acne), conduct of over 30 high-level meetings with FDA, EMA, and EU competent authorities, and the corporate presentation at the Activase ischemic stroke FDA advisory committee meeting, which resulted in a unanimous recommendation for approval. Democko holds a B.S. from Ohio State University.