SD biotech firm names new chief regulatory officer

Ana Sousa, M.S.J., has been named chief regulatory officer for San Diego-based Aspen Neuroscience, a private biotechnology company developing a therapy to treat Parkinson’s disease made from a patient’s own skin cells.

Sousa has been senior vice president of regulatory and quality at Aspen since 2021 and has served as project team leader for the company’s lead product, ANPD001, a personalized cell therapy under investigation to treat Parkinson’s disease by replacing lost dopamine neurons. In October, the U.S. Food and Drug Administration (FDA) granted fast track designation for ANPD001.

“Ana is a key member of the executive team and has been instrumental in building our organization and in driving our lead therapeutic candidate to the clinic,” Damien Mcdevitt, PH.D., Aspen’s president and chief executive officer said in a news release. “Under her tenure, we have... obtained FDA ‘fast track’ status for APD001. Now as we enter the clinic and broaden our pipeline, we will look to her continued leadership both in the U.S. and abroad.”

A senior drug development and regulatory executive with more than 20 years of industry experience, Sousa has successfully led global regulatory programs and developed key industry talent at Roche/genentech and Onyx/ Amgen, and built global regulatory departments at Principia Biopharma (Sanofi) and several other successful startup companies.

She received her undergraduate degree at Pace University, Lubin School of Business, and her master of science in jurisprudence degree with a concentration in health law and intellectual property at The Seton Hall University School of Law.

Martin named president and CEO at Plexium

Michael Martin, PH.D. has been named president and chief executive officer at Plexium, a pharmaceutical company headquartered in San Diego.

Martin joins Plexium following his 12-year tenure at Takeda Pharmaceuticals, serving most recently as the global head of the Center for External Innovation where he was a key member of

Takeda's leadership team. While in this role, he was responsible for external research and development activities including business development, search and evaluation, strategy and operations and academic alliances.

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Ana Sousa