Faculty – 2nd eRegulatory Submissions Summit

Michael Hellerstein
Director, Regulatory Affairs and Quality Systems, GEOVAX

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Mr. Hellerstein serves as Director of Regulatory Affairs and Quality Systems at GeoVax, a clinical-stage biotechnology company developing vaccines against infectious diseases and cancers. Initially trained as a molecular biologist, Mr. Hellerstein joined GeoVax in 2005 and has progressively expanded his job responsibilities. He has managed quality control since 2006, quality systems since 2007, outsourced manufacturing since 2008, regulatory affairs since 2014, and project management and government contracting since 2015. Prior to joining GeoVax in 2005, Mr. Hellerstein worked at several companies including Pfizer, Cell Signaling Technology, and Blue Sky Biotech, which he co-founded. Mr. Hellerstein obtained his A.B. in biology from Harvard University in 1999.

Sonja Justice
Associate Director, Regulatory Operations, AMICUS THERAPEUTICS

Suzanne Libby
Associate Manager, Regulatory Operations, AGIOS PHARMACEUTICALS

Lakshmi Ramkumar
Medical Writing Department Head, BOSTON BIOMEDICAL

Deborah Satoh
Head of CMC Submissions, TAKEDA

Marc Stern
Director, Regulatory Processes, Operations and Publishing, EAGLE PHARMACEUTICALS

Robert Stumpo
Director Global Regulatory Medical Writing, TEVA PHARMACEUTICALS