Tom Crean

Tom Crean has over 20 years of experience in regulatory affairs and CMC strategy. Tom began their career in 1999 as a Senior Research Associate at Antigenics. In 2003, they moved to Celldex Therapeutics as a Senior Scientist and was responsible for the development of an oral bacterial vector vaccine product. In 2007, they joined Altus Pharmaceuticals as a Senior Regulatory Affairs Associate and was responsible for the planning, compilation, and review of regulatory submissions. In 2009, they worked as a Contractor for Millennium: The Takeda Oncology Company in the Regulatory Dossier Management Group. In 2010, they joined Genzyme Biosurgery as an Associate Principal in Regulatory Affairs- CMC for Cell Therapy Products. In 2013, they moved to Novartis Vaccines and Diagnostics as an Associate Director in Regulatory Affairs- CMC and was the Module 3 Leader for Fluad vaccine BLA. In 2015, they joined Takeda Vaccines as an Associate Director in Regulatory Affairs- CMC Strategy. In 2018, they moved to Surface Oncology Inc. as the Director of Regulatory Affairs- CMC and was solely responsible for the coordination, authorship, preparation, review and timely filing and maintenance of CMC regulatory submissions. In 2020, they joined Intellia Therapeutics, Inc. as the Senior Director Regulatory Affairs- CMC and was solely responsible for Module 3 content for Intellia’s current CRISPR cell therapy clinical candidates. Currently, they are the Vice President Regulatory Affairs-CMC at Garuda Therapeutics.

Tom Crean has a diverse education history. Tom holds a MS in Regulatory Affairs and Health Policy from Massachusetts College of Pharmacy and Health Sciences, a Nat.Cert in Analytical Science from Waterford Institute of Technology, a B.Sc in Biotechnology from Imperial College London, and attended Garbally College.