Alicia Baker

Alicia Baker

Company: Labcorp Oncology

Job title: Executive Director, Regulatory Strategy & Head of Biosimilars Center of Excellence


Alicia Baker McDowell is an executive director and the head of the Biosimilars Center of Excellence based in Princeton, NJ.  Alicia has over 25 years of drug development experience including over 22 years in global regulatory strategy.  Alicia has registered products across the globe in over 90 countries and is experienced in direct agency interactions with health authorities including US FDA, EMA, Health Canada, MHRA, NMPA, PMDA, KFDA, TGA and others.  Her experience spans small molecules and biologics from both the innovator and biosimilar side of development.

Alicia has a BS in Biology from St. Joseph’s University, a MS in Regulatory Affairs/Quality Assurance from Temple University, a MS in Regulatory Science from the University of Southern California, and a Doctorate in Regulatory Science from the University of Southern California.

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