Speakers

David Awotwe-Otoo, PhD

Senior Pharmaceutical Quality Assessor, Division of Product Quality Assessment III, OPQA I, OPQ, CDER
Food and Drug Administration

I started working with the FDA as a graduate student intern in 2011. After graduating with a PhD in Pharmaceutical Sciences from Howard University, I worked as a ORISE (Oak Ridge Institute of Science Education) Fellow with the Division of Product Quality Research (DPQR) for six months before being hired permanently in 2012.

As a Senior Staff fellow with DPQR, I worked on complex regulatory research projects, including pre-formulation and formulation characterization of complex drug products and part of our group research formed the basis for CDER Research on bioprocess improvements for biosimilar drug products.

I am currently a Senior Pharmaceutical Quality Assessor (SPQA) with the Office of Lifecycle Drug Products, involved with the review of post-approval CMC changes to generic drugs.

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