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Paula Shadle
CORE Team at Cell One Partners


Paula Shadle is an independent consultant engaged in CMC quality and regulatory strategy for biopharmaceuticals and gene and cell therapy products.  Shadle Consulting was founded in 2001; Paula joined Cell One Partners, a consortium in CGT, in 2018. She has over 30 publications, five process patents, and held positions of increasing responsibility in process and analytical development, QA, QC, at firms that included GSK, Scios Inc, Chiron, Bayer, and Rhein Biotechnologie.  Dr. Shadle has advised firms in the USA, Canada, Europe and Japan on quality systems, technology transfer, CDMO selection and oversight, and CMC strategy.  She received B.S and Ph.D. in biochemistry from the University of California, and was a postdoctoral fellow at the Max Planck Institute.

Agenda Sessions

  • Raw Materials and Adventitious Agents in Cell and Gene Therapy