Mary Beth Pelletier, PhD

Apogee Therapeutics
VP, Quality Control
Dr. Mary Beth Pelletier is currently Vice President of Quality Control at Apogee Therapeutics. She has represented the Biotechnology Innovation Organization (BIO) on the ICH Expert Working Group (EWG)/Implementation Working Group (IWG) for Q2(R2) and Q14 since 2018, driving development of harmonized global guidance on analytical procedure development and validation. Previously she was Head of Quality Control for Intellia Therapeutics, where her team supported development of potentially curative CRISPR/Cas9 gene editing treatments. Prior to Intellia, Mary Beth was Head of Quality for Biogen's Gene Therapy Manufacturing greenfield startup in Research Triangle Park, NC, and she previously led Biogen QC Analytical Technology where her team supported development, optimization, validation, transfer, troubleshooting, and lifecycle maintenance of analytical methods for Biogen’s biologics and gene therapy portfolio from Phase 1 throughout the commercial lifecycle. Prior to her positions at Biogen, Mary Beth worked in biologics formulation development and analytical development. Mary Beth earned a bachelor’s degree in chemistry from Northwestern University in Evanston, IL, a Ph.D. in chemistry from The Scripps Research Institute in La Jolla, CA, and an MBA from North Carolina State University.

Related Articles

Industry Perspectives on Practical Application of Platform Analytical Procedures
Features
Industry Perspectives on Practical Application of Platform Analytical Procedures

Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...