CASSS has honored Kathryn Stein, PhD with its prestigious Hancock Award for Outstanding Achievements in CMC Regulatory Science.
This annual award recognizes outstanding and sustained contributions in the field of regulatory science. Stein was announced as the 2023 honoree during CASSS’ 26th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (commonly referred to as WCBP), held in Washington, DC on January 24-26.
“I want to thank all my technicians, students, post-docs, staff [and] fellows for all their contributions to the research in my lab, which provided me the time to work on regulating vaccines and monoclonals,” Stein said after accepting the award, “In my wildest dream I didn’t think I could turn on the television and see [monoclonals], as well as conjugate vaccines, advertised every day.”
“Although my research focused on meningococcal group C polysaccharides, I reviewed Haemophilus influenzae type B conjugate vaccines for human use. It was the most gratifying aspect of my career, to see them approve for use in toddlers and infants and to witness invasive Haemophilus disease disappear,” Stein said.
“Katy was a great choice to be the director of DMA. She understood the potential of the class of products, understood the reasons for the early failures, but had a vision for an approach to regulating mAbs and related products.” Shapiro said, speaking of what made Stein worthy of being the 11th recipient of the award.
Stein has retired twice, once from the FDA before working at MacroGenics, then again in 2016. She spent several years working part-time as a consultant and is now Principal at Kathryn Stein Consulting, LLC where she utilizes her experience from her illustrious career by consulting in the biotechnology space for biotech, venture capital, and legal firms.