Lili Belcastro
Associate Director Bristol Myers Squibb
Dr. Lili Belcastro is an Associate Director at Bristol-Myers Squibb. She leads the Early Development Raw Materials group within Cell Therapy Development. Lili has over fifteen years of experience in preclinical and clinical cancer biology, cell and gene therapy product development, and method development working with a variety of complex biological molecules, small molecule inhibitors, ancillary materials, starting materials, and gene editing materials. Lili holds a PhD in cancer biology from a joint program with the University of the Sciences (now Saint Joseph’s University) and The Wistar Institute in Philadelphia. She is also the Chair of the Expert Committee for Cell and Gene Therapies at the US Pharmacopeia 2025-20230 cycle.
Seminars
- Outlining USP’s role in defining quality expectations for raw materials used in pharmaceutical and biologic manufacturing
- Discussing how USP standards, reference materials, and tools help reduce variability and improve supplier qualification
- Highlighting ongoing initiatives to support risk-based raw material control and global regulatory alignment
- Firsthand experience contributing to a new ISO standard, focused on ancillary materials used in advanced therapies
- Overview of the U.S. TAG validation process and transition to a New Work Item Proposal within the ISO framework
- What this upcoming standard means for developers, manufacturers, and regulators over the next 3 to 4 years
