Lili Belcastro
Company: Bristol Myers Squibb
Job title: Associate Director
Bio:
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:
Chair’s Opening Remarks 9:00 am
day: Conference Day Two
Panel Discussion: Shaping the Future of Ancillary Materials in Cell & Gene Therapy Insights from ISO Standard Development 9:00 am
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 yearsRead more
day: Conference Day Two
Chair’s Closing Remarks 4:55 pm
day: Conference Day Two
Strengthening Raw Material Quality and Supply Chain Confidence Through USP Standards 9:45 am
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 alignmentRead more
day: Conference Day Two