Lili Belcastro
Associate Director, Raw Materials, Drug Product Process Development Bristol Myers Squibb
Lili Belcastro, PhD is an Associate Director in Cell Therapy Development at Bristol Myers Squibb, where she leads the early development raw materials team and serves as a subject matter expert in cell and gene therapy (CGT) ancillary materials, single-use systems, and starting materials. With over 15 years of experience in cancer biology, biologics, and advanced therapies, she focuses on raw material selection, qualification, and control to enable robust, scalable CGT manufacturing. Dr. Belcastro is Chair of the USP Bio4 CGT Expert Committee, contributes to global standards initiatives, publishes widely, presents internationally, and serves as adjunct faculty at Saint Joseph’s University.
Seminars
- Turning raw material failures into a catalyst – redefining supplier strategy through a centralized, data-driven MRC model
- Applying integrated risk scoring (beyond PRAM) to pinpoint and prioritize highest-risk suppliers
- Deployment of targeted technical due diligence visits to shift from reactive firefighting to proactive risk mitigation
- Addressing challenges in qualifying secondary suppliers for critical materials
- Understanding comparability and change control requirements when switching vendors
- Balancing supply chain flexibility with IP constraints
