Caitlyn Harvey
Senior Vice President - Technical Operations Convergent Therapeutics, Inc
Caitlyn Harvey is a biopharma leader with over 20 years of experience spanning process and analytical development, manufacturing, regulatory interactions, and commercialization across radioligand therapy, cell and gene therapy, vaccines, and biologics. She began her career at Acambis (now Sanofi), contributing to ACAM2000 BLA approval. She later advanced recombinant protein programs at Adnexus Therapeutics (acquired by Bristol Myers Squibb) and supported first commercial gene therapies at bluebird bio. Caitlyn led CMC and IND filings at Myeloid Therapeutics and is now VP and Head of Technical Operations at Convergent Therapeutics, supporting Phase II–III development and commercialization.
Seminars
- Understanding radiochemistry and CMC processes
- Exploring opportunities for downstream optimization
- Navigating challenging supply chains
- Weighing the trade-offs between centralized production hubs for quality control and the logistical challenge of rapid, decentralized distribution to a wider patient base
- Considering how short half-life isotopes like lead-212 drive the need for localized production and affect the balance between decentralization and centralised control
- Reducing shipping costs, minimizing decayrelated losses, and enhancing product stability by limiting exposure to radiolysis in decentralized manufacturing models
