Deep ATMP and biologics expertise
Experience with multiple ATMP product types (CART, Stem cell therapies, mRNA and DNA based medicines)
Successful CAR-T and stem cell project support
Module 3 authoring of IMPD, MAA and BLA
Multiple PEI Scientific Advice interactions
Preparation and participation in scientific advice meetings, representing CMC strategy and company positions
Robust early-development CMC strategy experience
Early engagement advice on manufacturing strategy and analytics to prevent regulatory hurdles in later phases
Project management capabilities
Certifications in project and program management with demonstrated experience in large programs
Flexible, efficient, and personally accountable consulting model
Flexible consulting options with ad-hoc support in every phase of drug discovery
