Enabling breakthroughs in cell and gene therapies
Advanced therapies present unique challenges across the healthcare ecosystem. Our early involvement, starting with assisting biopharma in establishing the first CAR-T products in 2017, has enabled us to develop tailored solutions to simplify and streamline the complexities of cell and gene therapies (CGTs). Our expertise runs deep in regulatory, logistics, commercialization, patient access, and beyond.
Regulatory Consulting
Consulting services and product development support to help establish and navigate regulatory pathways (CMC, FDA filings, meeting support, etc.)
Cold Storage and Shipping
Cryogenic storage infrastructure and environmentally sustainable self-cooling shipping technology.
Site-of-care and production logistics
Track and trace capabilities for complete chain of custody/chain of identity
Order-to-Cash Management
Established relationships with sites of care facilitate seamless ordering and A/R through a flash title model designed for CGTs
Real-World Evidence and Outcomes
Evidence generation and insights to establish value of CGT products for regulatory approval and payer support for reimbursement
Patient Access and Support
Full-service hub removes barriers to care and helps to ensure patient support and coordination at every touchpoint