Navigating The Path From FIH to Commercial Success: A CGT Development Playbook
For cell and gene therapy developers, reaching first-in-human studies is only the beginning. Decisions made at this stage can shape clinical execution, manufacturing scalability, patient access, evidence generation and commercial viability throughout the asset lifecycle. This practical playbook examines the critical transitions from first-in-human (FIH) development through commercialization.
What CGT Developers Need to Solve From FIH to Commercialization:
- Establish phase-appropriate endpoints, long-term follow-up plans, and CMC strategies during early development
- Build the regulatory, site, patient and logistics ecosystem required to execute complex CGT studies
- Prepare early clinical success for expansion across sites, geographies, indications, and patient populations
- Stress-test manufacturing, supply chain, treatment-center readiness, and patient support before late-phase scale
- Connect clinical evidence, durability and long-term safety with reimbursement, access, and post-approval requirements
Download the playbook to understand how decisions made at each stage can prepare a CGT program for what comes next.
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