Cell & Gene Therapy FAQ
Cell & Gene Therapy Insurance Questions, Answered
Each entry below is a buyer-side question CGT operators ask, with a plain-English answer and links to the cell & gene therapy practice page and the relevant longer Q&A entry.
Does a cell and gene therapy company need different insurance than a typical biotech?
How a cell and gene therapy insurance program differs from a standard clinical-stage biotech - higher clinical trial limits, a much longer claims tail from FDA long-term follow-up, and distinctive manufacturing exposures.
Why is gene therapy tail coverage so expensive?
Why the extended reporting period (tail) for gene therapy costs more than for other indications - the FDA 15-year long-term-follow-up window means the insurer is on risk for delayed claims for many years after the trial ends.
Do CAR-T and cell therapy companies need special insurance?
Why CAR-T and autologous cell therapy companies face distinctive insurance exposures - patient-specific batches that cannot be remade, chain of identity, cryogenic handling, and severe treatment-related toxicity.
What insurance does a viral vector or CGT contract manufacturer need?
The insurance a viral-vector producer or cell/gene therapy contract manufacturer needs - products and completed operations, property with validation and reprocessing, cryogenic and cold-chain cargo, and professional liability, plus sponsor-agreement requirements.
What is a retroactive date and why does it matter for gene therapy insurance?
Why preserving the retroactive date across renewals and carrier changes is critical for gene therapy - it keeps the claims-made chain intact so a delayed injury tied to earlier work is still covered.
Do academic or investigator-sponsored gene therapy trials need their own insurance?
How investigator-sponsored gene-therapy trials at academic medical centers coordinate coverage - academic self-insurance, standalone clinical trial liability for external sites, and long-tail considerations for the IND holder.
What happens to gene therapy insurance in an acquisition or licensing deal?
Why the long-tail liability of a gene therapy program is a diligence issue in acquisitions and licensing deals, and how the tail, retroactive dates, and run-off coverage are handled at the transaction.
How much clinical trial insurance does a gene therapy trial need?
Typical clinical trial liability limits for gene therapy - why first-in-human and pivotal programs commonly require $10M-$25M or more, with per-subject sub-limits reviewed by ethics committees.
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