Cell & Gene Therapy FAQ
Does a cell and gene therapy company need different insurance than a typical biotech?
A cell and gene therapy (CGT) company carries the same core lines as any clinical-stage biotech - clinical trial liability, directors and officers, general liability, workers compensation, and cyber - but two features make the program more demanding. The limits are higher, and the claims tail is much longer.
Gene-therapy trials carry the highest per-subject uncertainty in clinical research because the intervention is often irreversible and the populations are frequently rare-disease or pediatric, so clinical trial liability commonly runs $10M-$25M or more rather than the $5M-$10M a conventional early biotech might carry. And FDA expects long-term follow-up of up to 15 years, so a subject-injury claim can be reported more than a decade after dosing - which makes claims-made continuity and a long tail load-bearing in a way a standard biotech does not have to manage.
Manufacturing is the third difference: viral-vector production, autologous batches that cannot be remade, and cryogenic cold chain create exposures a small-molecule or standard biologic does not. So while the lines look similar on paper, the sizing, the form, and the manufacturing coverage are materially different.
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