Scientists behind the emergency CRISPR treatment for 'Baby KJ' published the FDA interactions and mapped a regulatory pathway for bespoke gene therapies, offering a template for academic and biotech developers pursuing individualized editing for ultra‑rare mutations. The University of Pennsylvania and Children’s Hospital of Philadelphia teams outlined their engagement with regulators and proposed procedural elements to support repeatable, approvable workflows, as reported by Endpoints and other outlets. The researchers plan to convert the single‑patient success into an approvable model that could be reimbursable and reproducible, while flagging manufacturing, quality control, and safety monitoring hurdles. Their documentation provides a practical guide for companies and investigators aiming to move custom CRISPR interventions from compassionate use to regulated development.