Researchers behind the Philadelphia case known as 'Baby KJ' have published their FDA interactions and are publicly mapping a regulatory pathway to scale bespoke, patient‑specific CRISPR therapies. The team released detailed communications and is engaging the agency to create a framework for one‑off investigational products that could treat ultra‑rare genetic mutations. The group, led by Kiran Musunuru and colleagues, is positioning their experience as a template for regulatory engagement, manufacturing timelines, and safety monitoring for individualized editing treatments. They will discuss these plans and operational learnings in public forums and interviews, seeking to standardize processes for future single‑patient investigational new drug (IND) submissions. If regulators adopt aspects of this playbook, it could lower barriers for personalized gene edits but will also raise questions about manufacturing scale, cost, and long‑term follow‑up obligations. Stakeholders in academic medicine, small biotechs, and patient‑advocacy groups will be watching FDA feedback closely.