A UC Berkeley team reported a protein‑engineering strategy that inserts additional nuclear localization signals into internal Cas9 loops to substantially increase nuclear import and gene‑editing efficacy in human T cells. The structural approach boosts editing performance without prohibitive expression losses. Separately, the Baby KJ investigators published FDA interaction records that document regulatory pathways for bespoke, patient‑specific gene therapies, giving academic and small‑company developers practical guidance on a nonstandard approval route. The Baby KJ disclosures clarify pre‑submission engagement, manufacturing expectations and safety data needs. Together, these developments chart both a technical path to more efficient ex vivo editing and a regulatory blueprint for individualized gene therapies — important inputs for companies and investigators translating single‑patient successes into broader clinical programs.