Cell therapy as precision medicine: Clinical, regulatory, and commercial lessons learned from advances in the islet and CAR-T fields

Cell therapies directed against numerous diseases have been demonstrated to either provide functional cures or durable clinical successes. Historically, the protocols underlying cell therapy have been pioneered by academic medical scientists who are leaders in their respective area. Increasingly, autologous cell therapy programs anchor clinical centers of excellence at top academic medical centers that invest in clinical-grade cell handing facilities to enable investigator-initiated studies and reimbursement of clinical care for select cell therapy use cases. Academic cell therapy programs are inherently personalized early during innovation cycles, until challenges with generalizability and scalability are deemed commercially tractable and opportunities for academic partnership with industry become feasible. The depth of knowledge and know-how of these academic programs is attractive to industry partners when a given cell therapy protocol presents an investment opportunity with a positive return on investment (ROI). Such industry partners are often biopharmaceutical companies with cell therapy business lines. This chapter provides considerations for health system administrators, investigators, and providers interested in cell therapy programs and details key opportunities and challenges associated with the multiple touchpoints of partnerships among academic cell therapy programs, patients, and industry.