Cell & Gene Therapy Update with Joe DePinto, InspiroGene by McKesson | TWIRx

Cell and gene therapy has entered a new phase. The science is advancing rapidly, but the harder question is increasingly becoming: How do we actually get these therapies to the right patient, at the right treatment center, with the financing, logistics, clinical support, and follow-up required?   That is the problem McKesson is trying to address through InspiroGene, its dedicated cell-and-gene commercialization business. McKesson built InspiroGene to connect manufacturers, payers, providers, treatment centers and patients across the CGT journey. McKesson   1. McKesson: Building the infrastructure around the therapy   A major area of focus for Joe and McKesson is what happens after a therapy proves clinically viable.   In 2026, Joe DePinto and Biologics by McKesson outlined the need for patient hubs purpose-built specifically for cell and gene therapies. These are more complex than conventional specialty-drug hubs because CGT may involve eligibility screening, treatment-center coordination, benefit investigation, financial assistance, scheduling, logistics, long-term follow-up and caregiver support. McKesson Biologics   McKesson has also developed an interactive map covering qualified treatment centers across 109 U.S. metropolitan regions, addressing another fundamental problem: patients may need to travel significant distances to receive CGT. McKesson   Question for Joe: “Joe, the scientific breakthrough gets most of the headlines, but is the bigger challenge now building the infrastructure that allows a patient to actually receive the therapy?”   Follow-up: “Where do you currently see the biggest friction — reimbursement, treatment-center capacity, logistics, patient identification, or ongoing follow-up?” 2. FDA is actively trying to speed cell and gene therapy development   FDA has made a noticeable regulatory shift in 2026.   In June, FDA issued draft guidance allowing gene-therapy developers to rely more heavily on existing platform knowledge and prior scientific information, potentially reducing redundant testing for products using similar genome-editing technologies. FDA has also issued guidance providing more flexibility around chemistry, manufacturing and controls for CGT products. U.S. Food and Drug Administration   FDA says it has now approved close to 50 cell and gene therapies, signaling that CGT is moving well beyond a small experimental category. U.S. Food and Drug Administration   TWIRx takeaway: The regulatory conversation is shifting from “Can we safely approve these therapies?” toward “How do we safely accelerate an entire therapeutic platform?”