Why Regulatory and Manufacturing Strategy Must Start Together

In this concluding segment of our Cell & Gene Live, “Distributed Manufacturing for CGT: Rent, Lease, or Buy in an Era of Overcapacity?,” experts Emily Moran, Founder, 3LB Consulting, LLC and Sugu Patro, Ph.D., Senior Vice President Global Process Development at Kite, a Gilead Company, our panelists explored why manufacturing and regulatory strategy can no longer operate in silos, emphasizing that alignment across CMC, regulatory planning, financing, and process development must begin at the earliest stages of asset design. The panelists highlighted how early regulatory engagement, strong manufacturing success rates, scalable platform technologies, integrated analytics, and digital infrastructure will be critical for helping CGT companies remain agile, fundable, and commercially viable as the industry continues to mature.