Significant shifts are underway in biopharmaceutical manufacturing and regulatory leadership. Eli Lilly announces sale of its New Jersey monoclonal antibody facility, moving towards advanced biologics production tailored to evolving market demands. Vinay Prasad’s abrupt FDA CBER departure, linked to controversies over Duchenne muscular dystrophy gene therapy regulation, triggers strategic reassessments. Concurrently, market responses to these leadership changes impact stocks of key cell and gene therapy developers, highlighting an industry in flux.