Christopher Schilling

Christopher Schilling, Chief Regulatory Officer at Forge Biologics, shares insights from his extensive experience in gene therapy and manufacturing. He discusses the FDA's PreCheck initiative aimed at streamlining U.S. biopharma facility buildouts. Key topics include the program’s goals for partnership and predictability, expected timelines, and the need for clear guidance on regulatory processes. Schilling highlights the importance of early engagement and the role of CDMOs in scaling complex therapies, advocating for more transparency from the FDA.