At the 2024 edition of the Biomanufacturing World Summit series we sat down with Diluks de Silva to talk about Cell and Gene Therapies. For many years we have been hearing these and other Advanced Therapy Medicinal Products (ATMPs) are moving towards commercialization, and each individual therapy that has been approved is heralded as a pioneer to be celebrated and studied for lessons learned and best practices. This year something like 40 cell and gene therapies came to market, and by every indication this is just the start of a whole new generation of medicine about to help patients around the world. What does that look like on the ground? What is the industry doing to prepare itself for what comes next? How do you control things like cost and scalability while you are still inventing how to manufacture the new therapies in the first place? How are these innovations pairing with medical devices, and what does that mean for the future of medicine? There is so much good work being done, and so much still to do. As always, the experts at Compliance Architects have a comprehensive understanding of where the industry is, where it is going, and what needs to happen to ensure everyone’s success. For everyone looking for the updates that matter most on this exciting frontier of medicine, give this episode a listen!
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Diluks De Silva
Vice President
Compliance Architects LLC

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Compliance Architects LLC

Compliance Architects LLC delivers high-value compliance, quality, and regulatory consulting services to companies directly regulated by the U.S. FDA and other global regulatory authorities. With capabilities ranging from quality systems implementations to audits, inspection readiness, enforcement remediation, and outsourced compliance services, Compliance Architects LLC has the experience, expertise, and delivery capability to significantly improve your company’s business outcomes. Jack Garvey is CA’s founder and CEO, a chemical engineer and a practicing regulatory attorney, and has spent his entire career helping companies navigate the challenges at the intersections of science, engineering, business, and law.