The evolving regulatory landscape is opening new doors for biopharma companies to bring therapies to market faster and more efficiently. Programs like the FDA’s Advanced Manufacturing Platform (AMT), FDA’s Therapeutic Platform Technology (TPT) and the EU’s Quality Innovation Group and Pharmaceutical Reform Legislation signal a shift toward regulatory models that incentivize cutting-edge technologies and collaborative innovation. For companies that strategically align their go-to-market approach with these evolving frameworks, the opportunity is clear: faster approvals, optimized supply chains, and maximized pipeline value. This session will explore how biopharma companies can leverage novel manufacturing technologies and platforms—not just to enhance efficiency and product quality, but also as a critical tool for accelerating regulatory approvals. By fostering early collaboration with suppliers and regulators, companies can de-risk their development timelines, streamline commercialization, and gain a competitive edge in an increasingly complex global market.