Accelerating the Medicines of Tomorrow to IND: Building Next-Generation Biologics with Future Clinical Success in Mind

As biologics pipelines become increasingly diversified, sponsors face growing pressure to accelerate next-generation biologics into the clinic while maintaining confidence in right-first-time manufacturability, high quality and long-term scalability.

This session will explore newly launched accelerated DNA-to-IND approaches to support bispecifics, Fc-fusions and high-concentration biologics. Through technical case studies and development data, attendees will learn how advances in high-productivity expression technologies, phase-appropriate integrated CMC strategies and streamlined execution can help reduce timelines while establishing a robust foundation for future clinical development.

The discussion will focus on how sponsors can advance critical portfolio milestones faster whilst minimizing the potential of development challenges down the line; balancing speed, risk management and scalability to support both near-term IND objectives and long-term program success.