Accelerating Early Phase Biologics From The Clinic To Commercialization

Early-phase biologics programs face a unique set of challenges—from navigating clinical trial design to preparing for scalable manufacturing and regulatory compliance. Success depends on more than scientific innovation; it requires strategic foresight across development, operations, and commercialization.

This webinar explores how integrated planning can streamline the transition from first-in-human studies to commercial readiness. Experts discuss how early decisions around formulation, analytical development, and manufacturing strategy can significantly impact timelines and long-term viability. Topics include aligning CMC activities with clinical milestones, anticipating regulatory expectations, and building flexibility into development plans to accommodate future scale-up.

For emerging biotechs and program leads, the insights shared offer a practical roadmap for reducing risk and maximizing efficiency. Whether you're preparing for IND submission or scaling up for late-phase trials, this session highlights the key considerations that can make or break a biologics program.

Watch the full webinar to learn how to build a development strategy that supports speed, quality, and long-term success.

Speaker: Dennis J. Yoon, PhD, Senior Director, Manufacturing Science and Technology, Abzena

Dennis J. Yoon leads a team focused on technology transfer, scale-up, and technical support for biologics manufacturing, guiding programs from process development through cGMP operations. With over 12 years of experience spanning medical devices and biopharmaceuticals, he has held progressive roles in operations and quality, bringing a broad perspective to complex manufacturing challenges. He earned his PhD in Biomedical Engineering from UCLA, where his research centered on engineering proteins for targeted cancer therapies—laying the foundation for his continued work in biologics development.