Partner Presentation: Optimizing Next-Gen Biologics Development: Strategies for Risk Reduction and Speed

Session details:

Small biotechs are at the forefront of therapeutic innovation but developing biologic drugs, especially next-generation molecular formats, comes with unique challenges and considerations that demand cross-functional, integrated strategies to meet clinical timelines.

Early de-risking strategies are essential to ensure clinical and commercial success. This talk explores how the right technologies and approaches can optimize candidate selection, streamline progression to cell line development, and accelerate speed to IND. We’ll examine how early use of advanced tools like in silico prediction for immunosafety and manufacturability, scalable expression platforms, and fit-for-purpose process development and analytical strategies can improve biomanufacturing outcomes.

Through real-world case studies, we’ll highlight common challenges in drug development and provide strategies to move biologic candidates efficiently from discovery to first-in-human studies. We’ll cover how these integrated approaches lead to smarter resource investment, reduced risk, and an accelerated path to IND submission and commercialization.