Advancing Phage Therapeutics into Late-Stage Clinical Trials: Bridging Translational Gaps to Enable Regulatory & Commercial Success
As early clinical results generate growing enthusiasm, the phage field now faces the critical hurdle of translating promising preclinical and early-phase data into robust, latestage clinical trials. Designing studies that satisfy regulatory expectations, demonstrate reproducible efficacy, and attract sustainable investment remains a defining challenge for the community.
Join this workshop to examine how leading developers are overcoming the translational,
operational, and strategic barriers limiting late-stage progress:
- How can trial design, patient selection, and endpoints be optimized to demonstrateconsistent efficacy across diverse infections and populations?
- What regulatory and manufacturing considerations must be addressed to align with IND/CTA and pivotal trial requirements?
- How can partnerships, data generation, and funding models evolve to de-risk and accelerate late-stage development?