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#phagetherapy #bacteriophage #amr #regulatoryscience #clinicaldevelopment #innovationinhealth #phageact

    
           
Regulatory Science Expert for Emerging Biological Products I Chief Regulatory Officer    6d

Phage Therapy – Key Takeaways from IAS-USA Bacteriophage Conference (Washington, Oct 12–14, 2025) Last week, the IAS-USA conference on bacteriophage therapy took place in Washington — a remarkable event that, surprisingly, went mostly under the radar in Europe. Here are a few highlights that stood out: 🔹 FDA (Cara Fiore Timothy Brennan) reminded that 87 % of their time is still dedicated to Expanded Access rather than clinical trials — and strongly encouraged the community to generate more structured clinical data.  🔹 Daria Van Tyne (University of Pittsburgh) shared impressive data: nearly 900 requests for phage therapy, underlining both demand and the need for structured programs.  🔹 Paul Turner (Yale University) presented the fascinating concept of “phage steering” — using evolutionary trade-offs to guide pathogens toward less virulent and more treatable forms.  🔹 Bacterial defense mechanisms – which include prophages- remain at the core of understanding resistance and refining therapeutic approaches.  🔹 Robin Patel (Mayo Clinic) emphasized the current reproducibility challenges in Phage Susceptibility Testing (PST), highlighting the need for inter-laboratory harmonization and method alignment.  🔹 Encouraging clinical data from BiomX and Locus Biosciences, both advancing well-designed trials with natural and engineered phages, confirm the growing maturity of this field. 🔹 Meanwhile, synthetic and cell-free phage production, together with AI-driven predictivity, are emerging as promising tools to accelerate next-generation phage development. 📘 Among the documents mentioned, the FDA Draft Guidance (June 2025) on antibacterial therapies for patients with unmet medical need is definitely worth reading. The conference confirmed how rapidly phage therapy science is evolving — from understanding evolution to integrating AI, manufacturing innovation, and regulatory alignment. 🙏 A warm thank you to the IAS–USA organizers, and to the conference co-chairs Graham Hatfull and Robert Schooley for such an excellent program and inspiring discussions. Many other outstanding talks couldn’t be covered here — I encourage everyone interested to explore the full program - https://lnkd.in/d8Xqp-Nb Already looking forward to the next edition! #PhageTherapy #Bacteriophage #AMR #RegulatoryScience #ClinicalDevelopment #InnovationInHealth #PhageACT BEAM Alliance, Biotechs of Europe innovating in Anti-Microbial Resistance

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