What does it take to build a phage therapy program from nothing — and keep your research lab running at the same time?In this episode, Joe and I sat down with Dr. Daria Van Tyne, PhD, Associate Professor of Medicine at the University of Pittsburgh and researcher in the Division of Infectious Diseases at UPMC.When Daria arrived at Pitt in 2018, she describes herself as "phage poor" — a lot of interest in phages, zero phages in hand.Today, her lab manufactures phage for dozens of compassionate use patients per year, all while continuing to publish research.Daria's commitment to owning the process end to end is especially fascinating to hear about — right down to personally doing the phage formulation herself every morning after preschool drop-off, because, as she put it: "if I'm making something that's going to be administered intravenously to patients, I want to be the one to own it."🔬 Highlights:Building a phage library from scratch: How Daria used multidrug-resistant clinical isolates as bait to fish phages out of hospital and municipal wastewater — ensuring clinical relevance from day one.The first cases: From a cystic fibrosis patient post-lung transplant with Burkholderia multivorans in 2020, to partnering with Ben Chan at Yale and Breck Duerkop at Colorado when they didn't have the right phages in-house.Making manufacturing sustainable: Only using phages so good undergrad students can make them grow reliably, batching workflows, pre-manufactured cocktails, protein low-bind tubes, and more.QC that works for her lab and the FDA: Whole genome sequencing for identity and purity, cesium chloride banding, endotoxin testing, USP-71 sterility.Working with the FDA: From nerve-wracking Friday evening conference calls for emergency INDs to the much calmer world of single-patient INDs and email correspondence — and why she sees the FDA as a partner, not a gatekeeper.The phage susceptibility testing problem: Why the field still lacks standardized, clinically translatable assays, and what it would take to make phage susceptibility testing work in a real clinical microbiology lab.Research questions that keep her up at night: Phage resistance evolution in patients, whether phages can clear biofilm infections, and what phage therapy actually does to the microbiome.The future she's hoping for: FDA-approved phage products, with compassionate use and clinical trials coexisting for the long tail of complex cases — and her biggest fear being that investor money kills the collaborative spirit that has made the field work.📺 Watch on YouTube: https://youtu.be/nbN4whcoJrU🔗 Learn more:Pittsburgh Phage Program (P3): https://dom.pitt.edu/id/research/phage/
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