Beyond the Batch

The most expensive sentence in biotech might be "I'll worry about that in Phase 3." In the first episode of Beyond the Batch, host Nathaniel Leies sits down with cohosts, Dr. Tiffany Rau and Dr. Philip Ramsey, to dig into the biggest failure modes in CMC (Chemistry, Manufacturing, and Controls) and why so many of them trace back to teams underestimating the journey ahead of them. Tiffany, a CMC consultant who's built out facilities and led regulatory strategy across vaccines, monoclonal antibodies, and cell and gene therapy, explains why teams so often misjudge the sheer number of interlocking decisions between preclinical work and commercialization. Phil, a statistician and longtime R&D consultant connects that same failure to a lack of technical continuity: fragmented teams, knowledge that walks out the door when someone changes roles, and no single person accountable for the project from day one. In this episode: What CMC actually means, and why it's the hub everything runs through The most dangerous mistake CMC practitioners make, and why it compounds for years Practical concepts and tools covered: Starting with the end in mind makes projects faster and more successful Systems engineers ("integrators") as critical (and often-times forgotten) contributors for cross-functional success Pareto frontier decision-making Why respecting what your cross-functional colleagues know is more than good manners Got a question, or want to hear your voice on a future episode? Write to us at beyondthebatch@predictum.com. We read everything, and we'd love to feature listener questions on the show. If this episode was useful, the best way to help it find more people like you is to subscribe, rate the show, and share it with someone who'd get value from it. Visit us at https://beyondthebatch.io to learn more. — Beyond the Batch is Predictum's podcast on CMC, data science, and the real-world problems facing R&D, quality, and manufacturing teams. Hosted by Nathaniel Leies (Predictum), with Dr. Tiffany Rau (CMC consultant) and Dr. Philip Ramsey (Professor Emeritus, University of New Hampshire; VP of Data & Analytics, Predictum). #CMC #Biotech #Podcast #PharmaManufacturing #LifeSciences

An excerpt from Beyond the Batch featuring Philip Ramsey Ph.D. discussing the "Prediction Crisis" in apllied science and engineering.