Beyond the Batch

Predictum Inc.
  • 0.0 (0)
  • Life Sciences

A podcast for scientists and engineers navigating the realities of complex science, who want practical ways to work smarter and get to new discoveries faster, and not learn everything the hard way. Featuring Philip Ramsey, Ph.D. and Tiffany Rau, Ph.D.

Episodes

  1. 4d ago

    The Most Dangerous CMC Mistake, Part 1: Underestimating the Journey

    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 throughThe most dangerous mistake CMC practitioners make, and why it compounds for yearsPractical concepts and tools covered: Starting with the end in mind makes projects faster and more successfulSystems engineers ("integrators") as critical (and often-times forgotten) contributors for cross-functional successPareto frontier decision-makingWhy respecting what your cross-functional colleagues know is more than good mannersGot 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

  • 1 Episode

About

A podcast for scientists and engineers navigating the realities of complex science, who want practical ways to work smarter and get to new discoveries faster, and not learn everything the hard way. Featuring Philip Ramsey, Ph.D. and Tiffany Rau, Ph.D.

Information

  • Creator
    Predictum Inc.
  • Years Active
    2026
  • Episodes
    1
  • Rating
    Clean
  • Copyright
    © 2026 Beyond the Batch