Beyond the Batch

Many projects fail or hit roadblocks. 
But the moment a project "fails"  usually comes too late, rather than much earlier when someone on the team knew failure to be a likely outcome.

Phil Ramsey and Tiffany Rau dig into why struggling R&D and development projects keep getting funded, how to tell when to stop or regroup, and why gap analyses save years of work.
In this episode:
Why a program that delivered zero commercial successes still got its leader promoted, and what that says about culture
Development reasons to stop or regroup: the wrong expression system, a CDMO platform that doesn't fit the molecule, or a pipeline that has moved on
Why stopping development isn't the same as failure
What success means at each stage, from the target product profile and QTPP to process variability you can't control
Three kinds of development projects (variant, derivative, breakthrough), and why breakthroughs need stopping criteria on day one
Treating data as inventory: findable, consistently named, and documented with its context
What tighter venture funding forces small teams to do, and when an aggressive timeline becomes a silly one
The gap analysis that would have caught a product the plant could never make
Chapters (placeholders from the pre-tightening edit; update from the final SRT):
00:00 Intro
00:23 Projects that should have been stopped
03:39 Development reasons to stop or regroup
05:17 Regrouping isn't failure
06:44 What success means from discovery to scale-up
09:49 Three kinds of development projects
12:31 Keeping data you can find and trust
15:52 Designed experiments and prediction
20:20 Funding pressure on small teams
23:29 What to do this week if your project is in trouble
26:09 Gap analysis and the chemistry nobody could make
Hosts:
Nathaniel Leies, host
Philip Ramsey, Ph.D., Emeritus Professor of Statistics, University of New Hampshire; Vice President of Data Science and Analytics, Predictum Inc.
Tiffany Rau, Ph.D., Owner, Rau Consulting; global biotech and pharmaceutical consultant across the drug development lifecycle
Mentioned: 
Beyond the Batch Ep. 2 on uncertainty
CoBaseKRM, an application for capturing knowledge from scientific and engineering modeling, produced by Predictum: https://cobasekrm.com
Contact: Send questions or a voice recording to beyondthebatch@predictum.com. More at beyondthebatch.io.
Produced by Predictum Inc., in partnership with Rau Consulting.

Every generation of scientists has faced complexity, but are today's kinetic systems (cell and gene therapies, advanced materials, complex manufacturing processes) are structurally harder to understand than what came before? 

In this episode, hosts, Dr. Tiffany Rau, Dr. Philip Ramsey, and Nathaniel Leies explain why classical statistical methods often aren't built for the job, why "boundary designs" miss where the real action happens, and why uncertainty (not just a prediction itself) has to be part of every decision.

They also get into designing for manufacturability, how regulators actually respond to quantified risk, and where machine learning methods designed for applied science and engineering problem solving actually helps.

This is Part 2 of our 2-part series on the most dangerous mistakes in CMC.

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Got a question? 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, please subscribe, rate the show, and share it with someone who'd get value from it.

🌐 Visit us on beyondthebatch.io to learn more.

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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).

Stock Media provided by Musinova / Pond5

#CMC #Biotech #Podcast #PharmaManufacturing #LifeSciences

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.