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PODCAST

Out of the Lab: Operationalizing Cell and Gene Therapy

Nicholas (Nico) Crudele

tech transfer, process control, travel requirements, audits These silent operational breakdowns prevent life-saving cell and gene therapy treatments from ever reaching patients, and kill IP-backed companies. This show is for executives on the path to clinic, de-risking their clinical assets. Leverage insights hard-earned from countless years in the industry, ranging from the manufactuirng floor through to leadership. Transform operations from your biggest risk into your greatest asset. See,

business entrepreneurship

All Episodes

00:21:15

You Don't Know What You Don't Know: The Hidden Traps...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2026/02/24

Why does a process that works perfectly in a university lab suddenly fail when it hits a manufacturing facility?In this episode, we sit down with François-Xavier (FX) Lacasse, a 28-year industry veteran, to unpack the notorious friction of tech transfer. We dive into the fundamental language barrier between academia ("research for research") and industry ("research for development"), and why strict GMP/GLP compliance is such a difficult bridge to cross.FX shares some brilliant

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01:03:53

Decentralizing the Cure: The Road to Community-Based...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2026/02/21

In this episode, host Nico sits down with repeat guest Lee Buckler to tackle the "80/20" problem in cell and gene therapy: the fact that while 80% of patients are treated in community settings, CAR-T therapies are currently stuck in high-level academic centers. We explore the history of patient access from the stem cell transplant model to the lessons learned from Dendreon’s Provenge and map out the infrastructure needed to bring these cures to the local level.From the "10-mile

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00:26:27

Tech Transfer Trauma: The High Cost of Going Back to...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2026/02/15

In the current investment landscape, the "cool science" era of Cell and Gene Therapy is over. Investors have moved from unbridled optimism to rigorous risk management, yet many IP-backed companies still treat manufacturing as an afterthought, a strategic error that kills margins and delays clinics.In this episode, Nico sits down with Silvio Tiziani, CEO of CCRM Australia, to dissect the "Manufacturability Gap": the critical friction point where regulatory complexity and

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00:10:04

The 80/20 Gap: Why Life-Saving Cures Are Stalling...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2026/01/28

"The number one hashtag on everybody's lips is patient accessibility."In this pre-episode teaser, we dive into the sobering reality of the "80/20 Gap" in cell and gene therapy. While the industry has celebrated the arrival of highly curative CAR T-cell therapies, a massive logistical wall has been hit. Lee Buckler joins us to unpack why sales of these "wonderful widgets" are flattening just as they should be scaling.We discuss:The Geographic Divide: Why 80% of

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00:52:44

The Scalability Trap: Why Flexibility is the Future...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2026/01/28

"The tradition is we start with open manual processes: flasks and clean rooms, thinking we can automate and scale and worry about cost of goods later."In this episode, Lee Buckler (Cell Therapy Group) and Nicholas Crudele (Method Made) explore why the "science project" phase of Cell & Gene Therapy often leads to a tech-transfer dead end. But the answer isn’t necessarily locking your process into a rigid, all-in-one "black box" early on.Lee argues for a different

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00:46:12

Tech Transfer 101: Engineering Out the "Secret Sauce"

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/12/13

If your process relies on the "golden hands" of a specific scientist, you don't have a product, you have a research project. Nicholas Crudele and Arnaud Deladeriere discuss the critical leap from academic science to GMP manufacturing in cell and gene therapy.We cover:What is CMC? (A primer for founders) .Why the "Product is the Process" mindset fails in cell therapy.How to use "process parameters" as dials to control patient variability.Why you should use GMP

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00:26:09

Demystifying CMC: Tech Transfer, Investor Pressures,...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/12/13

What exactly is CMC, and why is it the backbone of pharmaceutical quality? In this episode, Nicholas sits down with Jeffrey Seres to break down the complexities of Chemistry, Manufacturing, and Controls for early-stage founder-scientists.From the friction between aggressive VC timelines and operational realities to the future of documentation, we cover the critical gaps in moving from R&D to commercial manufacturing.Topics covered:Defining CMC: The control and oversight governing manufacturing

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00:40:23

The Light in the Lab: Why a Single Missed Detail Can...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/11/12

Are you an R&D-focused founder who thinks of manufacturing as a problem for "later"? This episode is a critical wake-up call.CMC expert and Managing Director David Bruehlmann joins the podcast to explain why a staggering number of promising therapies fail due to CMC issues and how treating "details" as an afterthought can lead to catastrophic failures.We dive into the story of a real-world tech transfer that failed, not because of the equipment, but because of a single,

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00:37:43

The Time Bomb in Your Tech Transfer: Why Tacit...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/10/04

Imagine your cell therapy is nearing Phase 3, but a multi-million dollar manufacturing run fails. The reason? A critical, undocumented step from your pre-clinical R&D was lost in translation years ago. This isn't a scientific failure; it's a business failure, and the seeds are often planted long before you scale. Your company's most valuable asset: the unwritten expertise of your scientists, could be the very thing that puts your clinical success at risk.In this episode, we talk with

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00:43:23

Beyond the Brochure: Mastering the CDMO Partnership...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/09/23

Beyond the Brochure: Mastering the CDMO Partnership for Successful Tech Transfer with Klaus DörreHow do you choose the right CDMO beyond a slick brochure? And once you do, how do you bridge the critical gap between brilliant R&D and the disciplined realities of GMP manufacturing?In this episode, we're joined by Klaus Dörre, a seasoned professional with deep experience across cell and gene therapy and biologics. Having worked on both the innovator and the CDMO side, Klaus offers a rare

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00:44:41

From Data to Scale: How Workplace Silos Break...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/08/14

From Data to Scale: How Workplace Silos Break Bioprocessing ModelsIn this episode of Method Made, host Nicholas Crudele sits down with digital bioprocessing expert Dr. Moritz von Stosch to uncover why even the most sophisticated bioprocessing models fail when workplace silos disconnect the people who run experiments from those who analyze the data.What You'll Learn:Why analytical variations of 10-20% still plague new modalities in cell and gene therapyHow separation between operators, sample

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00:22:21

Why Your Gene Therapy Tech Transfer Fails (A Lesson...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/08/05

In the high-stakes world of cell and gene therapy, we assume our challenges are unique. But what if the biggest threat to your tech transfer is a universal problem your team is blind to?In this episode of the Method Made podcast, Nicholas talks with David Horesh, a CEO who witnesses the same critical communication failure across dozens of industries—from aerospace and defense to cutting-edge biotech. The problem? Scientists and engineers are not speaking the same language, and it's killing

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00:20:20

Why Cell & Gene Therapy Manufacturing Needs Two...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/07/30

Ever wonder why cell and gene therapy manufacturing is so expensive? CDMO veteran Steven Keizer (15+ years experience) reveals a shocking operational reality: these procedures literally require two people to do what should be a one-person job.In this episode, Steven breaks down:Why sterile manufacturing forces operators to work with a dedicated scribeHow this violates FDA documentation requirements (but is necessary for patient safety)The fundamental disconnect between R&D teams who want blank

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00:16:29

How Much Detail Is Too Much in Tech Transfer...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/07/29

I asked Marina Goldfield this exact question on my latest podcast episode. Marina has 20 years of hands-on experience in biological manufacturing.Her answer was unequivocal:"Absolutely everything needs to be written down. There is no level of detail that's going to be too much. In my experience, it's always not enough."Marina explained that teams consistently discover missing details after problems occur: "You always figure out at the end like, oh, we should have written this

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00:33:07

The Data Crisis Killing Pharma Efficiency with...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/07/09

Pharma consultant Michele Bruschi breaks down why 80% of CDMOs and biotechs are still managing critical operations with spreadsheets and PDFs - and how this data crisis is creating massive competitive advantages for the companies that solve it.In this episode, we explore:Why "endless searching" for SOPs is costing weeks on every projectHow disconnected systems create operational chaos across the industryWhy efficiency and speed have replaced capacity as key differentiatorsThe hidden costs

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00:25:52

Why cell & gene therapy tech transfer takes 9-12...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/05/23

Cell and gene therapy faces a brutal reality: while traditional drugs make millions of doses per batch, personalized medicine makes one dose per patient. Yet each dose requires the same documentation burden - resulting in 16 three-ring binders and over 1,000 pages of paperwork per batch.In this episode, Jason Foster from Ori Biotech breaks down two critical bottlenecks killing industry scale-up:The Equipment Mismatch:Academic labs develop therapies using T-flasks and manual toolsCDMOs use completely

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00:45:21

CDMO Veteran Nithya Jesuraj Reveals the Documentation...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/05/23

Nithya shares what she's learned from years in CDMO business development and technical operations. From the post-pandemic CDMO boom to today's "minimum viable process" reality, she breaks down why small biotechs struggle with tech transfer documentation.Key insights:Why PowerPoint presentations aren't tech transfer documentation (and CDMOs are saying no)The mindset shift from academic protocols to manufacturing SOPsHow engineering runs become make-or-break decisions for cash-strapped biotechsWhy

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00:25:40

"You Don't Know What You Don't Know": Why Tech...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/05/22

In this eye-opening episode, we sit down with Heather, a seasoned business development expert at Chrysalis Bio, who reveals the hidden communication breakdowns that derail tech transfers long before any scientific issues arise.What You'll Learn:Why most companies approach tech transfer reactively instead of proactively—and how this costs millionsThe shocking disconnect between business development and operations that leads to "wrong client" scenariosHow 30% attrition in analytical teams still

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00:22:06

Tech Transfer in Cell & Gene Therapy

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/05/02

In this episode, I'm joined by Brian Newsom, CEO of Carrigent. We discuss the challenges in effective tech transfer in the Cell and Gene Therapy industry. This includes effective documentation in CGT, why nuanced detail capture in SOPs is mission critical during tech transfer, and the different risk profiles of effective documentation between personalized medicine and generic drug production.

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00:14:53

What Cell & Gene Therapy Can Learn About Tech...

Out of the Lab: Operationalizing Cell and Gene Therapy ·

2025/05/02

In this episode, we discuss some of the challenges and requirements for effective tech transfer from the perspective of biofuel bioprocessing expert Shekar Govindaswamy Ph.D.

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20 results

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