Out of the Lab: Operationalizing Cell and Gene Therapy
Episodes
The Hidden Costs of Cell Therapy: Post-Treatment Care Gaps with Patient-Parent Advocate Betsy Larrabee
27 Apr 2026
Contributed by Lukas
What happens after a patient survives a groundbreaking clinical trial?In this episode of Out of the Lab, host Nicholas Crudele sits down with Betsy La...
The Fatal Cost of Paper Records in Cell Therapy | Out of the Lab with Adrienne Mendoza
22 Apr 2026
Contributed by Lukas
In this episode of Out of the Lab, host Nico Crudele is joined by Adrienne Mendoza from BBG to unpack the massive operational challenges holding back ...
"Visceral Doesn't Count": The Cultural Divide Between Research & GMP | Tatyana Matveeva
14 Apr 2026
Contributed by Lukas
In this episode of the Out of the Lab Podcast, we sit down with Tatyana Matveeva, head of cGMP operations at Harvard, to discuss the documentation cha...
Surviving Stage 4 Cancer: Melinda Bachini on Cell Therapy Patient Access & Barriers
05 Apr 2026
Contributed by Lukas
In this episode of Out of the Lab, we sit down with patient advocate Melinda Bachini to explore the real-world operational barriers holding back acces...
The Cost of Waiting: Why Speed to Patient is the Ultimate Metric
21 Mar 2026
Contributed by Lukas
In this episode, we sit down with Jesus Zurdo, a patient advocate and bioprocessing veteran who has seen the cell therapy journey from both the cleanr...
Decentralization, Physician Adoption, and Data Sharing
21 Mar 2026
Contributed by Lukas
In this episode of the Out of the Lab: Operationalizing Cell Therapy Podcast, host Nico is joined by Claudia Zylberberg to discuss why, despite two de...
The "Gently" Trap: Navigating the Realities of Cell & Gene Therapy Assay Transfer
17 Mar 2026
Contributed by Lukas
Guest: Jennifer Hayne, VP & Head of Biologics Analytics Services at CatalentIn this technical deep dive of the Out of the Lab podcast, we explore ...
Laying the Rails for Advanced Therapies: Paul Chun on Cell & Gene Operations
11 Mar 2026
Contributed by Lukas
In this episode, we sit down with guest Paul Chun to explore the complex operational challenges within the cell and gene therapy sector. Chun grounds ...
You Don't Know What You Don't Know: The Hidden Traps in Tech Transfer with François-Xavier Lacasse
24 Feb 2026
Contributed by Lukas
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 Fran...
Decentralizing the Cure: The Road to Community-Based CAR-T
21 Feb 2026
Contributed by Lukas
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 whi...
Tech Transfer Trauma: The High Cost of Going Back to the Bench
15 Feb 2026
Contributed by Lukas
In the current investment landscape, the "cool science" era of Cell and Gene Therapy is over. Investors have moved from unbridled optimism t...
The 80/20 Gap: Why Life-Saving Cures Are Stalling (Teaser)
28 Jan 2026
Contributed by Lukas
"The number one hashtag on everybody's lips is patient accessibility."In this pre-episode teaser, we dive into the sobering reality of t...
The Scalability Trap: Why Flexibility is the Future of CGT Manufacturing
28 Jan 2026
Contributed by Lukas
"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 l...
Tech Transfer 101: Engineering Out the "Secret Sauce"
13 Dec 2025
Contributed by Lukas
If your process relies on the "golden hands" of a specific scientist, you don't have a product, you have a research project. Nicholas Cr...
Demystifying CMC: Tech Transfer, Investor Pressures, and the "Time vs. Money" Trap
13 Dec 2025
Contributed by Lukas
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 co...
The Light in the Lab: Why a Single Missed Detail Can Kill Your Tech Transfer
12 Nov 2025
Contributed by Lukas
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 ...
The Time Bomb in Your Tech Transfer: Why Tacit Knowledge is Your Biggest Business Risk
04 Oct 2025
Contributed by Lukas
Imagine your cell therapy is nearing Phase 3, but a multi-million dollar manufacturing run fails. The reason? A critical, undocumented step from your ...
Beyond the Brochure: Mastering the CDMO Partnership for Successful Tech Transfer with Klaus Dörre
23 Sep 2025
Contributed by Lukas
Beyond the Brochure: Mastering the CDMO Partnership for Successful Tech Transfer with Klaus DörreHow do you choose the right CDMO beyond a slick broc...
From Data to Scale: How Workplace Silos Break Bioprocessing Models
14 Aug 2025
Contributed by Lukas
From Data to Scale: How Workplace Silos Break Bioprocessing ModelsIn this episode of Method Made, host Nicholas Crudele sits down with digital bioproc...
Why Your Gene Therapy Tech Transfer Fails (A Lesson from Outside Pharma)
05 Aug 2025
Contributed by Lukas
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 univ...
Why Cell & Gene Therapy Manufacturing Needs Two People to Do One Job with Steven Keizer
30 Jul 2025
Contributed by Lukas
Ever wonder why cell and gene therapy manufacturing is so expensive? CDMO veteran Steven Keizer (15+ years experience) reveals a shocking operational ...
How Much Detail Is Too Much in Tech Transfer Documentation?
29 Jul 2025
Contributed by Lukas
I asked Marina Goldfield this exact question on my latest podcast episode. Marina has 20 years of hands-on experience in biological manufacturing.Her ...
The Data Crisis Killing Pharma Efficiency with Michele Bruschi
09 Jul 2025
Contributed by Lukas
Pharma consultant Michele Bruschi breaks down why 80% of CDMOs and biotechs are still managing critical operations with spreadsheets and PDFs - and ho...
Why cell & gene therapy tech transfer takes 9-12 months (and costs millions) with Jason Foster, CEO of Ori Biotech
23 May 2025
Contributed by Lukas
Cell and gene therapy faces a brutal reality: while traditional drugs make millions of doses per batch, personalized medicine makes one dose per patie...
CDMO Veteran Nithya Jesuraj Reveals the Documentation Gap Killing Biotech Tech Transfers
23 May 2025
Contributed by Lukas
Nithya shares what she's learned from years in CDMO business development and technical operations. From the post-pandemic CDMO boom to today's "minimu...
"You Don't Know What You Don't Know": Why Tech Transfers Fail Before the Science Even Starts with Heather from Chrysalys Bio
22 May 2025
Contributed by Lukas
In this eye-opening episode, we sit down with Heather, a seasoned business development expert at Chrysalis Bio, who reveals the hidden communication b...
Tech Transfer in Cell & Gene Therapy
02 May 2025
Contributed by Lukas
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 i...
What Cell & Gene Therapy Can Learn About Tech Transfer From Biofuels
02 May 2025
Contributed by Lukas
In this episode, we discuss some of the challenges and requirements for effective tech transfer from the perspective of biofuel bioprocessing expert S...