Out of the Lab: Operationalizing Cell and Gene Therapy
Nicholas (Nico) Crudeletech 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 manufacturing floor th... more
| Publishes | Weekly | Episodes | 34 | Founded | 10 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | BusinessEntrepreneurship | |||
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Latest Episodes
What happens when the biopharmaceutical industry tries to force living, hyper-perishable cell therapies into a legacy supply chain built for shelf-stable small molecules?
The entire system breaks down.
In this episode of Out of the Lab, host Nico s... more
What happens when a life-saving gene therapy is developed for a patient population of only 30 people? The traditional pharmaceutical business model completely breaks down.
In this episode of Out of the Lab, host Nico sits down with Craig Martin, CEO... more
"Cell and gene therapy developers are contending with the same problems the early pioneers of lean production contended with. Specifically, a frugal environment with scarce resources."
— Andrew, ScaleReady.
In this episode of Out of the Lab, we s... more
How do you scale a supply chain when an entire manufacturing run is for one patient, and the starting material is inside them?
In this episode of Out of the Lab, we dive deep into the messy, complex, and high-stakes world of cell and gene therapy (C... more
In this episode of Out of the Lab, we tackle the intersection of cutting-edge technology and strict biopharma regulation. We are joined by Jose Caraballo-Oramas (Founder & Principal Advisor, JCO Global Advisory LLC, former Vice President of Global Co... more
In this episode of the Out of the Lab Podcast, we sit down with Dr. Rishi Chavan from the Children's Hospital of Orange County. As a pediatric oncologist specializing in stem cell transplants, Dr. Chavan provides a unique perspective on bridging the ... more
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 Larrabee, a parent and patient advocate, to discuss the realities of pediatric CAR T-cell therapy. W... more
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 patient access in cell and gene therapy.
We discuss why the physical science isn't the primary bott... more
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Frequently Asked Questions About This Podcast
What is This Podcast about and what kind of topics does it cover?
This show focuses on the operational side of cell and gene therapies, with guests and hosts unpacking real-world challenges in tech transfer, manufacturing, quality systems, supply chains, and patient access. Episodes frequently center on cost structures, lean manufacturing, decentralized delivery, data sharing, and regulatory alignment, all through practical, outcomes-driven conversations aimed at de-risking assets heading toward clinic. A notable strength is the emphasis on actionable insights—such as how to speed patient access, streamline documentation, and design scalable transfer strategies—delivered by practitioners who have led or transformed manufacturing and distribution in CGT environments. The format tends to mix case-based narr... more
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this podcast launched 10 months ago and published 34 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
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What guests have appeared on this podcast?
Recent guests on this podcast include:
1. Craig Martin
2. Tatyana Matveeva
3. Jose Caraballo-Oramas
4. Dr. Rishi Chavan
5. Betsy Larrabee
6. Melinda Bachini
7. Paul Chun
8. François-Xavier Lacasse
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