Out of the Lab: Operationalizing Cell and Gene Therapy

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 sits down with Hedley Rees, Managing Director of PharmaFlow and a 40-year biopharma supply chain veteran, to pull back the curtain on why advanced thera...

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 and Founder of the Orphan Therapeutics Accelerato r, to dissect the radical operational and financial shifts required to bring advanced therapies to...

"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 sit down with Andrew from ScaleReady to discuss the operational parallels between historical manufacturing revolutions and the current challen...

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 (CGT) logistics. Joining us again is Tatyana Matveeva , Director of cGMP Operations at Harvard Medical School and Massachusetts General Hospital, to bre...

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 Compliance, Quality Systems & Quality Engineering at Kite Pharma), to discuss the real-world boundaries of AI in GxP environments. Jose breaks...

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 gap between clinical practice and the research of cell and gene therapies. We dive into the true purpose of standard operating procedures (SOPs) a...

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. While cell therapy offers incredible curative potential, Betsy reveals the massive gaps in post-treatment care and the illusion of a cancer "finish...

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 bottleneck, but rather the translation of that science to the community through three pillars: place, knowledge, and affordability. Adrienne shares how...

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 challenges in cell and gene therapy tech transfer. We dive deep into the cultural divide between GMP operations and research environments. Tatyana explains why therapies developed over decades in an academic setting struggle to transition into clinical...

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 access to cell and gene therapies. Melinda shares her incredible journey from receiving a stage four terminal cholangiocarcinoma diagnosis 16 years ago to becoming a pioneer in cell therapy treatments at the National Cancer Institute (NCI). Her story, whi...

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 cleanroom and the hospital bed. We challenge the industry’s obsession with Cost of Goods Sold (COGS) and explore why logistics and manufacturing speed are the true barriers to saving lives. Key topics discussed: The "Wait Time" Crisis: Why 26% of...

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 decades of innovation and improved manufacturing capability, patient access to cell therapies like CAR T is still limited by adoption and operational issues rather than science. She argues that decentralization should mean smarter, data-trusted orchest...

Guest: Jennifer Hayne, VP & Head of Biologics Analytics Services at Catalent In this technical deep dive of the Out of the Lab podcast, we explore the often-overlooked nuances of transferring assays from early-stage research into a GMP (Good Manufacturing Practice) environment.  Jennifer from Catalent joins us to discuss why "common sense" in a research lab doesn't always transla...

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 the conversation in the powerful story of Melinda Bachini, the first GI tumor patient to receive tumor-infiltrating lymphocyte (TIL) therapy for cholangiocarcinoma. Despite her success over a decade ago, Chun explains why this life-saving process rem...

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...

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...

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...

"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 widg...

"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 lo...

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...

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...

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 sto...

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 s...

Beyond the Brochure: Mastering the CDMO Partnership for Successful Tech Transfer with Klaus Dörre How 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 gen...

From Data to Scale: How Workplace Silos Break Bioprocessing Models In 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...