Out of the Lab: Operationalizing Cell and Gene Therapy

Why do processes that look clean on paper collapse during an FDA inspection? In this episode of Out of the Lab , host Nico Crudele sits down with ex-FDA auditors DeVaughn Edwards (GMP specialist) and Elvia Cervantes (GCP specialist) to break down the most common and preventable compliance disasters in cell and gene therapy. From night-shift compliance breakdowns and paper-only CDMO audits to data...

Why does selecting the cheapest CDMO quote often lead to millions of dollars in unexpected costs down the road? In this episode of Out of the Lab , host Nico sits down with industry veteran Shri Joshi, who has navigated cell and gene therapy operations across consulting, CDMO, and sponsor sides to break down the core ingredients of a successful drug development lifecycle. We explore why CDMO selec...

Why do brilliant R&D processes stall or fail when transferred into a GMP cleanroom? In this episode of Out of the Lab , host Nicholas Crudele sits down with Jerry from CellBri to unpack the unspoken assumptions, technical miscommunications, and equipment hurdles that delay cell therapy manufacturing. From the reality of using ice buckets instead of precise 4°C incubation to reducing batch COGS...

Is manufacturing complexity really the main bottleneck holding back cell and gene therapies, or are we ignoring the operational friction occurring right at the physician's desk? In this episode of Out of the Lab , host Nicholas Crudele sits down with Carl Schoellhammer, Partner at DeciBio, to discuss why the cell therapy industry must shift its focus from cleanroom COGS to physician awareness,...

What happens when a biopharma supply chain breaks upstream from the clinic? It doesn't just delay manufacturing, it forces doctors at the bedside to choose which patients receive curative therapy and which ones have to wait. In this episode of Out of the Lab , host Nicholas Crudele sits down with Dr. Angeliki Kotsianti, founder and scientific advisor of Oncolyze and former Senior Global Medica...

 In this episode of Out of the Lab , host Nico sits down with 20-year cell and gene therapy expert Alfred Sloan to dissect the operational and capital constraints facing advanced therapy development today. From the pressure to rapidly accelerate clinical timelines to the rising threat of global competition outcasting domestic manufacturing costs, Alfred breaks down why the industry must shift from...

How do 1 in 16 cell and gene therapies fail, not because of the biology, but because of the supply chain? In this episode of Out of the Lab , host Nico sits down with Mehran, a seasoned Cell & Gene Therapy supply chain consultant, to dissect why operational resilience must be engineered into your product long before tech transfer ever takes place. From CDMO selection gaps to un-addressable spe...

What happens when a foreign manufacturer gets put on an FDA import alert? Or when a single undocumented ingredient turns a harmless dietary supplement into an unapproved drug? In this episode of Out of the Lab , host Nico sits down with Dan and Binh from Wynngate Consulting. Bringing decades of insider FDA experience from compliance enforcement to foreign facility inspections, they pull back the c...

What are the hidden operational mistakes early-stage drug developers make before ever selecting a CDMO? In this episode of Out of the Lab , host Nicholas Crudele sits down with David Dismuke , Chief Technology Officer at Forge Biologics. Drawing on over 20 years of experience across both academic CDMOs, corporate CDMOs, and therapeutic developers, David breaks down why yield should not be your onl...

Why do biomanufacturing execution systems fail despite multi-million dollar investments? In this episode of Out of the Lab , host Nicholas Crudele sits down with biopharma automation and manufacturing execution system (MES) consultant Robert Perks to unpack the realities of digitizing biomanufacturing workflows. From early R&D data integration to navigating the FDA’s shift toward Computer Soft...

Has the pharmaceutical industry outsourced its way into a supply chain crisis? In this episode of Out of the Lab , host Nicholas Crudele sits down with repeat guest Hedley Rees to uncover the systemic risks embedded in the modern pharmaceutical manufacturing model. For decades, the industry has relied on outsourcing to CDMOs and offshoring to lower costs, but this shift has resulted in a devastati...

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...