HeyJaredOut of the Lab: Operationalizing Cell and Gene Therapy
tech transfer, process control, travel requirements, auditsThese 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…
- Indexed episodes, last 90 days
- 12
- Latest publication
- Sep 29, 2026
- Audience
- Checking…
- Earliest in this view
- Jul 7, 2026
Latest episodes
The 2 AM Audit Reality: Ex-FDA Regulators on CDMO Oversight, Night Shift Sins, and Data Integrity (opens the original)
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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 manipulation and informal quality decisions, DeVaughn and Elvia share unvarnished insights from thei
The $1M CDMO Selection Trap & Rethinking CMC Roadmaps with Shri Joshi (opens the original)
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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 selection must be treated as a development and risk-management decision rather than a simple procurement
Bunny Suits, Ice Buckets, and Slashing COGS: Bridging R&D and GMP Realities with Jerry (CellBri) (opens the original)
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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 from $150,000 down to under $20,000 using flexible automation, Jerry breaks down how effective communic
Beyond Manufacturing: Why Portal Fatigue and Physician Adoption Are Blocking Cell Therapy Access (opens the original)
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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, simplified prescribing workflows, and clinical adoption. Carl shares his perspective on the barriers st
The End of the Supply Chain Is the Patient: Shortages, Governance, and Risk with Dr. Angeliki Kotsianti (opens the original)
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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 Medical Benefit Risk Lead at Pfizer. Drawing on her unique perspective as both a treating physician and a seni
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