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Hosted by Nicholas (Nico) Crudele · 🇺🇸 US · EN-CA · 38 episodes
Established thought leaders with verified media credentials.
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 clinical assets. Leverage insights hard-earned from countless years in the industry, ranging from the manufacturing floor through to leadership. Transform operations from your biggest risk into your greatest asset. See, understand and prepare for the challenges ahead on your clinical journey.
Nicholas (Nico) Crudele hosts Out of the Lab: Operationalizing Cell and Gene Therapy, a business show with 38 episodes published.
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 Nic
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
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 (M
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
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 si
"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 episo
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 wor
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, for
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 uniqu
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 pe
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 s
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
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 fr
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 C
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 acc
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 rese
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 G
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 n
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 curren
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 manufacturi
Hedley Rees
PharmaFlow
1 appearance on this show
Dr. Rishi Chavan
Children's Hospital of Orange County
1 appearance on this show
Adrienne Mendoza
BBG
1 appearance on this show
Tatyana Matveeva
Harvard
1 appearance on this show
Jennifer Hayne
Catalent
1 appearance on this show
Silvio Tiziani
CCRM Australia
1 appearance on this show
Lee Buckler
Cell Therapy Group
1 appearance on this show
Nicholas Crudele
Method Made
1 appearance on this show
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Out of the Lab: Operationalizing Cell and Gene Therapy is hosted by Nicholas (Nico) Crudele. The show is categorised under business (entrepreneurship) and has published 38 episodes.
Out of the Lab: Operationalizing Cell and Gene Therapy has published 38 episodes.
Out of the Lab: Operationalizing Cell and Gene Therapy regularly covers business, entrepreneurship. It sits in the business category, with a entrepreneurship focus.
Out of the Lab: Operationalizing Cell and Gene Therapy is accessible for guests with genuine business expertise. A personalised, episode-aware pitch will still outperform a generic one every time.
Out of the Lab: Operationalizing Cell and Gene Therapy hasn't explicitly signalled guest openness in recent episodes. That doesn't rule out pitching. your hook just needs to be especially compelling and relevant to their recent content.
Episodes of Out of the Lab: Operationalizing Cell and Gene Therapy average 35 minutes. a focused format where a clear narrative arc and tight preparation matter most.
Our data rates Out of the Lab: Operationalizing Cell and Gene Therapy's guest bar at 80/100 (Premium tier). Established thought leaders with verified media credentials. Sign in to PitchCentric to see how your own Pod Score compares against this show.
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