Out of the Lab: Operationalizing Cell and Gene Therapy

Nicholas (Nico) Crudele
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tech 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 manufactuirng 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.

  1. 3D AGO

    Tech Transfer Trauma: The High Cost of Going Back to the Bench

    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 "Manufacturability Gap": the critical friction point where regulatory complexity and documentation failures amplify costs. We discuss the business case for early operational rigor, including: The Financial Reality of Rework: Why failing to consider GMP requirements during R&D leads to the ultimate nightmare scenario: returning to the lab bench for total process redesign. The "Widget" Investment Thesis: Silvio explains why the Australian market favors modular, versatile "widgets" over the "single magic box" approach and why this versatility makes for a more attractive, de-risked financial asset. From Founder to Executive: The necessary mindset shift from academic curiosity to commercial competence, and why your pitch must pivot from "technical novelty" to "risk management" to resonate with today's circumspect investors.Join us to learn how to transform operations from your biggest liability into your greatest asset.

    26 min

  2. JAN 28

    The 80/20 Gap: Why Life-Saving Cures Are Stalling (Teaser)

    "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 widgets" are flattening just as they should be scaling. We discuss: The Geographic Divide: Why 80% of cancer patients treated in community healthcare settings are effectively locked out of therapies available only at advanced medical centers (AMCs). The flattening of CAR T: A look at why adoption has stalled at 20%—the exact percentage of patients with easy access to city-center hubs. Beyond the Science: Why the "attractive option" of a cure disappears when a patient faces a five-hour drive, three weeks of city living costs, and a lack of local support systems. The Path to Decentralization: How "boxed-in" physical systems and operational engineering are working to bring manufacturing and processing closer to the patient’s home. If we don't move the therapy to the patient, we leave 80% of the population behind. Join us as we explore the infrastructure and "contractual engineering" required to break CAR-T out of the ivory tower and into the community. Stay tuned for the full episode.

    10 min

  3. JAN 28

    The Scalability Trap: Why Flexibility is the Future of CGT Manufacturing

    "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 locking your process into a rigid, all-in-one "black box" early on. Lee argues for a different path: the "daisy chain" of technologies. Instead of one box that does everything (and limits innovation), the future of the lab is a series of specialized "widgets" digitally connected to ensure compliance without sacrificing flexibility. We discuss how these widget technologies act as the digital glue for this daisy chain, capturing manual breakthroughs today and turning them into the automated, scalable protocols of tomorrow. Highlights: Why the "worry about it later" mentality around manufacturing is a company killer. The "One Box" vs. "Daisy Chain" debate: Why flexibility wins in R&D.

    53 min

  4. 12/13/2025

    Tech Transfer 101: Engineering Out the "Secret Sauce"

    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 to use "process parameters" as dials to control patient variability. Why you should use GMP materials as early as possible.

    46 min

  5. 12/13/2025

    Demystifying CMC: Tech Transfer, Investor Pressures, and the "Time vs. Money" Trap

    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 commercial manufacturing. Topics covered: Defining CMC: The control and oversight governing manufacturing quality. The Strategy Gap: Why rushed timelines destroy CMC strategy and how to mitigate "Time vs. Money" arguments with investors. Board Composition: Why startups need operational expertise, not just bankers and academics, on their boards. The Future of Docs: Why putting paper on an iPad isn't true digitization—and why full process automation is the real goal.

    26 min

  6. 11/12/2025

    The Light in the Lab: Why a Single Missed Detail Can Kill Your Tech Transfer

    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 story of a real-world tech transfer that failed, not because of the equipment, but because of a single, un-documented variable: the light exposure in the lab. This conversation is essential listening for any scientist, engineer, or founder preparing to scale their process. In this episode, you will learn: What CMC Strategy Is: Why it's not an "afterthought" but a strategic asset that must be built from day one. The "Quality by Design" Mindset: How to work backward from the patient to define your critical process parameters and control strategy. How to Choose a CDMO: Why the right partner is about cultural fit, size, and experience—not just the lowest cost. Why CGT is Harder: The fundamental difference between biologics ("the process is the product") and cell therapy ("the cell is the product"). The R&D vs. Engineering Mindset: The critical (and necessary) culture clash between scientists focused on results and engineers focused on robustness. If you would like to suggest future episode topics and/or guests, get in touch on LinkedIn

    40 min

  7. 10/04/2025

    The Time Bomb in Your Tech Transfer: Why Tacit Knowledge is Your Biggest Business Risk

    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 scientists, could be the very thing that puts your clinical success at risk. In this episode, we talk with Akshay Ravindranath, a manufacturing science and technology (MSAT) specialist with 10 years of frontline experience navigating the treacherous gap between R&D innovation and GMP execution. He reveals how seemingly minor details in the lab become major sources of technical risk. These risks lead to delays, and budget overruns during late-stage clinical manufacturing. For CEOs and CTOs, this conversation is not just about documentation, it's about strategic foresight. Listen to this episode to understand how to identify and secure your most critical intellectual assets now to de-risk your journey to Phase 3 and protect your company's valuation.Looking for a documentation solution to derisk before manufacturing? Drop us a line

    38 min

  8. 09/23/2025

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

    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 gene therapy and biologics. Having worked on both the innovator and the CDMO side, Klaus offers a rare 360-degree view of the tech transfer process. We dive into the essential, yet often overlooked, elements of a successful partnership, including the mindset shift required to move from the lab to the plant. In this episode, you will learn: The green flags to look for when selecting a manufacturing partner. Why robust analytics and well-defined potency assays are non-negotiable, even in early phases. The crucial difference between documenting research experiments and writing GMP-ready protocols and SOPs. How to build a relationship based on trust and transparency, turning your CDMO from a simple vendor into a true strategic partner. Key advice for early-stage companies on de-risking their CMC strategy to avoid costly delays. This conversation is a must-listen for founders, CMC leaders, and scientists on the journey from discovery to clinical production. If you are approaching your first tech transfer, see how we can help.

    43 min
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tech 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 manufactuirng 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.

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