Lab to Lives

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A therapy can be scientifically obvious and still never reach a patient. That contradiction is the centre of our conversation with Stephanie, CEO of WinQure Medicine, where we pull apart what really breaks when you try to develop drugs for ultra-rare disease, including “nano-rare” patients who may be one in a million.

We start with the lived reality: parents and carers who become accidental biotech founders, learning toxicology, regulatory approval, clinical operations, and manufacturing because the standard pharmaceutical machine is tuned for large markets. Stephanie shares how antisense oligonucleotides (ASOs) and other de-risked modalities can enable a radically leaner path, and why “fully compliant” matters when emotions run high and the stakes are life-changing. We also explore the practical bottlenecks that don’t show up on slide decks: how to find five eligible patients worldwide, how trial travel can be the real barrier, and why endpoints often miss what families actually care about.

From there we get concrete about solutions. WinQure’s AI-driven pipeline helps decide which stalled academic programmes are worth pushing through tox, clinical trials, and reimbursement, while Rare Key, their patient registry, flips the flow by starting with patients who want treatment and mapping feasibility upfront. We also dig into UK MHRA and EU policy shifts, baseline and natural history trial designs, outcome-based reimbursement, and the ethical limits of pricing in rare diseases.

If you care about biotech, clinical trials, patient engagement, and getting medicines from lab to lives without waste, listen now, then subscribe, share, and leave us a review. What would you change first to stop ultra-rare patients being left behind?
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Hosts
Alexander Booth
Chiara Chianese
Ivanna Rosendal Oshida

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12 million samples at minus 80 is not a fun fact, it is a daily responsibility. We sit down with Jennifer Man, Scientific Director at UK Biocentre in Milton Keynes, to unpack what “lab to lives” really demands once science meets real-world scale: operational readiness, rigorous compliance, and systems that protect patient samples while still moving fast enough to serve national research.

We explore how high throughput biobanking and sample processing actually works, from end-to-end workflows to the backbone role of a Laboratory Information Management System (LIMS). Jennifer explains why automation is essential for standardisation and traceability, yet never fully replaces skilled humans because quality control, verification, and deviation handling are where real life happens. We also dig into foresight: planning for downstream assays, safeguarding sample integrity, and why pilot studies can save a programme from expensive rework years later.

The conversation turns personal and practical, tracing Jennifer’s non-linear career path and the advantage of combining deep bench skills with wider organisational perspective. We talk about leadership, the tension between old processes and new methods, and the mindset shift that makes optimisation possible: leave ego at the door, separate business-as-usual delivery from process development, and stay curious even when AI and new technologies redefine the “terrain” of healthcare work.

If you want more honest conversations about translational science, clinical research operations, laboratory automation, and scaling innovation without wasting time or samples, subscribe, share the episode, and leave us a review.
Find Jennifer Man on LinkedIn
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Reach out to Ivanna Rosendal

Join the conversation on our LinkedIn page
Visit www.labtolives.com 

Hosts
Alexander Booth
Chiara Chianese
Ivanna Rosendal Oshida

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A clinical trial can have brilliant science and still stall for a painfully ordinary reason: the site does not get paid on time. We sit down with Patrick Mizer and Kevin Williams from LedgerRun to unpack why clinical trial site payments and contracts become a hidden bottleneck, how that pressure lands on research sites, and why sponsors and CROs only notice the “back office” when something breaks. If you care about trial timelines, study start-up, site experience, and getting therapies to patients faster, this conversation goes straight to the operational truth under the hype. 

We dig into what makes site payments different from normal accounts payable: complex budgets, protocol amendments, mismatched data across systems like EDC, and the reality that many sites are not built like finance departments. Kevin explains the idea of staying off the critical path, and Patrick shares what surprised him most when he entered the space: people have historically been the glue holding together fragmented workflows. We also explore global clinical trials, where country specific financial norms add another layer of complexity that software must respect. 

AI in healthcare is everywhere right now, so we get specific about what actually works. Patrick and Kevin walk through a human in the loop approach where AI reduces repetitive reconciliation work, while audit trails, permissions, and validation rules stay as strict as ever. We also discuss a compliance friendly architecture that keeps probabilistic AI outside the system of record, making it easier to explain, control, and govern in regulated environments. If you have ever wondered why change management beats features, you will recognise the tension between modern tools and “please let me keep emailing my invoice”. 

Subscribe, share this with someone in clinical operations, and leave a review if it helps. What part of the clinical trial process feels most overdue for practical innovation?
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Reach out to Ivanna Rosendal

Join the conversation on our LinkedIn page
Visit www.labtolives.com 

Hosts
Alexander Booth
Chiara Chianese
Ivanna Rosendal Oshida

Send us Fan Mail
A medicine can look perfect and still be wrong, and that gap between appearance and reality is where patients get hurt. We sit down with Dave Chametzky, who spent decades working alongside the pharmaceutical industry’s legal and protection efforts, to talk candidly about counterfeit drugs, how quickly fakes can hit the market, and what everyday buyers can do to lower their risk when shopping online.

We also get personal about what happens when a long pharma career ends, and why rebuilding identity matters as much as landing the next role. Dave shares the story behind his book, When Your Heart Says It’s Your Time To Soar, and we pull on a simple thread that becomes a bigger theme: your first love should be you. That lens changes how we think about resilience, curiosity, and showing up as a whole human being in a metrics-heavy industry.

Then we switch gears into AI in pharma and medtech with a quiz based on real FDA warning letters. What goes wrong when companies submit AI-generated documents without review, or misclassify an AI diagnostic tool as “exercise equipment”? We talk AI governance, GMP expectations, regulatory paperwork, and why human-in-the-loop is not optional when patient safety is on the line.

If you care about patient safety, pharmaceutical compliance, counterfeit medicine risks, and the real-world limits of automation, this one is for you. Subscribe, share with a colleague, and leave us a review so more people can learn how to move safer from lab to lives.
Support the show

________
Reach out to Ivanna Rosendal

Join the conversation on our LinkedIn page
Visit www.labtolives.com 

Hosts
Alexander Booth
Chiara Chianese
Ivanna Rosendal Oshida

Send us Fan Mail
Support the show

________
Reach out to Ivanna Rosendal

Join the conversation on our LinkedIn page
Visit www.labtolives.com 

Hosts
Alexander Booth
Chiara Chianese
Ivanna Rosendal Oshida