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Send us Fan MailA 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?Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida 

Send us Fan Mail12 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 LinkedInSupport the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida 

Send us Fan MailA 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?Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida 

Send us Fan MailA 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 RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida 

Send us Fan MailSupport the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida 

Send us Fan MailIf you have ever wondered why brilliant healthcare ideas still fail to reach patients, this conversation gets uncomfortably specific, in the best way. We sit down with Chiara, a former wet-lab genomics scientist who worked in male infertility, then pivoted into an MBA, startups, and pharma strategy roles in AI and analytics. She now co-founds Orby Grants to make grant writing and grant management accessible, and she brings a rare perspective on what it actually takes to translate life sciences innovation into real-world care.We dig into “mentech” and male reproductive health: why men’s infertility and sexual health can be treated as niche, how stigma stops people getting tested, and why the emotional load is routinely ignored. Chiara shares what it was like speaking to patients during her PhD work and how societal expectations can quietly drive worse health outcomes for everyone in a couple, not just one person.Then we get practical about AI in healthcare, including Chiara’s early chatbot project FerdiBot, built before ChatGPT made the idea mainstream. We talk timing, funding, co-founder fit, evidence, and the brutal truth that healthcare products cannot be judged like consumer apps. Along the way, we land on our favourite metaphor of the day: the “human being room”, where scientists, investors, clinicians, and patients drop the mask and have an honest conversation about needs and constraints.We finish with a fast GLP-1 quiz that explores effects beyond obesity, from cardiometabolic outcomes to addiction research and surprising societal changes. Subscribe for more Lab2Lives, share this with someone building in health, and leave a review with your biggest takeaway.Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida 

Send us Fan MailEurope looks like one market on a map, but try bringing a drug across borders and you quickly learn it behaves like many systems at once. We sit down with Daphne Smyth, a regulatory leader based in Ireland with 35+ years in pharmaceutical regulatory affairs, to unpack a mistake we keep seeing: companies build commercial teams first, then discover they have not built the regulatory pathway needed to launch at all. The result is not just delay, it is avoidable rework in clinical plans, manufacturing set-up, and the evidence story regulators expect.We spend a big part of the conversation on Chinese pharma and Chinese biotech moving into the EU. Daphne shares what surprises new entrants most: EU complexity, the need for the right legal structure, the reality of EMA procedures and committees, and the hard requirement that clinical data must be relevant to European patient populations, standards of care, and comparators. We also talk about ethnic sensitivity, PK/PD bridging, and why “we already developed it in China” can still mean going backwards to add studies. If Europe becomes too restrictive or simply too complicated, we risk blocking genuinely fascinating innovation.We then zoom out to the global drug development playbook: China’s scale and integrated biotech hubs, the US venture-driven model, Europe’s regulation-led caution, and why Australia keeps showing up as a fast route for early clinical trials. Finally, we lighten things up with a quick quiz on FDA Q2 2026 approvals, including the runaway earning potential of GLP-1 obesity drugs and how much of the quarter is actually oncology.If you enjoy practical regulatory strategy, market entry realities, and how to get medicines from lab to patients, subscribe, share the episode with a colleague, and leave us a review. What is the hardest “hidden rule” you have seen when entering a new healthcare market?Connect with Daphne Smyth on LinkedIn.Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida 

Send us Fan MailPharma doesn’t usually fail because the science is too hard. It stalls because humans are trying to do hard work inside a system that is overloaded, siloed and full of unwritten rules. We sit down with Isabelle, a physician with deep pharma experience who now works as a consultant, to unpack what really stops transformation and what actually helps teams move again. We talk about the five big value streams in a pharma company and why the friction between them becomes the real bottleneck. Isabelle explains why the “technical aspect is never the problem”, and why cross-functional delivery so often breaks on culture, incentives, role clarity and plain old nerves. We also dig into the surprising power of the “consultant hat”: the same truth can be welcomed from the outside and resisted from the inside, and that changes how leaders should use external support. From there we get practical: how complexity eats capacity, why organisations keep adding to the buffet without removing anything, and how “slower is faster” can be a real strategy when teams map blockers and cut low-value work. Then we play a sliding-doors biopharma quiz that brings it all to life, from big investment bets (semaglutide in obesity) to tough filing decisions, and the reminder that approval is not adoption in market access. If you care about organisational change in the pharmaceutical industry, pharma consulting, breaking down silos, and building systems that let people do great work, this one’s for you. Subscribe, share with a colleague, and leave a review with the biggest blocker you see in your organisation.Want to try the Sliding Doors in Biopharma Quiz? Find it here.Find Isabelle on her website elytraconsulting.com –and linkedin: https://www.linkedin.com/in/isabelle-catherine-widmer-md/Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida 

Send us Fan MailClinical trials are meant to generate evidence, not paperwork, but too many studies still depend on spreadsheets, duplicate data entry and unconnected systems. This episode we are joined by Karen Maduschke, a clinical trial technology leader with over 20 years of experience, from building one of the first interactive e-consent products to scaling trial tech through acquisition and entry into a global CRO environment. Together we explore one of most pressing challenges in Clinical Trials: moving faster without sacrificing integrity. Karen breaks down why “speed” is really a workflow problem, how poor integration creates site burden and error risk, and where new technologies and automation can genuinely help. We also talk about what must come alongside that shift: validation, information security, patient privacy and clear governance to protect patients and control risk. The episode also touches on practical tips if you are a founder selling into pharma R&D. We map the different corporate players you need to get on board and to buy into your product, not simply your technology - from clinical operations and procurement, to QA, legal, IT and information security. We also explain why pharma does not buy shiny tech, but reduced risk and faster delivery. FInally we finish with our ever fun game show round focused this episode on "How couch was this trial?" exploring the extent to which decentralisation in trials is becoming a reality? Subscribe for more, share this with a founder or trial leader who needs it, and leave us a review with your biggest barrier to a faster, cleaner transition from Labs to Lives.Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida 

Send us Fan Mail“Patients first” sounds simple until you follow the incentives.We’re joined by Dr Grant Coren, a genetics-trained PhD who moved from cancer research into decades of recruiting talent across the pharmaceutical industry and biotech. Together, we ask the uncomfortable question that sits under mission statements and glossy brand values: do pharma organisations truly value patients over profit, or do we build systems where profit is the only thing we reliably measure and reward?We explore why communication breaks down, from jargon-heavy emails to patient-facing information that is technically compliant but hard to understand. From there, the conversation widens into how risk aversion accumulates through thousands of “safe” micro decisions, why Big Pharma often outsources early discovery risk to biotech, and what happens when acquired biotechs get assimilated into slower, more process-heavy cultures. We also talk leadership and psychological safety: brilliant people can want change and still feel unable to back a decision if being wrong is punished.Technology and data get a hard look too. AI in pharma is attracting billions, but adoption is often blocked by culture, incentives, and a habit of hiding behind regulation rather than engaging regulators to modernise clinical trials. We then zoom out to funding realities and industrial policy, including whether state involvement and public-private partnerships could help fix market failures, especially as cell and gene therapies challenge old pricing and reimbursement models.If you care about patient-centric drug development, clinical trials, biotech innovation, and the future of healthcare incentives, you’ll find plenty to argue with and plenty to take back to your team. Subscribe, share this with a colleague, and leave a review with your take: what would you change first to put patients ahead of profit?Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander BoothChiara ChianeseIvanna Rosendal Oshida