Advertise on podcast: Transformation in Trials

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

Send us Fan Mail If 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 Rosendal Join the conversation on our LinkedIn page Visit www.labtolives.com  Hosts Alexander Booth Chiara Chianese Ivanna Rosendal Oshida

Send us Fan Mail Europe 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 Rosendal Join the conversation on our LinkedIn page Visit www.labtolives.com  Hosts Alexander Booth Chiara Chianese Ivanna Rosendal Oshida

Send us Fan Mail Pharma 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 Rosendal Join the conversation on our LinkedIn page Visit www.labtolives.com  Hosts Alexander Booth Chiara Chianese Ivanna Rosendal Oshida

Send us Fan Mail Clinical 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 Rosendal Join the conversation on our LinkedIn page Visit www.labtolives.com  Hosts Alexander Booth Chiara Chianese Ivanna 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 Rosendal Join the conversation on our LinkedIn page Visit www.labtolives.com  Hosts Alexander Booth Chiara Chianese Ivanna Rosendal Oshida

Send us Fan Mail AI is everywhere in pharma right now, yet drug development still feels slow, fragmented, and full of avoidable rework. We sit down with Anastasia Christianson, former SVP and Global Head of AI Data and Analytics at Pfizer and now Managing Principal at EPAM Life Science Consulting, to get specific about what actually blocks progress in clinical trials and what AI can realistically change. We dig into the uncomfortable pattern behind many “successful” AI deployments: a model fixes one bottleneck, then the system simply jams up somewhere else. Anastasia makes the case for end to end thinking across trial design, feasibility, patient recruitment, engagement, site operations, and data flow. We talk about why niche AI products are easier to build, why coordination is harder than modelling, and how digital health’s app explosion offers a warning for today’s AI tooling. Along the way, we unpack digitalisation, data standards, FAIR data, and why “perfect data” is not the same as “useful data”. The most practical segment centres on patients: how AI can help build cohorts, find eligible participants, answer questions, reduce fear, improve convenience, and prevent dropouts that cost time and money. We also turn FDA denials into a quick quiz to highlight a key truth of life sciences innovation: approvals can fail due to control arm choices, surprising trial requirements, or manufacturing site inspection findings even when the science looks promising. If you care about AI in clinical trials, R&D productivity, and how to turn data into faster access to medicines, you’ll get both a reality check and a playbook. Subscribe for more, share this with a colleague in clinical operations or data science, and leave a review telling us: where do you see the biggest bottleneck right now? 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 The clinical trial system is starting to look like a motorway at a standstill: more and more drugs are lining up, but the lanes ahead are already full. We sit down with Pamela Tenart to unpack why the industry may have reached the limit of human-only clinical development, and why “adding more people” is no longer a realistic plan when experienced CRAs, site co-ordinators and trial operators are already stretched thin. From there, we get practical about what agentic AI could change inside clinical trial operations. We talk about AI agents that can pull context across CTMS, EDC, safety reporting and TMF, helping monitors prepare for site visits, flag missing fields, propose next best actions, draft communications, and reduce the dead time where teams are simply waiting for updates. The point is not to automate judgement, but to automate the admin and co-ordination work so humans can focus on strategy, enrolment, quality, and patient safety with a clear audit trail and human-in-the-loop control. We also zoom out to the bigger bottleneck: sponsors, CROs and sites are part of one connected system, so optimising one party can just shift the pain elsewhere. Along the way we explore why better, more sensitive endpoints can shorten trial timelines, how policy and regulation might need to evolve, and a memorable metaphor from industrial history: electricity boosted individual productivity first, but factories only truly improved once they were rebuilt for the new technology. If you’re working in clinical research, drug development, biotech, or health tech, this conversation will help you think more clearly about where AI genuinely shortens the critical path and where it simply adds noise. Subscribe, share the episode with a colleague, and leave us a review. Which clinical trial workflow would you redesign first? 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 A medicine can be proven safe and effective, approved by regulators, and still fail the one test that matters: actually reaching patients in the real world. We sit down with Anish, a deep commercial thinker, to unpack what pharmaceutical commercialisation really is when you strip away the slogans and look at incentives, bottlenecks, and human behaviour.  We start with our five value streams model of the pharmaceutical industry and use it to explore a provocative idea: modern big pharma often functions like a financial institution with extraordinary risk tolerance and time horizons. That framing changes how you think about R&D outsourcing, late stage development, pricing negotiations, market access, and the “programme management” required to bring a drug from molecule to monitored use.  From there we move into the last mile of healthcare delivery: patient experience, physician capacity, restrictions on direct to consumer communication, and why “patient centricity” is hard in practice. We discuss remote care and digital health, including internet hospitals, plus the safety risks of self medication and the very real problem of adherence, from finishing a course to staying on track with GLP-1 medicines. If you care about pharma strategy, drug launch, market access, and what makes innovation stick, this one is for you.  Subscribe for more, share this with a colleague who works on commercial or patient support, and leave a review. What is the biggest barrier you have seen between approval and real patient access? Try the quiz from the show yourself: https://forms.gle/uepGynopoLpguYKw8  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 This is the first episode in the rebranded show! Drug and medical device breakthroughs do not reach patients because they’re clever in a lab. They reach patients when innovation, regulatory strategy, partnerships, clinical evidence and commercial reality line up at the same time, and that’s where things get messy. We’re launching Lab to Lives with a simple goal: talk honestly about what slows life sciences down and what actually helps. We start by introducing our new co-host dynamic and mapping where we each work across the life sciences “value streams” from early R&D to compliance and commercialization. With perspectives from diagnostics, medtech and pharma, we explore why devices and drugs now overlap, why manufacturing is often the blind spot, and why modern startups can look less like research labs and more like project management teams coordinating CROs across an ecosystem. Then we go straight into one of the biggest debates in biotech and medtech: is regulation the barrier, or is it our approach to proving safety and efficacy? We unpack risk-benefit thinking, the power of precedent, and why innovators often choose the safest regulatory path even when a different approach could unlock better products. Along the way, we talk about culture clashes between startups and big pharma, incentives that shape decisions, and how to regain agency by building a clear evidence argument regulators can assess. If you care about drug development, medical devices, regulatory affairs, FDA and EMA expectations, and the real mechanics of translating science into patient impact, come join the conversation. Subscribe, share this with someone building in life sciences, and leave a review with the barrier you think we should tackle next. Drug Name or Pokémon? Try the Quiz! 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 What happens when we stop calling people “subjects” and start inviting them to help build the solutions they need? We sit down with pharmacist and patient engagement leader Mark Duman to unpack how language, literacy, and lived experience can transform clinical trials, medtech, and digital health from the ground up. Mark introduces his three Cs—co-creation, choice, and coaching—and shows how each one moves care from doing to people toward working with and learning from them. We dig into the hidden pitfalls of relying solely on patient advocacy groups, why representation matters, and how to reach the millions who never join a mailing list but live with the biggest burdens. Mark shares a practical bridge: “staff as patients,” an internal, compliant way for organisations to hear real stories and test assumptions. From there, we explore informed consent that genuinely informs, outcomes data people can understand, and the right to know who is treating you and how good they are—without drowning in jargon. The conversation then zooms out to health literacy and data literacy as core citizenship skills. Wearables, home testing, and portals promise insight, but only if people can interpret trends, risk, and uncertainty. We talk about building inclusive paths for both digital-first and low-tech preferences, making space for community-driven solutions. Parents in rare diseases show what’s possible when lived experience meets scientific rigour: they convene experts, shape protocols, and even spark new therapies. That is the “meeting of experts” mindset—clinical knowledge and daily life experience on equal footing. Finally, we take on prevention and incentives. Can industry support prevention without fearing cannibalisation? Some already do, and the smarter lens treats trust and long-term health impact as strategic assets. We close with concrete steps any team can take: map patient journeys, test language for clarity, co-design eConsent, reduce protocol burden, compensate fairly, and measure how patient input changes recruitment and retention. Subscribe, share with a colleague who designs studies or products, and leave a review telling us one phrase you’ll stop using and what you’ll say instead. 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 Ever wondered why a clean CSR still leaves you unsure how a trial actually ran? We dive into the hidden layer that explains the “how”: audit trails across EDC, IRT, eConsent, and ePRO. With guests Ellis Hiroki of Study OS (now rebranded  siteroAI) and Nechama Katan of Wicked Problem Wizard, we unpack how E6(R3) shifts sponsors from “we can export logs” to “we continuously analyse them,” and why process measures—not just outcomes—are essential to real RBQM. We break down the obstacles that keep teams stuck in CSV purgatory: fragmented vendor data, missing standards, timestamp chaos, and brittle one-off scripts. Nachama shares pragmatic use cases that matter—like ePRO entries after discontinuation or suspicious mass updates—and how to prioritise by likelihood, detectability, and severity. Ellis explains why general AI isn’t enough, and how a purpose-built, agentic approach uses models to plan steps and generate validated SQL or code, rather than hallucinated answers. The result is auditable reasoning, repeatable checks, and faster paths from a clear question to a trusted signal. From there, we connect signals to action. Analytics without workflow creates noise; analytics with RBQM workflows produce root causes and durable fixes. We explore how audit logs become the first true process dataset in clinical operations, and how broader operational inputs—logistics, communications, and training—can also be measured when systems are API-first and integrated. If you’ve ever watched a leadership question trigger a scramble in stats programming, this conversation shows a cleaner route: experts ask in plain English, the system produces valid code and dashboards, and teams focus on insight rather than plumbing. If this resonates, follow the show, share it with a colleague, and leave a review. Your feedback helps us bring more practical, high-signal conversations to the clinical trials community. 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 Want clinical research that respects real life? We sit down with Caroline Potts, GM of Site and Patient Services at MRN, to rethink how patients are recruited and supported when the standard trial model collides with work, school, caregiving, and distance. We start at the site level, exploring why trial sites remain the beating heart of studies, then unpack how participants actually arrive: investigator databases, advocacy networks, disease-specific portals, and focused social campaigns that reach people where they already are. From there, we tackle the hidden friction in protocols. Do you really need a physical exam at every visit, or can a trained nurse complete most procedures at home, at work, or even at a holiday address? Caroline gets specific about what’s possible outside the clinic—centrifuges, compliant drug delivery, courier timing—and where the red lines remain, like imaging. The conversation separates hype from substance on decentralised trials, arguing that the true shift is operational flexibility, not just apps. We also assess AI’s promise in finding eligible patients while calling for rigorous validation and thoughtful use alongside human support. The heart of the episode is practical patient centricity. We discuss rare diseases and long travel times, evening and weekend scheduling, reimbursement barriers, and how small design choices can either invite people in or push them away. Participants commit years of their lives to studies; the least we can do is meet them halfway. Caroline closes with a bold wish: compress timelines across the entire development arc. Precision medicine has moved forward; trial operations must catch up. If this resonates, follow the show, share it with a colleague, and leave a review to help more listeners find thoughtful conversations on modern clinical research. 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 Two leaders from Sionna Therapeutics walk through a 15‑year journey from Genzyme science to a public company advancing NBD1‑targeted therapies in cystic fibrosis. We examine why most patients still fall short of normal CFTR, how a predictive assay de‑risks choices, and what it takes to finance, hire, and execute with patients as the North Star. Visit: sionnatx.com 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 What if the documents behind a clinical trial were written with the patient’s voice in mind and delivered at the speed modern science deserves? We sit down with writer, consultant, and patient-advocate Bilal Bham to unpack how protocols, clinical trial applications, and clinical study reports actually get made, why structure beats chaos, and where AI genuinely shortens timelines without cutting corners. From first protocol outlines to final submissions, Bilal shares a process that blends proprietary AI with rigorous human review to turn dense source data into clear, regulator-ready narratives. The conversation gets real about the craft. Bilal argues that new writers still need to learn documents end-to-end: where to find truth in source files, how to build arguments across sections, and how to keep stakeholders aligned from biostats to clinical operations. AI helps when you feed it the right ingredients, starting with comprehensive bullet-pointed outlines rather than instant prose. That discipline shaves weeks off delivery and keeps quality high, especially when regulators are exploring AI on their side of the table and expect traceability, accuracy, and transparent logic. We also explore the power of inclusion. Living with Graves’ disease and thyroid eye disease, Bilal explains how patient experience sharpens trial design, consent language, and symptom reporting. Diversity is not a banner; it is better science. Recruiting across local communities in the UK, US, and Europe strengthens external validity and reveals gene-environment differences that change safety and efficacy. Pair that with plain-English patient summaries, fair compensation, and trusted community partners, and you get trials that are faster to run, easier to understand, and more likely to help the people who need them most. If you care about clinical trials, regulatory writing, medical communications, AI in pharma, and building inclusive studies that actually work in the real world, this conversation is for you. Subscribe, share with a colleague, and leave a review with your take: where should inclusion start in clinical research? 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