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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.
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Hosts
Alexander Booth
Chiara Chianese
Ivanna Rosendal Oshida

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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/
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Do you want to try the quiz from this episode? Find the link on our LinkedIn profile: https://www.linkedin.com/company/labtolives/ 
Would you like to join the show as a guest or collaborator? Find out how on our website: https://www.labtolives.com/ 

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Hosts
Alexander Booth
Chiara Chianese
Ivanna Rosendal Oshida

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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.
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Do you want to try the quiz from this episode? Find the link on our LinkedIn profile: https://www.linkedin.com/company/labtolives/ 
Would you like to join the show as a guest or collaborator? Find out how on our website: https://www.labtolives.com/ 

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Visit www.labtolives.com 

Hosts
Alexander Booth
Chiara Chianese
Ivanna Rosendal Oshida

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“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?
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Do you want to try the quiz from this episode? Find the link on our LinkedIn profile: https://www.linkedin.com/company/labtolives/ 
Would you like to join the show as a guest or collaborator? Find out how on our website: https://www.labtolives.com/ 

Support the show

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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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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?
Visit Labtolives.com
Do you want to try the quiz from this episode? Find the link on our LinkedIn profile: https://www.linkedin.com/company/labtolives/ 
Would you like to join the show as a guest or collaborator? Find out how on our website: https://www.labtolives.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