Lab to Lives

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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?
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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 aka the MedTech Guy
Dimitri Borisevich aka the start-up Guy
Ivanna Rosendal aka the R&D pharma Gal

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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 
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 aka the MedTech Guy
Dimitri Borisevich aka the start-up Guy
Ivanna Rosendal aka the R&D pharma Gal

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!
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 aka the MedTech Guy
Dimitri Borisevich aka the start-up Guy
Ivanna Rosendal aka the R&D pharma Gal

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.
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 aka the MedTech Guy
Dimitri Borisevich aka the start-up Guy
Ivanna Rosendal aka the R&D pharma Gal

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.
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 aka the MedTech Guy
Dimitri Borisevich aka the start-up Guy
Ivanna Rosendal aka the R&D pharma Gal