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Send us a text 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. Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.  I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce. Join the show as a guest - apply via this Form.  Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text 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 Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.  Getting treatment to patients faster requires well-functioning organizations. How do we do that? Ivanna Rosendal has written a book called Maneuvering Monday, about how a group of people try to make their organization better. You are certain to have a good laugh at their expense. And potentially get inspired how you can help make your company better. I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce. Join the show as a guest - apply via this Form.  Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text 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? Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.  I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce. Join the show as a guest - apply via this Form.  Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text A routine dental visit, a few days of diarrhea, and then the unthinkable: septic shock and a life lost within 24 hours. Our guest, Christian John Lillis, shares how losing his mother Peggy to a community-acquired C. diff infection exposed a silent public health crisis and led him to co-found the Peggy Lillis Foundation (https://cdiff.org/). From that moment, advocacy turned concrete: raising awareness, training volunteers to speak with lawmakers and media, and pushing for policies that reflect the true burden of C. diff and other infectious diseases. We dig into what a modern, patient-centred clinical trial should look like. Christian explains why initial cure is not the only outcome that matters; for C. diff, the recurrence rate can define whether someone can work, travel, or care for family. We unpack why decentralized trials, telehealth diagnostics, and home nursing can transform access, speed up recruitment, and improve diversity—critical for evidence that holds up in real life. We also examine antibiotic stewardship, exploring how pathogen-targeted therapies can reduce collateral damage and help fight antimicrobial resistance while maintaining or improving efficacy and tolerability. Policy and incentives are central. Christian outlines the limits of market-driven R&D for smaller but deadly pathogens like VRE and CRE, and why tools such as GAIN, LPAD, and potential subscription models are needed to fund anti-infectives society desperately requires. We talk global spread, declining vaccination, and the communications gap that leaves many people vulnerable to misinformation. On the personal level, he shares practical steps for self-advocacy: bring someone to urgent visits, prepare questions, be firm and respectful, and share your story to fuel change. If you care about patient advocacy, clinical trial innovation, C. diff awareness, antibiotic resistance, and public health, this conversation offers both a roadmap and a rallying cry. Subscribe, share with a friend who works in healthcare, and leave a review telling us one change you’d make to make trials truly patient centred. Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.  Getting treatment to patients faster requires well-functioning organizations. How do we do that? Ivanna Rosendal has written a book called Maneuvering Monday, about how a group of people try to make their organization better. You are certain to have a good laugh at their expense. And potentially get inspired how you can help make your company better. I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce. Join the show as a guest - apply via this Form.  Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text What if millions of electronic health records could transform how we understand medicine? In this thought-provoking conversation with Dr. Manfred Stapff, physician and real-world evidence pioneer, we uncover how anonymized patient data is revolutionizing healthcare research. Dr. Stapff reveals how the 21st Century Cures Act dramatically accelerated electronic medical record adoption in the US, creating unprecedented opportunities for researchers. Today, with 90-95% of American hospitals digitized and similar progress across parts of Europe, we're witnessing a fundamental shift in how medical knowledge is generated. But this transformation comes with crucial questions about data quality, privacy, and interpretation. Fascinatingly, real-world evidence offers solutions to problems traditional clinical trials can't address. While trials remain essential for developing new treatments, aggregated real-world data can help identify unexpected disease patterns, like rising cancer rates in younger populations. The sheer scale of this information—potentially millions of patient experiences—creates statistical power that individual studies could never achieve. The conversation takes a particularly compelling turn when Dr. Stapff shares his vision for democratizing medical knowledge. "What did we do 40 years ago when we had a question? We asked our doctor," he explains. "If we had access to electronic medical records... we could have access to the experience of thousands of physicians who treat hundreds of thousands or even millions of patients." This democratization could fundamentally change how patients understand their conditions and treatment options. Explore the emerging world of federated data networks, statistical literacy challenges, and why Dr. Stapff believes pharmaceutical companies should measure success not just in dollars but in lives improved. Whether you're a healthcare professional, researcher, or simply curious about the future of medicine, this episode offers valuable insights into how data is reshaping healthcare as we know it. Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.  Getting treatment to patients faster requires well-functioning organizations. How do we do that? Ivanna Rosendal has written a book called Maneuvering Monday, about how a group of people try to make their organization better. You are certain to have a good laugh at their expense. And potentially get inspired how you can help make your company better. I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce. Join the show as a guest - apply via this Form.  Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Cloud computing is transforming biotech by offering purpose-built infrastructure that supports AI-driven drug discovery and development while meeting strict regulatory requirements. Dr. Ilya Burkov explains how Nebius provides full-stack solutions that democratize access to powerful technology, enabling researchers to achieve breakthroughs that previously required generations. • Cloud computing market was built for general purpose workloads but biotech needs specialized infrastructure for sensitive data and AI models • GPUs enable parallel processing that accelerates AI applications—like "a whole classroom solving math problems at once" versus CPUs solving one at a time • Applications include drug discovery, genomics, protein structure modeling, quantum chemistry, and single-cell modeling for cancer treatment • Nebius provides full-stack solutions with hardware and software layers, working with NVIDIA to offer specialized packages • Democratizing access to AI infrastructure is leveling the playing field between small biotechs and large pharmaceutical companies • Scientists can now accomplish in their lifetime what previously would have taken multiple generations of researchers • Breaking down silos between data teams and institutions is crucial for accelerating healthcare innovation Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Dominik Lysek, CEO of PharmaTrail, explains how blockchain technology can solve trust issues in clinical trials by providing an incorruptible audit trail that verifies data integrity. This solution could significantly accelerate the time required for regulatory approvals, partnerships, and acquisitions, ultimately getting treatments to patients faster. • Blockchain provides a complete, unchangeable audit trail where data can only be added, never deleted • Most clinical data (99.9%) has integrity, but proving this to outsiders is time-consuming and costly • PharmaTrail uses private blockchain technology alongside traditional databases for optimal security and functionality • Blockchain verification can maintain momentum through due diligence processes, preventing deals from stalling • The technology creates trust by enabling independent verification of data integrity • Current systems face challenges with data credibility that delay patient access to treatments • Private blockchains protect patient data while still providing the benefits of immutable record-keeping Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Dr. Shervin Molayem shares his journey of innovation in dentistry, starting with his discovery of a connection between periodontal disease and COVID-19 severity that became the world's most-read dental article of 2020. He discusses groundbreaking technologies including AI-powered diagnostic tools and a revolutionary non-surgical treatment that regenerates bone tissue around teeth. • Discovered connection between gum disease and COVID-19 severity through interleukin-6 levels • Developing Trust AI, a dental co-pilot that gives practitioners instant access to research, bridging the 17-year gap between research and practice • AI dental diagnostics can detect 37% more pathology than human eyes by distinguishing 250 shades of gray versus only 30 • Created non-surgical periodontal regeneration technology using piezoelectric nanoparticles that kill bacteria and stimulate bone growth • Oral infections affect overall health with links to heart disease, stroke, and Alzheimer's disease • Clinical research needs greater transparency to eliminate bias, potentially using blockchain technology to make science "fraud-proof" • The volume of research is doubling every three years, making AI essential for clinicians to keep pace You can find Dr. Shervin Molayem on LinkedIn or Instagram under "DentalSurgeon," or try his free dental chatbot at [email protected]. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Chris Wood discusses how early diagnostics of lung cancer through artificial intelligence and medical imaging can lead to better survival rates through early intervention.  • Lung cancer takes more lives than breast, prostate and colon cancer combined, with approximately 70% of cases caught at late stages • The National Lung Screening Trial showed that screening high-risk populations reduced mortality by 20% • I-ELCAP research demonstrated an 80% twenty-year survival rate for early-stage cancers detected with CT scans and treated surgically • Preventive healthcare is shifting from general advice to personalized screening protocols based on individual risk factors • AI applications in medical imaging now assist with detection, characterization, and triage of disease • Lung biopsies have a 22% complication rate, making non-invasive diagnostic methods particularly valuable • AI-powered imaging can provide additional information to help clinicians decide whether to perform biopsies • In clinical trials, AI imaging analysis could improve patient selection and help trials reach endpoints more efficiently  • Medical imaging gives patients visual information about their bodies that can motivate healthier lifestyle changes • The future of healthcare will likely focus on improving quality of life rather than simply extending lifespan If you have a suggestion for a guest for our show, reach out to Sam Parnell or Ivanna Rosendal on LinkedIn. You can find more episodes on Apple Podcasts, Spotify, Google Podcasts or in any other player. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Building high-performing teams in life sciences requires understanding how neurodiversity can be an advantage and designing work systems that enable different brain types to collaborate effectively. • A high-performing team continues to function when everything around it has fallen apart • Star players can become crutches that mask underlying team issues • Life sciences faces unique challenges: financial pressures, outdated technology, layoffs, and pervasive lack of trust • Teams often develop learned helplessness after years of having initiatives rejected • Only 10-15% of people are needed to drive revolutionary change in an organisation • Traditional management approaches fail because they don't account for individual differences • Standard practices like the "feedback sandwich" often backfire depending on neurotype • Creating concrete team habits that normalize desired behaviours works better than abstract training • Tracking waste can give teams agency and hope while improving processes • Many come to life sciences wanting to make a difference—reconnecting to this purpose is powerful If you'd like to learn more about building high-performing teams in life sciences, reach out to Nehama Katan at wickedproblemwizards.com or find Rajesh Anandan at team-x.ai. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Sebastian Andruszczak, Chief Growth Officer at Holisticon (part of the Nexer Group), brings fresh perspective to the conversation around generative AI adoption in pharmaceutical companies. Drawing from his unique background in sales, marketing, and technology, Sebastian cuts through the hype to address fundamental challenges that prevent successful AI implementation in life sciences. The conversation reveals a critical insight often overlooked in the rush to adopt new technology: without proper data governance, organizations risk "scaling disaster." Sebastian walks us through the specific challenges pharmaceutical companies face - from ever-changing data sources creating inconsistent AI responses, to linguistic variations causing subtle differences in interpretation across global teams. These issues become magnified when implementing AI at enterprise scale, potentially undermining the very efficiencies these technologies promise. Sebastian outlines a methodical, four-part approach to building effective AI systems: starting with data governance fundamentals, then data engineering, followed by traditional machine learning, and finally generative AI applications. This structured approach has proven successful for companies like Beringer Ingelheim, whose ambitious knowledge management system has already saved one million working hours by processing over 800,000 documents across 200 departments in 70+ countries. What makes this episode particularly valuable is Sebastian's candid assessment of the industry's current state. While acknowledging the transformative potential of strategic AI initiatives in drug discovery and knowledge management, he challenges the fear-driven implementation happening in many organizations. His "magic wand" wish for the industry reflects this pragmatism: focus first on data quality - a decades-old challenge that finally has the perfect justification for investment. Whether you're directly involved in pharmaceutical technology implementation or interested in how AI adoption affects life sciences advancement, this episode provides practical insights on building systems that deliver genuine value rather than just following technological trends. Connect with Sebastian on LinkedIn to continue the conversation. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Why do we wait until we're severely unwell before seeking help? In this thought-provoking episode, I'm joined by Eva Papadopoulou, a mental health professional and expert in digital and AI-enabled healthcare solutions, to explore the transformative potential of preventative mental healthcare. Eva reveals the stark reality of our current healthcare systems - less than 10% of budgets are allocated to prevention, despite evidence showing preventative approaches lead to better outcomes and cost savings. Using dental care as a compelling example, she illustrates how cultural shifts can transform how we approach healthcare. "We take care of our mind and body before it breaks, not after," Eva explains, offering a vision where mental wellbeing is nurtured proactively rather than repaired reactively. We delve into key areas ripe for preventative intervention, including youth mental health (with most conditions developing before age 25) and workplace wellbeing, where burnout and absenteeism cost businesses billions annually. Technology emerges as a powerful enabler through apps, wearables, and AI systems that can detect early warning signs and deliver personalized support at scale. Eva emphasizes that successful health tech must be co-designed with users and integrated seamlessly into clinical pathways, while better health education is essential to help people interpret their health data meaningfully. The conversation culminates with Eva's powerful vision for healthcare's future: shifting from short-term thinking to long-term investment that prioritizes prevention over crisis management. "Invest in the future instead of firefighting in the present," she urges, inviting listeners to imagine a society where understanding and maintaining mental wellbeing becomes as routine as brushing our teeth. Connect with Eva on LinkedIn to continue this important conversation about transforming healthcare through prevention. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Rob Freistat, President of Uncommon Cures, discusses how clinical trials are transforming to accelerate drug development and ensure patients receive treatments faster, particularly in the rare disease space. • Current market uncertainty and investment challenges in biotech, especially for rare disease research • Approximately two-thirds of clinical trial processes add no value and aren't required by regulations • Many clinical trial failures occur not because drugs don't work but because trials can't recruit enough patients • Companies often treat development phases as "islands" rather than planning for commercial success from the beginning • Rare disease economics require greater efficiency since development costs must be recovered from much smaller patient populations • Reviving shelved drug candidates represents a potentially valuable opportunity • Patients should have greater input in trial design and outcome measures that matter to them • Better communication between sponsors and regulators could significantly improve drug development Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Jonathan Hill takes us on a fascinating journey through the cutting-edge world of DNA sequencing and its revolutionary potential for early disease detection. As both an academic professor at Brigham Young University and co-founder of Wasatch BioLabs, Hill shares how third-generation sequencing technologies are transforming our ability to identify diseases years before symptoms appear. The conversation centers on a groundbreaking approach using native methylation calling—a method that identifies specific chemical modifications to DNA—to detect neurodegeneration in conditions like Alzheimer's and Parkinson's. Hill explains how these diseases damage the brain for up to a decade before symptoms emerge, creating a critical window where treatment could be most effective. By detecting the unique methylation signatures of dying neurons from cell-free DNA in the bloodstream, Wasatch BioLabs' technology aims to revolutionize diagnosis and treatment monitoring. What makes this platform particularly powerful is its versatility. The same technology that identifies dying neurons can be adapted to detect signatures from other dying cell types, potentially offering early diagnostics for autoimmune diseases, various cancers, and other conditions—all from a simple blood draw. Beyond the science, Hill reveals his passion for nurturing the next generation of biotech entrepreneurs. He's created a unique ecosystem at BYU where students with innovative ideas receive the mentorship, lab facilities, and business connections needed to translate academic discoveries into real-world applications. Drawing parallels to the tech boom of Silicon Valley, Hill emphasizes that biotech is experiencing its moment of explosive innovation, though with unique regulatory and infrastructure challenges. The episode concludes with a thoughtful discussion on regulatory hurdles in life sciences and how streamlining these processes—while maintaining safety standards—could accelerate innovation and save countless lives. For anyone fascinated by the intersection of cutting-edge science, entrepreneurship, and healthcare transformation, this conversation offers an inspiring glimpse into the future of medicine. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

Send us a text Vectors are the unsung heroes of cell and gene therapy—molecular couriers that transport therapeutic genes into human cells to treat disease. But as Alan Griffith, Head of Global Operations at Vector Builder reveals, creating these sophisticated delivery vehicles is far more complex than most realize. Drawing from over a decade of experience developing gene therapies before joining the CDMO sector, Griffith offers rare insight into what makes manufacturing these therapies so challenging. Vector design emerges as the critical yet underappreciated factor determining success or failure. "The fundamental sequence and vector composition itself is so fundamental to manufacturability," Griffith explains, noting how seemingly minor elements can dramatically impact production at scale. This knowledge has evolved painfully over the past decade, with clinical holds and manufacturing failures teaching hard lessons. The relationship between therapy developers and contract manufacturers proves equally crucial. Rather than transactional exchanges, successful partnerships require deep collaboration and shared risk. "Working with a CDMO is like dancing with someone you don't know," Griffith observes, emphasizing how Vector Builder aims to understand diseases and vector compositions thoroughly rather than simply executing manufacturing orders. Cost remains perhaps the greatest challenge facing cell and gene therapies. While small molecule drugs might be considered expensive at $10,000 per dose, that figure would be remarkably affordable for gene therapies. Strategies to address this include better vector design to reduce manufacturing failures, more targeted delivery requiring smaller doses, and challenging the "one-and-done" assumption that has proven more complex in reality as expression often diminishes over time. Looking ahead, Griffith sees complementary roles for both viral vectors and emerging non-viral delivery systems like lipid nanoparticles and exosomes. He predicts viral vectors will continue to dominate certain applications for decades due to their unmatched effectiveness, while non-viral approaches may offer manufacturing advantages and potentially lower costs. Cell and gene therapies are revolutionary treatments with vectors serving as "molecular couriers" that deliver genetic materials to target cells, but manufacturing these therapies presents significant challenges in scaling, cost, and regulatory compliance. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page