Transformation in Trials

Ivanna Rosendal
  • 5.0 (1)
  • LIFE SCIENCES
  • UPDATED BIWEEKLY

A podcast about the transformations in clinical trial. As life science companies are pressured to deliver novel drugs faster, data, processes, applications, roles and change itself is changing. We speak to people in the industry that experience these transformations up close and make sense of how the pressure can become a catalyst for transformation. 

  1. Inside Sionna’s Bid To Normalize CFTR Function

    12/17/2025

    Inside Sionna’s Bid To Normalize CFTR Function

    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

    32 min
  2. AI Won’t Replace Writers, But Writers Who Use AI Will Outpace The Rest with Bilal Bham

    12/03/2025

    AI Won’t Replace Writers, But Writers Who Use AI Will Outpace The Rest with Bilal Bham

    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

    24 min
  3. From Grief To Global Advocacy For Clinical Research In Infectious Diseases with Christian John Lillis

    11/19/2025

    From Grief To Global Advocacy For Clinical Research In Infectious Diseases with Christian John Lillis

    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

    31 min
  4. Decoding Real-World Evidence: Beyond Clinical Trials with Manfred Stapff

    09/10/2025

    Decoding Real-World Evidence: Beyond Clinical Trials with Manfred Stapff

    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

    32 min
  5. Democratizing Drug Development Through AI-Native Platforms with Ilya Burkov

    08/27/2025

    Democratizing Drug Development Through AI-Native Platforms with Ilya Burkov

    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

    19 min
  6. Incorruptible Evidence: Blockchain's Promise for Faster Drug Approvals w. Dominik Lysek

    08/13/2025

    Incorruptible Evidence: Blockchain's Promise for Faster Drug Approvals w. Dominik Lysek

    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

    28 min
  7. Revolutionizing Dentistry: AI and Research Innovation with Dr. Shervin Molayem

    07/30/2025

    Revolutionizing Dentistry: AI and Research Innovation with Dr. Shervin Molayem

    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 shervin@trustdentistryai.com. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page

    39 min
  8. How early diagnostics of lung cancer can lead to better survival rates with Chris Wood

    07/02/2025

    How early diagnostics of lung cancer can lead to better survival rates with Chris Wood

    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

    37 min
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About

A podcast about the transformations in clinical trial. As life science companies are pressured to deliver novel drugs faster, data, processes, applications, roles and change itself is changing. We speak to people in the industry that experience these transformations up close and make sense of how the pressure can become a catalyst for transformation. 

Information

  • Creator
    Ivanna Rosendal
  • Years Active
    2022 - 2025
  • Episodes
    87
  • Rating
    Clean
  • Copyright
    © 2025 Transformation in Trials
  • Show Website
    Transformation in Trials

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