Transformation in Trials

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

  Send us a textWhat 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 RosendalJoin the conversation on our LinkedIn page

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• Democratizing Drug Development Through AI-Native Platforms with Ilya Burkov

  Send us a textCloud 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 innovationSupport the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn page

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

  Send us a textDominik 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-keepingSupport the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn page

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

  Send us a textDr. 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 paceYou can find Dr. Shervin Molayem on LinkedIn or Instagram under "DentalSurgeon," or try his free dental chatbot at [email protected] the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn page

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

  Send us a textChris 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 lifespanIf 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 RosendalJoin the conversation on our LinkedIn page

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