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© 2025 Transformation in Trials
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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.
85 Episodes
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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...
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 infras...
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 (9...
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 • ...
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...
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 • Te...
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 technolo...
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 out...
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 ...
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 meth...
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 c...
Send us a text The untapped potential of electronic health records has long been recognized in clinical research, but extracting meaningful insights from this treasure trove of data has remained an elusive challenge—until now. Vish Srivastava, founder of Century Health, reveals how artificial intelligence is revolutionizing real-world evidence by unlocking critical patient data trapped in EHRs. Traditional patient registries that once took a decade to amass just 1,000 patients can now be cre...
Send us a text Join us for a conversation with guest Shelli Pavone, co-founder of Inlightened, to uncover the untapped potential of diversity in clinical trials. Discover how historical mistrust, structural barriers, and exclusion criteria continue to hinder diverse patient recruitment. Shelli sheds light on the transformative impact inclusive trials have on scientific integrity, safety, and the generalizability of results. By embracing diversity, not only do we align with regulatory expectat...
Send us a text In this episode we dive into Brain-Computer Interface (BCI) technology, where the brain's faint signals are harnessed to create life-changing applications. Andreas Forsland and Greg Johns emphasize the importance of community-driven innovation, guided by the Brainiac Council—a unique assembly of patients, caregivers, and experts. This collaborative approach ensures that the solutions developed address real-world challenges, improving communication and independence for those wit...
Send us a text This episode reveals alarming statistics about patient access to clinical trials, highlighting that only 3% of patients currently have access to participate. Our guest, Jill Pellegrino, CEO of Auto Recruitment, shares innovative strategies to engage the other 90% of the patient population and discusses the importance of digital advertising, pre-screening, and patient support in the recruitment process. • Discussion on the low percentage of patient access to clinical trials&nbs...
Send us a text Why has SAS been the cornerstone of clinical trials for decades, and what is causing the shift to R now? Join us on "Transformation in Trials" as we explore this pivotal transition with Sunil Gupta, a seasoned programmer who has navigated both worlds. Sunil elaborates on SAS's long-standing dominance due to its robust programming capabilities and ease of use for FDA reviewers. However, the landscape is changing as R garners attention for its graphical prowess and collaborative ...
Send us a text Prepare to transform your understanding of vendor oversight in clinical trials as we welcome Jessica Cordes, a senior consultant and trainer at the Clinical Excellence Consultancy. Jessica brings her wealth of experience to highlight the intricate responsibilities that sponsors must navigate when outsourcing tasks. Our conversation promises to equip you with insights on maintaining control, mitigating risks, and leveraging technology like AI and machine learning to future-proof...
Send us a text How do you navigate the complexities of manufacturing cell and gene therapies that are tailored to individual patients? Find out as we sit down with Dr. Bruce Levine from the University of Pennsylvania to unpack the intricacies of clinical research in this groundbreaking field. From the unique emphasis on chemistry, manufacturing, and controls (CMC) to the logistical hurdles of sourcing and modifying patient-derived cells, Dr. Levine offers an expert's perspective on the challe...
Send us a text What if re-engaging with your purpose could revolutionize your job satisfaction and mental health? Join us for our conversation with Jill Donahue, a leader in life sciences whose personal journey through psychology, behavioral science, and a profound personal tragedy has fueled her mission to improve communication and trust within the healthcare community. Jill opens up about how these experiences led her to create initiatives like her book "A Dose of Inspiration" and the Auror...
Send us a text When nine out of ten clinical trials don't cross the finish line, it's time to ask tough questions and seek innovative answers. That's exactly the journey we embark on with Vinodh Balaraman from KolateAI in our latest podcast episode. Together, we unravel the complex knot of challenges that lead to clinical trial failures, from flawed study designs to enrollment obstacles and the unexpected curveballs thrown by the approval of competitor drugs. But it's not all doom and gloom; ...
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