Transformation in Trials

Send us a text [https://www.buzzsprout.com/twilio/text_messages/1906263/open_sms] 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. ________ Reach out to Ivanna Rosendal [https://www.linkedin.com/in/ivannarosendal/] Join the conversation on our LinkedIn page [https://www.linkedin.com/company/transformation-in-trials/]

Send us a text [https://www.buzzsprout.com/twilio/text_messages/1906263/open_sms] 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 ________ Reach out to Ivanna Rosendal [https://www.linkedin.com/in/ivannarosendal/] Join the conversation on our LinkedIn page [https://www.linkedin.com/company/transformation-in-trials/]

Send us a text [https://www.buzzsprout.com/twilio/text_messages/1906263/open_sms] 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. ________ Reach out to Ivanna Rosendal [https://www.linkedin.com/in/ivannarosendal/] Join the conversation on our LinkedIn page [https://www.linkedin.com/company/transformation-in-trials/]

Send us a text [https://www.buzzsprout.com/twilio/text_messages/1906263/open_sms] 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. ________ Reach out to Ivanna Rosendal [https://www.linkedin.com/in/ivannarosendal/] Join the conversation on our LinkedIn page [https://www.linkedin.com/company/transformation-in-trials/]

Send us a text [https://www.buzzsprout.com/twilio/text_messages/1906263/open_sms] 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 created with unprecedented efficiency through AI-powered data extraction. The breakthrough lies in advanced language models that can interpret unstructured clinical notes, transforming them into structured, analyzable data points while maintaining patient privacy. This technological revolution has profound implications across the drug development lifecycle. In multiple sclerosis research, analyzing 10+ years of longitudinal patient data has illuminated disease progression patterns beyond relapses, informing the next generation of treatments. For approved medications like GLP-1s, real-world evidence is uncovering potential applications in conditions ranging from metabolic disorders to neurodegenerative diseases, potentially fast-tracking label expansions that would traditionally require years of additional clinical trials. The vision is transformative: reducing the $2.6 billion, 12-year journey of drug development to a fraction of that time while ensuring treatments reach the right patients faster. While Century Health initially focuses on gastroenterology, neurology, and rheumatology in the US market, the underlying technology promises to revolutionize clinical research globally. As Vish notes, "It feels like we can create dramatically better outcomes for patients if we can just make the data that's already collected from their care accessible and actionable." ________ Reach out to Ivanna Rosendal [https://www.linkedin.com/in/ivannarosendal/] Join the conversation on our LinkedIn page [https://www.linkedin.com/company/transformation-in-trials/]