A podcast about the transformations in clinical trial. As life science companies are pressured to deliver novel drugs faster, data, processes, applications, rol...
Tomorrow's Cures Are Hiding in Today's Patient Records with Vish Srivastava
Send us a textThe 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 RosendalJoin the conversation on our LinkedIn page
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24:18
Championing Diversity to Transform Clinical Research with Shelli Pavone
Send us a textJoin 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 expectations, but we also pave the way for innovation and trust in our healthcare systems. This episode promises to expand your understanding of why diversity in trial participation is a scientific necessity rather than just a moral obligation.Explore the importance of diversifying clinical trial staff to boost trial success and enrollment rates. Shelli discusses breaking the mold of traditional investigator homogeneity by incorporating minority physicians, which fosters trust and enhances trial outcomes. Her insights into the creation of Inlightened reveal a passion for revolutionizing access to healthcare expertise, championing diverse voices, and pushing for equitable innovation. Uncover how Enlightened endeavors to challenge the constraints of conventional investment patterns and encourages the industry to embrace ideas that promise greater societal benefits. This episode covers: • Exploration of historical mistrust in clinical trials• Challenges faced in diversifying patient recruitment• Benefits of having diverse voices in clinical research• The FDA's evolving stance on diversity in clinical trials• The role of diverse investigators in influencing patient enrolment• Strategies to reduce barriers and increase participation• Shelli's journey and passion for healthcare innovation• The overarching need for change in the clinical trial landscapeShelli Pavone: https://www.linkedin.com/in/shelli-pavone-a729b2/ Inlightened: https://getinlightened.com/ ________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn page
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32:07
Revolutionizing Neurological Care: Andreas Forsland and Gregg Johns on Assistive Technology and Brain-Computer Interfaces
Send us a textIn 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 with severe impairments. The discussion also highlights a groundbreaking clinical trial with the University of Waterloo, showcasing how AI-enhanced devices can reduce social isolation and enhance quality of life.We also cover:• Importance of user feedback in product design • Communication technology for ALS, Parkinson's, and more • The regulatory challenges of medical device development • Integrating AI to improve user experience and interaction • Future vision for accessible health technology • Ethical considerations surrounding brain-computer interfacesGuests:Andreas Forsland: https://www.linkedin.com/in/andreasforsland/Gregg Johns: https://www.linkedin.com/in/gregg-johns-product-leader/ ________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn page
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56:23
Revolutionizing Patient Recruitment in Clinical Trials: Unlocking Access and Accelerating Drug Development with Jill Pellegrino
Send us a textThis 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 • Barriers for physicians and research sites in patient enrollment • Strategies to engage patients through digital advertising • Importance of pre-screening for trial eligibility • The role of EMR technology in improving recruitment • Ensuring patient engagement post-initial interest • Feedback and response from clinical trial sites • Future plans for wider patient access to clinical trials • Emphasis on patient-centric approaches in clinical research This week, if you have any questions about Auto Recruitment or want to connect with Jill, visit https://www.autorecruitment.com.________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn page
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29:08
Navigating the Shift: From SAS to R in Clinical Trials with Sunil Gupta
Send us a textWhy 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 potential. The conversation highlights the growing trend of new graduates versed in R and Python, which alleviates the shortage of SAS programmers and signifies a modernization wave in clinical trials, ultimately aiming to accelerate drug development.Our discussion takes a deep dive into the collaborative spirit driving this transition, particularly through initiatives like Pharmaverse. This specialized extension of Tidyverse is designed to optimize clinical data workflows within the pharmaceutical industry. Sunil shares insights into how clinical programming is evolving, focusing on standardized data models and the unification of CDISC standards. The conversation underscores the importance of collaboration and resource sharing, allowing organizations to tackle complex challenges efficiently and improve patient outcomes while adapting to R's open-source environment and its growing acceptance in pharmaceutical submissions.Transitioning from SAS to R is not just about adopting a new tool; it's about mastering new skills and embracing change. Sunil discusses the challenges he faced when learning R, from understanding its functional approach to navigating intricate syntax. He offers personal anecdotes that reflect his journey and the broader industry shift, emphasizing the importance of validation processes and resource optimization. As we conclude this episode, we express gratitude for the platform to discuss these transformative changes and invite listeners to engage with us on future topics, continuing to share success stories that inspire more organizations to embrace the power of R.________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn page
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.
Ireland