Transformation In Trials podcast

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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.

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#Science #Fitness #Biology #Entrepreneur #Business #Medicine #Sam Parnell & Ivanna Rosendal #Ivanna Rosendal #Sam Parnell

Transformation in Trials

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#Science #Fitness #Biology #Entrepreneur #Business #Medicine #Sam Parnell & Ivanna Rosendal #Ivanna Rosendal #Sam Parnell

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1
Creating virtuous cycles in drug development with Rob Freishtat 45:14

約 9 日前45:14

45:14

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 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 Join the conversation on our LinkedIn page…

1
Bridging Academia and Biotech: Creating Innovators of Tomorrow with Jonathon Hill 32:03

約 23 日前32:03

32:03

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 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 Join the conversation on our LinkedIn page…

1
From Lab to Patient: Why Vector Design Makes or Breaks Cell Therapies with Alan Griffith 56:22

5 weeks前56:22

56:22

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 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 Join the conversation on our LinkedIn page…

1
Tomorrow's Cures Are Hiding in Today's Patient Records with Vish Srivastava 24:18

7 weeks前24:18

24:18

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 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 Join the conversation on our LinkedIn page…

1
Championing Diversity to Transform Clinical Research with Shelli Pavone 32:07

9 weeks前32:07

32:07

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 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 landscape Shelli Pavone: https://www.linkedin.com/in/shelli-pavone-a729b2/ Inlightened: https://getinlightened.com/ ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

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Revolutionizing Neurological Care: Andreas Forsland and Gregg Johns on Assistive Technology and Brain-Computer Interfaces 56:23

11 weeks前56:23

56:23

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 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 interfaces Guests: Andreas Forsland: https://www.linkedin.com/in/andreasforsland/ Gregg Johns: https://www.linkedin.com/in/gregg-johns-product-leader/ ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Revolutionizing Patient Recruitment in Clinical Trials: Unlocking Access and Accelerating Drug Development with Jill Pellegrino 29:08

14 weeks前29:08

29:08

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 • 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 Rosendal Join the conversation on our LinkedIn page…

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Navigating the Shift: From SAS to R in Clinical Trials with Sunil Gupta 34:59

23 weeks前34:59

34:59

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 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 Rosendal Join the conversation on our LinkedIn page…

1
Enhancing Vendor Oversight and Communication Strategies in Clinical Trials with Jessica Cordes 47:18

24 weeks前47:18

47:18

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 your oversight strategies. Metrics are more than numbers—they're a lifeline in managing vendor relationships. Learn how robust oversight can impact patient safety and compliance metrics. We’ll explore the necessity of tailoring KPIs to specific risks and the importance of a risk-based approach that starts from vendor selection and continues through ongoing management. Jessica’s emphasis on creating a standard operating procedure framework will guide you in ensuring consistency and accountability in sponsor-vendor interactions. Effective communication is the cornerstone of successful clinical trials. Through personal anecdotes and practical advice, we tackle the challenges of unit-based contracts and introduce milestone-based contracts for enhanced efficiency. From vendor selection to team building, Jessica shares her consultancy insights tailored for small and mid-sized biotech and pharma companies. We also consider the upcoming ICH E6 R3 guidance, emphasizing fit-for-purpose procedures in quality management systems, all while advocating for improved collaboration among stakeholders to enhance patient-centricity and accelerate drug development. ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Navigating Cell and Gene Therapy: Insights and Challenges with Dr. Bruce Levine 34:42

38 weeks前34:42

34:42

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 challenges and advancements that set these therapies apart from traditional drugs. We also shine a light on the vital role of the International Society for Cell and Gene Therapy in driving forward these innovative treatments. In another riveting segment, we delve into the recent FDA investigation into cases of T-cell malignancies following CAR T-cell therapy. With data gleaned from voluntary reporting databases, we scrutinize causality, immortal time bias, and the need for improved reporting standards. Dr. Levine shares his thoughts on the importance of thorough patient follow-up and effective communication of risks and benefits. We also explore the evolution of cell and gene therapy, tracing Dr. Levine's journey from his early days in immunology research to his pivotal role in shaping the field. This episode is a must-listen for anyone interested in the dynamic and ever-evolving world of cell and gene therapy. ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

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Reconnecting with Purpose: Transforming Job Satisfaction and Patient Care in Life Sciences with Jill Donahue 40:53

41 weeks前40:53

40:53

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 Aurora Project, both aimed at fostering a deeper sense of purpose among life sciences professionals. Step into the world of Johnny, a shuttle bus driver in Phoenix, who discovered how focusing on spreading happiness could significantly transform his work experience and income. This inspiring tale serves as a powerful reminder that a purpose-driven mindset can make a difference in any role, from healthcare to pharma and beyond. Jill and our hosts discuss practical strategies for connecting with your "why" and engaging audiences during presentations through personal motivations and stories, highlighting how genuine connections can enhance both professional and personal experiences. The conversation shifts to the pharmaceutical industry’s much-needed transformation towards patient partnership. Jill passionately advocates for a shift from product-centric to patient-centric narratives, emphasizing the importance of presenting treatment options and building expertise in specific disease states. This approach, she argues, not only improves patient care but also makes the role of pharma representatives more fulfilling. Tune in to hear Jill's excitement about her book, "A Dose of Inspiration: 100 Purpose Stories from Pharma Leaders," and her dream of igniting a sense of purpose in everyone within the industry. Notes: A Dose of Inspiration: 100 Purpose Stories from Pharma Leaders can be found on Amazon or as a free download at www.excellerate.ca/freebook More information about The Power of Purpose can be found here Jill can be reached here on LinkedIn ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Revolutionizing Clinical Trials: The Promise of AI and Predictive Analytics with Vinodh Balaraman 29:40

42 weeks前29:40

29:40

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; we shine a light on the potential of AI to bring about much-needed predictive capabilities, paving the way for trials that are as efficient as they are effective. Ever wondered how big data and predictive analytics could be the game-changers in drug development? Our conversation takes a deep dive into the role of AI in forecasting how patients will respond to treatments, potentially transforming the hit-and-miss nature of clinical trials into a targeted approach. We discuss the transformative power of a SaaS business model and shared knowledge bases, considering how they could overhaul the pharmaceutical landscape. Despite the industry's tentative steps toward data sharing, we explore the gradual shift as medical professionals begin to wield these cutting-edge tools to make smarter, data-driven decisions. Bringing a dose of humanity to the tech talk, I share my personal motivation stemming from a family member's battle with rheumatoid arthritis—a catalyst for my commitment to pushing the envelope in clinical development. The episode concludes with a reflection on how AI stands on the brink of revolutionizing medical affairs and real-world studies, but is often met with skepticism. By fostering a culture open to change and innovation, we envision a future where clinical trials become more successful and efficient. Join us as we discuss the landscape of trials and the untapped potential that KolateAI brings to this critical field. Guest: Vinodh Balaraman ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Exploring Patient-Centric Innovations in Digestive and Women's Health with Ariadna Maso 38:24

48 weeks前38:24

38:24

Send us a text Navigating the tumultuous sea of inflammatory bowel disease (IBD) is no small feat, and Ariadna Maso of Sanno Health is our compass on this voyage. As the mastermind behind a company that's reshaping how we understand and manage gut health, Ari shares her intimate understanding of the patient's struggle, from the stinging uncertainty of diagnosis to the often overlooked psychological toll. Our conversation goes beyond the standard medication narrative and into the realm of holistic care, where anti-inflammatory diets and mental health support take center stage. Ari's insights into ongoing research illuminate a path for integrating these lifestyle modifications into patient care, offering a beacon of hope for those navigating these often-rough waters. When it comes to personalizing patient care, digital biomarkers are the wayfinders charting a course through the previously uncharted territories of healthcare. But the journey is fraught with challenges: data diversity, operational hurdles, and the sheer volume of information from tools like wearables. In this episode, Ariadna navigates us through these operational storms, detailing how Sanno Health evolved from an app into a comprehensive platform that's not only tracking patient health but is actively engaging them in their treatment. We also probe into the stark disparities between industry perceptions of patient-centric care and the realities patients face, unveiling the transformative potential of incorporating patient feedback directly into clinical trial designs. Join us as we explore the diverse therapeutic landscapes that stand to benefit, including digestive health and the burgeoning realm of women's health, and the far-reaching implications of data-driven medical advancements. Guest Ariadna Masó ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
Large Language Models in Clinical Trials with Eirini Schlosser 34:17

1 year前34:17

34:17

Send us a text This week we sit down with Erini Schlosser, CEO of Dyania Health, and chart the pioneering advancements in large language models within healthcare. This episode promises to reveal how the shift from simple entity recognition to sophisticated reasoning models has revolutionized drug discovery and the curation of electronic medical records, all while unpacking the challenges of data privacy, computational demands, and the hunt for specialized AI talent. Discover the fusion of technology and medicine where the collaborative potential for real-world data utilization in evidence-based studies emerges as a beacon for innovation amidst the complexities of modern clinical trials. As we explore the parallels of AI training to medical education, you'll be enthralled by stories of AI models undergoing meticulous fine-tuning by our in-house physicians, echoing the rigorous journey of medical residents. Irene lifts the veil on her own path, which led from a lineage steeped in medicine, through the worlds of biochemistry and investment banking, to the groundbreaking integration of NLP into healthcare at Dyania Health. Our conversation shines a light on the future of automating clinical research, where AI not only answers but justifies with evidence, promising an unprecedented era in the management and interpretation of medical data. Tune in for an intimate look at the challenges overcome and the milestones achieved in teaching machines to navigate the intricacies of human health. Guest: Eirini Schlosser ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

1
The Evolution of Clinical Trials Through Wearable Devices with Wessam Sonbol 33:13

1 year前33:13

33:13

Send us a text Uncover how the seamless fusion of wearables with patient data is revolutionizing clinical trials in our latest conversation with Wessam Sonbol, the Founder and CEO of Delve Health. We navigate the transformation from cumbersome paper reporting to the sophisticated use of Patient Reported Outcomes and the continuous insights wearable technology offers. As we dissect the benefits and hurdles of this evolving data landscape, you’ll get an insider perspective on the intricacies of managing vast health metrics and setting benchmarks for impactful analysis. Plus, Wessam shares his knowledge on the reliability and strategic employment of wearables in clinical research, offering a glimpse into how these devices are altering the way we approach health monitoring. In our discussion, the concept of 'wearables as a service' emerges, a trailblazing model crafted by Delve Health to elevate the clinical study experience for both patients and researchers. Wessam delves into the rigorous process of selecting wearables that align with trial goals, sharing how gadgets like Fitbits undergo efficacy evaluation. Be prepared to discover how innovations like automated compliance and concierge teams are mitigating study site burdens and boosting data quality. We also tackle the broader spectrum of challenges and advancements in clinical research, contrasting the swift advancements in wearable tech with the methodical progress of drug trials. Join us to envision a future that prioritizes patient-centric care, reduced tool burden, and heightened automation, and don't miss Wessam's call to action for ongoing dialogue that aims to reshape the patient experience in the health and life sciences arena. Guest: Wessam Sonbol ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

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Transformation in Trials

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