Transformation In Trials podcast

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Inhalt bereitgestellt von Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal. Alle Podcast-Inhalte, einschließlich Episoden, Grafiken und Podcast-Beschreibungen, werden direkt von Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal oder seinem Podcast-Plattformpartner hochgeladen und bereitgestellt. Wenn Sie glauben, dass jemand Ihr urheberrechtlich geschütztes Werk ohne Ihre Erlaubnis nutzt, können Sie dem hier beschriebenen Verfahren folgen https://de.player.fm/legal.

Science Will Win

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Part 1 — The Case of the Missing Vaccine 48:45

vor 6 Tagen48:45

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Medical advancements don’t just spring up—they happen by building on decades of previous discoveries. Today, one of these advancements might be on the verge of another breakthrough. But what had to happen first for it to exist? In this episode, co-hosts Dr. Raven Baxter and Dr. Ronald Gamble explore how a vaccine candidate for a deadly, once-mysterious bacterial disease came to be. The story takes them from one doctor’s groundbreaking connection in the 70s, all the way to a real lab where vaccines are being developed today. Featured Guests : – Carol Baker, Pediatric Infectious Disease Specialist – Isis Kanevsky, Senior Director, Vaccines, Pfizer – Ksenia Krylova, Senior Director, Vaccines, Pfizer Dive into the episode here : 02:54 - Getting into the problem 05:11 - The basics of immunity and vaccine science 09:32 - What is a conjugate vaccine? 14:44 - Group B Strep: A case study 22:23 - Talking to a GBS pioneer 31:40 - A trip to the lab 43:08 - What's next, and closing thoughts Season 5 of Science Will Win is created by Pfizer and hosted by Dr. Raven Baxter and Dr. Ronald Gamble. It’s produced by Acast Creative Studios. Check out our social media platforms to take a deeper look into the labs and stories we discuss during the episodes: Instagram (@pfizerinc), TikTok (@pfizer) Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.…

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.

84 Episoden

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

Transformation in Trials

updated vor etwa einem Jahr

Serie-Home•Feed

84 Episoden

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

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Transformation in Trials

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Decoding Real-World Evidence: Beyond Clinical Trials with Manfred Stapff 31:41

vor 8 weeks31:41

31:41

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 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 Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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Democratizing Drug Development Through AI-Native Platforms with Ilya Burkov 18:32

vor 10 weeks18:32

18:32

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 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 innovation Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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Incorruptible Evidence: Blockchain's Promise for Faster Drug Approvals w. Dominik Lysek 27:44

vor 12 weeks27:44

27:44

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 (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-keeping Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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Revolutionizing Dentistry: AI and Research Innovation with Dr. Shervin Molayem 38:48

vor 14 weeks38:48

38:48

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 • 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 pace You can find Dr. Shervin Molayem on LinkedIn or Instagram under "DentalSurgeon," or try his free dental chatbot at shervin@trustdentistryai.com. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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How early diagnostics of lung cancer can lead to better survival rates with Chris Wood 36:59

vor 18 weeks36:59

36:59

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 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 lifespan If 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 Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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From Hopeless to High-Performing: Transforming Pharma Teams with Rajesh Anandan and Nechama Katan 53:36

vor 20 weeks53:36

53:36

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 • Teams often develop learned helplessness after years of having initiatives rejected • Only 10-15% of people are needed to drive revolutionary change in an organisation • Traditional management approaches fail because they don't account for individual differences • Standard practices like the "feedback sandwich" often backfire depending on neurotype • Creating concrete team habits that normalize desired behaviours works better than abstract training • Tracking waste can give teams agency and hope while improving processes • Many come to life sciences wanting to make a difference—reconnecting to this purpose is powerful If you'd like to learn more about building high-performing teams in life sciences, reach out to Nehama Katan at wickedproblemwizards.com or find Rajesh Anandan at team-x.ai. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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Data Governance in the Age of Generative AI with Sebastian Andruszczak 36:08

vor 22 weeks36:08

36:08

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 technology: without proper data governance, organizations risk "scaling disaster." Sebastian walks us through the specific challenges pharmaceutical companies face - from ever-changing data sources creating inconsistent AI responses, to linguistic variations causing subtle differences in interpretation across global teams. These issues become magnified when implementing AI at enterprise scale, potentially undermining the very efficiencies these technologies promise. Sebastian outlines a methodical, four-part approach to building effective AI systems: starting with data governance fundamentals, then data engineering, followed by traditional machine learning, and finally generative AI applications. This structured approach has proven successful for companies like Beringer Ingelheim, whose ambitious knowledge management system has already saved one million working hours by processing over 800,000 documents across 200 departments in 70+ countries. What makes this episode particularly valuable is Sebastian's candid assessment of the industry's current state. While acknowledging the transformative potential of strategic AI initiatives in drug discovery and knowledge management, he challenges the fear-driven implementation happening in many organizations. His "magic wand" wish for the industry reflects this pragmatism: focus first on data quality - a decades-old challenge that finally has the perfect justification for investment. Whether you're directly involved in pharmaceutical technology implementation or interested in how AI adoption affects life sciences advancement, this episode provides practical insights on building systems that deliver genuine value rather than just following technological trends. Connect with Sebastian on LinkedIn to continue the conversation. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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Prevention Pays: How Technology Is Revolutionizing Mental Health with Eva Papadopoulou 27:14

vor 24 weeks27:14

27:14

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 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. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 28 weeks45:14

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 Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 30 weeks32:03

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. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 32 weeks56:22

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. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 34 weeks24:18

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." Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 36 weeks32:07

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/ Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 38 weeks56:23

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/ Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 41 weeks29:08

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. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 50 weeks34:59

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. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 51 weeks47:18

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. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 1 year34:42

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. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 1 year40:53

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 Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 1 year29:40

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 Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 1 year38:24

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 Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 2 years34:17

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 Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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

vor 2 years33:13

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 Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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Innovating Clinical Trial Design with Pierre Colin and Boaz Adler 1:07:03

vor 2 years1:07:03

1:07:03

Send us a text Unlock the secrets of clinical trial design with industry experts Pierre Colin and Boaz Adler as they join us for a deep dive into the early-stage planning that shapes the future of pharmaceuticals. They provide a look at the collaboration between clinicians, statisticians, and regulatory experts that's critical for determining the right patient populations, dosages, and study endpoints. With their guidance, we explore how statistical software and scenario planning play pivotal roles in estimating patient numbers, study durations, and costs, transforming clinical trial design into a fine art. As we navigate through the evolution of statistical methods, our guests share their insights on the need for adaptability in clinical trial designs, especially in areas like oncology with unique endpoints such as overall survival. They spotlight the importance of cross-company collaborations and direct FDA discussions in driving innovations. The conversation also illuminates the ever-growing contributions of R-coding, a testament to the individuality of each study, allowing for customized and cutting-edge approaches to trial design. To wrap up, we spotlight the dynamic landscape of drug development where biostatistics paves the way for groundbreaking designs. Our guests emphasize how feedback from scientific communities influences new methodologies, shifting the focus from traditional success measures to concepts like assurance and power in the promising zone. They also highlight the invaluable role of Bayesian designs, as exemplified by COVID-19 vaccine trials, in ethically accelerating drug development. As we close, remember that this field is ripe with diverse opportunities, and we invite you to reach out with your curiosities and follow-up questions. Join us for this episode that's not just about the science of trials, but the transformation they undergo, ensuring the journey of drug development continues to revolutionize patient care. Guests: Pierre Colin: https://www.linkedin.com/in/pierre-colin-11139028/ Boaz Adler: https://www.linkedin.com/in/boazadler/ Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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Mastering the Art of Clinical Trial Partnerships: Insights from Jason Gubb on Outsourcing and Co-Creation 36:36

vor 2 years36:36

36:36

Send us a text Embark on a journey through the dynamic landscape of clinical trial outsourcing with Jason Gubb, the co-founder of ClinOps Clarity and Emergent Teams. As we navigate the historical shift from predominantly in-house operations to the intricate web of external partnerships, Jason sheds light on the critical decision-making processes that shape the pharmaceutical and biotech industries. Grapple with the challenges and opportunities presented by R&D budget constraints and learn how emerging biotech firms are steering through fluctuating funding currents. Discover a world where the right choice of vendors can make or break a clinical trial, and how companies balance the scales of internal project management and external collaboration. With Jason's sage guidance, gleaned from his tenure at GSK and his entrepreneurial ventures, we dissect the artistry behind cultivating successful clinical trial partnerships. He shares insights on the transformative effects of smart decision-making and the vigour of challenging established practices while ensuring that every partnership is rooted in open communication and shared goals. Jason also illuminates the impact of a patient-focused ethos and addresses the nuances between co-creation and mere collaboration. So tune in to expand your understanding of the pivotal role that culture and relationships play in shaping the outcomes of clinical trials and to witness the emergence of alliances that are as resilient as they are innovative. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

1
Breaking Barriers for Diversity in Clinical Trials with Sam Whitaker 41:34

vor 2 years41:34

41:34

Send us a text In this conversation with Sam Whitaker, we delve into the pivotal issues faced by underrepresented groups—particularly those from lower-income backgrounds—highlighting the disparity in current demographics and the consequences it bears on the reliability of drug efficacy and safety data for diverse populations. We go beyond the surface to examine the complexities surrounding compensation for trial participants, debunking the myth that stipends serve as an incentive and instead revealing the net financial loss many endure. With Sam's expertise, we explore why the current compensation structures pose significant barriers for those in lower-income brackets. Sam Whitaker's insights prompt us to question the ethical responsibilities of Institutional Review Boards (IRBs) in safeguarding participant welfare, particularly in terms of payment evaluation. The conversation scrutinizes the pressing need for standardized compensation practices, emphasizing the potential financial harm and barriers these present to willing participants. Our discussion raises awareness about the delicate balance between the pursuit of scientific knowledge and the imperative of ethical consideration in the realm of human testing. Lastly, we shine a light on the legislative efforts aiming to dismantle the financial hurdles that deter diverse participation in clinical trials. Tax implications for low-income participants and the risks to their welfare benefits take center stage, with bipartisan support emerging as a beacon of hope in the push for reform. Sam shares the impactful work being done through Mural Health, including the Portrait Project, which seeks to humanize and democratize the clinical research process. Join us to understand how these initiatives are not just transforming patient involvement, but reshaping the landscape of clinical trials for the betterment of all. Guest: Sam Whitaker Mural Health Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

1
“Adaptive Clinical Trial Design: Large-Scale Study Simulation to Design for Results with Boaz Adler 38:34

vor 2 years38:34

38:34

Send us a text This week we speak to Boaz Adler from Cytel's Software Division. This episode promises to illuminate the intricacies of trial design through the lens of Monte Carlo simulation, revealing how this potent approach crafts trials resilient to a myriad of scenarios. Boaz delves into the pivotal roles of interim monitoring and strategic market positioning post-trial, offering a masterclass in the art of clinical trial conception that withstands the test of uncertainty. As we navigate the vast landscape of clinical trial simulation, the topic of scale takes center stage. The conversation orbits around pioneering software platforms like Solara and East, which are reshaping trial design by integrating a kaleidoscope of variables and uncertainties. This episode pulls back the curtain on the potential of cloud computing to revolutionize simulations, providing a glimpse into the future where clinical trials are executed with unparalleled speed and precision. With Boaz' expertise, we ponder the industry's readiness to trust probabilistic outcomes and how regulatory bodies are warming up to the simulation-based approaches that these software platforms enable. Finally, we bridge the gap between biostatistics and market access, highlighting the increasing influence of health outcomes research on clinical trial design. The discourse delves into the balancing act of incorporating quality of life measures for regulatory and reimbursement decisions, the finesse required to blend standard software with bespoke coding, and the imperative of enhanced inter-departmental synergy. My own path to life sciences underscores the episode's reflective tone, leading to a broader examination of Cytel's extensive contributions to the field, from their roots in Monte Carlo simulation software to a comprehensive suite of services that spans the full spectrum of statistical programming and evidence-based research. Join us for this enlightening episode to gain an insider's perspective on the dynamic confluence of biostatistics and pharmaceutical innovation. Guest: Boaz Adler Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

1
Towards a more Agile Vendor Qualification: A Discussion with Dele Babalola and Rani Naik 49:32

vor 2 years49:32

49:32

Send us a text Ever wondered why the life sciences industry is stuck in redundant vendor qualification processes? Picture an organization where quality is designed rather than inspected. Yes, it's possible and we're about to paint that picture for you in this stimulating conversation with our guests, Dele Babalola and Rani Naik. They've got their fingers on the pulse of the GxP space and are ready to share their insights on the pressing need to evolve from redundant processes. Pay attention as Rani unfolds her unique vision for an agile, phase-appropriate quality organization. Imagine a world where vendor qualification is not a daunting task but a streamlined process. We got you thinking, right? Dele and Rani join us to unravel this concept further. It's all about being proactive, focusing on effective oversight, and perhaps venturing into the world of pre-approved vendors. From discussing the role of certification bodies to emphasizing the significance of a proactive approach, we've got this topic well covered. Enter the world of vendor management where challenges are like a complex puzzle waiting to be solved. This is where Dele and Rani's expertise shines as they shed light on transparency, collaboration, and the risk-based approach. Here's a plus - they also detail the potential value of remote audits and the importance of having an internal individual who can ensure clear process flow. As we wrap up, we can't help but yearn for a more innovative industry that's ready to take leaps. You won't want to miss this candid conversation. Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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Becky Baggett on the Science and Strategy Behind Successful Clinical Trials 23:56

vor 2 years23:56

23:56

Send us a text Get ready to learn about clinical trials operations from an expert. This episode is an opportunity to learn all about the essential aspects of managing such trials and the core role of contract research organizations (CROs) in the process. We have the privilege of introducing Becky Baggett, Associate Vice President of Project Delivery at Rho, who unravels the complexities of clinical trials for us. She not only lays out the distinct stages and components of a clinical trial but also enlightens us on the crucial collaboration between the sponsor and the CRO, the importance of clinical research sites, data management, and project management. She underscores the absolute necessity of establishing solid relationships, trust, and experience in this highly controlled and regulated field. As we navigate further, we plunge into the thrilling and demanding world of technology in clinical trials. This part is a trove of information on how technology can streamline trials and why it's crucial to tailor technological applications to the specific needs of therapeutic areas. This episode is not just about information, but also about engaging in a thought-provoking discussion, where we examine the subtleties of conducting trials across different therapeutic areas. We end on a note of aspiration, echoing the collective wish for increased funding in the industry, which could potentially fast track more life-saving medications from lab to market. Guest Becky Baggett Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

Transformation in Trials

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Designing Adaptable and Inclusive Labs for Biotech with Marilee Lloyd 35:10

vor 2 years35:10

35:10

Send us a text Ever wondered what goes into designing a modern, adaptable, and inclusive lab space? Join us as we uncover the intricacies of laboratory planning with architect and lab planning leader, Marilee Lloyd. Marilee takes us behind the scenes of designing new research labs, divulging the importance of flexibility, adaptability, and the use of modular benching. She sheds light on the unique challenges and considerations of modernizing older labs, while emphasizing the impact of thoughtful lab design on achieving clinical outcomes. We also engage in a lively discussion on sustainable and inclusive lab design with our guest. Marilee's passion for diversity in the life sciences industry and her dedication to creating environmentally-friendly and welcoming lab spaces is truly inspiring. From reducing air changes and utilizing high-performance fume hoods to fostering inclusivity with elements of nature and thoughtful design, Merilee provides a unique perspective on lab planning. Guest: Marilee Lloyd Support the show ________ Reach out to Ivanna Rosendal Join the conversation on our LinkedIn page…

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