Welcome to The Real-World Evidence Perspective, a podcast hosted by Dr. Manfred Stapff—physician, researcher, and trusted voice in evidence-based thinking. In a time when misinformation spreads faster than truth, Dr. Manfred Stapff uses real-world data to help listeners uncover clarity amidst confusion. From healthcare to headlines, each episode explores how real-life evidence can help us make better decisions and see the world more accurately. If you're ready to think deeper and challenge w ...
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Dr Manfred Stapff Podcasts
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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Vaccines and Society: Balancing Science, Ethics, and Politics
15:06
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15:06By Dr. Manfred Stapff
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Obesity affects nearly 40% of Americans, making it one of today’s most urgent health crises. In this episode, Dr. Manfred Stapff cuts through confusion and misinformation to show what the data truly reveal about nutrition and obesity. Dr. Manfred explains why excess calories not burned through daily activity drive weight gain, and how obesity fuels…
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Data, Decisions, and Danger: What Evidence Reveals About Tattoos and Cannabis
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15:38Marijuana smoking and tattoos are personal choices. What does the evidence really say about their health risks? In this episode, Dr. Manfred Stapff cuts through the myths, and delivers the science-backed truth about weed, ink, and your well-being. Using a major California study, he explains why cannabis users face a threefold higher risk of oral ca…
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Beyond the 18% Hike: What’s Broken in the Health Care System of UnitedHealthcare
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10:58Healthcare costs are rising, but are the reasons valid? In this episode, Dr. Manfred Stapff examines UnitedHealthcare’s proposed 18% rate hike and asks: where’s the evidence? Using authoritative data from CMS and PricewaterhouseCoopers, Dr. Manfred reveals how this price increase sharply diverges from national healthcare cost trends. He confronts t…
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Uncovering the Correlation Between Measles, Vaccines, and Autism
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14:37Vaccines and autism spark fierce debate, where science meets emotion. This episode offers sharp, confident clarity. Dr. Manfred Stapff cuts through decades of controversy on breaking down the supposed link between the measles vaccine and autism. With firm, science-backed insights, he shows how rigorous research, not headlines, has shaped what we kn…
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Facts, Fear, and Future: Exposing Misinformation with Real-World Evidence
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30:38In a world overwhelmed by conflicting headlines, viral rumors, and half-baked statistics, how can one tell what's real? In this episode, Dr. Manfred Stapff breaks down the science behind real-world evidence (RWE) and reveals how it can be used to separate fact from fiction in public health, media, and policy conversations. He carefully guides audie…
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Decoding Real-World Evidence: Beyond Clinical Trials with Manfred Stapff
31:41
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31:41Send 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 dramatica…
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Democratizing Drug Development Through AI-Native Platforms with Ilya Burkov
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18:32Send 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 breakth…
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Incorruptible Evidence: Blockchain's Promise for Faster Drug Approvals w. Dominik Lysek
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27:44Send 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 …
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Revolutionizing Dentistry: AI and Research Innovation with Dr. Shervin Molayem
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38:48Send 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 trea…
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How early diagnostics of lung cancer can lead to better survival rates with Chris Wood
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36:59Send 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…
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From Hopeless to High-Performing: Transforming Pharma Teams with Rajesh Anandan and Nechama Katan
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53:36Send 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 u…
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Data Governance in the Age of Generative AI with Sebastian Andruszczak
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36:08Send 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 pre…
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Prevention Pays: How Technology Is Revolutionizing Mental Health with Eva Papadopoulou
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27:14Send 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 curr…
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Creating virtuous cycles in drug development with Rob Freishtat
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45:14Send 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-thi…
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Bridging Academia and Biotech: Creating Innovators of Tomorrow with Jonathon Hill
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32:03Send 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 abilit…
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From Lab to Patient: Why Vector Design Makes or Breaks Cell Therapies with Alan Griffith
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56:22Send 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 ex…
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Tomorrow's Cures Are Hiding in Today's Patient Records with Vish Srivastava
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24:18Send 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 u…
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Championing Diversity to Transform Clinical Research with Shelli Pavone
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32:07Send 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 tria…
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Revolutionizing Neurological Care: Andreas Forsland and Gregg Johns on Assistive Technology and Brain-Computer Interfaces
56:23
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56:23Send 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. Thi…
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Revolutionizing Patient Recruitment in Clinical Trials: Unlocking Access and Accelerating Drug Development with Jill Pellegrino
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29:08Send 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 adver…
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Navigating the Shift: From SAS to R in Clinical Trials with Sunil Gupta
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34:59Send 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 cap…
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Enhancing Vendor Oversight and Communication Strategies in Clinical Trials with Jessica Cordes
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47:18Send 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 p…
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Navigating Cell and Gene Therapy: Insights and Challenges with Dr. Bruce Levine
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34:42Send 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, an…
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Reconnecting with Purpose: Transforming Job Satisfaction and Patient Care in Life Sciences with Jill Donahue
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40:53Send 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 th…
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Revolutionizing Clinical Trials: The Promise of AI and Predictive Analytics with Vinodh Balaraman
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29:40Send 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 flawe…
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Exploring Patient-Centric Innovations in Digestive and Women's Health with Ariadna Maso
38:24
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38:24Send 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…
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Large Language Models in Clinical Trials with Eirini Schlosser
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34:17Send 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 rec…
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The Evolution of Clinical Trials Through Wearable Devices with Wessam Sonbol
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33:13Send 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…
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Innovating Clinical Trial Design with Pierre Colin and Boaz Adler
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1:07:03Send 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 r…
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Mastering the Art of Clinical Trial Partnerships: Insights from Jason Gubb on Outsourcing and Co-Creation
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36:36Send 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 th…
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Breaking Barriers for Diversity in Clinical Trials with Sam Whitaker
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41:34Send 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 surfa…
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“Adaptive Clinical Trial Design: Large-Scale Study Simulation to Design for Results with Boaz Adler
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38:34Send 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 ma…
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Towards a more Agile Vendor Qualification: A Discussion with Dele Babalola and Rani Naik
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49:32Send 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 f…
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Becky Baggett on the Science and Strategy Behind Successful Clinical Trials
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23:56Send 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 Deliver…
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Designing Adaptable and Inclusive Labs for Biotech with Marilee Lloyd
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35:10Send 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 …
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Dr. Peter Small on Cough Science and the Impact of Acoustic Diagnostics
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23:44Send us a text Ever wondered about the science behind a simple cough? What if we told you that a cough is not as simple as it seems and AI technology could revolutionize how we perceive it? Come along as we host Dr. Peter Small, acoustic epidemiologist and Chief Medical Officer of Hyfe, who enlightens us on the complexity of measuring coughs in cli…
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Exploring Generative AI in Life Sciences with Nechama Katan
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33:55Send us a text Join us in a conversation with Nechama Katan, as we investigate the world of generative AI in life sciences, a realm where technology meets business, and where Nechama, an expert in innovative data in the clinical space of life sciences, will guide us. We're taking a deep dive into the ever-evolving realm of technology in life scienc…
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How Cell and Gene Therapy Manufacturing is transforming Life Sciences with Jason Bock
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40:53Send us a text What if a pharmaceutical company can be deconstructed and re-assembled in a new configuration? This is already happening in cell and gene therapy manufacturing. Join us for an enlightening conversation with Jason Bock, the founder and CEO of CTMC, who has been at the forefront of this intersection between clinical research and manufa…
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Clinical Trial Supply is like an entire Galaxy with Ryan Keane
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39:52Send us a text How is the pharmaceutical and biotech industry changing in the current financial climate? Our guest today, Ryan Keane, founder and CEO of Korio, shines a bright light on these subjects and more. This discussion is an exploration of our current healthcare landscape, dissecting the challenges companies face as they introduce new techno…
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Harnessing the Power of Open-Source in Pharmacovigilance with Lionel Van Holle
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41:51Send us a text Ready to lift the lid on the untapped potential of open-source technology in clinical trials? Strap in for a fascinating journey with our guest Lionel van Holle, the founder of Open Source PV. We'll unveil the transformative power of open-source tech in the life sciences industry, including its innate transparency, parallel developme…
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Exploring the Intersection of Healthcare, Marketing, and the Power of Programmatic Advertising
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26:11Send us a text Ever wondered how the healthcare industry can leverage the power of marketing? Join us as we unravel the mysteries of programmatic marketing with the CEO and founder of Doceree, HJ. He takes us through the innovative platform that reshapes how messages are targeted to healthcare professionals. From reaching physicians, nurses, and ph…
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Inventing New Endpoints with Richard Nkulikiyinka
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49:47Send us a text Join us in a fascinating conversation with our special guests, Richard Nkulikiyinka, as we unravel how endpoints in trials are transforming and the significant role they play in determining trial efficiency. We also delve into innovations in oncology endpoints and discuss the challenges and opportunities in cardiovascular trials. Tun…
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Innovative Trial Design and Re-Imagined Endpoints with Richard Nkulikiyinka
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42:25Send us a text Understand the complexities of clinical trial design from a seasoned expert. We speak to our esteemed guest, Richard Nkulikiyinka , a senior leader in clinical development. Richard illuminates the often-misunderstood world of trial design, from setting objectives and identifying target populations to the nitty-gritty like data collec…
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From Dropout to Award-Winning Scientist: A Journey in Biotech with Pradeep Sacitharan
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42:40Send us a text Join us as we talk to Pradeep Sacitharan, a serial dropout turned award-winning scientist. Starting life as a war refugee and working in London bars, Pradeep's life took a radical turn following a near-death experience, propelling him into the world of drug development. He navigates us through his fascinating journey in the biotech w…
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Decentralized Clinical Trials as Treatment Options with Ewa Lindqvist
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45:20Send us a text Ever imagined the immense potential that decentralized clinical trials (DCTs) could unlock for patients and sponsors? This week, we're going on a deep dive into the world of DCTs with our esteemed guest, Ewa Lindqvist, a trailblazer in this space. Brace yourself for an enlightening conversation about how DCTs are paving the way for i…
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Exploring the Impact of Open Source Software on the Pharmaceutical Industry with Katja Glass
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34:50Send us a text Prepare to uncover the transformative potential of open source software in the pharmaceutical industry! Our distinguished guest, Katja Glass, an influential open source ambassador, joins us on this enlightening journey. We'll explore the rising popularity of open source solutions in the pharmaceutical industry, its myriad benefits, a…
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The Ethical and Legal Challenges in Unapproved Drug Access: A Talk with Patti Zettler
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32:20Send us a text Imagine being given a shot at a cure before it's even approved. That's the fascinating world of expanded access programs for unapproved investigational interventions that we're exploring today with our esteemed guest, Patti Zettler, law professor and chair of the International Society for Cell and Gene Therapies Expanded Access Worki…
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Bridging the Gender Gap in Medical Research: The Potential of Wearable Technology
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38:53Send us a text Imagine you're on an eight-year journey trying to diagnose an autoimmune disease. Suzaan Sauerman, our insightful guest today, faced this exact challenge. Sauerman, a visionary in female representation in clinical trials, uncovers the persistent gender gap in this field and posits an innovative solution—wearable technology. We dig in…
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The Hidden Factors Behind Executive Retention in Life Sciences
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33:04Send us a text Let's face it, executive turnover in the life sciences industry is a conundrum. Companies are offering competitive compensation, fostering positive work cultures, and providing opportunities to contribute to meaningful work, yet many executives continue to leave. In our intriguing dialogue with the insightful Federico Grayeb, we delv…
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