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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Navigating Cell and Gene Therapy: Insights and Challenges with Dr. Bruce Levine
34:42
34:42
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Send us a Text Message. 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, manufact…
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Reconnecting with Purpose: Transforming Job Satisfaction and Patient Care in Life Sciences with Jill Donahue
40:53
40:53
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40:53
Send us a Text Message. 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 …
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Revolutionizing Clinical Trials: The Promise of AI and Predictive Analytics with Vinodh Balaraman
29:40
29:40
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29:40
Send us a Text Message. 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, f…
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Exploring Patient-Centric Innovations in Digestive and Women's Health with Ariadna Maso
38:24
38:24
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38:24
Send us a Text Message. 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 un…
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Large Language Models in Clinical Trials with Eirini Schlosser
34:17
34:17
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34:17
Send us a Text Message. 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 me…
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The Evolution of Clinical Trials Through Wearable Devices with Wessam Sonbol
33:13
33:13
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33:13
Send us a Text Message. 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…
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Innovating Clinical Trial Design with Pierre Colin and Boaz Adler
1:07:03
1:07:03
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Send us a Text Message. 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 determin…
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Mastering the Art of Clinical Trial Partnerships: Insights from Jason Gubb on Outsourcing and Co-Creation
36:36
36:36
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36:36
Send us a Text Message. 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 pro…
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Breaking Barriers for Diversity in Clinical Trials with Sam Whitaker
41:34
41:34
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41:34
Send us a Text Message. 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 …
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“Adaptive Clinical Trial Design: Large-Scale Study Simulation to Design for Results with Boaz Adler
38:34
38:34
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38:34
Send us a Text Message. 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 str…
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Towards a more Agile Vendor Qualification: A Discussion with Dele Babalola and Rani Naik
49:32
49:32
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49:32
Send us a Text Message. 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 go…
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Becky Baggett on the Science and Strategy Behind Successful Clinical Trials
23:56
23:56
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23:56
Send us a Text Message. 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 Projec…
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Designing Adaptable and Inclusive Labs for Biotech with Marilee Lloyd
35:10
35:10
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35:10
Send us a Text Message. 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…
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Dr. Peter Small on Cough Science and the Impact of Acoustic Diagnostics
23:44
23:44
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23:44
Send us a Text Message. 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 coug…
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Exploring Generative AI in Life Sciences with Nechama Katan
33:55
33:55
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33:55
Send us a Text Message. 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 li…
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How Cell and Gene Therapy Manufacturing is transforming Life Sciences with Jason Bock
40:53
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40:53
Send us a Text Message. 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 a…
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Clinical Trial Supply is like an entire Galaxy with Ryan Keane
39:52
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39:52
Send us a Text Message. 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 n…
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Harnessing the Power of Open-Source in Pharmacovigilance with Lionel Van Holle
41:51
41:51
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41:51
Send us a Text Message. 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 …
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Exploring the Intersection of Healthcare, Marketing, and the Power of Programmatic Advertising
26:11
26:11
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Send us a Text Message. 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, nurse…
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Inventing New Endpoints with Richard Nkulikiyinka
49:47
49:47
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49:47
Send us a Text Message. 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 tr…
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Innovative Trial Design and Re-Imagined Endpoints with Richard Nkulikiyinka
42:25
42:25
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42:25
Send us a Text Message. 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 da…
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From Dropout to Award-Winning Scientist: A Journey in Biotech with Pradeep Sacitharan
42:40
42:40
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42:40
Send us a Text Message. 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 …
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Decentralized Clinical Trials as Treatment Options with Ewa Lindqvist
45:20
45:20
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45:20
Send us a Text Message. 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 …
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Exploring the Impact of Open Source Software on the Pharmaceutical Industry with Katja Glass
34:50
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34:50
Send us a Text Message. 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 be…
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The Ethical and Legal Challenges in Unapproved Drug Access: A Talk with Patti Zettler
32:20
32:20
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32:20
Send us a Text Message. 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 Acc…
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Bridging the Gender Gap in Medical Research: The Potential of Wearable Technology
38:53
38:53
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38:53
Send us a Text Message. 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. …
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The Hidden Factors Behind Executive Retention in Life Sciences
33:04
33:04
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33:04
Send us a Text Message. 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…
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Ravi Samavedam: On demand clean rooms for clinical trial supply
34:23
34:23
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34:23
Send us a Text Message. This week we speak to Ravi Samavedam, Chief Innovation Officer for Azzur Group, about how on demand clean rooms can transform the business model for biotechs. We start out by exploring what the standard two choices biotech’s typically have for clinical trial manufacturing: Building their own infrastructure Outsourcing to a c…
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Leif Kuse: Nudging the industry towards innovation with group purchasing for biotechs
33:36
33:36
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33:36
Send us a Text Message. This week we speak to Leif Kuse, who is Lead Trailblazer of Drug Development Outsourcing Disruption and CEO PHARALL. We speak about group purchasing for biotechs in clinical trials. We start out by exploring how CRO contracting usually happens for biotechs, where clinical trials are typically outsourced to CROs. Biotech outs…
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Tirrell Payton: Transforming the mindset in Life Sciences from Punitive to Innovative
50:14
50:14
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50:14
Send us a Text Message. This week we speak to Tirrell Payton, Managing Partner at Nooma Group Consulting, about mindset in life sciences. We speak about how there is a disconnect between the level of risk willingness among the top levels in organizations and middle managers. Middle managers are often afraid to make a mistake - and become the “perma…
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Philip Russmeyer: Revolutionising clinical trials with true data anonymization
44:26
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44:26
Send us a Text Message. This week we speak to Philip Russmeyer, Founder & CEO of Fitfile, about the promises that true data anonymization holds for transforming clinical trials. We dive into the differences between tokenization, anonymization and pseudonymisation of data. And how the difference is whether individuals can ever be identified or if th…
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Sam Ewing: Virtual Wards & Digital Endpoints
29:23
29:23
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29:23
Send us a Text Message. This week we host Sam Ewing, who is the Global Head of Pharma Partnerships at Doccla. We speak about endpoint development in general - and digital endpoint development in particular. We define digital endpoints as something that happens in a patient's home, and is mediated by a smartphone with some technology associated with…
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Christian Born Djurhuus: Rethinking the waterfall approach of drug development
36:17
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36:17
Send us a Text Message. This week we host Christian Born Djurhuus, who is a physician by training, a self-proclaimed geek and has had an impressive career in life sciences in the intersections between drug development, leadership and technology. We speak about how the waterfall mentality is prevalent in life sciences, where specifications are devel…
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Simon Taylor: We need to deal with technological debt at clinical sites
33:45
33:45
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33:45
Send us a Text Message. This week we speak to Simon Taylor, Head of European Solutions Consulting at Florence Healthcare. We focus on site oriented technology transformation. We speak about the current challenges that clinical sites face, such as the high degree of churn within the healthcare industry, the increasing complexity of protocols and the…
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Ole Henriksen: How health technology assessments transformed clinical development
39:32
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39:32
Send us a Text Message. This week we speak to Ole Henriksen, Associated Partner of Nordic Healthcare Group and pharmaceutical market access expert. We speak about how health technology assessments (HTA) has impacted how we conduct clinical trials. Health Technology Assessment (HTA) emerged first as a research area in decision aids. Later, during th…
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Kimberly Tableman: Does true transformation in trials start with the clinical protocol?
44:17
44:17
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44:17
Send us a Text Message. This week we are hosting Kimberly Tableman, Founder and CEO of ESPERO Health, and speak about how clinical trial protocols are being re-imagined in our industry. We dive into what a protocol actually is and what it describes. Protocols are currently being developed with a lot of manual research. WIth googling, phoning friend…
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André Chagwedera: Patients should decide which research is funded
34:36
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34:36
Send us a Text Message. This week we have André Chagwedera in the studio, the Founder and CEO of Fleming Protocol. We focus on health data, and what it would mean for patients to own their data. One of the consequences of patients owning their data would be that patient communities would have a say in which areas to conduct clinical research in as …
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Raj Indupuri: Data is the currency of the life sciences industry
46:14
46:14
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46:14
Send us a Text Message. We speak to Raj Indupuri, the co-founder & CEO of eClinical Solutions, about why data plays such a key role in our industry. And dispute this being true for as long as we have had clinical trials, the recent technological advancements open up the possibilities for true data-driven decision making. Even though the clinical sp…
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Lars Rosendal: Leadership as the differentiating factor when drug development is uncertain
40:43
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40:43
Send us a Text Message. Today we speak with Lars Rosendal, the VP of Global Clinical Operations at LEO Pharma. We speak about how clinical development is an innovation game - and how both governments and patients are willing to pay for innovation. Patients in many major diseases are well served. That means we need to push the innovation to bring so…
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Rebecca Godfrey: How does a specialist transform into a leader?
44:23
44:23
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44:23
Send us a Text Message. In this episode we speak to Rebecca Godfrey, the author of The Leadership Vaccine, about transforming specialists into leaders. In The Leadership Vaccine we follow a story of how a company transforms itself - and discovers the five pillars of leadership. We speak about how the state of leadership in life sciences is improvin…
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Sophia Zilber: Getting to quality research from patient registries
33:11
33:11
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Send us a Text Message. Today is World Rare Disease day. It is only fitting that we speak to Sophia Zilber who is a statistical programmer, but also Board Member & Director of Patient Registries at the Cure MITO Foundation, about bridging the gap between the life sciences industry and patient registries in rare diseases. Sophia has experienced firs…
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Johan Lauritsen: There needs to be a simple apply button to participate in a clinical trial
43:01
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Send us a Text Message. We speak to Johan Lauritsen, CEO & Founder of Probe, about how clinical trials can be an alternative to treatment. Johan himself tried to enrol in a clinical trial for his rare chronic disease. This was an uphill battle and he never succeeded - but the experience did kindle his desire to make clinical trials available for pa…
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Maya Zlatanova: Setting the clinical trial up for success by listening to the healthcare ecosystem
35:55
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Send us a Text Message. We speak to Maya Zlatanova, the CEO and Founder of Trialhub and FindMeCure about trial strategy for clinical trials. We speak about the amount of information necessary to digest in order to answer the many complex questions during trial start-up, and how starting from the templates of previous trials can both be time-saving,…
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Dr. Daniel Fox: Transforming the balance between sites and sponsors
33:56
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Send us a Text Message. This week we speak to Dr. Daniel Fox, founder & CEO of Clinical Research Payment Network about how the power dynamic between sponsors and sites is shifting. We speak about the harms of “talkdown tech” and how sites can take back control over their own processes. We speak about the predominant model today and how sponsors in …
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Brian D Smith: Transforming the debate on drug pricing vs. innovation
43:09
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43:09
Send us a Text Message. This week we speak to Brian D Smith, professor and author of a brand new book New Drugs, Fair Prices. In the book and on the show Brian suggests that we can have our cake and eat it too - meaning that we can have fair drug prices, yet still encourage pharmaceutical innovation. Brian talks us through what it means to apply a …
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Graham Dutfield: As drugs become more precise, so needs the patent system
42:26
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42:26
Send us a Text Message. We speak to Graham Dutfield, professor of International Governance and author of That High Design of Purest Gold on the evolution of IP regulation in Pharma and how it could be transformed in the future. Patents are a historic tool, but have undergone an evolution. Patents started out in the 1470’s in Venice, and as an examp…
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Kristin Carlsson Petri: How pharmacometrics modelling can augment and replace clinical trials
33:10
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Send us a Text Message. This week we dive into pharmacometrics as a discipline and the potential for replacing and augmenting clinical trials with modelling. We speak to Kristin Carlsson Petri, who is a Director of Pharmacometrics. Pharmacometrics modelling is a range of mathematical modelling techniques that can quantify our knowledge of drug biol…
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Temitope Keyes: Digitizing clinical trials from paper to decentralized trials
39:32
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Send us a Text Message. For this episode we explore the evolution of the collaboration and partnership structure between sponsors, CROs and technology vendors in life sciences with Temitope Keyes, Executive Director of Encapsia. Temitope has had a front row seat to the digitization of the clinical trial process. We speak about the paper handling sy…
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Dr. Elin Haf Davies: Benefits of designing trials for paediatric patients first
38:01
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Send us a Text Message. We speak to Dr. Elin Haf Davies, CEO and founder of the technology company Apartito. We dive into the topic of designing trials with especially paediatric patients in mind. Elin shares with us her perspective on this topic from her background from healthcare, regulatory authorities, pharma and now also tech. Elin takes us th…
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Andreas Dam: Transforming how pharma engages with patients and HCPs
37:19
37:19
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Send us a Text Message. Are pharmaceutical companies allowed to engage with patients and HCPs? Judging by how infrequent such interactions are, you might get the sense that it is strictly forbidden. Though such interactions are regulated, navigating these for the promise of understanding the perspective of the clinicians as well as patients is wort…
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