Explorez tous les épisodes du podcast Lab to Lives
| Titre | Date | Durée | |
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| Navigating Cell and Gene Therapy: Insights and Challenges with Dr. Bruce Levine | 06 Aug 2024 | 00:34:42 | |
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.
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| Reconnecting with Purpose: Transforming Job Satisfaction and Patient Care in Life Sciences with Jill Donahue | 17 Jul 2024 | 00:40:53 | |
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.
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| Towards a more Agile Vendor Qualification: A Discussion with Dele Babalola and Rani Naik | 20 Dec 2023 | 00:49:32 | |
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.
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| Becky Baggett on the Science and Strategy Behind Successful Clinical Trials | 13 Dec 2023 | 00:23:56 | |
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.
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| Designing Adaptable and Inclusive Labs for Biotech with Marilee Lloyd | 06 Dec 2023 | 00:35:10 | |
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.
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| Dr. Peter Small on Cough Science and the Impact of Acoustic Diagnostics | 29 Nov 2023 | 00:23:44 | |
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 clinical trials. Hear how traditional cough assessment methods are falling short and the challenges the FDA faces when validating new cough-suppressing medications. Furthermore, we discuss the severe impact of chronic cough on individuals, exacerbated by the COVID-19 pandemic, and how acoustic AI offers a unobtrusive and privacy-preserving solution for cough counting.
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| Exploring Generative AI in Life Sciences with Nechama Katan | 22 Nov 2023 | 00:33:55 | |
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.
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| How Cell and Gene Therapy Manufacturing is transforming Life Sciences with Jason Bock | 15 Nov 2023 | 00:40:53 | |
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 manufacturing. Discover the unique challenges of setting up a manufacturing network for autologous cell therapies and how this relationship between clinical and manufacturing sites differs from traditional methods. Jason shares his journey of moving to MD Anderson Cancer Center, setting up a biotech firm, and transforming the supply chain, thereby expediting product development.
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| Clinical Trial Supply is like an entire Galaxy with Ryan Keane | 08 Nov 2023 | 00:39:52 | |
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 technology, the sudden shift in the vendor landscape, and the unexpected destruction of value in biotech due to companies discarding or divesting their assets.
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| Harnessing the Power of Open-Source in Pharmacovigilance with Lionel Van Holle | 01 Nov 2023 | 00:41:51 | |
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 development capabilities, and cost-effectiveness. Lionel shares insights into the diversity of SAS, R, and Python programmers involved in this field, revealing how the open-source revolution is just around the corner.
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| Exploring the Intersection of Healthcare, Marketing, and the Power of Programmatic Advertising | 25 Oct 2023 | 00:26:11 | |
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 pharmacists with personalized messages to rolling out patient savings programs, the benefits are limitless. All while staying compliant with data privacy and security guidelines. Buckle up for a deep dive into the world of automated marketing as HJ shares how their multi-tenant model disrupts the traditional process of segmentation.
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| Inventing New Endpoints with Richard Nkulikiyinka | 18 Oct 2023 | 00:49:47 | |
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. Tune in as we explore the use of composite endpoints in heart failure trials and exciting functional endpoints that are potentially leading the way for approval studies.
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| Revolutionizing Clinical Trials: The Promise of AI and Predictive Analytics with Vinodh Balaraman | 10 Jul 2024 | 00:29:40 | |
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.
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| Innovative Trial Design and Re-Imagined Endpoints with Richard Nkulikiyinka | 11 Oct 2023 | 00:42:25 | |
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 collection, visit schedules, and maintaining quality. The spotlight shines on patient-centric approaches, as Richard persuasively argues for designing trials that are more patient-friendly without sacrificing quality.
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| From Dropout to Award-Winning Scientist: A Journey in Biotech with Pradeep Sacitharan | 04 Oct 2023 | 00:42:40 | |
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 world, recounting his trials and triumphs in the field.
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| Decentralized Clinical Trials as Treatment Options with Ewa Lindqvist | 27 Sep 2023 | 00:45:20 | |
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 increased access to new treatments and real-time data for physicians, all while slashing costs and inefficiencies.
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| Exploring the Impact of Open Source Software on the Pharmaceutical Industry with Katja Glass | 19 Sep 2023 | 00:34:50 | |
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, and the profound impact of sharing tools, processes, and software.
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| The Ethical and Legal Challenges in Unapproved Drug Access: A Talk with Patti Zettler | 13 Sep 2023 | 00:32:20 | |
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 Working Group. We delve into the history of these programs, the FDA's role in their regulation, and the surge of interest they've seen in the last decade. Ever wondered why a patient would be willing to be a first mover on a yet-to-be-approved drug? Patti provides enlightening insights into this unique field.
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| Bridging the Gender Gap in Medical Research: The Potential of Wearable Technology | 05 Sep 2023 | 00:38:53 | |
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 | 30 Aug 2023 | 00:33:04 | |
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 delve into why this is happening and how job embeddedness could be a key factor in predicting retention. Grayeb's perspective brings to light the deeper dynamics at play in the industry, such as the abundance of job offers executives receive and the high level of isomorphism, making it easier for them to switch roles within the industry.
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| Ravi Samavedam: On demand clean rooms for clinical trial supply | 14 Jun 2023 | 00:34:23 | |
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:
Both options have pros and cons. Many of the cons can be mitigated by the third option that Ravi suggests - renting the infrastructure. This enables the biotech to keep control with the manufacturing process and keep experimenting, while avoiding the upfront investment in the infrastructure that may change. We also dive into the compliance of the facilities, and how outsourcing the quality assurance of the facilities themselves can allow the biotech’s to focus on the production process and science. Even though the clean rooms for the different companies are in the same facilities, there is no exchange of air or supplies between the rooms - and also limited exchange of ideas between the individual production lines due to confidentiality. As a small biotech it is easy to fall into the trap of going overboard with GMP regulation adherence. And how GMP stamina is necessary to know where to draw the line of sufficient quality. Guest: Ravi Samavedam https://www.linkedin.com/in/ravi-samavedam-65a8345/ Azzur
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| Leif Kuse: Nudging the industry towards innovation with group purchasing for biotechs | 07 Jun 2023 | 00:33:36 | |
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 outsourcing is especially tricky, because in especially smaller companies, there may not be competencies to handle a sudden increase of people working for the company by adding a partner to the organization. There are several models for collaborating with vendors - from a turnkey project, where you just “hand over the key” to a vendor, and wait for the results - to a close explorative collaboration, where the partner is basically a part of your organization. We discuss the difference in services and pricing that is on the table for big pharmaceutical companies and biotechs, exploring the dynamics of the market and collaboration models. There is no ideal CRO for a biotech - it all depends on what is needed, and how a collaboration can be established. Leif provides examples of great collaborations between CROs and biotech companies - where processes, culture and contracts all meshed. The patient stands to benefit from successful collaboration between sponsors and CROs. The trials can be executed more smoothly and drugs can make it to market more rapidly. Lastly we discuss if the pharmaceutical value chain could be decentralized in general, with companies like PHARALL brokering different parts of the value chain into a coherent whole. Guest: Leif Kuse https://www.linkedin.com/in/leif-kuse-32042411/ PHARALL
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| Tirrell Payton: Transforming the mindset in Life Sciences from Punitive to Innovative | 30 May 2023 | 00:50:14 | |
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 “permafrost layer” where change has a tough time to take root. We also speak about how institutional storytelling about past failures in a company can hinder people to try new things. These stories can act as invisible guardrails that limit what can be tried in an organization. Without being actual current constraints. We speak about how remote work in life sciences worked really well during the pandemic. But that it somehow stopped working. This is in fact a well understood phenomenon, where we initially could ride on the connections created pre-pandemic: Now as teams have experienced churn, people can no longer rely on that personal connection. .And remote connection does not substitute the connections forged in person. Clinical trials often consist of people working for different organizations - like sponsors and CROs - who still need to gel together to do good work. To make this work, you need to be intentional to make this work. A lack of teamwork is often the root cause for poor performance in a clinical trial. We speak about the key challenges in pharma right now, and how companies are shifting towards rare dieseases. And how the current toolkit we have does not suit the problem. Guest: Tirrell Payton https://www.linkedin.com/in/tirrellpayton/ Nooma Group
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| Exploring Patient-Centric Innovations in Digestive and Women's Health with Ariadna Maso | 28 May 2024 | 00:38:24 | |
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.
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| Philip Russmeyer: Revolutionising clinical trials with true data anonymization | 23 May 2023 | 00:44:26 | |
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 the data is masked with a token that can potentially be removed. The risk of secondary use of data that has been tokenized has held back research and data sharing between healthcare and life sciences. One of the reasons is that collecting consent from individuals costs about 400 USD per consent. One of the downsides of anonymization is that data cannot be unified across sources for an individual to get a full picture of health data. We speak about the differences between US and EU attitudes and legislation about personal data protection and how these are converging towards stronger privacy protection. For good reason, since personal health data is worth 10x more on the dark web compared to financial data. Collection of consent also matters in the sense that 80-90% of a trial is still delayed due to longer recruitment timelines than anticipated. That can be reduced if the trial protocol rests on a larger volume of anonymized relevant data. Anonymized data can also serve as a larger and more ethical control arm for clinical trials. Same goes for long-term follow up of clinical trials and the potential to re-use data collected once in additional trials. We speak about the siloed nature of health data between healthcare and life sciences and how Fitfile attempts to work end-to-end between the entire data creation lifecycle. Which is not always simple, but optimises the use of health data. Guest: https://www.linkedin.com/in/philiprussmeyer/ Fitfile https://www.linkedin.com/company/fitfile/ Notes: GPDPR Program of the NHS: https://digital.nhs.uk/data-and-information/data-collections-and-data-sets/data-collections/general-practice-data-for-planning-and-research European Journal of Human Genetics: ADPPA: https://www.congress.gov/bill/117th-congress/house-bill/8152/text
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| Sam Ewing: Virtual Wards & Digital Endpoints | 16 May 2023 | 00:29:23 | |
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 it. The benefits of digital endpoints for patients are tangible. They would not need to visit sites as often. That would make it easier to be a trial participant, and increase the diversity of clinical trial participants. That in turn would lead to better ecological validity of the data. We also speak about how a virtual ward is analogous to decentralised trials and how some of the data collected in a virtual ward setting could be used for clinical trials - potentially reducing the scale and complexity of clinical trials in the future. Connecting the healthcare system and the clinical research setting could mean that we can re-use the data collected in one or the other setting. Guest: Samuel Ewing https://www.linkedin.com/in/samuelewing/ Doccla https://www.linkedin.com/company/doccla/ Notes: Digital endpoint approval https://www.clinicalresearchnewsonline.com/news/2023/02/16/a-long-time-coming-on-digital-endpoints Digital Medicine Initiative
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| Christian Born Djurhuus: Rethinking the waterfall approach of drug development | 03 May 2023 | 00:36:17 | |
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 developed by one group and tossed over the fence to the next group. This creates friction and elongates development timelines. But there is also a challenge with developing drugs without the necessary feedback from the market - or that the market moves on from the initial dream of how a drug would perform in the market. We speak about how no matter how well we plan out drug development, risks will materialize. Planning may give an illusion of control, but the mentality of understanding that a plan is a nice baseline to navigate according to, but not actual reality, is crucial for navigating. Christian predicts that our industry will pivot towards developing patient solutions to a higher degree rather than drugs alone. These need to be tailored to the diseases they are targeting - but also patient profiles. We dive into how speaking to each other across professional domains is key to creating most possible value. But also that domain knowledge is essential for digitization. The life cycles of technology and health are very different. We speak about the example of Chat GPT and drug development lifecycles - but also those of organizations. And that life sciences needs to catch up to the speed of technology. Guest: Christian Born Djurhuus https://www.linkedin.com/in/christian-born-djurhuus-58a4395/
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| Simon Taylor: We need to deal with technological debt at clinical sites | 26 Apr 2023 | 00:33:45 | |
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 prevalence of paper as the primary recording mechanism. We speak about how to help sites quit their paper dependencies, and how the regulatory landscape stands in the way of adapting more digital ways of working. Sites have been given technologies to use by the sponsors that have not worked for them in the past - and have created an expectation that technology will not help make the process easier. We speak about the discrepancies between CROs, sponsors and sites. And how there is room for improvement to ensure that everyone wins from collaboration. Decentralized clinical trials are not well equipped to adopt additional technologies unless they can successfully move all of their processes into a more digital operating model on a more fundamental level. The regulatory agencies have been encouraging diversity in clinical trial recruitment. Representation in research is currently skewed, so additional focus is needed. But it translates into a new kind of work for clinical sites - of physically going to new areas to recruit patients. Guest: Simon Taylor https://www.linkedin.com/in/simon-taylor-56143638/ Florence Healthcare
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| Ole Henriksen: How health technology assessments transformed clinical development | 19 Apr 2023 | 00:39:32 | |
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 the 1990s, as a formal requirement for reimbursement. Due to it being a requirement in many markets, it is often called “the 4th hurdle”. It should be understood in addition to regulatory requirements on efficacy, safety and quality, HTA poses a 4th requirement of therapeutic value or value for money. The main purpose of conducting an assessment in the first place is to inform decision making. The research question or decision problem is: Should we include the technology as part of standard of care (and reimburse it)? Historically clinical trials were used to gain market access by passing regulatory requirements – efficacy, safety and quality. The emergence of HTA meant that data and information on the technologies at time of marketing should also be used to assess the value of the technology vs. existing clinical practice and in clinical practice. This is perhaps one of the big dilemmas in medical development today that we have regulatory authorities who grant priority review/fast track and so on, but HTA authorities asking for more certain effects to be documented at reimbursement. Guest: Ole Henriksen https://www.linkedin.com/in/ole-henriksen-b911705/ Nordic Healthcare Group https://nordichealthcaregroup.com/
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| Kimberly Tableman: Does true transformation in trials start with the clinical protocol? | 10 Apr 2023 | 00:44:17 | |
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 friends and re-using existing protocols in word documents. Trials today are being conducted in a more complex environment than before. This means that it is necessary to adapt the trial design as the trial is executed. Creating a trial and executing it unchanged is becoming more rare and requirements for additional digitization in this space are increasing. Trial design is also a very collaborative process involving 10-12 stakeholders. Using a system that supports collaborative creation is key to avoid the pitfalls of versioning and overwriting of comments. Writing the protocol with data collected from the current market can make the protocol more robust and accelerate timelines. That is what Espiro health aims to provide in their protocol platform. Making it easy is the trick to ensure adoption. We also speak about the dynamics that lead to rigidity in the pharmaceutical space and how having sufficient inflow of money in especially big pharma leads to containing the status quo. Speaking out of her experience as a founder, we dive into what it means to start a technology company in the life sciences space and how funding is key to getting off the ground. Guest: Kimberly Tableman https://www.linkedin.com/in/kimberly-tableman/ ESPERO Health https://www.linkedin.com/company/espero-health/
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| André Chagwedera: Patients should decide which research is funded | 30 Mar 2023 | 00:34:36 | |
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 well as the design of clinical protocols. Fleming Protocol is a patient peer-to-peer network built on the blockchain. Where Fleming Protocol focuses on providing the tooling to make this network work, they work closely with patient communities, researchers and industry to understand the currently unmet needs and funnel those into research. Having built the solution on the blockchain builds traceability into the process of what gets funded and researched and how these priorities happen. We dive into how this would happen with the mechanisms in the blockchain as well as the needed competencies from the industry. Guest: André Chagwedera https://www.linkedin.com/in/andrechagwedera/ Fleming Protocol
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| Raj Indupuri: Data is the currency of the life sciences industry | 23 Mar 2023 | 00:46:14 | |
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 space has been digitising for many years, digitization is not necessarily transformative. Pockets of evolution have been attempted in a siloed way - not reaching all the way across the value chain. This creates a fragmented experience for the end users. We speak about platforms and ecosystems of platforms, and how to make the collaboration between stakeholders and technology seamless. And maintaining systems openness. This means that competing providers need to collaborate - as frenemies - for the betterment of research. We imagine what the current transformation in the digital space means for internal IT departments in life sciences, and what kinds of skills and competencies are needed - and which are no longer required. This episode is a little different. Sam works for the company that Raj is the CEO of. And this time around Ivanna gets questions and answers them too.
Guest: Raj Indupuri https://www.linkedin.com/in/rajindupuri/ eClinical Solutions
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| Lars Rosendal: Leadership as the differentiating factor when drug development is uncertain | 13 Mar 2023 | 00:40:43 | |
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 something to market that is either much safer, or has a higher degree of efficacy. When it comes to bringing a drug through the entire clinical value chain, there is a lot of uncertainty as it is. When you are trying to aim for innovation, the uncertainty increases. What this uncertainty does to a company depends on the company size. Being in a mid-sized pharmaceutical company means that there is some room for taking risks, but also a need to balance the uncertainty with the need to ensure continued operations. We dive into what this means for trial design in different stages of clinical trials - and how some of these stages can be outsourced, whereas others should be best kept in house to build relationships with HCPs pre-drug launch. We speak about leadership in the clinical area - and the benefits of understanding the entire clinical life cycle. Drug development is both an innovation game and a horse race. Leadership is what will allow your organization to run fast - but also dare to fail in pursuit of a deep purpose. Lars recently re-organized his leadership team to structurally ensure cross-functional collaboration and drive a competitive edge. We speak about the ideas behind this restructuring, and also how it has addressed some of the most stubborn challenges of our industry. Off-mic, Lars Rosendal and Ivanna Rosendal did try to figure out if there is a family relation - but there did not appear to be one. Guest: Lars Rosendal https://www.linkedin.com/in/lars-rosendal-2520a16/
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| Rebecca Godfrey: How does a specialist transform into a leader? | 07 Mar 2023 | 00:44:23 | |
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 improving as the science of leadership is gaining a more prominent position. And how the regulatory requirements of our industry can bring forth creative potential in leadership. We discuss how leadership may not require technical expertise, and the difference between leading people and leading delivery - and why separating line management from delivery management can be beneficial for specialists. Line management should not be the only way to progress in your career. Another topic we discuss is how to foster cross-functional collaboration - and how creating a shared responsibility in the leadership team leads to high performance. Rebecca also takes us through the five pillars of leadership as she describes in the book and why they together make an organization click into place. Guest: Rebecca Godfrey https://www.linkedin.com/in/rebecca-godfrey/ The Leadership Vaccine: https://www.amazon.com/Leadership-Vaccine-innovation-efficiency-resilience/dp/1781334536
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| Large Language Models in Clinical Trials with Eirini Schlosser | 03 Apr 2024 | 00:34:17 | |
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.
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| Sophia Zilber: Getting to quality research from patient registries | 27 Feb 2023 | 00:33:11 | |
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 first hand how rare diseases lack both data and funding. Using her personal tragedy and statistical programming skills, Sophia engaged in patient advocacy groups attempting to collect patient data for research. Pharmaceutical companies are often looking for data sources to understand diseases. And patient advocacy groups are eagerly collecting data in the hopes that it will make a difference for finding treatment and cures. But in many cases the data collected is not usable for actual research purposes. Currently there is no guidance on how to create a patient registry that will contain a high enough quality of data to be used for research. Sophia is actively working to change that through multiple efforts, such as a Phuse working group - and shares with us her advice for how to ensure data quality. Guest: Sophia Zilber https://www.linkedin.com/in/sophiazilber/ Cure MITO Foundation https://www.linkedin.com/company/cure-mito-foundation/ Phuse: https://www.linkedin.com/company/phuse/
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| Johan Lauritsen: There needs to be a simple apply button to participate in a clinical trial | 16 Feb 2023 | 00:43:01 | |
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 patients. Enrolling in a trial for a patient is not easy - even though especially chronic patients are very much willing to participate. But it is not easy for the physician to recruit patients for a clinical trial either. The problem is on both ends of the spectrum. There is no democratic access to clinical trials for patients. Even though a patient may be eligible, they may not enrol participants who are new to trials. Johan also takes us through his solution for bridging the patients who are willing to participate - and the clinical sites recruiting for a clinical trial. Guest: Johan Lauritsen https://www.linkedin.com/in/johanlauritsen/ PROBE https://www.linkedin.com/company/probe-dk/ Links:
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| Maya Zlatanova: Setting the clinical trial up for success by listening to the healthcare ecosystem | 08 Feb 2023 | 00:35:55 | |
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, but may also limit your perspective on what is possible with this specific trial. By asking the question of “what can go wrong” can help open the innovative power of clinical trial design. This can also help the understanding of patients and sites in the real world, and lead to better decisions. This question can also lead to better empathy with the stakeholders, and help anticipate some of the issues that may arise in the trial based on the design. Finding data that can reliably support the answer for this question is another challenge yet to be solved. This is complicated further by the collaboration between the CROs and sponsors, where the responsibility to collect the data necessary to support key decisions may fall between two chairs. Aligning your clinical trial to the real world would ideally lead to adjustments of the clinical trial as it is ongoing - but that is prohibitively expensive and difficult. When you are having trouble recruiting patients for your trial though, it may be worth the cost to pivot your trial during conduct. Here patient listening may be a way to understand what else might be possible for your trial. Patient recruitment slowing down may be a lagging indicator of trouble with your trial design. Having conversations with your investigators proactively can help you uncover potential issues with your trial before they manifest as recruitment problems. Understanding the entire ecosystem that the clinical trial takes place in can help you understand which alternatives to participating in a trial the patients may value more. Guest: Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/ Trialhub and FindMeCure: https://trialhub.findmecure.com/
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| Dr. Daniel Fox: Transforming the balance between sites and sponsors | 02 Jan 2023 | 00:33:56 | |
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 the name of efficiency introduce systems and processes to sites that may or may not work in the specific clinical setting of that site. One of the key reasons for this tendency is the information asymmetry between sponsors and sites.
One of the problems with this approach is that it does not work. Sites are different both individually - but also according to specialities and geographies. Another issue is that it is not legally feasible in the structure between sponsors and sites.
Site-facing technologies are bridging the gap, with the needs of the sites front and centre of the functionality. This is emerging as talk-up tech - initiated by sites, because it allows them to run clinical trials in the best possible way.
A related term we uncover is site centricity. Physicians are the most stable element of healthcare - whether sponsors or sites exist or not. The physicians will continue to provide healthcare to patients long after the trial is completed. Optimising the clinical trial ecosystem for their needs makes sense.
We dive into the PACT-score and how it is addressing the asymmetries between sites, CROs and sponsors - giving back control and options to sites for which trials they select to participate in.
Guest: Dr. Daniel Fox: https://www.linkedin.com/in/daniel-fox-mph-phd-3955b222/ Clinical Research Payment Network: https://www.crpaynet.com/
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| Brian D Smith: Transforming the debate on drug pricing vs. innovation | 21 Dec 2022 | 00:43:09 | |
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 generalised Darwinian approach to the life sciences ecosystem and how considering the complex adaptive ecosystem as a whole opens up new perspectives to solving the polarising debate about drug prices on one hand and encouraging innovation on the other. Applying this theoretical perspective ends up with some very practical solutions to some of the ailments of our industry. Getting to the solutions, we travel through some of the habitats of the ecosystem to discover the challenges the industry faces. We dive deeper into the discovery habitat. The purpose of this habitat is about creating new knowledge. This is often done in universities and publicly funded labs. Predictivity is one of the challenges in this industry - meaning that it is not directly transferable to actual medicine. Understanding translational science better will help us ensure a better conversion rate between discovery and actual drugs. You do not solve problems in a complex adaptive ecosystem with just one solution. Like removing one weed in your garden will not create a flowerbed. You need to apply a range of solutions and react to how the ecosystem reacts. In the book, Brian suggests 27 solutions to the problems in our ecosystem - and all are interconnected. These solutions are societal projects - not just government projects or industry projects. Revisit Episode 8 of Season 1 where Brian first guested us: https://transformationintrials.buzzsprout.com/1906263/10832267-brian-d-smith-changing-your-dna-to-pursue-a-novel-business-model Guest: Brian D Smith: https://www.linkedin.com/in/drbriandsmith/ Who is Professor Brian D Smith video: https://youtu.be/35HFWM6tbTc Pragmedic website https://www.pragmedic.com/ Brian’s email for sample chapter or other questions: brian.smith@pragmedic.com
Book: New Drugs, Fair Prices Book trailer video: https://youtu.be/aozQuvjMRCw Publisher’s website with discounted book: https://www.routledge.com/New-Drugs-Fair-Prices-Managing-the-Pharmaceutical-Innovation-Ecosystem/Smith/p/book/9781032361055
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| Graham Dutfield: As drugs become more precise, so needs the patent system | 15 Dec 2022 | 00:42:26 | |
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 example Christoffer Columbus had a patent to explore the new world. Only in the late 18th century did patents become associated with exclusive rights to exploit an invention in return for disclosing the recipe for it.
The purpose of patents is to incentivise companies to take on the considerable risk and heavy investment in researching and developing drugs. Without patents, competitors could replicate a successful drug without having to take on the investment and risk.
But even though the intention behind patents is to ensure further innovation, it also creates perverse incentives in life sciences. This is mainly because new uses of existing drugs can also be patented as well as human genes and other biologics.
We speak about how the biotech revolution changes the patent landscape by introducing complex technologies that require multiple patents to ensure protection to reap the benefits of the investment in their development. The industry is changing with a rise in the sheer volume of patents on both the drugs themselves, but also the manufacturing methods.
The professionalisation of invention - the intententive pursuit of invention - was in fact the greatest revolution of the pharmaceutical industry. We look back to the history of the pharmaceutical industry and how the centre of gravity changed from originally being centred in Germany, but moving to the UK and eventually the US - shaped by the world wars.
When turning to the future, we speak about the importance of biomarkers. They have the potential to transform medicine that works mediocre in the broad population to working exceptionally well in a specific subset of the population. There are also more approvals of novel drugs than in previous decades.
But there is still an issue with a lack of research in diseases in underserved populations as well as rare diseases, where the market for the drug may be small. The potential for technology transfer is also still unutilized, and getting this right might help us prevent another pandemic.
Graham envisions a menu of incentive structures for different kinds of disease areas that may differ for areas like chronic pain, antibiotics or rare diseases. That would be a more precise tool for getting the kind of invention we want in areas, that may currently be outside of the reach of patents.
Guest: Graham Dutfield: https://www.linkedin.com/in/graham-dutfield-2013a91b5/ That High Design of Purest Gold: https://www.amazon.com/That-High-Design-Purest-Gold/dp/9811222479
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| Kristin Carlsson Petri: How pharmacometrics modelling can augment and replace clinical trials | 08 Dec 2022 | 00:33:10 | |
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 biology and disease as well as trial information. The power of the methodology lies in the integration of knowledge across drug development and different compounds.
Even though pharmacometrics modelling is coming of age in recent years, it is not a new discipline. Its origins trace back to work conducted in the ‘50s and ‘60s, and one of the modelling programs most commonly used today were built in the 1970s in the Fortran language. The development of computers and computing power has allowed the discipline to grow, since the modelling is highly dependent technology.
Now the regulatory bodies request pharmacometrics analysis and the FDA has its own unit that conducts pharmacometric analysis on the data provided. Both the EMA and FDA encourage inclusion of pharmacometrics analysis especially for paediatrics studies.
In paediatrics studies pharmacometrics modelling is especially powerful. This is an area where data is usually scarce and fewer patients. But this population should still be offered evidence based medicine. By drawing on existing data from adult studies, some of the gaps can be closed without additional burden on the patients.
There are several examples of regulatory bodies accepting label expansion into paediatrics without the need to run clinical trials - relying solely on evidence from pharmacometric models. This is an opportunity - since it takes typically 10 years from a drug being developed for adults to it being approved for children. Closing this gap will increase access to evidence-based drugs for paediatric patients.
The area could grow even faster if data sharing across especially pharma and academia could be accelerated, and AI and machine learning could be applied to it. This is difficult, since the legal challenges of sharing data blok an efficient exchange.
We also speak about datasets collected continuously from wearables, and how they are challenging some of the techniques developed in decades past - and how these may need to be updated to the new technological possibilities.
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| Temitope Keyes: Digitizing clinical trials from paper to decentralized trials | 30 Nov 2022 | 00:39:32 | |
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 system that used to characterise clinical processes, and how “validation” that we now use to refer to systems validation used to refer to the validation of the printed paper. An entire ecosystem of vendors was required to make the paper ecosystem function, and the debate back then was whether to in-source or out-source, say, printing.
The evolution away from paper was absolutely necessary to get an overview of what was actually happening in the trial. The safety issues with Vioxx is an example of how data buried in paper can endanger patients. Data submitted on paper also makes it prohibitive to find trends across trials and drug profiles.
Temitope takes us through the digitization arc of the clinical process starting from the phone-based IVR systems to manage drug supply. Next came the development of the clinical database. Pharmaceutical companies attempted to build them themselves, but the complexity also forced specialisation in the industry and the creation of many of the technology vendors we work with today.
Clinical operations is the most expensive part of a clinical trial budget, because it is human-intensive and humans are expensive. CTMS attempts to help provide an overview of the many people involved in a clinical trial.
As more and more systems started supporting the clinical processes, the cost became prohibitive. CROs entered the space to offer pieces of systems to sponsors for a lower price, and in that way became technology companies themselves.
We also speak about how we brought all the technology together to end-to-end solutions that allow decentralized clinical trials. Guest: Temitope Keyes: https://www.linkedin.com/in/temitopekeyes/ Encapsia: https://encapsia.com/
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| Dr. Elin Haf Davies: Benefits of designing trials for paediatric patients first | 16 Nov 2022 | 00:38:01 | |
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 through the mindset change the industry has undergone from believing that clinical trials in children were unethical, to regulatory bodies requiring life science companies to conduct trials in children to increase treatment options for this population.
Finding ways to make clinical trials a positive experience for children requires that you think about how you design the administration of the drug - but also how you design the trial itself. Using endpoints that were designed for adults will leave you with inconclusive results in children. Designing endpoints that are age appropriate, disease specific, passive and pain free will make all the difference for your trial.
What is missing from the equation is the tools for making paediatric-friendly clinical trials. Developing tools that will work for children will likely benefit the adult population too - because you are forced to reduce complexity and think about ease of use.
Measuring endpoints in a passive fashion carries the promise to make clinical trials easier to participate in for both children and adults - with tools like analysis of video recordings and wearables. We also speak about how wearables and passive means of collecting data do not replace the human element of care - especially not in a paediatric setting. Guest: Elin Haf Davies: https://www.linkedin.com/in/elin-haf-davies-414b5211/ Aparito: https://www.aparito.com/ Links: EMA on mandate to conduct paediatric trials: https://www.ema.europa.eu/en/documents/other/european-paediatric-initiative-history-paediatric-regulation_en.pdf FDA draft guidance on paediatric trials: https://www.fda.gov/news-events/press-announcements/new-fda-draft-guidance-aims-protect-children-who-participate-clinical-trials
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| Andreas Dam: Transforming how pharma engages with patients and HCPs | 06 Nov 2022 | 00:37:19 | |
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 worthwhile.
We speak to Andreas Dam, the founder and CEO of Daman, about patient empowerment in clinical trials and how pharma can come closer to patients and HCPs.
Life sciences are impacted by two major trends: the larger consumerization trend and the shift of healthcare payer focus on outcomes. For the first, patients take greater ownership of their treatment. For the second, additional data about patients’ everyday lives are needed to determine how to prioritize the best treatment.
Patient reported outcomes are becoming an integrated part of clinical trials in part because regulatory bodies are requiring data on evaluating the value of the drug on the overall health of the patients.
There are benefits of measuring patient health continuously rather than just at site visits. Ecological momentary assessment describes the difference between what you can measure in a controlled setting, and the actual reality. Our minds are programmed to forget the bad part of our lives and are influenced by the setting in the clinic when we recollect how the state of our health has been in the time period leading to the visit.
Indirectly measuring the patient data from wearables rather than answering questionnaires is one of the ways that co-creating with patients creates trial design that fits more neatly into the lives of patients.
Increased use of technology is challenging the predominant pharmaceutical business model with long lifecycles. Building software tools and wearables meant for patients require quick iteration and feedback from the end users. In this sense the digital transformation in pharma is not just about technology, but also a transformation in patient focus. Technology can help promote shared decision making between patients and doctors. The patient is the expert in living their life with their disease and the doctor is the medical expert. Looking at the same data can ensure a more equal conversation and improve collaboration. Guest: Andreas Dam: https://www.linkedin.com/in/andreasdam/ Daman: https://www.damandigital.com/ RheumaBuddy: https://rheumabuddy.com/
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| The Evolution of Clinical Trials Through Wearable Devices with Wessam Sonbol | 27 Mar 2024 | 00:33:13 | |
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.
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| Alexander Gray: Re-defining early-phase development to explore opportunities for assets | 27 Oct 2022 | 00:42:10 | |
The Life Science industry is both known for great leaps of innovation on the product side, and conservatism of process and practice on the other side. In this episode we dive into the actual state of innovation on the product side as we speak to Alexander Gray, the Chief Medical Officer of IDEA Pharma. The innovative potential of phase II trials in Life Sciences today is often lost, since the indication is locked in too early in the process. Instead we speak about how keeping the indication open might allow the asset to drive the research to more favorable uses. Especially in broad disease areas such as immunology, oncology and CNS it can pay to wait with settling on the final indication until well into the phase 2 trials. Allowing the asset to lead to the indication can lead to better asset-indication matches and better results in further clinical trials. We also speak about how it might be possible to keep the phase 2 trials open for longer - and the benefits of involving stakeholders from non-research areas in the development process. This can help expand the view of the asset’s potential and lead to more holistic decision making. That kind of holistic decision making can be difficult to achieve in especially larger companies, where the functional areas may be divided not only organizationally, but also geographically. Alexander also shares how the joining up of Commercial and R&D organisations have developed throughout the past 25 years, going from less to more collaboration - but also swinging back again occasionally. Specialization is both a gift and a curse in Life Sciences - leading both to highly knowledgeable people, but also makes cross-functional and cross-therapeutic thinking difficult. This sometimes means that the reasoning behind a molecule can also get lost in the mechanics of drug development later in the development process. Going back to the science can ensure a focus on the best use of the asset. Guest: Alexander Gray https://www.linkedin.com/in/alexander-gray-934a653/ IDEA Pharma https://www.ideapharma.com/ Link to the link between GLP-1 on addiction: https://pubmed.ncbi.nlm.nih.gov/34532853/#:~:text=Glucagon%2Dlike%20peptide%201%20(GLP%2D1)%20is%20released,a%20potential%20anti%2Daddiction%20treatment.
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| Dr. Jack Pearson and Sofie Askervall: Digital contraception and data science-based clinical research | 17 Oct 2022 | 00:37:18 | |
We speak to Dr. Jack Pearson and Sofie Askervall from Natural Cycles about digital contraception and clinical trials based on data science. We explore how an app can become approved by the FDA as a contraception and the benefits of being more involved with your own reproductive health. Besides being used by women as a hormone-free contraceptive, Natural Cycles can use the platform to collect additional data for research purposes. Self-proclaimed “nerds with PhDs” collaborate with academic institutions to answer questions such as “does the Covid vaccine influence the menstrual cycle?” Having access to users already engaging with your app on a daily basis lowers the barrier for assembling additional data for clinical research - whether related to women’s health or not. This increases the speed at which clinical research can be conducted. Besides clinical research, curious stats can also be extracted from the app - such as what day users logged as the most stressful, and how the most frequent days to have sex varies across countries. We also speak about how interacting with your contraceptive method on a daily basis changes the relationship with reproductive health. Both in the sense of gaining more understanding for it, involving a partner or significant others or reaching out to the support team from Natural Cycles with questions. Users may find Natural Cycles easier to use in the future with the announcement of the new collaboration with Oura, taking the manual task of measuring temperature each morning out of the equation. Besides being more convenient, this collaboration provides additional data that can be incorporated into future studies. Guests: Sofie Askervall: https://www.linkedin.com/in/sofie-askervall-ba311845/ Jack Pearson: https://www.linkedin.com/in/jack-pearson-6a8ab190/ Natural Cycles: https://www.naturalcycles.com/ References: Published Research by Natural Cycles: https://www.naturalcycles.com/research-library Association between menstrual cycle length and covid-19 vaccination: global, retrospective cohort study of prospectively collected data: https://bmjmedicine.bmj.com/content/1/1/e000297 FDA 510(K) pathway: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
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| Nechama Katan: Psychological safety as a prerequisite for solving wicked problems in life sciences | 03 Oct 2022 | 00:40:59 | |
In this episode Sam and Ivanna dive into the topic of wicked problem solving in life sciences with wicked problem wizard Nechama Katan. To understand wicked problems we explore complex problems as a contrast. Examples of complex problems are a game of chess or a clinical trial data submission to authorities. Both have a lot of steps involved, but in the end you know whether you succeeded or not. Unlike complex problems the rules and outcomes of wicked problems are ambiguous. The problem itself may not be agreed upon or can be seen from multiple diverging perspectives, and the problem does not end - it ends once no more resolutions are attempted. Transitioning to a model where we can conduct trials in 1/100th of the time it takes today requires that we pull the common model apart, and put it back together in a radically different way. This is hard, since the “right way” of solving problems that most leaders have been taught are fit for complex problems - and many are at a loss of what to do when a problem is wicked. We speak about how language and psychological safety are key to being able to solve wicked problems - but that it is hard to achieve when innovation moves at the speed of meetings in life sciences. We explore which maneuvers can be taken for wicked problems and how solutions may emerge.
Nechama Katan: linkedin.com/in/nechama Blog: https://nechamakatan.wordpress.com/ References: Wicked Problems & Social Complexity: http://www.cognexus.org/wpf/wickedproblems.pdf PMI Wicked Problem Solving Certification: https://www.pmi.org/wicked-problem-solving Cynefin model: https://thecynefin.co/about-us/about-cynefin-framework/ Amy Edmondsen on Psychological Safety: https://amycedmondson.com/psychological-safety/ Living your best year ever: https://store.darrenhardy.com/products/living-your-best-year-ever Innovation at the speed of trust: https://www.speedoftrust.com/
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| G.T. LaBorde: Arming clinicians with therapeutic options at the point of care | 23 Sep 2022 | 00:46:08 | |
We speak to G.T. LaBorde, the CEO of IllumiCare about clinical trial recruitment at the point of care. Patients want to participate in clinical trials. Health care professionals are willing to refer patients. But there is a disconnect between point of care and clinical trial recruitment. “90% of providers say they feel comfortable talking to patients about clinical trials. Only 0.2 % actually do. That is an amazing disparity!”
G.T. talks to us about how this gap can be bridged at the point of care, making sure that providers can actually inform patients of the trials relevant to them in their geography. The current way of getting an eligible patient into a trial often requires heroics from the health personnel, manually reaching out to patients and remembering currently ongoing trials. Heroics may also be required from the patient side. For some patients, clinical trials can be the only treatment option. All existing courses of treatment may have been exhausted, and they are willing to embark on researching clinical trials on their own. G.T. walks us through how to embed information about clinical trials in the systems that clinicians already work in, without adding additional noise to the regular workflow. This type of seamless integration can simplify referral of the right patients to the right trials. This also means that patients can be recruited from a larger population base that may not search for a clinical trial on their own accord - yet the provider gets the final say. This is important to not taking patients thriving on current care off it just to participate in a trial. An analogy to the tool that IllumiCare built is a marketing platform at point of care to the provider who is taking care of the patient - like a marketing funnel. The study description would be like an ad, and referral would be analogous to a conversation event. 442 years of combined healthtech experience at IllumiCare is bringing this transformation to life. Guest: G.T. LaBorde: https://www.linkedin.com/in/gtlaborde/ IllumiCare: https://illumicare.com/
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