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Transformation in Trials

Sam Parnell & Ivanna Rosendal

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A podcast about the transformations in clinical trial. As life science companies are pressured to deliver novel drugs faster, data, processes, applications, roles and change itself is changing. We speak to people in the industry that experience these transformations up close and make sense of how the pressure can become a catalyst for transformation.
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Maneuvering Monday

Ivanna Rosendal & Anne Katrine Carlsson Sejr

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In this podcast, we invite you to follow the fictional story of Marie as she maneuvers the organizational culture and dysfunctions in the company Zebra Apps. Once a week, we invite guest experts to discuss what happens in the episode, and provide tools and insights into what Marie could do. Let's maneuver Mondays together!
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What is the future of Health? In The Circle Podcast we welcome you into the world of innovators & leaders from the Medical and Health Technology field in Scandinavia. Through Sci-Fi stories, you get to know, who's who in the Medicon Valley Circle. ---------------------- Hosted by Faisal Kamal Faisal holds a Masters Degree in Pharmaceutical Science from Copenhagen University, where he is an external lecturer. Faisal is an experienced Regulatory Affairs professional working in the device indus ...
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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 t…
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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…
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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 off…
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Unlock the secrets of clinical trial design with industry experts Pierre Colin and Boaz Adler as they join us for a deep dive into the early-stage planning that shapes the future of pharmaceuticals. They provide a look at the collaboration between clinicians, statisticians, and regulatory experts that's critical for determining the right patient po…
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Embark on a journey through the dynamic landscape of clinical trial outsourcing with Jason Gubb, the co-founder of ClinOps Clarity and Emergent Teams. As we navigate the historical shift from predominantly in-house operations to the intricate web of external partnerships, Jason sheds light on the critical decision-making processes that shape the ph…
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In this conversation with Sam Whitaker, we delve into the pivotal issues faced by underrepresented groups—particularly those from lower-income backgrounds—highlighting the disparity in current demographics and the consequences it bears on the reliability of drug efficacy and safety data for diverse populations. We go beyond the surface to examine t…
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This week we speak to Boaz Adler from Cytel's Software Division. This episode promises to illuminate the intricacies of trial design through the lens of Monte Carlo simulation, revealing how this potent approach crafts trials resilient to a myriad of scenarios. Boaz delves into the pivotal roles of interim monitoring and strategic market positionin…
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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 p…
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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 u…
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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 benc…
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In the last commentary episode of chapter 4, we talk to Mary Lemmer, who is not only the founder of the company Improve, but also a keynote speaker, conference session facilitator, longtime entrepreneur, writer/author, and improv comedian. The story episode is full of attempts to solve the team communication and culture problems that have been iden…
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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. H…
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Marie and Mark are interviewing for the CFO position, and Marie learns from the employees in the Finance department that they are not wishing for a specialist manager, but a leader to represent them in the management team. Natalie suggests the VP of Sales, Jaque, which disappoints Mark. Jason returns to Zebra Apps, and Paul bakes cinnamon buns for …
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Join us in a conversation with Nechama Katan, as we investigate the world of generative AI in life sciences, a realm where technology meets business, and where Nechama, an expert in innovative data in the clinical space of life sciences, will guide us. We're taking a deep dive into the ever-evolving realm of technology in life sciences. We'll take …
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In the second part of chapter 4, we are lucky to get hands-on advice from queer millennial expat leader Laurence Paquette who works as Vice President of Marketing for the large renewable energy company Vestas. The story episode is full of drama, and the conflict avoidance reaches a new high when Zebra Apps' management fails at setting boundaries wh…
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Marie gets closer to Jenni and starts to understand the pressure she is facing from Natalie. Shaine accepts a pay cut to make up for the salary disparity, but it is too late to avoid mass mutiny. After a dramatic incident in the office, Marie is sent home on sick leave. During her time off, Marie is approached by the previous employee, UX Designer …
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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. Discov…
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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 sudde…
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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…
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In the first commentary episode of chapter 4, we are lucky to have "post transformation dude" Joe Auslander in the studio to share his great perspectives from his work which he describes as 'physical therapy of the delivery world and organizational transformation'. We talk about how to avoid getting lost in trying to fix 'people problems', how hold…
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Mark, Marie and Paul spend a full day offsite to share and celebrate failures, with the purpose of starting to solve their department’s dysfunctions. Marie and Paul learn that Mark has been fighting Natalie to focus on culture since he started in Zebra Apps. Mark also admits that he has not been doing his job as a leader and investing in the HR dep…
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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 …
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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 expl…
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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 sch…
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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, recountin…
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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…
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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…
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In the last commentary episode of chapter 3, we talk to global business leader Vivek Menon about the challenges Marie faces as this chapter comes to an end. Based on many years of leadership experience, Vivek shares his thoughts on the topics of the episode, which all revolve around organizational dysfunction. We talk about equal pay for equal work…
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The identity of the corporate rebel is revealed. Will he get away with it? Marie aggressively confronts Paul about the salary disparities in the engineering department. Later, she learns from Mark that Paul is under a lot of pressure because of a legal dispute with the ex-CFO Frank. Marie and her team facilitates a townhall meeting where the employ…
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Is purpose your boss? In the second commentary episode of chapter 3, we have an interesting talk with Marc-Peter Pijper about holocracy, purpose, how to succeed and learn together as a team, equal pay for equal work, motivation, and not least the many metaphors of Marie's story. Is the pile of junk in the basement a metaphor for all the problems of…
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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 de…
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Going to get the cinnamon buns from the pile of junk in the basement, Marie finds a hidden sugar stash and meets the datacenter technician Willie. During lunch hour in the canteen that day, a dramatic happening occurs, involving sugar and a banner falling from the stairwell. Marie and Erik learn from Shaine, who was recently headhunted from ConvoSy…
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In this first commentary episode of chapter 3, we are delighted to talk to Rob England and Dr. Cherry Vu, partners in life and in their company Teal Unicorn. Together as a team, they transform organizations to New Ways of Working and Managing by being 'midwifes to the solution' for their customers (listen to the episode to find out what we mean). H…
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Imagine you're on an eight-year journey trying to diagnose an autoimmune disease. Suzaan Sauerman, our insightful guest today, faced this exact challenge. Sauerman, a visionary in female representation in clinical trials, uncovers the persistent gender gap in this field and posits an innovative solution—wearable technology. We dig into the heart of…
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In this first episode of chapter 3, all the sugar packets mysteriously disappear from the tables in the canteen. Sheila feels bad about her experience with Frank, and Marie and her team members get together for a structured exercise to cope with failure, each sharing a mistake and celebrating the learnings. Will this exercise help Sheila feel bette…
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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…
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In this special edition episode, international thought leader, author, lecturer and practitioner Christian Nissen interviews Ivanna and AK about the first two chapters of Marie's journey in Zebra Apps. What do you think Marie should do? Join the conversation on our LinkedIn page Reach out to us: Anne Katrine & Ivanna…
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In this final commentary episode of chapter 2, Futocracy Network host Dr. Ross Wirth joins us to provide some constructive criticism to Marie and her approaches. What are some of the missed opportunities and facilitation basics that Marie failed to get right at the leadership offsite? How could the five levels of involvement help Zebra Appa succeed…
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The culture program is approved at the leadership meeting. Marie meets with Todd from HR in ConvoSystems to get the scoop on Jaque, and Todd shares some unsettling news about Anne and Zebra Apps co-founder Richard. Marie and her team facilitates the leadership offsite meeting. Marie’s team member Sheila has an uncomfortable facilitation session wit…
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Author and coach Heidi Helfand helps us dissect the second episode in chapter 2 of Marie's journey. While Marie learns more about Mark and his background, an unknown company rebel hangs post-its on the recently installed soda fridges. Heidi Helfand shares her insights on how Marie and Mark's relationship could be improved using Organizational Relat…
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While Marie gets closer to understanding Mark and his background, an unknown company rebel hangs post-its with insults on all the soda fridges. The HR Development team members plan the culture program, and Mark and Marie presents it to Natalie. But how will she react to the resurfaced company values? And is she even ready to approve a culture progr…
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Silicon Valley veteran Sam McAfee from Startup Patterns helps us kick off chapter 2 of Marie's journey in this episode. What does it say about a company when it takes an archeological process to uncover previous work done to define and distribute company values? What can we learn from 20th century literature about mind games in the office? And what…
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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 contract manufacturing or…
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Chapter 2 kicks off with a member of the leadership team testing Marie's patience - and Marie learning something new about why Anne left Zebra Apps. Marie also discovers that Natalie did define a mission statement and company values when she founded the company. So how will Marie tackle the culture program presentation for the leadership team? And …
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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 tr…
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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 chang…
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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 …
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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 dig…
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This week Benoit Hurel, a partner at The Ready, helps Marie maneuver Zebra Apps. Benoit advices Marie to try radical change at a non-radical scale and to dance with the system instead of fighting it. Guest: Benoit Hurel: https://www.linkedin.com/in/benoit-hurel/ The Ready: https://www.theready.com/ Methodologies and tools mentioned: OS canvas: http…
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