This week we sit down with Erini Schlosser, CEO of Dyania Health, and chart the pioneering advancements in large language models within healthcare. This episode promises to reveal how the shift from simple entity recognition to sophisticated reasoning models has revolutionized drug discovery and the curation of electronic medical records, all while unpacking the challenges of data privacy, computational demands, and the hunt for specialized AI talent. Discover the fusion of technology and medicine where the collaborative potential for real-world data utilization in evidence-based studies emerges as a beacon for innovation amidst the complexities of modern clinical trials.

As we explore the parallels of AI training to medical education, you'll be enthralled by stories of AI models undergoing meticulous fine-tuning by our in-house physicians, echoing the rigorous journey of medical residents. Irene lifts the veil on her own path, which led from a lineage steeped in medicine, through the worlds of biochemistry and investment banking, to the groundbreaking integration of NLP into healthcare at Dyania Health. Our conversation shines a light on the future of automating clinical research, where AI not only answers but justifies with evidence, promising an unprecedented era in the management and interpretation of medical data. Tune in for an intimate look at the challenges overcome and the milestones achieved in teaching machines to navigate the intricacies of human health.

Guest:
Eirini Schlosser

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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 offers. As we dissect the benefits and hurdles of this evolving data landscape, you’ll get an insider perspective on the intricacies of managing vast health metrics and setting benchmarks for impactful analysis. Plus, Wessam shares his knowledge on the reliability and strategic employment of wearables in clinical research, offering a glimpse into how these devices are altering the way we approach health monitoring.

In our discussion, the concept of 'wearables as a service' emerges, a trailblazing model crafted by Delve Health to elevate the clinical study experience for both patients and researchers. Wessam delves into the rigorous process of selecting wearables that align with trial goals, sharing how gadgets like Fitbits undergo efficacy evaluation. Be prepared to discover how innovations like automated compliance and concierge teams are mitigating study site burdens and boosting data quality. We also tackle the broader spectrum of challenges and advancements in clinical research, contrasting the swift advancements in wearable tech with the methodical progress of drug trials.

Join us to envision a future that prioritizes patient-centric care, reduced tool burden, and heightened automation, and don't miss Wessam's call to action for ongoing dialogue that aims to reshape the patient experience in the health and life sciences arena.

Guest:
Wessam Sonbol

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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 populations, dosages, and study endpoints. With their guidance, we explore how statistical software and scenario planning play pivotal roles in estimating patient numbers, study durations, and costs, transforming clinical trial design into a fine art.

As we navigate through the evolution of statistical methods, our guests share their insights on the need for adaptability in clinical trial designs, especially in areas like oncology with unique endpoints such as overall survival. They spotlight the importance of cross-company collaborations and direct FDA discussions in driving innovations. The conversation also illuminates the ever-growing contributions of R-coding, a testament to the individuality of each study, allowing for customized and cutting-edge approaches to trial design.

To wrap up, we spotlight the dynamic landscape of drug development where biostatistics paves the way for groundbreaking designs. Our guests emphasize how feedback from scientific communities influences new methodologies, shifting the focus from traditional success measures to concepts like assurance and power in the promising zone. They also highlight the invaluable role of Bayesian designs, as exemplified by COVID-19 vaccine trials, in ethically accelerating drug development. As we close, remember that this field is ripe with diverse opportunities, and we invite you to reach out with your curiosities and follow-up questions.

Join us for this episode that's not just about the science of trials, but the transformation they undergo, ensuring the journey of drug development continues to revolutionize patient care.

Guests:
Pierre Colin: https://www.linkedin.com/in/pierre-colin-11139028/
Boaz Adler: https://www.linkedin.com/in/boazadler/

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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 pharmaceutical and biotech industries. Grapple with the challenges and opportunities presented by R&D budget constraints and learn how emerging biotech firms are steering through fluctuating funding currents. Discover a world where the right choice of vendors can make or break a clinical trial, and how companies balance the scales of internal project management and external collaboration.

With Jason's sage guidance, gleaned from his tenure at GSK and his entrepreneurial ventures, we dissect the artistry behind cultivating successful clinical trial partnerships. He shares insights on the transformative effects of smart decision-making and the vigour of challenging established practices while ensuring that every partnership is rooted in open communication and shared goals. Jason also illuminates the impact of a patient-focused ethos and addresses the nuances between co-creation and mere collaboration. So tune in to expand your understanding of the pivotal role that culture and relationships play in shaping the outcomes of clinical trials and to witness the emergence of alliances that are as resilient as they are innovative.

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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 the complexities surrounding compensation for trial participants, debunking the myth that stipends serve as an incentive and instead revealing the net financial loss many endure. With Sam's expertise, we explore why the current compensation structures pose significant barriers for those in lower-income brackets.

Sam Whitaker's insights prompt us to question the ethical responsibilities of Institutional Review Boards (IRBs) in safeguarding participant welfare, particularly in terms of payment evaluation. The conversation scrutinizes the pressing need for standardized compensation practices, emphasizing the potential financial harm and barriers these present to willing participants. Our discussion raises awareness about the delicate balance between the pursuit of scientific knowledge and the imperative of ethical consideration in the realm of human testing.

Lastly, we shine a light on the legislative efforts aiming to dismantle the financial hurdles that deter diverse participation in clinical trials. Tax implications for low-income participants and the risks to their welfare benefits take center stage, with bipartisan support emerging as a beacon of hope in the push for reform. Sam shares the impactful work being done through Mural Health, including the Portrait Project, which seeks to humanize and democratize the clinical research process. Join us to understand how these initiatives are not just transforming patient involvement, but reshaping the landscape of clinical trials for the betterment of all.

Guest:
Sam Whitaker
Mural Health

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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 positioning post-trial, offering a masterclass in the art of clinical trial conception that withstands the test of uncertainty.

As we navigate the vast landscape of clinical trial simulation, the topic of scale takes center stage. The conversation orbits around pioneering software platforms like Solara and East, which are reshaping trial design by integrating a kaleidoscope of variables and uncertainties. This episode pulls back the curtain on the potential of cloud computing to revolutionize simulations, providing a glimpse into the future where clinical trials are executed with unparalleled speed and precision. With Boaz' expertise, we ponder the industry's readiness to trust probabilistic outcomes and how regulatory bodies are warming up to the simulation-based approaches that these software platforms enable.

Finally, we bridge the gap between biostatistics and market access, highlighting the increasing influence of health outcomes research on clinical trial design. The discourse delves into the balancing act of incorporating quality of life measures for regulatory and reimbursement decisions, the finesse required to blend standard software with bespoke coding, and the imperative of enhanced inter-departmental synergy. My own path to life sciences underscores the episode's reflective tone, leading to a broader examination of Cytel's extensive contributions to the field, from their roots in Monte Carlo simulation software to a comprehensive suite of services that spans the full spectrum of statistical programming and evidence-based research. Join us for this enlightening episode to gain an insider's perspective on the dynamic confluence of biostatistics and pharmaceutical innovation.

Guest:
Boaz Adler

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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 pulse of the GxP space and are ready to share their insights on the pressing need to evolve from redundant processes. Pay attention as Rani unfolds her unique vision for an agile, phase-appropriate quality organization. 

Imagine a world where vendor qualification is not a daunting task but a streamlined process. We got you thinking, right? Dele and Rani join us to unravel this concept further. It's all about being proactive, focusing on effective oversight, and perhaps venturing into the world of pre-approved vendors. From discussing the role of certification bodies to emphasizing the significance of a proactive approach, we've got this topic well covered. 

Enter the world of vendor management where challenges are like a complex puzzle waiting to be solved. This is where Dele and Rani's expertise shines as they shed light on transparency, collaboration, and the risk-based approach. Here's a plus - they also detail the potential value of remote audits and the importance of having an internal individual who can ensure clear process flow. As we wrap up, we can't help but yearn for a more innovative industry that's ready to take leaps. You won't want to miss this candid conversation.

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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 unravels the complexities of clinical trials for us. She not only lays out the distinct stages and components of a clinical trial but also enlightens us on the crucial collaboration between the sponsor and the CRO, the importance of clinical research sites, data management, and project management. She underscores the absolute necessity of establishing solid relationships, trust, and experience in this highly controlled and regulated field.

As we navigate further, we plunge into the thrilling and demanding world of technology in clinical trials. This part is a trove of information on how technology can streamline trials and why it's crucial to tailor technological applications to the specific needs of therapeutic areas. This episode is not just about information, but also about engaging in a thought-provoking discussion, where we examine the subtleties of conducting trials across different therapeutic areas. We end on a note of aspiration, echoing the collective wish for increased funding in the industry, which could potentially fast track more life-saving medications from lab to market.

Guest
Becky Baggett

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