Transformation in Trials

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Why has SAS been the cornerstone of clinical trials for decades, and what is causing the shift to R now? Join us on "Transformation in Trials" as we explore this pivotal transition with Sunil Gupta, a seasoned programmer who has navigated both worlds. Sunil elaborates on SAS's long-standing dominance due to its robust programming capabilities and ease of use for FDA reviewers. However, the landscape is changing as R garners attention for its graphical prowess and collaborative potential. The conversation highlights the growing trend of new graduates versed in R and Python, which alleviates the shortage of SAS programmers and signifies a modernization wave in clinical trials, ultimately aiming to accelerate drug development.

Our discussion takes a deep dive into the collaborative spirit driving this transition, particularly through initiatives like Pharmaverse. This specialized extension of Tidyverse is designed to optimize clinical data workflows within the pharmaceutical industry. Sunil shares insights into how clinical programming is evolving, focusing on standardized data models and the unification of CDISC standards. The conversation underscores the importance of collaboration and resource sharing, allowing organizations to tackle complex challenges efficiently and improve patient outcomes while adapting to R's open-source environment and its growing acceptance in pharmaceutical submissions.

Transitioning from SAS to R is not just about adopting a new tool; it's about mastering new skills and embracing change. Sunil discusses the challenges he faced when learning R, from understanding its functional approach to navigating intricate syntax. He offers personal anecdotes that reflect his journey and the broader industry shift, emphasizing the importance of validation processes and resource optimization. As we conclude this episode, we express gratitude for the platform to discuss these transformative changes and invite listeners to engage with us on future topics, continuing to share success stories that inspire more organizations to embrace the power of R.

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Prepare to transform your understanding of vendor oversight in clinical trials as we welcome Jessica Cordes, a senior consultant and trainer at the Clinical Excellence Consultancy. Jessica brings her wealth of experience to highlight the intricate responsibilities that sponsors must navigate when outsourcing tasks. Our conversation promises to equip you with insights on maintaining control, mitigating risks, and leveraging technology like AI and machine learning to future-proof your oversight strategies.

Metrics are more than numbers—they're a lifeline in managing vendor relationships. Learn how robust oversight can impact patient safety and compliance metrics. We’ll explore the necessity of tailoring KPIs to specific risks and the importance of a risk-based approach that starts from vendor selection and continues through ongoing management. Jessica’s emphasis on creating a standard operating procedure framework will guide you in ensuring consistency and accountability in sponsor-vendor interactions.

Effective communication is the cornerstone of successful clinical trials. Through personal anecdotes and practical advice, we tackle the challenges of unit-based contracts and introduce milestone-based contracts for enhanced efficiency. From vendor selection to team building, Jessica shares her consultancy insights tailored for small and mid-sized biotech and pharma companies. We also consider the upcoming ICH E6 R3 guidance, emphasizing fit-for-purpose procedures in quality management systems, all while advocating for improved collaboration among stakeholders to enhance patient-centricity and accelerate drug development.

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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.

In another riveting segment, we delve into the recent FDA investigation into cases of T-cell malignancies following CAR T-cell therapy. With data gleaned from voluntary reporting databases, we scrutinize causality, immortal time bias, and the need for improved reporting standards. Dr. Levine shares his thoughts on the importance of thorough patient follow-up and effective communication of risks and benefits. We also explore the evolution of cell and gene therapy, tracing Dr. Levine's journey from his early days in immunology research to his pivotal role in shaping the field. This episode is a must-listen for anyone interested in the dynamic and ever-evolving world of cell and gene therapy.

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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.

Step into the world of Johnny, a shuttle bus driver in Phoenix, who discovered how focusing on spreading happiness could significantly transform his work experience and income. This inspiring tale serves as a powerful reminder that a purpose-driven mindset can make a difference in any role, from healthcare to pharma and beyond. Jill and our hosts discuss practical strategies for connecting with your "why" and engaging audiences during presentations through personal motivations and stories, highlighting how genuine connections can enhance both professional and personal experiences.

The conversation shifts to the pharmaceutical industry’s much-needed transformation towards patient partnership. Jill passionately advocates for a shift from product-centric to patient-centric narratives, emphasizing the importance of presenting treatment options and building expertise in specific disease states. This approach, she argues, not only improves patient care but also makes the role of pharma representatives more fulfilling. Tune in to hear Jill's excitement about her book, "A Dose of Inspiration: 100 Purpose Stories from Pharma Leaders," and her dream of igniting a sense of purpose in everyone within the industry.

Notes:
A Dose of Inspiration: 100 Purpose Stories from Pharma Leaders can be found on Amazon or as a free download at www.excellerate.ca/freebook

More information about The Power of Purpose can be found here

Jill can be reached here on LinkedIn

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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.

Ever wondered how big data and predictive analytics could be the game-changers in drug development? Our conversation takes a deep dive into the role of AI in forecasting how patients will respond to treatments, potentially transforming the hit-and-miss nature of clinical trials into a targeted approach. We discuss the transformative power of a SaaS business model and shared knowledge bases, considering how they could overhaul the pharmaceutical landscape. Despite the industry's tentative steps toward data sharing, we explore the gradual shift as medical professionals begin to wield these cutting-edge tools to make smarter, data-driven decisions.

Bringing a dose of humanity to the tech talk, I share my personal motivation stemming from a family member's battle with rheumatoid arthritis—a catalyst for my commitment to pushing the envelope in clinical development. The episode concludes with a reflection on how AI stands on the brink of revolutionizing medical affairs and real-world studies, but is often met with skepticism. By fostering a culture open to change and innovation, we envision a future where clinical trials become more successful and efficient. Join us as we discuss the landscape of trials and the untapped potential that KolateAI brings to this critical field.

Guest:
Vinodh Balaraman

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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 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.

When it comes to personalizing patient care, digital biomarkers are the wayfinders charting a course through the previously uncharted territories of healthcare. But the journey is fraught with challenges: data diversity, operational hurdles, and the sheer volume of information from tools like wearables. In this episode, Ariadna navigates us through these operational storms, detailing how Sanno Health evolved from an app into a comprehensive platform that's not only tracking patient health but is actively engaging them in their treatment. We also probe into the stark disparities between industry perceptions of patient-centric care and the realities patients face, unveiling the transformative potential of incorporating patient feedback directly into clinical trial designs. Join us as we explore the diverse therapeutic landscapes that stand to benefit, including digestive health and the burgeoning realm of women's health, and the far-reaching implications of data-driven medical advancements.

Guest
Ariadna Masó

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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 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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