The State of Patient Engagement: From a Patient Advocate
Manny Vazquez (our new host) interviews Trishna Bharadia, a patient engagement consultant and advocate. Since receiving a life-changing diagnosis 15 years ago, Trishna has made it her mission to strive for patient-centered healthcare.
This goal has recently taken on new urgency: the FDA and EMA are pushing sponsors for evidence that patient preferences are being accounted for in clinical research. Using real-life examples, Trishna and Manny discuss the benefits to sponsors of involving patients early in trial design and educating them on study findings.
As Trishna explains, patients will think of things sponsors won’t from living every day with their conditions.
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38:27
Is a Heavy Tech Burden the Price of Progress for Sites?
Richard Young passes the torch to Manny Vazquez, our new podcast host, and shares his reflections before turning off his mic for the final time. Later, Manny is joined by renowned industry thinker and site leader Brad Hightower, owner of clinical research center Hightower Clinical in Oklahoma.
They discuss whether the growing tech burden is the price of progress for sites, plus tips on how sponsors can make sites’ lives easier. Brad also explains a few implications of the recent FDA draft guidance on DCTs and the upcoming site conference he helped to set up, ‘Save Our Sites’.
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52:43
AI and Clinical Transformation: High-Value or Hype?
Novo Nordisk’s Vice President for Clinical Data Operations and Insights Ibrahim Kamstrup-Akkaoui joins Richard this week for episode 4 of Season 3. As Ibrahim explains, the pace of innovation in clinical development is accelerating, sometimes generating billions of relevant data points for study teams to manage.
AI is already adding value and can help organizations sustainably manage this growth. They discuss how to start small and think big with AI and concrete examples of where it is delivering for Novo Nordisk, such as generating meaningful test data and study builds.
This discussion reflects the views and opinions of Ibrahim Kamstrup-Akkaoui in a personal capacity and does not represent those of Novo Nordisk.
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Does Data Science Require Data Perfection?
Pfizer’s Vice President for Data Monitoring and Management Demetris Zambas joins Richard in the hot seat and shares his fascinating journey through life sciences: from how his childhood experiences of receiving vaccines shaped his values to his contributions to our industry’s leading companies, and everything in between.
They discuss the evolution of data science, the potential applications of AI, and whether we still need to strive for data perfection. Although the tools have changed, the mission and successful traits of a strong data scientist remain consistent — and could soon be enhanced by an AI assistant.
This discussion reflects the views and opinions of Demetris Zambas in a personal capacity and does not represent those of Pfizer.
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The Launch of Boehringer Ingelheim’s One Medicine Program
Nicole Raleigh hosts this special episode on-site from Boehringer Ingelheim’s Human Pharmacology Center in Biberach, Germany. Andrea Kloeble and Daniel Schwenk are part of the team reimagining drug development at Boehringer Ingelheim through the One Medicine Platform.
They explain how their organization strives for medical excellence, and why exponential growth in study data volumes and sources requires a connected technology ecosystem. And Richard is in the guest seat this week to put this transformative initiative into industry context: as he explains, life sciences is no longer willing to accept single-use data.
Unblinded: A Clinical Trial Podcast (formerly The State of Digital Clinical Trials) is a Veeva podcast hosted by Manny Vazquez, Senior Director, Clinical Data Strategy. Manny will be speaking to a series of expert guests from across pharma, biotech, and CROs to discuss their experiences, challenges, and ideas for the future of clinical trials.
Ireland