Rethinking Rare Disease: Innovation and What's Next

K2 Medical Research and Populace Health on Winning in CNS

In this episode of SCRS Talks, Jimmy Bechtel sits down with Sean Stanton, Founder and CEO of K2 Medical Research, and Christian Burns, Founder and President of Populus Health, to explore how their two organizations are working together to advance CNS drug development. With decades of combined experience across psychiatry, neurology, and neurodegeneration, Sean and Christian discuss what makes CNS trials uniquely challenging, what it takes to earn and maintain trust with sponsors and CROs, and why communication is just as critical as performance metrics. They also share their outlook on the future of the space, from biomarkers and precision health to the growing potential of psychedelics across therapeutic areas, and why CNS research feels less like a job and more like a mission.

The Missing Voice in AI Drug Development

In this episode of SCRS Talks, Jimmy Bechtel sits down with Donna Cryer, Chief Patient Officer at Cryer Health and active FDA patient advocate, to explore the critical difference between patient inclusion and patient leadership in drug development. Drawing on her own lifelong experience as a patient, Donna makes the case for why having patients in real positions of authority is not just a values statement but a strategic necessity, especially as AI becomes more embedded in every stage of the research process. From AI governance and model training to the risks of replacing human experience with simulated data, this conversation challenges the industry to stop treating patients as an afterthought and start building their perspectives into the foundation of how research gets done.

AI at Your Site: Compliance and What It Takes

AI is moving fast, and research sites are feeling the pressure to keep up. But before diving in, there are some foundational questions every site should be asking. Jimmy sits down with Marc Wartenberger, VP of Compliance and Security at CRIO, to break down what a defensible AI validation approach actually looks like, why under-documentation is the most common compliance mistake sites are making right now, and what the January 2026 FDA and EMA joint guidance means for day-to-day site operations. If your site is anywhere on the AI journey, this one is worth your time.

From Reactive to Real-Time: How AI Is Reshaping Clinical Trial Operations

Josh Stent, CEO of Momentum Clinical Research, joins Jimmy Bechtel to share how his 19-site network in Australia and New Zealand is using AI and automation to cut administrative burden, improve data accuracy, and get more time back for patients. From centralized data reporting to automated invoicing and smarter recruitment funnels, this episode breaks down what practical AI adoption actually looks like at the site level.

Rethinking Rare Disease: Innovation and What's Next

The rare disease space is often overlooked, but it may be the most important laboratory we have for the future of medicine. Jimmy sits down with Rob Freishtat, board member of the Foundation for mRNA Medicines, to talk about what is actually driving collaboration between academic institutions and industry, what a changing regulatory landscape means for sites, and why financial viability and patient access are not as opposed as people think. Tune in now.