The Beat

How Bari Kowal and Regeneron Are Redesigning Clinical Trials for Speed, Access, and Impact

Episode Summary

Accelerating drug development from ten years to one is possible when data, technology, and clinical trial design finally work together. In this episode, Bari Kowal, Senior Vice President of Development Operations & Portfolio Management for Regeneron, discusses how modernizing clinical trials, strengthening data infrastructure, and using AI responsibly can expand patient access and accelerate development. She emphasizes that education is a significant missing link in clinical research and that true progress depends on interoperability rather than flashy standalone tools. Bari highlights the need for clean, structured data and strong partnerships with health systems to integrate genetics, EMRs, and real-world information for more personalized and preventive medicine. She also explores the future of drug development, emphasising the importance of reducing cycle time, fostering regulatory collaboration, streamlining protocols, ensuring site readiness, and simplifying trial complexity while leveraging digital biomarkers effectively. Tune in and learn how thoughtful trial design, better data, and smarter collaboration can reinvent the path from discovery to patient impact.

Episode Notes

About Bari Kowal:

Bari Kowal is a senior biopharmaceutical executive with over 30 years of experience leading global operations, clinical development, and strategic portfolio management. As Senior Vice President at Regeneron, she oversees development operations, enterprise-wide portfolio strategy, risk management, and major technology initiatives, helping guide the company’s continued growth and innovation. Her career spans leadership roles at Pfizer, ICON Clinical Research, Valera Pharmaceuticals, PDL BioPharma, GenVec, and Covance, where she built high-performing teams and drove operational excellence across clinical operations and strategic programs. Bari also serves on the Board of Directors of TransCelerate BioPharma Inc., contributing to industry-wide efforts to streamline and strengthen clinical trial execution. She is known for her governance expertise, collaborative leadership style, and ability to deliver organizational transformation at scale. Bari holds a master’s degree in neuroscience from New York University, with additional academic training from the University of Pennsylvania and Binghamton University.

Things You’ll Learn:

• Expanding access to clinical trials requires educating both patients and physicians, many of whom are unfamiliar with how to engage in research. Better awareness can dramatically increase participation and diversify trial populations.
• Technology alone will not speed up drug development unless systems are connected end-to-end. Interoperability is the real catalyst for reducing inefficiencies across discovery, development, and regulatory submission.
• Clean, structured data is the foundation of meaningful AI adoption in healthcare. Without it, predictive models and trial optimization tools cannot reach their potential.
• Trial complexity is one of the most significant barriers to faster development timelines. Streamlining procedures, reducing unnecessary tests, and learning from regulatory feedback can significantly accelerate progress.
• Sustainable clinical research requires equipping trial sites with greater capacity and support. Even when the right patients are identified, sites must be capable of enrolling and managing them effectively.

Resources:

• Connect with and follow Bari Kowal on LinkedIn.
• Follow Regeneron on LinkedIn and visit their website.