From Wearables to Real-World Evidence: Drew Schiller on the Future of Life Sciences

Episode Description In this episode of scientifica sessions, we dive into the rapidly evolving world of real-world evidence (RWE) and patient-generated health data (PGHD) with Drew Schiller, Co-Founder and CEO of Validic. As life sciences companies increasingly look beyond traditional clinical trials, Drew shares how data from wearables, remote monitoring devices, and connected health platforms can be used—even by resource-constrained startups—to support medical strategy, evidence generation, and value-based care. The conversation explores how early-stage biotechs and emerging life sciences companies can responsibly harness patient-generated data without massive infrastructure investment or regulatory missteps. Drew offers practical guidance on where PGHD fits within the broader evidence ecosystem, how Medical Affairs and clinical teams can use it effectively, and what leaders need to understand as the line between wellness tools and regulated medical devices continues to blur. Tabari and Drew also discuss the evolving regulatory environment, including the FDA’s recent action related to WHOOP’s Blood Pressure Insights feature, and what it signals for companies integrating wearable and remote monitoring data. The episode highlights how to balance innovation with compliance—and why getting this right is essential for long-term credibility and scalability. Whether you’re building a lean startup or operating at commercial scale, this episode provides concrete strategies for leveraging real-world data to improve patient outcomes, strengthen value narratives, and support modern, value-based care models. What We Covered RWE & PGHD Foundations Defining real-world evidence for resource-limited companies Where patient-generated data fits in the evidence landscape Common misconceptions about collecting and using real-world data Practical Life Sciences Use Cases The most accessible PGHD sources for lean teams Using RWE to inform medical and clinical strategy Opportunities for personalization and continuous insight generation Balancing privacy, interoperability, and evidence quality PGHD, Pharma Strategy & Value-Based Care How patient-generated data supports value-based care models The shift from volume to value—and its impact on evidence strategy Real-world examples of remote monitoring in action Why Medical Affairs and Commercial teams should prioritize PGHD Regulatory Considerations Lessons from the FDA’s WHOOP action Navigating the boundary between wellness tools and medical devices Staying compliant while leveraging continuous data streams The future of life sciences–digital health partnerships Strategic Guidance for Leaders Considerations for CMOs and VPs of Medical Affairs The role of PGHD in value dossiers and HEOR submissions Platform decisions for startups versus larger organizations If this conversation sparked new ideas, subscribe to scientifica sessions for unfiltered conversations with the leaders shaping what’s next in biotech, medtech, and pharma. Contact the show: podcast@kronosscientifica.com Original music featured in this episode: Whirl · A Night in November · Night Walk · Rico Clave · Bubble Trouble · UP! · A Different Cat Episode recorded July 21, 2025. All information is current as of the recording date.