The Digital Biomarker Breakthrough: Turning Signals Into Surrogates

Digital biomarkers are rapidly moving from experimental endpoints to validated measures capable of transforming drug development and precision medicine. As AI, sensors, and behavioral analytics mature, pharma and techbio companies are building the frameworks to make these signals clinically credible and regulatorily sound. The challenge now lies in standardizing validation, ensuring interoperability, and proving value across R&D, clinical, and commercial domains.

This masterclass explores how leading organizations are integrating digital biomarkers into trial design, regulatory submissions, and post-market evidence generation. Experts will discuss emerging FDA and EMA expectations, evolving payer perspectives, and how to connect signal accuracy with economic and clinical relevance. Attendees will leave with a clear view of how digital biomarkers are reshaping the science, strategy, and sustainability of next-generation therapeutics.

Join us to discuss:

• What validation and evidence frameworks define a regulatory-grade digital biomarker?

• How are digital biomarkers transforming trial design, patient stratification, and outcome measurement?

• How can pharma, techbio, and payers align around standards that make digital endpoints both credible and reimbursable?