Over the past few years, the FNIH Biomarkers Consortium has launched a series of Digital Measures Workshops designed to bring regulators, payers, and patients together to streamline digital measure development and implementation processes. The first workshop, which was conducted in February 2020, was instrumental in helping the U.S. Food and Drug Administration (FDA) bring forward the Innovative Science and Technology Approaches for New Drugs (ISTAND) program. The workshop also helped the FDA redefine its nomenclature around digital health and biomarkers and focus on digital measures.

More recently, the FNIH Biomarkers Consortium hosted its second digital measures workshop last September in Zurich, Switzerland, with a goal of emphasizing patient-centricity in shaping and improving how digital measures are identified, designed, and implemented. This workshop established a global footprint for FNIH and its partners, engaging the European Medicines Agency (EMA) and other international partners in a way that hadn’t been previously possible.

“Through our history, the FNIH has defied the status quo by using its unique position to create stronger relationships between FDA and industry,” explained Dana Connors, Director, Cancer Research Partnerships, FNIH. “We continue that trend now by bringing NIH, FDA, and EMA to the same table. Through the Digital Measures Workshops, we are designing an opportunity to build stronger bridges between patients, regulators, industry, and payers than has ever existed before.”

Looking forward, as part of the 2023 workshop, the FNIH is hoping to convene a remarkable 150-250 people, including patients, companies, regulators, NIH researchers, technologists, and more. FNIH will provide the critical link between NIH, regulators, and industry to ensure that all players have a seat at the table, that patients are included, and that the field can collectively identify processes and checks so that digital health leads to useful tools, not just more gadgets.