As we continue to advance the development of high-value digital endpoints, a common, unifying language is essential. Successful collaboration across different stakeholders and broad adoption across multiple regulatory regions are contingent on scientific conversations where experts can talk to, not past, one another. Regulatory acceptance requires that we don’t abandon the scientific lexicon that has served us so well for decades of safe and successful drug development.
So how do we avoid getting trapped in a digital Tower of Babel as we advance digital endpoints for use in drug development? Join experts from EMA, FDA, and the life science and med-tech industries as they discuss the lingua franca that binds them. Referencing the digital health glossaries from the Digital Medicine Society (DiMe) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), these experts will debunk some of the language trends that have caused confusion – that’s right, not everything we measure digitally is a biomarker! – and share case examples illustrating how core scientific concepts, appropriately articulated using the right scientific terms, have powered outsized success in digital endpoint development and deployment.
