ARTICLE SUMMARY:
The use of real-world evidence is rapidly increasing throughout medtech. Paul Coplan is spearheading that effort at J&J’s medtech group, which received the first FDA-approved label extension using RWE. In part 1 of a 2-part discussion embracing the breadth of this expansion, we speak with Coplan about J&J’s breakthrough, and global applications—most notably in China.
An unintended benefit of the COVID-19 pandemic was the increased use of remote and virtual technologies that proved beneficial and are likely to remain in place. One other methodology that has been growing dramatically post-pandemic is the use of real-world evidence throughout the life sciences. Medtech, in particular, is looking to capitalize on the advantages that RWE can provide in terms of efficiency and cost savings, most notably in areas like clinical trials and postmarketing surveillance.
Johnson & Johnson has been among the medtech leaders employing real-world evidence, with its MedTech Epidemiology & Real-World Data Science team, led by VP Paul Coplan, ScD. Coplan brings extensive background both in pharma and medtech to this position, where he has been able to apply certain elements of the drug industry’s RWE experience to medical devices. One result has been J&J being the first medtech company to receive an FDA-approved label extension for a product using real-world evidence. That had been a personal goal of Coplan’s, as he describes in this interview.