Successful Drug Device Development Begins At The Earliest Stage

Drug-device combinations generally have two alternative purposes: to enable a new use, indication, or effect; or to extend a product’s life cycle. Each alternative brings a particular set of technology choices and influences the timeline in product development. But both demand a level of coordination and planning — starting at the earliest possible point — that companies often cannot or do not achieve. One large pharma company addressing the challenge is Janssen Research & Development, LLC, one of the pharmaceutical companies of Johnson & Johnson, where Douglass Mead, director of regulatory affairs and medical devices and combination products, leads the regulatory strategy for a drug delivery device team dedicated to parallel development of drug-device combination products.

Janssen recruited Mead in 2006 from the device industry to navigate the regulatory pathways for its new auto-injector combined with large molecule drugs such as monoclonal antibodies (mAbs). As combination product regulations evolved, he recognized the full extent of the Janssen portfolio — about 30 drug-device combinations either on the market or in the pipeline. These included everything from prefilled hypodermic syringes and auto-injectors to transdermal patches, as well as kitted devices such as oral syringes and vaginal applicators. In short order, he was working closely with a new drug delivery group that has grown to about 40 people, consisting equally of medical device and drug delivery/packaging experts, as an operating unit within the company’s drug-development program.