Associate Principal Scientist Merck & Co, Inc Kenilworth, New Jersey
The global drug-device combination product market is driven by a growing patient and physician preference for patient-centric treatment options, with an anticipated compound annual growth rate of ~8% from 2022 to 2030. However, drug-device combination products present unique technical, supply chain, and regulatory challenges in development. Additionally, device platforms are increasingly incorporating novel materials and technologies with potential impact to drug product quality and manufacture. Furthermore, devices are often introduced in later stages of development, necessitating robust yet lean and facile approaches to define an integrated control strategy while enabling speed to market. We herein discuss key technical considerations in injectable drug-device combination product development, including best practices for establishing drug product compatibility with new, unique, and difficult device platforms.
Learning Objectives:
Describe the unique considerations in drug-device combination product development
Develop a bridging strategy between early stage and late stage development for combination products
Utilize best practices to robustly establish drug product compatibility with new, unique, and difficult device platforms