By Fran DeGrazio, former Chief Scientific Officer, Diane Paskiet, Director Scientific Affairs, and Peggy Frandolig, Sr. Manager Scientific Affairs, West Pharmaceutical Services, Inc.
Drug-device combination products (DDCPs), such as injectables, can consist of a biological product and a device, a drug and a biological product, or a drug, device, and a biological product or simply a drug and a device. DDCPs leverage new technologies that provide many advantages for patients, such as self-administration conveniences and safety, and, for payers, improved adherence. However, DDCPs are complex and challenging to develop.
This white paper examines how to establish a holistic approach to DDCP development and how to assess and manage risk throughout the development and approval process.