Zhaoyang Li
Director Clinical Pharmacology at Sanofi , USA
Title: Practical considerations in clinical strategy to support the development of biologics device combination products
Biography
Biography: Zhaoyang Li
Abstract
Over the past thirty years, biotechnology products have grown enormously, becoming the main stream of targeted therapeutic agents and promising to bolster the future treatment options for challenging and rare diseases. This increasing trend of developing biologics has boosted intensive efforts in developing various types of biologics-device combination (BDC) products, in which the primary mode of action (PMOA) is from the biological agent. The development of a BDC product is an intricate and evolving process, from the drug substance to the final delivery system, and can take multiple iterations at any of the steps. These iterations could involve changes in cell line, manufacturing site, formulation, primary container, or safety features. Moreover, because of the complexity of the work involved and the high investment required, the commercial target dosage form(s) may not be available by the time the pivotal trials commence. These changes, occurring at different stages of a BDC product development, can present substantial challenges and often require a scientifically sound and robust clinical bridging strategy before they can be introduced into the clinic safely and efficiently.