Preclinical Development – Chemical
2019 PharmSci 360
Design and development of novel drug formats, formulations, and delivery technologies can involve significant deviations from the development process for traditional systemically or orally administered drug products. This presentation will demonstrate the added complexity of development relative to traditional drug products using two case studies of retinal therapeutics: (1) the Port Delivery System for ranibizumab, and (2) Degradable PLGA rods. Via these case studies, the talk will highlight unique challenges such as: troubleshooting novel clinical procedure related challenges with preclinical models, preclinical model selection considerations, immunogenicity and inflammation in the context of long duration preclinical studies, impacts of scaling complex CMC processes through development stages on SA and PKPD.