Integrating Advanced Formulation Expertise with On-Demand Phase 1 Clinical Manufacturing and Adaptive Clinical Testing
Summary: Conventional manufacturing of dosage forms for small molecule drugs in centralized facilities is not well-suited to meet the need of adaptive clinical trials for early-phase dose escalation and confirmatory trials. Current approaches for developing finished dosage forms for adaptive Phase 1 trials are limited to simple formulations, owing to the limited understanding of drug products and manufacturing processes in early development. While this approach may be suitable for water-soluble compounds, it may not address the issue of challenging molecules that would need advanced drug delivery technologies. In this webinar experts will discuss a unique approach that integrates advanced formulation expertise with on-demand Phase 1 clinical manufacturing, adaptive clinical testing, statistical and regulatory support to help achieve flexible and efficient First-in-Human studies and fast development for challenging molecules. Webinar in collaboration with Bionow