Successful Phase 1 Adaptive Trials- Through the Lens of Clinical Operations, Formulation Development, and Regulatory Compliance
Summary: Conventional manufacturing of dosage forms for small molecule drugs in centralized facilities is not well-suited to meet the needs of adaptive clinical trials for early-phase dose escalation and confirmatory trials. Current approaches for developing finished dosage forms for adaptive phase I trials are limited to simple formulations, owing to the limited understanding of drug products and manufacturing processes in early development. While the centralized approach may be suitable for water-soluble compounds, it may not address issues of challenging molecules, which would need to be overcome using advanced drug delivery technologies.
In this webinar, experts from Catalent and HMR will discuss a unique approach that integrates advanced formulation expertise with on-demand phase I clinical manufacturing, adaptive clinical testing, and regulatory support, to help achieve flexible and efficient first-in-human studies and fast development of challenging molecules.
Participants will discover how a strategic partnership between a contract and development manufacturing organization (CDMO) and contract research organization (CRO) can play a significant role in accelerating clinical trial supply manufacturing in support of an adaptive trial design and reduce clinical development timelines and costs while increasing success rates.