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 sa国际传媒官网网页入口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.