Boosting Phase 1 Success: A Dedicated Scientific Partner, Accelerated Timelines & Minimal API
Summary: To ensure a successful phase 1 clinical study, it is crucial to carefully plan and lay the essential groundwork for achieving key milestones. These milestones include achieving adequate in vivo drug exposure in glucagon-like peptide (GLP) dose-escalation studies and determining the appropriate clinical dose range and dose forms for phase 1. Achieving these milestones while resolving technical challenges is the key to increasing the likelihood of a clinical trial’s success and progress beyond phase 1.
In this webinar, participants will learn about a comprehensive strategy to streamline development and derisk clinical studies. Experts will focus on the importance of physiologically based pharmacokinetic (PBPK) modeling, formulation, and technology expertise while sparing API and managing funding and timeline challenges. Case studies on navigating these challenges will be shared, providing attendees with insights into the issues that arise across a wide range of challenging molecules in nearly every project. Join this webinar to learn how Catalent’s approach to early-phase drug development, with an emphasis on an accelerated timeline and enhanced developability assessment, can speed up phase 1 readiness and beyond.