cGMP Manufacturing at the CRU: Driving Efficiency for Early Phase I and Human AME Studies

Cost is a major factor in executing a clinical trial. Sponsors are continually seeking ways to reduce their financial risk in early Phase I and human absorption, metabolism and excretion (hAME) studies. Beginning a full CMC campaign only to have to cancel it or change formulation based on late toxicology results or safety data can add expensive delays. Regulatory changes are also impacting Phase I drug manufacture, where on-site cGMP capability can offer solutions in meeting the requirements while still being nimble with costs and timeline. In these pivotal early Phase I studies, sponsors need timely access to key data to ensure quality of their manufacturer drug project. Clinical research units (CRUs) with in-house cGMP pharmacies are helping streamline the process and trim drug manufacturing costs, especially for challenging studies that required AME. Watch this recorded webinar to learn about the requirements of hAME studies, regulatory oversight in the U.S., and the role of the cGMP pharmacy to minimize risk during production. You will learn how CRUs with cGMP pharmacies compare to "traditional" CRUs, and hear more about the process timeline from formulation decision to clinical preparation and dosing.