by Dr. Christopher Scull
Academic medical centers have traditionally relied on the pharmaceutical industry to perform preclinical studies for new drugs because of the tremendous resources required for FDA-regulated work. However,industry sponsors are now demanding more preclinical work from academic scientists before entering partnerships fordrug development. The result of this shift is an increased demand for FDA-regulated preclinical studies that are compliant with regulations for Good Laboratory Practices (GLP). By establishing in-house GLP testing facilities, academic centers can streamline drug development and perform studies at a much lower cost than contracting work with outside labs. Implementation of a GLP-compliant program, however, is fraught with challenges. Even the newest animal care facilities may not be properly equipped for GLP compliance, and animal care staff are frequently unaccustomed to the increased scrutiny and documentation that are required by the FDA. This session will review the FDA requirements for GLP-compliant animal studies, and discuss the current challenges in preparing for FDA audits and training staff to work in a GLP environment.