Regulated Nonclinical Studies

Dr. Weaver in the lab.Vaccines, therapeutics and diagnostics result from the direct translation of basic science discoveries to products. While discovery has long been the purview of academic researchers, product development has largely been the work of industry. With a growing need for products to safeguard against biothreats and emerging and re-emerging infectious diseases, combined with a greater emphasis by the National Institutes of Health on product oriented research, academic scientists are becoming increasingly aware of the regulatory requirements associated with product development and product licensure. To address this need, an institutional Office of Regulated Nonclinical Studies was established in 2010, under direction of the Provost/Dean of the School of Medicine, that provides regulatory expertise and infrastructure to support studies that are to be performed under Quality Systems utilizing the Food and Drug Administration (FDA) Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies (21 CFR Part 58) as a reference standard. The mission statement for the Office of Regulated Nonclinical Studies is to provide scientific, regulatory and good laboratory practice oversight and support to research and development programs during planning and conduct of in vitro and in vivo nonclinical studies conducted to support the licensure of biologics.

The Office provides leadership to the scientific community at the University of Texas Medical Branch (UTMB) in the design, conduct and analysis of animal studies to support efficacy of biologics under the FDA’s Animal Rule (21 CFR Parts 314 and 601, Federal Register, May 31, 2002). In accordance with current FDA guidance for industry for the Animal Rule, these studies will be conducted under GLP-based quality plans in facilities that are appropriate for biological containment of pathogens and provide biosafety for personnel. Associated activities include implementation of standardized, well documented and reproducible methods, including assay and equipment qualification/validation. UTMB’s Office of Regulated Nonclinical Studies personnel have regular interactions with the FDA, NIAID, BARDA and other relevant federal regulatory and funding agencies to enhance our ability to defend against biothreats and emerging infectious diseases.

The Office of Regulated Nonclinical Studies contains a Regulatory and Scientific Affairs (RSA) Branch and a Regulatory Operations (RO) Branch that function in parallel to support the conduct and oversight of regulated studies. Scientific and regulatory expertise for the design and conduct of animal model studies is provided by the RSA Director and Study Directors, who supervise a scientific team that supports the development and conduct of the study. The RO Branch is directed by a Registered Quality Assurance Professional (RQAP-GLP) who supervises an independent Quality Assurance (QA) Unit, an archivist, and a document management program. The RO Branch also provides training on the Good Documentation Practices and Writing Standard Operating Procedures. Synergistic efforts supporting regulated studies occur in the Galveston National Laboratory (GNL) and the Animal Resource Center (ARC). The Office of Regulated Nonclinical Studies assists the Sealy Center for Vaccine Development (SCVD) in accomplishing its goals of bringing potential therapeutics and vaccine candidates from the initial basic science and discovery research phase through the preclinical development phase, for products that will be evaluated under traditional approval pathways involving efficacy trials in humans and for products that will be evaluated under the Animal Rule.

For more information on the GNL and Regulated Nonclinical Studies at UTMB click here (PDF).