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 recently established, under direction of the Provost/Dean of the School of Medicine, that provides regulatory infrastructure to support studies that are to be performed under Good Laboratory Practice (GLP) (21 CFR Part 58) and Quality Management System (QMS) regulations. The mission statement for the Office of Regulated Nonclinical Studies is to provide scientific, regulatory and good laboratory practice 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.

Development of in vitro and in vivo models to determine purity, potency, stability, safety and toxicity of molecules being developed as human therapeutics requires the implementation of standardized and reproducible methods and documentation practices that support data included in investigational new drug (IND) and biological license applications (BLA) submitted to Regulatory Authorities. Once methods are developed, the Office assists in establishing reproducibility and validation of these methods, including independent Quality Assurance (QA) reviews. The Office also 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 Animal Rule. These studies will be conducted under GLP requirements in facilities that are appropriate for biological containment and safe for those involved. UTMB is a participating member of the Alliance for Biosecurity, a consortium of organizations representing the biologics industry, commercial research institutions and university research programs that interact with the FDA, NIAID, BARDA and HHS to enhance our ability to defend against biothreats and emerging infectious diseases.

The Office of Regulated Nonclinical Studies contains a Scientific and Regulatory Affairs Branch and a Regulatory Compliance Branch that operate 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 Scientific Director of Regulated Nonclinical Studies. The Scientific Director supervises a scientific team that supports the development and conduct of the study. The Regulatory Compliance Branch is directed by a Registered Quality Assurance Professional (RQAP-GLP) who supervises a team that provides the supporting regulatory components necessary to satisfy the GLP regulations, including an independent Quality Assurance (QA) Unit, an archivist, and a document control program. Synergistic efforts supporting GLP compliance occur in the Galveston National Laboratory (GNL) and the Animal Resource Center (ARC). Each facility has a central coordinator that provides 100% of their effort towards building and supporting Quality Management Systems in order to support GLP studies at UTMB. 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, after which a product is then ready to be tested in humans and receives further safety and efficacy testing in clinical trials studies.

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