Regulatory Sciences Overview

The U.S. Food and Drug Administration defines Regulatory Science as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products”. The ORNcS Regulatory Science Branch works with US Federal funding agencies, commercial and non-profit pharmaceutical product developers, Contract Research Organizations, and other international scientific and regulatory agencies to design and execute regulated nonclinical studies to develop/refine animal models, test the efficacy of candidate vaccines and therapies, and to develop and evaluate in vitro assays that support those studies.

Our primary focus is supporting the development of medical countermeasures (MCMs) for emerging infectious diseases, utilizing UTMB’s unique biocontainment laboratory facilities - including the Galveston National Laboratory and Shope laboratory - to facilitate licensure of MCMs under non-traditional regulatory pathways such as the US FDA Animal Rule or Accelerated Approval, or for Emergency Use Authorization. Regulated nonclinical studies at UTMB are led by a Study Director appointed by the ORNcS Scientific Director and conducted in accordance with a formal SOP-driven quality system and sponsor approved quality agreements that utilize the 21 CFR 58 Good Laboratory Practice regulations as the reference standard.

The ORNcS Regulatory Science team includes UTMB faculty members with over 50 years of combined experience in biocontainment studies (Biological Safety Levels 2, 3, and 4) and more than 25 years of combined experience in contract work supporting the licensure of MCMs to biological threat agents via the US FDA Animal Rule. These investigators lead a core group of technical staff trained for work on regulated studies in high biocontainment, and work in close partnership with the ORNcS Regulatory Operations, veterinary staff from UTMB’s Animal Resources Center, and other UTMB investigators conducting infectious diseases research.