C06OD032021

Radiobiology Research Suite Expansion of the Trimetis GLP Vivarium at UTHSC

There is no radiation medical countermeasure (RCM) drug approved by the FDA that meets the criterion of a gastrointestinal (GI) or lung radiomitigator – an agent that mitigates GI acute radiation syndrome (GI-ARS) or lung-ARS when administered after the exposure. A critical barrier to progress in the development of RCM drugs is that a traditional human clinical trial is not an option. Therefore, FDA approval of an RCM is done under their Animal Rule (21 CFR 314.600) that requires a detailed understanding of its mechanism of action, demonstration of safety and efficacy in animal models, including nonhuman primates (NHP), and its safety in humans.

The recent withdrawal of Altasciences Corp., the only GI-ARS qualified contract research organization from RCM preclinical testing, has created a critical shortage and a national strategic vulnerability in qualified drug development sites in the USA. Although the NIH, DOD, BARDA, NASA, and several pharmaceutical companies are intensively pursuing RCM development projects, there is no domestic test site currently available with an established and validated NHP model for the evaluation of RCM drug candidates, particularly for GI-ARS. This is compounded by the US dependence on foreign (PR Chinese) suppliers of rhesus macaques.

The University of Tennessee Health Sciences Center (UTHSC) has a unique resource: the Trimetis Life Sciences Animal Facility (TAF). Since 2016, TAF has been operated and managed by UTHSC under its PHS assurance and AAALAC accredited program. The TAF is a state-of-the-art vivarium housing small- and large-animals, including nonhuman primates, operated under FDA-approved Good Laboratory Practice (GLP), thereby meeting the needs of academic and industry researchers both regionally and nationally.

The purpose of this proposal is to equip TAF with a radiation biology suite suitable for the development of radiation countermeasure (RCM), radioprotective, and radiosensitizer drugs under the Animal Rule. Installation of an irradiation suite at TAF will have a significant impact beyond the needs of RCM drug development: it will be optimal for the evaluation of radiotherapy sensitizers for cancer treatment, including general preclinical research, and drug testing with toxicology and pharmacokinetic studies.

The UTHSC-owned Plough Center for Sterile Drug Delivery, where GMP manufacturing and compounding of test articles is done, and the Regional Biocontainment Laboratory, where GLP radiation injury rodent models have already been in operation, are within a few hundred feet of the TAF and provide an unparalleled comprehensive drug development infrastructure that will meet all national academic and industry research and drug regulatory approval needs. The new state-of-the-art facility will also develop domestically bred cynomolgus monkey radiation models, thereby eliminating the US dependence on foreign suppliers.

University Of Tennessee

NOT APPLICABLE

93.352 - Construction Support

National Institutes of Health (NIH) [HHS]

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Memphis, Tennessee 38163 United States

Single Zip Code

Biomedical Research Facilities (C06 Clinical Trial Not Allowed) (PAR-21-139)

Amendment Since initial award the End Date has been shortened from 05/31/26 to 07/31/23 and the total obligations have decreased 100% from $3,115,346 to $0.