Saturday, April 20, 2024
4/20/2024
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 development of RCM drugs is that a traditional human clinical trial is not an option. Therefore, FDA approval of a RCM is done under their Animal Rule (21 CFR 314.600) that requires 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 models 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 an radiation biology suite suitable for 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, 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 also develop domestically bred cynomolgus monkey radiation models thereby eliminating the US dependence on foreign suppliers.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
