# Academic Development of a Training Program for GLP in ABSL 3/4

> **NIH FDA U24** · UNIVERSITY OF TEXAS MED BR GALVESTON · 2020 · $60,000

## Abstract

Project Summary:
To protect our nation's security, medical countermeasures (MCMs) for high consequence
pathogens (HCPs) must be developed to treat and prevent threats to global health. Fifteen years
ago, the United States Department of Health and Human Services Food and Drug Administration
(FDA) published the final rule for New Drug and Biological Drug Products; Evidence needed to
Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or
Feasible (21 CFR Parts 314 and 601, Federal Register, May 31, 2002). The Animal Rule (AR),
as often referenced, states that for drugs/biologics developed to ameliorate or prevent serious or
life-threatening conditions caused by exposure to lethal or permanently disabling toxic
substances, when human efficacy studies are not ethical and field trials are not feasible, FDA may
grant marketing approval based on adequate and well-controlled animal efficacy studies when
the results of those studies establish that the drug is reasonably likely to produce clinical benefit
in humans. Because of the highly infectious nature of HCPs, these studies are often performed in
high or maximum biocontainment (BSL-3/4). The logistics of assuring accurate and reliable data
collected from these environments is challenging. These products are subsequently evaluated
through clinical trials during a public emergency. Data derived from the nonclinical AR studies
and the clinical studies for HCPs are reviewed by FDA and global authorities to draw a regulatory
conclusion; therefore, data quality and integrity are imperative.
 In 2012, the FDA and the University of Texas Medical Branch at Galveston (UTMB) collaborated
to design and implement an education program to cross educate sponsors, scientists,
veterinarians, physicians, nurses, quality assurance personnel, regulators, reviewers, and policy-
makers to enable the conduct of regulated studies supporting product approval via the FDA's AR.
These studies require compliance with the FDA Good Laboratory Practice regulations (21 CFR
Part 58) to the extent practicable in order to assure data quality and integrity. The result was a
robust education program that delivered annual training to 269 registered attendees from 2013-
2017. The FDA and UTMB plan to expand the education program curriculum to include a course
addressing the conduct of HCP clinical trials and also expand the catalog of on-line courses for
distance education of individuals conducting HCP clinical trials at remote sites. Knowledge gained
will address barriers to progress and increase communication between parties involved in the
conduct, policy-making, funding, review, and inspections of studies necessary for the
advancement of MCMs and protection of human health.

## Key facts

- **NIH application ID:** 10062840
- **Project number:** 3U24FD006294-03S1
- **Recipient organization:** UNIVERSITY OF TEXAS MED BR GALVESTON
- **Principal Investigator:** Trevor Brasel
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $60,000
- **Award type:** 3
- **Project period:** 2017-09-05 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10062840

## Citation

> US National Institutes of Health, RePORTER application 10062840, Academic Development of a Training Program for GLP in ABSL 3/4 (3U24FD006294-03S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10062840. Licensed CC0.

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