Academic Development of a Training Program for Good Laboratory Practices in High Containments Environments
To protect our Nation’s security, medical countermeasures must be developed to treat and prevent infections with microorganisms that threaten our Nation’s health. Fourteen 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 rule, which allows the equivalent of human phase III clinical trials to be performed in animal studies when the human studies are not ethical or feasible, is often cited as “the Animal Rule.”
Because of the highly infectious nature of the disease-causing agents, these studies are often performed in high or maximum (BSL3/4) biocontainment laboratories. The logistics of assuring accurate and reliable data as collected and transferred from a BSL3/4 laboratory, conducting the study under regulatory oversight, maintaining animal records equating to clinical case files, characterizing the disease-causing agent, and designing the appropriate study to satisfy the regulatory reviewers that the data is equivalent to the outcome in humans is challenging and complicated.
In order to gain a better understanding of the complexities involved in executing these studies, the FDA and the University of Texas Medical Branch at Galveston (UTMB) have collaborated to design and implement a training program to cross educate sponsors, scientists, veterinarians, quality assurance personnel, regulators, reviewers, and policy-makers to enable the conduct of regulated studies product approval via the Animal Rule.
The four and one-half day training program is offered annually utilizing expert faculty from the Food and Drug Administration, academia, and business and industry. The course includes laboratory activities conducted in mock Biosafety Level (BSL) 2 and BSL-4 training laboratories to emphasize the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL4 laboratory environment. An on-line training module on the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) is included as a course pre-requisite.
Overall Course Objectives:
Principal Investigator: Trevor L. Brasel, Ph.D.
Project Director: Melissa Eitzen, M.S., RQAP-GLP
With support from UTMB’s Laboratory Biosafety Training Program
RFA-FD-12-024: Academic Development of a Training Program for Good Laboratory Practices in High Containments Environments (U24)
Federal Register /Vol. 77, No. 117 /Monday, June 18, 2012 /Notices
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.
Product Development Under the Animal Rule
FDA Guidance for Industry. October 2015
Medical Countermeasures Initiative Fiscal Year 2014 Program Update