UTMB and FDA Educational Collaboration Training Program
Achieving Data Quality and Integrity in Maximum Containment Laboratories Course
Course Dates: April 8 - 12, 2019
Background
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. For additional background information, visit official FDA Course Website.
Overall Course Objectives:
- Determine requirements needed to conduct high quality studies to develop appropriate Medical Countermeasures (MCMs);
- Identify criteria used to evaluate MCMs in animal models that reflect human disease;
- Examine modern methods to comply with data quality standards when conducting animal studies in maximum containment.
Principal Investigator: Trevor L. Brasel, PhD
and Melissa Eitzen, MS, RQAP-GLP; With support from UTMB's National Biocontainment Training Center
References:
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
http://www.gpo.gov/fdsys/pkg/FR-2012-06-18/pdf/2012-14741.pdf
FDA Medical Countermeasures Initiative Fiscal Year 2013 Program Update
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.
http://www.fda.gov/ohrms/dockets/98fr/053102a.htm
Product Development Under the Animal Rule
FDA Guidance for Industry. October 2015
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM399217.pdf
Medical Countermeasures Initiative Fiscal Year 2014 Program Update
http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/AboutMCMi/ucm450804.htm