Achieving Data Quality and Integrity in Maximum Containment Laboratories
Overview
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.
Target Audience
Physicians, nurses, scientists, pathologists, veterinarians, biosafety professionals, quality assurance personnel, regulators, agency reviewers, policy-makers, and sponsors.
Learning Objectives
At the conclusion of this activity, the participant should be able to:
- 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
Jason Barr, M.S. - Contributor
Director, Occupational Health and Safety
National Institutes of Health
Disclosure: Nothing to disclose
Kevin Barrett, B.S.N., R.N. - Planning Committee, Contributor
Registered Nurse of National Institute, Allergy and Infectious Diseases
National Institutes of Health
Disclosure: Nothing to disclose
David Beasley, Ph.D. - Contributor
Professor, Department of Microbiology and Immunology
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Dennis Bente, D.V.M., Ph.D. - Contributor
Associate Professor, Department of Microbiology & Immunology
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Charles Bonapace, Pharm.D. - Contributor
Director, Division of New Drug Study Intefrity
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Trevor Brasel, Ph.D. - Contributor
Assistant Professor, Department of Microbiology & Immunology
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Ricardo Carrion, Ph.D. - Contributor
Professor
Texas Biomedial Research Institute
Disclosure: Nothing to disclose
Zhou Chen, M.D., Ph.D. - Contributor
Lead Pharmacologist
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Carol Clarke, D.V.M., D.A.C.L.A.M. - Contributor
Research Program Manager for Animals, Animal and Plant Health Inspection Service
The United States Department of Agriculture
Disclosure: Nothing to disclose
Ian Crozier, M.D. - Contributor
Medical Affairs Scientist
Frederick National Lab
Disclosure: Nothing to disclose
Lorraine Terrell Davis, B.A. - Planning Committee
Training Specialist II
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Nicolette deVore, Ph.D. - Contributor
Senior Scientist, Center for Biologics Evaluation and Research
The United States Food and Drug Administration
Disclosure: Nothing to disclose
William (Bill) Dowling, Ph.D. - Contributor
Non-Clinical Vaccine Development Leader
Coalition for Epidemic Preparedness Innovations
Disclosure: Nothing to disclose
Melissa Eitzen, M.S., R.Q.A.P.-G.L.P., M.T.(A.S.C.P.) - Activity Director, Contributor
Director, Regulatory Operations
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Coleman Erwin, B.S.N. - Contributor
Training and Research Nurse
United States Army Medical Research Institute of Infectious Diseases
Disclosure: Nothing to disclose
Vaunette Fay, Ph.D., R.N. - Planning Committee
Professor, Cizik School of Nursing
The University of Texas Health Science Center at Houston
Disclosure: Nothing to disclose
Kelly Flint, B.S. - Contributor
Safety and Occupational Health Manager
National Institutes of Health
Disclosure: Nothing to disclose
Simon GP Funnell, Ph.D. - Contributor
Scientific Leader, Quadram Institute Bioscience
Public Health England
Disclosure: Nothing to disclose
Jennifer Goodrich, Ph.D. - Contributor
Deputy Director
National Biodefense Analysis and Countermeasures Center
Disclosure: Nothing to disclose
Bob Gump, B.S., C.M.A.R. - Planning Committee
Biologist, Interdisciplinary Scientist
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Lisa Hensley, Ph.D. - Contributor
Associated Director of Science
National Institutes of Health
Disclosure: Nothing to disclose
Denise Hinton, M.S., R.N. - Contributor
Chief Scientist
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Michael Holbrook, Ph.D. - Contributor
Principal Scientist, National Institute of Allergy and Infectious Diseases – Integrated Research Facility
National Institutes of Health
Disclosure: Nothing to disclose
Anna Honko, Ph.D. - Contributor
Research Associate Professor
Boston University School of Medicine
Disclosure: Nothing to disclose
R.A.D.M., Estella Jones, D.V.M. - Planning Committee, Contributor
Deputy Director, Office of Counterterrorism and Emerging Threats
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Andrew Kocsis, D.V.M. - Contributor
Senior Biocontainment Veterinarian
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Matthew Lackemeyer, M.S. - Contributor
Lead Aerobiologist, National Institute of Allergy and Infectious Diseases – Integrated Research Facility
National Institutes of Health
Disclosure: Nothing to disclose
H. Clifford Lane, M.D. - Contributor
Clinical Director, National Institute of Allergy and Infectious Diseases
National Institutes of Health
Disclosure: Nothing to disclose
Lynda Lanning, D.V.M., D.A.B.T. - Contributor
Toxicologist/Toxicologic Pathologist
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Hanni Lee-Lewis, D.V.M., Ph.D. - Contributor
Veterinary Medical Officer
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Jim Little, M.S. - Contributor
Chief, Non-Clinical Operations
The United States Department of Health & Human Services
Disclosure: Nothing to disclose
Tracy MacGill, Ph.D. - Contributor
Director, Medical Countermeasures Regulatory Science
The United States Food and Drug Administration
Disclosure:
Ownership Interests: AstraZeneca
Employment: PATH, Program Officer, Malaria Vaccine Initiative (spouse) PATH is a public health non-profit.
Thomas Maruna, M.Sc., M.A. - Planning Committee
Senior Scientific Program Manager, Medical Countermeasures Initiative
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Hugh McClure III, B.S. - Contributor
National Expert in Bioresearch Monitoring
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Jayco McCowan, D.B.A. - Planning Committee
Training/Program Manager
The University of Texas Medical Branch
Disclosure: Nothing to disclose
Carolyn Mentzer, B.S., R.Q.A.P.-G.L.P., R.Q.A.P.-G.C.P - Contributor
Chief, Quality Assurance & Regulatory Compliance Office
The United States Army Medical Research Institute of Infectious Diseases
Disclosure: Nothing to disclose
Brent Morse, D.V.M., D.A.C.L.A.M. - Contributor
Animal Welfare Program Specialist, Division of Compliance Oversight
Office of Laboratory Animal Welfare
Disclosure: Nothing to disclose
Gene Olinger, Ph.D. - Contributor
Professor
Kansas City University
Disclosure: Nothing to disclose
Brian O’Shea, Ph.D., C.B.S.P., S.M.(N.R.C.M.) - Contributor
Senior Manager of Biosafety Laboratory – 3 Operations
Pfizer
Disclosure: Nothing to disclose
M. Louise Pitt, Ph.D. - Contributor
Science Advisor
The United States Army Medical Research Institute of Infectious Diseases
Disclosure: Nothing to disclose
Andrea Powell, Ph.D. - Contributor
Pharmacologist
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Janie Russell, B.S., R.A.C., C.Q.E., C.Q.A. - Contributor
Senior Regulatory Affairs Manager of Office of Regulatory Affairs
National Institutes of Health
Disclosure: Nothing to disclose
Daniel Sanford, Ph.D. - Contributor
Research Leader
Battelle
Disclosure: Nothing to disclose
Scott Shearrer, R.B.P. - Contributor
Engineer
MRIGlobal
Disclosure: Nothing to disclose
Brianna Skinner, D.V.M., M.P.H. - Planning Committee
Senior Regulatory Veterinarian of Veterinary Medicine
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Marisa St. Claire, Ph.D. - Contributor
Chief Veterinary Medical Officer of National Institute of Allergy and Infectious Diseases – Division of Clinical Research
National Institutes of Health
Disclosure: Nothing to disclose
Vernon Toelle, Ph.D. - Contributor
Supervisory Consumer Safety Officer
The United States Food and Drug Administration
Disclosure: Nothing to disclose
Mark Williams, Ph.D. - Contributor
Chief, Research Resources
Office of Biodefense, Research Resources and Translational Research
National Institutes of Health
Disclosure: Nothing to disclose
Caroline Zeiss, B.V.Sc., Dip A.C.V.P. & A.C.L.A.M., Ph.D. - Contributor
Professor of Comparative Medicine
Yale University School of Medicine
Disclosure:
Ownership Interests: Moderna, Biontech, Johnson and Johnson
Elizabeth Zumbrun, Ph.D. - Contributor
Study Director and Principal Investigator
The United States Army Medical Research Institute of Infectious Diseases
Disclosure: Nothing to disclose
Physicians
Baylor College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Baylor College of Medicine designates this live activity for a maximum of 24.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nursing
Cizik School of Nursing at UTHealth is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.
The Cizik School of Nursing at UTHealth designates this live activity for a maximum of 20.25 ANCC contact hours. Nursing contact hours will be awarded for successful completion of program components based upon documented attendance and completion of evaluation materials.
Available Credit
- 24.00 AMA PRA Category 1 Credit™
- 20.25 ANCC
- 24.00 Attendance