Achieving Data Quality and Integrity in Maximum Containment Laboratories

June 14, 2021 to June 18, 2021

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
Course summary
Available credit: 
  • 24.00 AMA PRA Category 1 Credit™
  • 20.25 ANCC
  • 24.00 Attendance
Course opens: 
06/01/2021
Course expires: 
10/31/2021
Event starts: 
06/14/2021 - 9:00am
Event ends: 
06/18/2021 - 2:00pm
Rating: 
0
Virtual
Galveston, TX
United States

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
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