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Animal Models for Assessing Countermeasures to Bioterrorism Agents (2011)

Chapter: Appendix D: Presentations to the Committee

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Suggested Citation:"Appendix D: Presentations to the Committee." National Research Council. 2011. Animal Models for Assessing Countermeasures to Bioterrorism Agents. Washington, DC: The National Academies Press. doi: 10.17226/13233.
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Appendix D

Presentations to the Committee

Animal Models for Assessing Countermeasures to Bioterrorism Agents September 17-18 2009

  Thursday, September 17, 2009
1:00 – 2:00 pm TMTI: Mr. Jean Reed, Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense/Chemical Characterization (DATSD (CBD/CD)) and Dr. Richard Jaffe, Senior Medical Advisor, ANSER, INC
  Introduction and sponsor’s needs.
2:00 – 3:00 pm TMTI: Dr. Randall Kincaid, Scientific Director
  The scientific needs and purpose of TMTI; scientific portfolio and animal models.
3:00 – 4:00 pm TMTI: Dr. Heather Wargo
  MCM portfolio and current animal model use.
4:00 – 5:00 pm BARDA: Dr. Thomas Dreier
  Advanced/integrated developer’s needs for animal models.
  Friday, September 18, 2009
8:00 - 10:00 am NIAID: Dr. Michael Kurilla, Director, Office of BioDefense Research Affairs
  The role of NIAID.
12:25 – 1:30 pm NIAID: Dr. Judith Hewitt, Chief, Biodefense Research Resources Section
  Animal models and the NIAID portfolio.
Suggested Citation:"Appendix D: Presentations to the Committee." National Research Council. 2011. Animal Models for Assessing Countermeasures to Bioterrorism Agents. Washington, DC: The National Academies Press. doi: 10.17226/13233.
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Animal Models for Assessing Countermeasures to Bioterrorism Agents November 15-17, 2009

  Sunday, November 15, 2009
1:30 – 2:30pm Dr. Louise Pitt, Director, Center for Aerobiological Sciences, USAMRIID
  GLP studies in biocontainment: Toward Animal Rule licensure_Issues, challenges and humane endpoints.
2:30 – 3:30pm Dr. Thomas Hartung, Director, Center for Alternatives to Animal Testing, Johns Hopkins
  Definition and validation of alternative models.
  Monday, November 16, 2009
9:00 – 10:00am Dr. Kenneth Drake, CEO, Seralogix
  In silico approaches to disease modeling.
10:00 - 11:00am Dr. Rui-Ru Ji, Bristol-Myers Squibb
  Transcriptional dose-response profiling.
11:15am - 12:15pm Dr. Lisa Hensley, Chief, Viral Therapeutics, Virology Division, USAMRIID
  Telemetry uses in BSL facilities and clinical trials.
12:45 – 2:15pm Mr. Robert Brockway, Director, Product Marketing, Data Sciences International
  Advanced telemetry methods in the context of Animal Rule. Respiration and safety pharmacology translational models.
  Dr. Russell Bialecki, Director, Safety Pharmacology North America, AstraZeneca Pharmaceuticals
  Automated PK/PD and metabolic analysis integration with chronic telemetric monitoring in rodent models.
2:15 – 3:15pm Dr. Steven Opal, Director, Infectious Diseases Division, Memorial Hospital of Rhode Island
  Surrogate markers in translational research (where animal to human translation is not an option).
3:15 – 4:15pm Dr. Donald Low, Microbiologist-in-Chief, Mount Sinai Hospital, Toronto, Canada
  Surrogate markers as decision-making tools in clinical medicine.
4:30 – 5:30pm Dr. Charles Lin, Wellman Center for Photomedicine, Massachusetts General Hospital
  Non-biocontainmnet imaging in the context of Animal Rule requirements.
5:30 – 6:30pm Dr. Peter Jahrling, Director, NIAID Integrated Research Facility and Dr. Daniel Mollura, Staff Clinician, NIH Clinical Center, and Staff Scientist, NIAID Integrated Research Facility
Suggested Citation:"Appendix D: Presentations to the Committee." National Research Council. 2011. Animal Models for Assessing Countermeasures to Bioterrorism Agents. Washington, DC: The National Academies Press. doi: 10.17226/13233.
×
Medical imaging in biocontainment in the context of Animal Rule requirements.
  Tuesday November 17, 2009
9:00 - 10:00am Dr. Bruce Aronow, Scientific Director, Center for Computational medicine, University of Cincinnati College of Medicine
  Virulence networks’ detection and host defense interaction.
10:00 - 11:00am Dr. Steve Niemi, Director, Center for Comparative Medicine, Massachusetts General Hospital
  The animal as patient: The ICU approach to animal research subjects.
Suggested Citation:"Appendix D: Presentations to the Committee." National Research Council. 2011. Animal Models for Assessing Countermeasures to Bioterrorism Agents. Washington, DC: The National Academies Press. doi: 10.17226/13233.
×

Animal Models for Assessing Countermeasures to Bioterrorism Agents February 3-5, 2010

  Wednesday, February 3, 2010
9:30 – 11:00 am Dr. Steven Leary, Chair, AVMA Panel on Euthanasia
  Ethical considerations of euthanasia in biodefense research.
  Dr. Steve Niemi, Director, Center for Comparative Medicine,
  Massachusetts General Hospital
  Humane endpoints in infectious diseases and biodefense research.
11:00 am – 12:00 pm Dr. James Roth, Director, Center for Food Security and Public Health, Iowa State University
  Development of biological countermeasures for CBRN agents in animals: Lessons learned.
2:00 – 3:00 pm Dr. Nicholas Vietri, USAMRIID
  Fine-tuning animal models under the Animal Rule.
3:00 – 4:00 pm Dr. Drusilla Burns, FDA
  A conversation about the Animal Rule.
4:00 – 5:00 pm Ms. Hilde Boone, European Medicines Agency
  The European perspective on early approval mechanisms for new drugs.
  Thursday, February 4, 2010
9:00 – 10:00 am Dr. William Smith, Acting Deputy Commander, USAMRICD
  Development and licensure of pyridostigmine bromide under the Animal Rule.
  Dr. Renae L. Malek, Senior Scientist, Medical Identification and Treatment Systems
  Advanced developer Animal Rule perspective.
10:00 am - 12:00 pm Dr. Sally Bolmer, SVP, Human Genome Sciences
  Insights from development of an MCM for anthrax under the Animal Rule.
2:15 – 3:15 pm Dr. Andrew Rowan, EVP, The Humane Society of the United States
  Biodefense research and animal experimentation.
Suggested Citation:"Appendix D: Presentations to the Committee." National Research Council. 2011. Animal Models for Assessing Countermeasures to Bioterrorism Agents. Washington, DC: The National Academies Press. doi: 10.17226/13233.
×
Page 123
Suggested Citation:"Appendix D: Presentations to the Committee." National Research Council. 2011. Animal Models for Assessing Countermeasures to Bioterrorism Agents. Washington, DC: The National Academies Press. doi: 10.17226/13233.
×
Page 124
Suggested Citation:"Appendix D: Presentations to the Committee." National Research Council. 2011. Animal Models for Assessing Countermeasures to Bioterrorism Agents. Washington, DC: The National Academies Press. doi: 10.17226/13233.
×
Page 125
Suggested Citation:"Appendix D: Presentations to the Committee." National Research Council. 2011. Animal Models for Assessing Countermeasures to Bioterrorism Agents. Washington, DC: The National Academies Press. doi: 10.17226/13233.
×
Page 126
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The Transformational Medical Technologies (TMT) has been a unique component of the U.S. Department of Defense (DoD) medical biodefense efforts since 2006. Its mission is to advance countermeasure research and development in support of the broader goal of the DoD to protect warfighters from emerging infectious diseases and future genetically engineered biological weapons. The TMT, using advanced science and technology approaches, focused on the development of roadspectrum countermeasures that target common host and pathogen pathways or enhance the host's immune response. Many of these pathogens are lethal or cause such debilitating diseases in humans that it is ethically inappropriate to test the efficacy of these countermeasures in human volunteers. In lieu of human participants, these products may be tested in animals and approved for human use under the provisions of the Food and Drug Administration (FDA)'s 2002 Animal Rule. The reliance on animal models for the development and licensure of medical countermeasures against biothreats is challenging for a number of reasons.

The ad hoc Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents prepared a consensus report that would address the challenges stemming from developing and testing medical countermeasures against biothreat agents in animal models. Animal Models for Assessing Countermeasures to Bioterrorism Agents evaluates how well the existing TMT-employed or candidate animal models reflect the pathophysiology, clinical picture, and treatment of human disease as related to the agents of interest. The report addresses the process and/or feasibility of developing new animal models for critical biodefense research, placing emphasis on the need for a robust and expeditious validation process in terms of the FDA's Animal Rule. The report also evaluates alternatives to the use of animal models based on the premise of the Three Rs.

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