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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. 123

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124 ANIMAL MODELS FOR ASSESSING COUNTERMEASURES 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

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125 APPENDIX D Medical imaging in biocontainment in the context of Animal Rule requirements. Tuesday November 17, 2009 Dr. Bruce Aronow, Scientific Director, Center for Computational medicine, University of Cincinnati College of Medicine 9:00 - 10:00am Virulence networks’ detection and host defense interaction. Dr. Steve Niemi, Director, Center for Comparative Medicine, Massachusetts General Hospital 10:00 - 11:00am The animal as patient: The ICU approach to animal research subjects.

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126 ANIMAL MODELS FOR ASSESSING COUNTERMEASURES 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.