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. |
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 |
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. |
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. |