Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 123
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
OCR for page 124
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
OCR for page 125
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.
OCR for page 126
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.
