HHS PHEMC Enterprise Stakeholder's Workshop 2008
Wednesday, September 24th, 2008 spacer Thursday, September 25th, 2008       spacer Friday, September 26th, 2008
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Opening and Keynote Addresses 8:00 - 9:30 am
Salons III and IV
video Session
Webcast
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Replay
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Robin A. Robinson, PhD
Deputy Assistant Secretary for Preparedness and Response
Director, Office of Biomedical Advanced Research and Development Authority
U.S. Department of Health and Human Services

Introduction of Secretary Michael O. Leavitt by
RADM W. Craig Vanderwagen, MD
Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services


Secretary Michael O. Leavitt
U.S. Department of Health and Human Services

Robert P. Kadlec, MD
Special Assistant to the President for Homeland Security
Senior Director, Biodefense Policy
Homeland Security Council, The Executive Office of the President


RADM W. Craig Vanderwagen, MD
Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services



B R E A K Salons I and II 9:30 - 9:50 am


E X H I B I T S Salons I and II 8:00 am - 7:00 pm

PHEMCE PARTNER EXHIBITS

U.S. DEPARTMENT OF DEFENSE
. Armed Forces Radiobiology Research Institute (AFRRI) .

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
. Centers for Disease Control and Prevention (CDC) Radiation Studies Branch .

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; NATIONAL INSTITUTES OF HEALTH
. Biodefense and Emerging Infections Resource Program, NIAID .
. National Library of Medicine . U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE
. Biomedical Advanced Research and Development Authority (BARDA) .
. www.MedicalCountermeasures.gov .

. U.S. DEPARTMENT OF HOMELAND SECURITY .



BARDA INDUSTRY DAY EXHIBITS

CLEVELAND BIOLABS, INC.
. Single Injection of Novel Radioprotector CBLB502 Rescues Lethally Irradiated Non-Human Primates .

NATIONAL WEATHER SERVICE, NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION
. But I'm Not a Meteorologist: U.S. Public and Private Weather Enterprise Support to the Medical Community .

STATE UNIVERSITY OF NEW YORK AT BUFFALO AND MEDICAL CONSERVATION DEVICES, LLC
. Aseptic Shared Ventilation: An Alternative to Pandemic Ventilator Rationing .


Federal Progress in Medical Countermeasure Preparedness 9:50 am - 12:30 pm
Salons III and IV
video Session
Webcast


Moderator: Carol D. Linden, PhD
Principal Deputy Director, Office of Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services


Jon R. Krohmer, MD, FACEP
Acting Assistant Secretary and Chief Medical Officer
Office of Health Affairs
U.S. Department of Homeland Security


Michael Kurilla, MD, PhD
Director, Office of Biodefense Research Affairs, Division of Microbiology and Infectious Diseases
Associate Director for Biodefense Product Development, National Institute of Allergy and Infectious Diseases
National Institutes of Health
U.S. Department of Health and Human Services


Robin A. Robinson, PhD
Deputy Assistant Secretary for Preparedness and Response
Director, Office of Biomedical Advanced Research and Development Authority
U.S. Department of Health and Human Services


Jean D. Reed, SES
Special Assistant to the Secretary of Defense for Chemical and Biological Defense and Chemical Demilitarization Programs
Office of the Assistant to the Secretary of Defense (Nuclear, Chemical, and Biological Programs)
U.S. Department of Defense


Greg Burel
Director, Division of Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services


Kevin Yeskey, MD
Deputy Assistant Secretary for Preparedness and Response
Director, Office of Preparedness and Emergency Operations
U.S. Department of Health and Human Services



L U N C H    ON    Y O U R    O W N 12:30 - 2:00 pm

BARDA INDUSTRY DAY: Session I 2:00 - 4:00 pm
Salons V Salons VI Jefferson Room

ANTHRAX
THERAPEUTICS



Moderator: Michael A. Balady, PhD, MPH
Director for Acquisition Management Systems;
Office of Biomedical Advanced Research and Development Authority;
U.S. Department of Health and Human Services


2:00 - 2:30 pm
ValortimTM, an Anti-toxin
Monoclonal Antibody,
for the Treatment and
Post-exposure Prophylaxis
of Inhalational Anthrax


Matthew Meldorf, PharmAthene, Inc.






2:30 - 3:00 pm
Development of a Human
Anthrax Immune Globulin
Intravenous (AIGIV)
Therapeutic Agent for
Treatment of Anthrax Disease


Ajoy Chakrabarti, Emergent Biosolutions



3:00 - 3:30 pm
An Immunoadhesin
Therapy for
Inhalation Anthrax


Archana Belle, Planet Biotechnology, Inc.








3:30 - 4:00 pm
Characterization of B. anthracis
Inhalation Model in Cynomolgus
Monkeys and Rabbits for
Evaluation of Therapeutic
Treatment


Thi-Sau Migone, HGSI


VACCINE
INNOVATIONS



Moderator: Gerald R. Kovacs, PhD
Acting Associate Director for CBRN Programs;
Office of Biomedical Advanced Research and
Development Authority;
U.S. Department of Health and Human Services


2:00 - 2:30 pm
Alternative Vaccine Delivery:
Advanced Intranasal Delivery
Platform for Packaging,
Stockpiling and Dispensing
Liquid and Reconstituted
Emergency Vaccines and
Bioterror Countermeasures in
Chaotic and Austere Conditions


Timothy Sullivan, Mystic Pharmaceuticals


2:30 - 3:00 pm
The LT Adjuvant Patch
as a Platform Technology to
Enhance Biodefense Vaccines


Nigel Thomas, Intercell USA, Inc.






3:00 - 3:30 pm
The Broadly Applicable
alphaGal Technology
for Antiviral Vaccines


Ramon Flick, BioProtection Systems Corporation






3:30 - 4:00 pm
Thermo-stabilization to Enable
Extended Ambient Storage
of Viral Vaccines


Andre Habel, Stabilitech Ltd

CHEMICAL, RADIOLOGICAL,
AND NUCLEAR
THERAPEUTICS


Moderator: Ronald Manning, PhD
Branch Chief, Chemical, Radiological, and Nuclear
Medical Countermeasures; Office of Biomedical
Advanced Research and Development Authority;
U.S. Department of Health and Human Services


2:00 - 2:30 pm
Rectal Diazepam in
Nerve Agent Attacks:
Efficacy in Seizure Control
and Cognitive/Behavioral
Recovery


Romy Nocera, Valeant Pharmaceuticals






2:30 - 3:00 pm
Effectiveness of Donepezil,
Rivastigmine and (±)Huperzine-A
in Preventing Soman Acute
Toxicity and Lethalty:
Comparison with Galantamine


Edson Albuquerque,
University of Maryland School of Medicine



3:00 - 3:30 pm
Developing Treatments for
Chemical Weapon Attacks:
The UMDNJ-Rutgers University
CounterACT Research Center
of Excellence


Jeffrey Laskin,
UMDNJ-Robert Wood Johnson
Medical School



3:30 - 4:00 pm
Medical School
Syndrome Resulting from Acute
Exposure to Ionizing Radiation

Lena A. Basile, Neumedicines, Inc.

Medical Countermeasures at the Point of Care 2:00 - 3:00 pm
Salons III and IV
video Session
Webcast


Moderator: Maribeth Love
Deputy Director for Logistics
Office of Preparedness and Emergency Operations
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services


THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS (PREP) ACT
Brian Kamoie, JD, MPH
Deputy Assistant Secretary for Preparedness and Response
Director, Office of Policy, Strategic Planning, and Communications
U.S. Department of Health and Human Services


ADDRESSING END USER QUESTIONS ABOUT THE EMERGENCY USE AUTHORIZATION
CDR Carmen Maher, BSN, MA, RN, RAC
Policy Analyst
Office of Counterterrorism and Emerging Threats
Office of the Commissioner
Food and Drug Administration
U.S. Department of Health and Human Services


Stephen Papagiotas, MPH
Public Health Advisor / Emergency Coordinator
Division of Bioterrorism Preparedness and Response
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services


Susan E. Gorman, PharmD, MS
Associate Director for Science, Division of Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services


REQUESTING FEDERAL MEDICAL COUNTERMEASURE ASSETS
Kevin Yeskey, MD
Deputy Assistant Secretary for Preparedness and Response
Director, Office of Preparedness and Emergency Operations
U.S. Department of Health and Human Services


Greg Burel
Director, Division of Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services


Medical Countermeasures at the Point of Care, Session I   continued 3:00 - 4:00 pm
The Role of Point-of-Care Diagnostics in Triage and Treatment Decisions
Salons III and IV
video Session
Webcast


Moderator: Jerome A. Donlon, MD, PhD

POINT-OF-CARE DIAGNOSTIC NEEDS
FOR CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR THREATS

Jerome A. Donlon, MD, PhD
Chief Science Advisor
Office of Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services


THE INFLUENZA POINT-OF-CARE DIAGNOSTICS EXPERIENCE
Roxanne Shively, MS, MT (SM)
Project Officer
Office of Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services


END USER CONSIDERATIONS
Luciana Borio, MD
Senior Associate
The Center for Biosecurity of the University of Pittsburgh Medical Center
Baltimore, Maryland


REGULATORY PATHS FOR POINT-OF-CARE DIAGNOSTICS
Sally A. Hojvat, PhD
Director, Division of Microbiology Devices
Office of In-vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Food and Drug Administration
U.S. Department of Health and Human Services


QUESTIONS FOR THE PANEL


B R E A K Salons I and II 4:00 - 4:20 pm

BARDA INDUSTRY DAY: Session II 4:20 - 6:00 pm
Salons V Salons VI Jefferson Room

ANTHRAX
THERAPEUTICS
continued


Moderator: Matthew Lawlor, PhD
Program Analyst
Office of Biomedical Advanced Research
and Development Authority
U.S. Department of Health and Human Services



4:20 - 4:45 pm
TR-701: A New
OXAZOLIDINONE Therapeutic
with Activity Against Bacillus
anthracis and a Broad Spectrum
of Clinically Relevant Drug-
Resistant Pathogens


Jeffrey Stein, Trius Therapeutics




4:45 - 5:10 pm
Antisense Screening in
Bacillus anthracis for
Drug Discovery


Karen Shaw, Trius Therapeutics

PLATFORM TECHNOLOGIES
AND
DIAGNOSTICS


Moderator: Dawn Myscofski, PhD, MBA
Deputy Director, Policy, Planning, and
Requirements Division
Office of Biomedical Advanced Research and
Development Authority
U.S. Department of Health and Human Services


4:20 - 4:45 pm
Development of a Clinical Stage
Electroporation Delivery Platform
to Enhance DNA Vaccines


Brian Livingston, Ichor Medical Systems









4:45 - 5:10 pm
Technology Platform for
Rapid Identification of Highly
Pathogenic Viruses

Ida-Maria Sintorn,
Vironova AB



5:10 - 5:35 pm
Point-of-Care and Laboratory
Diagnostics for Detection
of Potentially Pandemic
Influenza Strains


George Sigal,
Meso Scale Diagnostics, LLC




5:35 - 6:00 pm
Rapid Clinical Surge-Testing for
Biodefense and Emerging
Infectious Disease


Don Straus, First Light Biosciences


RADIOLOGICAL
AND NUCLEAR
THERAPEUTICS


Moderator: Joanna M. Prasher, PhD
Senior Policy Analyst
Office of Biomedical Advanced Research and
Development Authority
U.S. Department of Health and Human Services



4:20 - 4:45 pm
Protectan CBLB502 Prevents
and Mitigates Hematopoietic and
Gastrointestinal Acute Radiation
Syndromes by Mobilizing
Multiple Natural Defense
Mechanisms


Andrei Gudkov,
Cleveland BioLabs, Inc. and
Roswell Park Cancer Institute



4:45 - 5:10 pm
SPARED: The Salix Program
of Radioprotector Evaluation
and Development


Christopher Jahraus,
Assurance Oncology Services, LLC



5:10 - 5:35 pm
Nanotherapeutics Inhaled
Gentamicin and Oral DTPA
Programs


James Talton,
Nanotherapeutics, Inc.

Medical Countermeasures at the Point of Care - Session II: 4:20 - 6:00 pm
Rapid Medical Countermeasure Dispensing
Salons III and IV
video Session
Webcast


Moderator: Greg Burel
Director, Division of Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services


FEDERAL PREPARATION AND SUPPORT FOR EMERGENCY COMMUNICATIONS
Gretchen Michael
Communications Director
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services


STRATEGIES AND SUGGESTIONS
Matthew Minson, MD
Senior Medical Officer for Strategic Initiatives
Office of Policy, Strategic Planning, and Communications
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services


DISPENSING AT THE STATE LEVEL: COMMONWEALTH OF VIRGINIA
Robert Mauskapf
State Strategic National Stockpile Planner
Virginia State Department of Health
Richmond, Virginia


THE DEPARTMENT OF HEALTH AND HUMAN SERVICES CHEMPACK PROGRAM
Steven Adams, MPH
Deputy Director, Division of Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services


THE MEDKITS MODEL
Richard Besser, MD
Director
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services


PERSONAL PREPAREDNESS AND ANTHRAX ANTIMICROBIAL MEDKITS
Alan Liss, PhD
Deputy Director, Regulatory and Quality Affairs
Office of the Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services



BARDA Industry Day Poster Session and Networking Reception 6:00 - 7:00 pm
Salons I and II


VACCINES
Agostini H EMERGENT BIOSOLUTIONS
Development of a Trivalent LHN ABE Recombinant Botulinum Vaccine

Aman MJ INTEGRATED BIOTHERAPEUTICS INC.
Advanced Development of a Recombinant Staphylococcal Enterotoxin B (SEB) Vaccine (STEBVax)

Catron D SYNTIRON LLC
Iron-regulated Bacterial Surface Proteins as Broadly Protective Vaccines

Gaal M SAFC PHARMA
Challenges and Strategies for Rapid Construction and Manufacture of Viral Vaccines and Therapeutics

Yokote H THE CHEMO-CERO-THERAPEUTIC RESEARCH INSTITUTE (KAKETSUKEN)
Update of an Attenuated Smallpox Vaccine LC16m8 Research



PLATFORM TECHNOLOGIES
Kincaid R VERITAS, INC.
A Novel, Rapidly Deployable Bacteriophage Vector System for Emergency Preparedness Vaccination

Mann D VASCULAR BIOSCIENCES, INC.
Vascular Pharmacogenomics via Endoarterial Biopsy: A Model for Medical Countermeasures
against CBRN Pulmonary Vascular Injuries

Stephen E DEFENCE R&D CANADA
Defence R&D Canada's Nucleic Acid-Based Anti-Viral Program

Wajid A XOMA (US) LLC
Use of Platform Technologies to Accelerate Development and Production of Antibodies against Botulinum Toxin Type A



DIAGNOSTICS / BIODOSIMETRY / BIOASSAY
Aristarkhov A EXIQON
Systematic Approach for Detection of Radiation Exposure

Colston B QUANTALIFE INC.
Quantitative PCR using Picoliter Droplets

D'Costa S BECKMAN COULTER, INC.
The CD4 Initiative: Enabling the Development of a Simple Point of Care Assay for CD4 Testing in
HIV Infected Individuals in Resource Limited Settings

Gillet D CEA
Application of Different PCR-Based Technologies for Rapid Screening of Botulinum Neurotoxins A,
B, E, F Producing Clostridium Botulinum, Clostridium Baratii, and Clostridium Butyricum



THERAPEUTICS
Armstrong S DSTL
Recombinant Butyrylcholinesterase (rBuChE) Therapy Following VX Poisoning by the Percutaneous
Route: Preliminary Results from Guinea Pig Studies

Benson C ORTHO-MCNEIL-JANSSEN SCIENTIFIC AFFAIRS, LLC
Length of Stay in Hospitalized Community-Acquired Pneumonia (CAP) Patients Treated with
Levofloxacin 750 mg IV or Moxifloxacin 400 mg IV

Kirman I ELUSYS THERAPEUTICS
Pharmacokinetic and Safety Parameters of ETI-204, a Therapeutic Monoclonal Antibody Targeting
Anthrax Protective Antigen (PA)

McCool WS RXBIO, INC.
Rx100 – A Novel Radioprotectant & Radiomitigator

Meldorf M PHARMATHENE, INC.
Efficacy of Intravenous ValortimTM, an Anti-toxin Monoclonal Antibody, in the Treatment of
Inhalational Anthrax in the African Green Monkey Model

Mody S ORTHO-MCNEIL-JANSSEN SCIENTIFIC AFFAIRS
Reduced Length of Mechanical Ventilation in Patients with Ventilator Associated Pneumonia Treated
with Doripenem versus Imipenem

Orschell C INDIANA UNIVERSITY SCHOOL OF MEDICINE
Effect of a Long-lasting G-CSF in Mitigating Lethality in Mice after Exposure of LD20/30 or LD45/30
Dose of Radiation

Pinyerd H IMMUNEREGEN BIOSCIENCES INC.
Viprovex® Enhances Tamiflu® Safety/Efficacy in Influenza A/H3N2 Exposed Cotton Rat

Ramstedt U UNITHER VIROLOGY
Broad Spectrum Antiviral Therapeutic Based on Iminosugar Derivatives

Repine J UNIVERSITY OF COLORADO DENVER HEALTH SCIENCES CENTER
Ergothioneine Treatment for the Acute Respiratory Distress Syndrome

Ruiz A THE UNIVERSITY OF TEXAS AT AUSTIN
Comparison of Levofloxacin 750mg Daily vs. Ceftriaxone 1g plus Azithromycin 500mg Daily for the
Empiric Treatment of Hospitalized Community-Acquired Pneumonia (CAP) Patients

Saward L CANGENE CORPORATION
Correlation of the Immunological Epitopes in the HC50 Region of the Botulinum Toxins with
Neutralizing Potency of the Equine Anti-toxin Antibodies

Toth D CANGENE CORPORATION
Characterization of the Immune Response Profile of an Intravenous Immunoglobulin (Cangene AIGIV)
to Anthrax Lethal Toxin with Correlation to In-Vitro Potency

Wilson C ENDACEA, INC.
Efficacy for L-97-1 as a Medical Countermeasure in a Bioterrorism Animal Model of Pneumonic Plague