HHS PHEMC Enterprise Stakeholder's Workshop 2008
Wednesday, September 24th, 2008 Thursday, September 25th, 2008 Friday, September 26th, 2008
A NATION PREPARED 8:00 - 9:00 am
Public Health Emergency Medical Countermeasure
Response at the Federal, State, and Local Levels
Salons III and IV
Session
Webcast

Replay
8:00-9:00am &
9:00-10:00am		 Click Here For Technical Support


KEYNOTE ADDRESS
on
PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES RESPONSE
by

Tevi D. Troy, PHD
Deputy Secretary
U.S. Department of Health and Human Services

A NATION PREPARED: Public Health Emergency Medical Countermeasure Response at the Federal, State, and Local Levels

Moderator: Gerald W. Parker, DVM, PhD, MS
Principal Deputy Assistant Secretary
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services

HHS SUPPORT FOR STATE MEDICAL COUNTERMEASURE PREPAREDNESS
Stephanie M. Dulin, MBA
Chief, Program Preparedness Branch; 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

LOCAL PUBLIC HEALTH PREPAREDNESS
Jack Herrmann, MSEd, NCC, LMHC
Senior Advisor, Public Health Preparedness
National Association of County and City Health Officials (NACCHO)
Washington, DC

CONCERNS AND INFORMATION NEEDS OF THE GENERAL PUBLIC
Steven M. Becker, PhD
Associate Professor of Public Health
Vice Chair, Department of Environmental Health Sciences
The University of Alabama at Birmingham


Strategies and Suggestions for 9:00 - 10:00 am
Developing and Sustaining a Biodefense Industry
Salons III and IV
Session
Webcast

Replay
8:00-9:00am &
9:00-10:00am		 Click Here For Technical Support


Moderator: 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

Thomas V. Inglesby, MD
Deputy Director and Chief Operating Officer
The Center for Biosecurity of the University of Pittsburgh Medical Center; Baltimore, Maryland

Patrick J. Scannon, MD, PhD
Executive Vice President, Chief Biotechnology Officer
XOMA (US) LLC; Berkeley, California

Sara Radcliffe, MPH, MP
Vice President, Science and Regulatory Affairs
Biotechnology Industry Organization (BIO); Washington, DC

QUESTIONS FOR THE PANEL


B R E A K Salons I and II 10:00 - 10:20 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 .


Progress and Path Forward for BARDA 10:20 am - 12:00 pm
Salons III and IV
Session
Webcast

Replay
10:20-12:00pm
12:00-12:30pm		 Click Here For Technical Support


Moderator: Monique K. Mansoura, PhD
Director of Policy, Planning, and Requirements Division
Acting 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

WORKING AS AN INDUSTRY PARTNER WITH BARDA
Paul Chaplin, PhD
Executive Vice President, Research and Development and Chief Science Officer
Managing Director, Bavarian Nordic GmbH; Martinsried, Germany

James T. Matthews, PhD
Senior Director, Public Policy, Science and Health Policy; sanofi pasteur; Washington, DC

James H. Davis, PhD, JD
Executive Vice President and General Counsel; Human Genome Sciences; Rockville, Maryland

THE BARDA STRATEGIC PLAN
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


National Biodefense Science Board 12:00 - 12:30 pm
Salons III and IV
Session
Webcast

Replay
10:20-12:00pm
12:00-12:30pm		 Click Here For Technical Support


Moderator: Patricia Quinlisk, MD, MPH
Chairperson, National Biodefense Science Board (NBSB)


MARKETS AND SUSTAINABILITY
MG John S. Parker, MD, FACS, FCCP (U.S. Army, Retired)
Member, National Biodefense Science Board
Chairperson, NBSB Markets and Sustainability Working Group

MEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT PROCESSES
Patrick J. Scannon, MD, PhD
Member, National Biodefense Science Board
Chairperson, NBSB Medical Countermeasure Research and Development Processes Working Group

PANDEMIC INFLUENZA
Andrew T. Pavia, MD
Member, National Biodefense Science Board
Chairperson, NBSB Pandemic Influenza Working Group; Co-Chairperson, NBSB Personal Preparedness Working Group

DISASTER MENTAL HEALTH
Patricia Quinlisk, MD, MPH
Chairperson, National Biodefense Science Board
Chairperson, NBSB Disaster Mental Health Subcommittee

Summary Remarks
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


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

BARDA INDUSTRY DAY: Session III 2:00 - 4:00 pm
Salons V Salons VI

PANDEMIC INFLUENZA
MEDICAL COUNTERMEASURES


Moderator: Michael L. Perdue, PhD
Acting Director, Division of Influenza and Emerging Diseases
Office of Biomedical Advanced Research and Development Authority
U.S. Department of Health and Human Services

2:00 - 2:30 pm
Host-Targeted Protection from Pandemic
Influenza, SARS and other Respiratory Threats
with Hiltonol® (Poly-ICLC) Nasal Spray: Broad
Spectrum Activation of Mucosal Innate and
Adaptive Immunity in Mice and Humans

Andres Salazar, Oncovir, Inc.


2:30 - 3:00 pm
Update on Development of Fludase®
as a Broad-Spectrum Therapeutic and
Prophylactic Agent for Pandemic Influenza


David Wurtman, NexBio, Inc


3:00 - 3:30 pm
Novel Methods for Mediating
Hypercytokinemia in
Influenza A (H5N1) Infections


Jose I. Saldana,
National Heart and Lung Institute, Imperial College London


3:30 - 4:00 pm
A System for Rapid Production
of Medical Countermeasures

Vidadi Yusibov,
Fraunhofer USA CMB
VACCINES


Moderator: Gary L. Disbrow, PhD
Chief, Smallpox Vaccines and Therapeutics
Office of Biomedical Advanced Research and Development Authority
U.S. Department of Health and Human Services

2:00 - 2:30 pm
The Development of a Safer
Smallpox Vaccine Suitable for Use in
Healthy and Immune Suppressed People

Paul Chaplin, Bavarian Nordic






2:30 - 3:00 pm
Current Status of BioThrax
(Anthrax Vaccine Adsorbed)
Enhancement Programs

Gary Nabors, Emergent BioSolutions, Inc.



3:00 - 3:30 pm
Efficient and Versatile Pan-Filo Vaccine
is 100% Effective as a Biodefense Vaccine
Against Ebola and Marburg Viruses

John Y. Dong, GenPhar, Inc.




3:30 - 4:00 pm
A Pan-Filovirus Vaccine Based on
Virus-like Particles (VLPs) against
Ebola and Marburg Virus Infection

Kelly Warfield, Integrated Biotherapeutics, Inc.


Medical Countermeasures at the Point of Care - Session III: 2:00 - 4:00 pm
Responding to a Radiological or Nuclear Event
Salons III and IV
Session
Webcast

Replay		 Click Here For Technical Support


Moderator: C. Norman Coleman, MD
Associate Director, Radiation Research Program, National Cancer Institute
Senior Medical Advisor and Chief of the CBRN Team, Office of Preparedness and Emergency Operations
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services

NATIONAL RESPONSE PLANNING FOR A RADIOLOGICAL OR NUCLEAR EVENT
B. Tilman Jolly, MD
Associate Chief Medical Officer for Medical Readiness
Office of Health Affairs
U.S. Department of Homeland Security

FEDERAL AND STATE COORDINATION FOLLOWING AN EVENT
Robert C. Whitcomb, Jr., PhD, CHP
Senior Scientific Advisor, Radiation Studies Branch
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services

C. Norman Coleman, MD
Associate Director, Radiation Research Program, National Cancer Institute
Senior Medical Advisor and Chief of the CBRN Team, Office of Preparedness and Emergency Operations
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services

CITY PREPAREDNESS EFFORTS
Katherine Uraneck, MD
Senior Medical Coordinator
Healthcare Emergency Preparedness Program
New York City (New York) Department of Health and Mental Hygiene

COUNTY PREPAREDNESS EFFORTS
Glen K. Tao, PharmD
Pharmacy Services Chief, Strategic National Stockpile Coordinator
Emergency Preparedness and Response Program
County of Los Angeles (California) Department of Public Health

HOSPITAL PREPAREDNESS EFFORTS
Mark S. Smith, MD, FACEP
Chairman, Division of Emergency Medicine
Director, ER One
Washington Hospital Center; Washington, DC


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

BARDA INDUSTRY DAY: Session IV 4:20 - 6:00 pm
Salons V Salons VI

PANDEMIC INFLUENZA VACCINES


Moderator: Sheng Q. Li, DVM
Project Officer, Pandemic Influenza Program
Office of Biomedical Advanced Research and Development Authority
U.S. Department of Health and Human Services

4:20 - 4:45 pm
Depot Formulations for a
Single Dose Pandemic Influenza Vaccine

Marc Mansour,
ImmunoVaccine Technologies, Inc.


4:45 - 5:10 pm
Rapid and Efficient Production
of Potent Influenza Vaccines

Alan Shaw,
VaxInnate Corporation





5:10 - 5:35 pm
Live Attenuated Influenza Vaccine —
A Viable Solution to Meet US Pandemic
Preparedness Goals!


Alan Taggart
MedImmune


5:35 - 6:00 pm
Development of Alphavirus Replicon
Vaccines Against Biological Threat Agents

Jonathan Smith,
AlphaVax, Inc.
THERAPEUTICS


Moderator: Kevin Gilligan, PhD
Branch Chief, Antiviral Drugs Pandemic Influenza
Office of Biomedical Advanced Research and Development Authority
U.S. Department of Health and Human Services

4:20 - 4:45 pm
Discovery and Development of
Antiviral Drugs for Biodefense

Dennis Hruby,
SIGA Technologies


4:45 - 5:10 pm
IC14 is a Potential Countermeasure
for Serious CBRN and Public Health
Threats Including Pandemic Flu,
Blast Injury and Bioterrorism

Timothy Axtelle,
Implicit Bioscience, Inc.


5:10 - 5:35 pm
A Rapidly Responsive Platform
for Antiviral Therapeutics Using
Multi-targeted siRNA Cocktail Against
High-Pathogen Viral Infection

Patrick Lu,
Sirnaomics, Inc.



Medical Countermeasures at the Point of Care - Session IV: 4:20 - 6:00 pm
Issues in a Radiological or Nuclear Event
Salons III and IV
Session
Webcast

Replay		 Click Here For Technical Support


Moderator: Richard J. Hatchett, MD
Associate Director for Radiation Countermeasures Research and Emergency Preparedness
National Institute of Allergy and Infectious Diseases
National Institutes of Health
U.S. Department of Health and Human Services

STRATEGIC NATIONAL STOCKPILE RESOURCES
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

TREATMENT DECISIONS FOLLOWING A RADIATION EVENT
CAPT Judith L. Bader, MD
Senior Medical Advisor
Office of Preparedness and Emergency Operations
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services

MEDICAL COMMUNITY PERCEPTIONS, CONCERNS, AND REACTIONS
TO A RADIATION EVENT
Steven M. Becker, PhD
Associate Professor of Public Health
Vice Chair, Department of Environmental Health Sciences
The University of Alabama at Birmingham

BIOASSAYS FOR TREATMENT DECISIONS
Robert L. Jones, PhD
Chief, Inorganic and Radiation Analytical Toxicology Branch
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services

BIODOSIMETRY NEEDS FOR TRIAGE AND POPULATION MONITORING
Ronald Manning, PhD
Project Officer and Branch Chief, Chemical, Radiological, and Nuclear Medical Countermeasures
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

LONG-TERM HEALTH NEEDS FOLLOWING A RADIATION EVENT
Robert C. Whitcomb, Jr., PhD, CHP
Senior Scientific Advisor, Radiation Studies Branch
Centers for Disease Control and Prevention
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