2007 Biomedical Advanced Research and Development Authority (BARDA)

WHERE:

Fairmont Washington DC, 2401 M Street, NW, Washington, DC 20037

WHEN:

August 3, 2007

MEETING REPORT:

2007 BARDA Industry Day Report

WHY:

The goal of the 2007 BARDA Industry Day is to provide an open forum for companies interested in working with the Federal Government to showcase technological advances in medical countermeasures to manmade and naturally occurring threats. Representatives from companies who have registered as presenters will demonstrate the progress of current activities in advanced research and development of medical countermeasures that will contribute to the success of the HHS Pandemic Influenza Plan, Project BioShield, BARDA, and the HHS PHEMCE Strategy and Implementation Plan.

The 2007 BARDA Industry day will consist of concurrent breakout sessions on the following topics: vaccines, therapeutics, medical diagnostic products, and non-pharmaceutical countermeasures. During these breakout sessions, industry stakeholders will present their product information to representatives from throughout the federal government, international agencies, industry, and academia

HHS looks forward to receiving valuable input from all participants during the HHS BARDA Industry Day.

ATTENDEES:

The 2007 HHS BARDA Industry Day is an open meeting designed to provide a forum for representatives from relevant industries, academia, federal agencies and, international agencies who have an interest in working with the Federal Government in support of the HHS Pandemic Influenza Plan, the HHS PHEMCE Strategy and Implementation Plan, and Project BioShield.

BARDA:

BARDA will incorporate all the programs, mission responsibilities and organizational functions previously housed in the Office of Public Health Emergency Medical Countermeasures, which will be subsumed in the reorganization process. The BARDA office will manage Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, nuclear agents, as well as manage the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield.

HHS PANDEMIC INFLUENZA PLAN:

The National Strategy for Pandemic Influenza (November 2005) designates HHS as the lead agency for public health and medical response for pandemic preparedness and response. Effective implementation of the HHS Pandemic Influenza Plan relies on support from partners throughout HHS, other federal, state, and local governmental agencies, and industrial partners. BARDA is responsible for implementing several key goals of the HHS Pandemic Influenza Plan.

HHS PHEMCE STRATEGY and IMPLEMENTATION PLAN:

HHS, through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), has developed a Strategy and an Implementation Plan to efficiently integrate the requirements for, and the advanced development and acquisition of, medical countermeasures for CBRN threat agents. The first stage was the development of the HHS PHEMCE Strategy for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Strategy), which was published in the Federal Register on 20 March 2007 and is consistent with the principles expressed by the White House in Medical Countermeasures against Weapons of Mass Destruction .

The second stage was development of the HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological, and Nuclear Threats. The HHS PHEMCE Implementation Plan is a prioritized plan with near-term (FY07-08), mid-term (FY09-13) and long-term (FY14-23) goals for research, development, and acquisition of medical countermeasures that is consistent with the guiding principles and priority setting criteria defined in the HHS PHEMCE Strategy. The HHS PHEMCE Implementation Plan is supported by a number of HHS funding streams, including NIH biodefense research and development, advanced development monies, Strategic National Stockpile resources, and the Special Reserve Fund authorized under Project BioShield. It was published in the Federal Register on 23 April 2007.

PROJECT BIOSHIELD:

The Project BioShield Act of 2004 (Project BioShield) was enacted to accelerate the acquisition and availability of safe and effective medical countermeasures to protect the United States from CBRN threats. Project BioShield created a $5.6 billion Special Reserve Fund for use over 10 years (FY 2004 - FY 2013) to acquire medical countermeasures for the Strategic National Stockpile.