Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development

Added: Jun 02, 2009 7:51 am Modified: Aug 13, 2009 10:27 amTrack Changes BARDA - Strategic and Technology Science Division

Broad Agency Announcement Synopsis Notice



Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development



The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDAs mission includes managing the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological, and nuclear agents (CBRN), in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the PHEMCE Implementation Plan for CBRN Threats and the National Strategy for Pandemic Influenza. The Implementation Plan for CBRN agents is located on the Assistant Secretary for Preparedness and Response (ASPR) website http://www.hhs.gov/aspr/barda/phemc/index.html and the National Strategy for Pandemic Influenza on the website http://www.pandemicflu.gov.



The Pandemic and All Hazard Preparedness Act (PAHPA) directs BARDA to promote (i) innovations in technologies that may assist countermeasure and product advanced research and development, (ii) research on and development of research tools and other devices and technologies, and (iii) research to promote strategic initiatives. Through this Broad Agency Announcement (BAA), BARDA seeks to advance the technological and scientific advancements of medical countermeasures for biodefense CBRN and emerging infectious disease threats, including pandemic influenza. The PAHPA is located on the ASPR website http://www.hhs.gov/aspr/opsp/pahpa/index.html.



This Broad Agency Announcement (BAA) is specifically designed to promote science and technology advancements of platforms applied to MCM development for the Strategic Science and Technology Division (SSTD) of BARDA and will be open to all responsible Offerors. Specific instructions on the preparation and submittal of offers and administrative actions will be published in the BAA expected to be released on or about 15 June 2009. The Governments intent is to solicit potential advancements in science and technology in the following BARDA SSTD Areas of Interest:



1. Technologies to accelerate evaluation of vaccines and therapeutics.



2. Formulation chemistry, protein stabilization, and vaccine delivery technologies as applied to products in advanced stages of development or to licensed products.



3. Innovative methods in bioprocess development and manufacturing.



4. Methods and technologies to advance development of diagnostic tests for the rapid diagnosis of human infections.



The BARDA SSTD Areas of Interest are designed to target platform technologies focused on (1) product development improvements to enhance the safety, efficacy, and ease of use of MCM, (2) reducing time and cost of MCM development, evaluation, and manufacturing, and (3) advanced development of innovative diagnostic platforms for the rapid detection of priority pathogens. The specific application of the technologies will focus on biodefense (CBRN agents) and emerging infectious disease (EID) threats, including pandemic flu, particularly as applied to candidate products in late stages of product development. BARDA anticipates that demonstration of the utility of these novel platforms in biodefense and EID generating validated data suitable for analysis of candidate products and have direct application to commercial-scale manufacturing or testing processes. The development activities should be fully integrated with regulatory activities associated with product development efforts.



BARDA anticipates awarding multiple contracts and/or cooperative agreements for research and development efforts from this BAA that have sufficient potential for success; are of interest to the Government; and support one or more of the listed BARDA SSTD Areas of Interest.



Please contact the Contracting Officer for additional information.



Contracting Office Address:



Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response (OS/ASPR), Biomedical Advanced Research and Development Authority (BARDA), 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, USA

Added: Jun 02, 2009 7:51 am BARDA - Strategic and Technology Science Division

Broad Agency Announcement Synopsis Notice



Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development



The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDAs mission includes managing the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological, and nuclear agents (CBRN), in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the PHEMCE Implementation Plan for CBRN Threats and the National Strategy for Pandemic Influenza. The Implementation Plan for CBRN agents is located on the Assistant Secretary for Preparedness and Response (ASPR) website http://www.hhs.gov/aspr/barda/phemc/index.html and the National Strategy for Pandemic Influenza on the website http://www.pandemicflu.gov.



The Pandemic and All Hazard Preparedness Act (PAHPA) directs BARDA to promote (i) innovations in technologies that may assist countermeasure and product advanced research and development, (ii) research on and development of research tools and other devices and technologies, and (iii) research to promote strategic initiatives. Through this Broad Agency Announcement (BAA), BARDA seeks to advance the technological and scientific advancements of medical countermeasures for biodefense CBRN and emerging infectious disease threats, including pandemic influenza. The PAHPA is located on the ASPR website http://www.hhs.gov/aspr/opsp/pahpa/index.html.



This Broad Agency Announcement (BAA) is specifically designed to promote science and technology advancements of platforms applied to MCM development for the Strategic Science and Technology Division (SSTD) of BARDA and will be open to all responsible Offerors. Specific instructions on the preparation and submittal of offers and administrative actions will be published in the BAA expected to be released on or about 15 June 2009. The Governments intent is to solicit potential advancements in science and technology in the following BARDA SSTD Areas of Interest:



1. Technologies to accelerate evaluation of vaccines and therapeutics.



2. Formulation chemistry, protein stabilization, and vaccine delivery technologies as applied to products in advanced stages of development or to licensed products.



3. Innovative methods in bioprocess development and manufacturing.



4. Methods and technologies to advance development of diagnostic tests for the rapid diagnosis of human infections.



The BARDA SSTD Areas of Interest are designed to target platform technologies focused on (1) product development improvements to enhance the safety, efficacy, and ease of use of MCM, (2) reducing time and cost of MCM development, evaluation, and manufacturing, and (3) advanced development of innovative diagnostic platforms for the rapid detection of priority pathogens. The specific application of the technologies will focus on biodefense (CBRN agents) and emerging infectious disease (EID) threats, including pandemic flu, particularly as applied to candidate products in late stages of product development. BARDA anticipates that demonstration of the utility of these novel platforms in biodefense and EID generating validated data suitable for analysis of candidate products and have direct application to commercial-scale manufacturing or testing processes. The development activities should be fully integrated with regulatory activities associated with product development efforts.



BARDA anticipates awarding multiple contracts and/or cooperative agreements for research and development efforts from this BAA that have sufficient potential for success; are of interest to the Government; and support one or more of the listed BARDA SSTD Areas of Interest.



Please contact the Contracting Officer for additional information.



Point of Contact(s):



Anthony S. Kram, Contracting Officer

Phone: 202-205-4709

Fax: 202-205-6061

Email: Anthony.Kram@hhs.gov



Kyle Roberts, Contracting Officer (Alternate)

Phone: 202-260-0747

Fax: 202-205-6061

Email: Kyle.Roberts@hhs.gov



Contracting Office Address:



Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response (OS/ASPR), Biomedical Advanced Research and Development Authority (BARDA), 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, USA