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

Awarded Award Notice Posted

Solicitation number
BARDA-BAA-12-100-SOL-00013
Agency
Immediate Office of the Secretary Department of Health and Human Services
Awarded
to DNA Electronics, Inc.
Set-aside
No set-aside

Opportunity facts

Contract number
HHSO100201400015C Federal IDV award
NAICS code
541711 Research and Development in Biotechnology
PSC
Not on record

Notice details come from SAM.gov. Updated .

Notice text

6 versions

Update #6 · Latest ·

Added: Oct 01, 2014 1:47 pm This contract is for the clinical development of AB103, a CD28 co-stimulatory receptor antagonist, in patients diagnosed with necrotizing soft tissue infections (NSTI).

Update #5 ·

Added: Mar 19, 2012 9:35 am Modified: Jan 18, 2013 3:17 pmTrack Changes The presentation slides from Multi-BAA Pre-Proposal Conference which was held on July 16, 2012 in Washington DC are included as an attachment to this solicitation.

The mission of the Biomedical Advanced Research and Development Authority (BARDA) is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. BARDA funding bridges the "valley of death" characterizing the late stages of product development. BARDA's support ensures continuity of funding at a critical point for medical countermeasures developed by industry or emerging from the basic research and preclinical development activities sponsored by the National Institutes of Health (NIH). In procuring medical countermeasures for the Strategic National Stockpile, BARDA enhances the capabilities of the Centers for Disease Control and Prevention (CDC) to organize an effective response.

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. The 2011 BARDA Strategic Plan defines BARDA's vision and lays out a series of capability goals over a five year period (2011-2016). Amongst BARDA's guiding principles is supporting the development of novel platform technologies that provide flexible systems for the production of medical countermeasures against a variety of threats. Through this Broad Agency Announcement (BAA), BARDA seeks to address, in part, BARDA's Goal 4, responsive and nimble programs and capabilities to address novel and emerging threats, as well as support the technological and scientific advancements of medical countermeasures for biodefense and pandemic influenza. The PAHPA and BARDA Strategic Plan are located on the ASPR website: http://www.phe.gov/Preparedness/legal/pahpa/pages/default.aspx and http://www.phe.gov/about/barda/Pages/2011barda-stratplan.aspx.


This Broad Agency Announcement (BAA) is a continuation of a previous BAA (BARDA-BAA-11-100-SOL-00001) and is similarly designed to promote science and technology advancements of platforms applied to MCM development for the Strategic Science and Technology Division (SST) of BARDA.


The Government's intent is to solicit potential advancements in science and technology in the following BARDA SST Areas of Interest:


1.Pipeline acceleration and evaluation of candidate vaccines and therapeutics.


2.Product improvements to enhance safety, efficacy, ease of use, and manufacturability of MCM.


3.Product repurposing to treat novel and emerging pathogens.


4.In vitro diagnostic platforms for the rapid diagnosis of human infection.


The specific application of the technologies will focus on biodefense, pandemic influenza, and other emerging infectious diseases (EID). BARDA is open to evaluation of technologies at multiple stages of development, but advanced development activities of products specific for CBRN and Influenza will not be considered. Development activities are to be fully integrated with regulatory activities associated with product development efforts.


BARDA anticipates awarding multiple contracts and/or other transactions 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 SST Areas of Interest.


Contact Information:
Comments to this announcement, referencing synopsis BARDA-BAA-12-100-SOL-00013 may be submitted to SST-BAA@hhs.gov.


Contracting Office Address:
Office of the Assistant Secretary for Preparedness & Response (ASPR)
Department of Health and Human Services
330 Independence Ave. SW
G640
Washington, District of Columbia 20201
United States


Please contact the Contracting Officer for additional information.


Point of Contact(s):


Elizabeth Steiner, Contracting Officer
Phone: 202-205-8926
Fax: 202-205-4520
Email: Elizabeth.Steiner@hhs.gov

Nathaniel Cohen, Contract Specialist
Phone: 202-205-8968
Fax: 202-205-4520
Email: Nathaniel.Cohen@hhs.gov

Update #4 ·

Added: Dec 10, 2012 4:59 pm The submission deadline dates for Quad Charts/White Papers are January 7, 2013, March 7, 2013, and June 7, 2013.

Update #3 ·

Added: Mar 19, 2012 9:35 am Modified: Jul 20, 2012 4:34 pmTrack Changes The presentation slides from Multi-BAA Pre-Proposal Conference which was held on July 16, 2012 in Washington DC are included as an attachment to this solicitation.

The mission of the Biomedical Advanced Research and Development Authority (BARDA) is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. BARDA funding bridges the "valley of death" characterizing the late stages of product development. BARDA's support ensures continuity of funding at a critical point for medical countermeasures developed by industry or emerging from the basic research and preclinical development activities sponsored by the National Institutes of Health (NIH). In procuring medical countermeasures for the Strategic National Stockpile, BARDA enhances the capabilities of the Centers for Disease Control and Prevention (CDC) to organize an effective response.

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. The 2011 BARDA Strategic Plan defines BARDA's vision and lays out a series of capability goals over a five year period (2011-2016). Amongst BARDA's guiding principles is supporting the development of novel platform technologies that provide flexible systems for the production of medical countermeasures against a variety of threats. Through this Broad Agency Announcement (BAA), BARDA seeks to address, in part, BARDA's Goal 4, responsive and nimble programs and capabilities to address novel and emerging threats, as well as support the technological and scientific advancements of medical countermeasures for biodefense and pandemic influenza. The PAHPA and BARDA Strategic Plan are located on the ASPR website: http://www.phe.gov/Preparedness/legal/pahpa/pages/default.aspx and http://www.phe.gov/about/barda/Pages/2011barda-stratplan.aspx.


This Broad Agency Announcement (BAA) is a continuation of a previous BAA (BARDA-BAA-11-100-SOL-00001) and is similarly designed to promote science and technology advancements of platforms applied to MCM development for the Strategic Science and Technology Division (SST) of BARDA.


The Government's intent is to solicit potential advancements in science and technology in the following BARDA SST Areas of Interest:


1.Pipeline acceleration and evaluation of candidate vaccines and therapeutics.


2.Product improvements to enhance safety, efficacy, ease of use, and manufacturability of MCM.


3.Product repurposing to treat novel and emerging pathogens.


4.In vitro diagnostic platforms for the rapid diagnosis of human infection.


The specific application of the technologies will focus on biodefense, pandemic influenza, and other emerging infectious diseases (EID). BARDA is open to evaluation of technologies at multiple stages of development, but advanced development activities of products specific for CBRN and Influenza will not be considered. Development activities are to be fully integrated with regulatory activities associated with product development efforts.


BARDA anticipates awarding multiple contracts and/or other transactions 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 SST Areas of Interest.


Contact Information:
Comments to this announcement, referencing synopsis BARDA-BAA-12-100-SOL-00013 may be submitted to SST-BAA@hhs.gov.


Pre-proposal Conference:
The presentation slide show from Multi-BAA Pre-Proposal Conference (which was held on July 16, 2012 in Washington DC) is included as an attachment to this solicitation.

Contracting Office Address:
Office of the Assistant Secretary for Preparedness & Response (ASPR)
Department of Health and Human Services
330 Independence Ave. SW
G640
Washington, District of Columbia 20201
United States


Please contact the Contracting Officer for additional information.


Point of Contact(s):


Carolyn Keeseman, Contracting Officer
Phone: 202-260-0950
Fax: 202-205-6061
Email: Carolyn.Keeseman@hhs.gov


Elizabeth Steiner, Contract Specialist
Phone: 202-205-8926
Fax: 202-205-6061
Email: Elizabeth.Elmazahi@hhs.gov

Update #2 ·

Added: Mar 19, 2012 9:35 am Modified: Jun 08, 2012 3:45 pmTrack Changes The mission of the Biomedical Advanced Research and Development Authority (BARDA) is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. BARDA funding bridges the "valley of death" characterizing the late stages of product development. BARDA's support ensures continuity of funding at a critical point for medical countermeasures developed by industry or emerging from the basic research and preclinical development activities sponsored by the National Institutes of Health (NIH). In procuring medical countermeasures for the Strategic National Stockpile, BARDA enhances the capabilities of the Centers for Disease Control and Prevention (CDC) to organize an effective response.

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. The 2011 BARDA Strategic Plan defines BARDA's vision and lays out a series of capability goals over a five year period (2011-2016). Amongst BARDA's guiding principles is supporting the development of novel platform technologies that provide flexible systems for the production of medical countermeasures against a variety of threats. Through this Broad Agency Announcement (BAA), BARDA seeks to address, in part, BARDA's Goal 4, responsive and nimble programs and capabilities to address novel and emerging threats, as well as support the technological and scientific advancements of medical countermeasures for biodefense and pandemic influenza. The PAHPA and BARDA Strategic Plan are located on the ASPR website: http://www.phe.gov/Preparedness/legal/pahpa/pages/default.aspx and http://www.phe.gov/about/barda/Pages/2011barda-stratplan.aspx.


This Broad Agency Announcement (BAA) is a continuation of a previous BAA (BARDA-BAA-11-100-SOL-00001) and is similarly designed to promote science and technology advancements of platforms applied to MCM development for the Strategic Science and Technology Division (SST) of BARDA.


The Government's intent is to solicit potential advancements in science and technology in the following BARDA SST Areas of Interest:


1.Pipeline acceleration and evaluation of candidate vaccines and therapeutics.


2.Product improvements to enhance safety, efficacy, ease of use, and manufacturability of MCM.


3.Product repurposing to treat novel and emerging pathogens.


4.In vitro diagnostic platforms for the rapid diagnosis of human infection.


The specific application of the technologies will focus on biodefense, pandemic influenza, and other emerging infectious diseases (EID). BARDA is open to evaluation of technologies at multiple stages of development, but advanced development activities of products specific for CBRN and Influenza will not be considered. Development activities are to be fully integrated with regulatory activities associated with product development efforts.


BARDA anticipates awarding multiple contracts and/or other transactions 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 SST Areas of Interest.


Contact Information:
Comments to this announcement, referencing synopsis BARDA-BAA-12-100-SOL-00013 may be submitted to SST-BAA@hhs.gov.


Pre-proposal Conference:
Please note that a Pre-Proposal Conference will take place in Washington, DC at the Humphrey Building (DHHS Headquarters) on Monday, July 16. Please look in the posted BAA for information regarding time, registration, the call in number, and other attendance requirements. It is recommended that you register as soon as possible, as the room has a capacity limit.

Contracting Office Address:
Office of the Assistant Secretary for Preparedness & Response (ASPR)
Department of Health and Human Services
330 Independence Ave. SW
G640
Washington, District of Columbia 20201
United States


Please contact the Contracting Officer for additional information.


Point of Contact(s):


Carolyn Keeseman, Contracting Officer
Phone: 202-260-0950
Fax: 202-205-6061
Email: Carolyn.Keeseman@hhs.gov


Elizabeth Steiner, Contract Specialist
Phone: 202-205-8926
Fax: 202-205-6061
Email: Elizabeth.Elmazahi@hhs.gov

Update #1 ·

Added: Mar 19, 2012 9:35 am The mission of the Biomedical Advanced Research and Development Authority (BARDA) is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. BARDA funding bridges the "valley of death" characterizing the late stages of product development. BARDA's support ensures continuity of funding at a critical point for medical countermeasures developed by industry or emerging from the basic research and preclinical development activities sponsored by the National Institutes of Health (NIH). In procuring medical countermeasures for the Strategic National Stockpile, BARDA enhances the capabilities of the Centers for Disease Control and Prevention (CDC) to organize an effective response.

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. The 2011 BARDA Strategic Plan defines BARDA's vision and lays out a series of capability goals over a five year period (2011-2016). Amongst BARDA's guiding principles is supporting the development of novel platform technologies that provide flexible systems for the production of medical countermeasures against a variety of threats. Through this Broad Agency Announcement (BAA), BARDA seeks to address, in part, BARDA's Goal 4, responsive and nimble programs and capabilities to address novel and emerging threats, as well as support the technological and scientific advancements of medical countermeasures for biodefense and pandemic influenza. The PAHPA and BARDA Strategic Plan are located on the ASPR website: http://www.phe.gov/Preparedness/legal/pahpa/pages/default.aspx and http://www.phe.gov/about/barda/Pages/2011barda-stratplan.aspx.


This Broad Agency Announcement (BAA) is a continuation of a previous BAA (BARDA-BAA-11-100-SOL-00001) and is similarly designed to promote science and technology advancements of platforms applied to MCM development for the Strategic Science and Technology Division (SST) of BARDA.


The Government's intent is to solicit potential advancements in science and technology in the following BARDA SST Areas of Interest:


1.Pipeline acceleration and evaluation of candidate vaccines and therapeutics.


2.Product improvements to enhance safety, efficacy, ease of use, and manufacturability of MCM.


3.Product repurposing to treat novel and emerging pathogens.


4.In vitro diagnostic platforms for the rapid diagnosis of human infection.


The specific application of the technologies will focus on biodefense, pandemic influenza, and other emerging infectious diseases (EID). BARDA is open to evaluation of technologies at multiple stages of development, but advanced development activities of products specific for CBRN and Influenza will not be considered. Development activities are to be fully integrated with regulatory activities associated with product development efforts.


BARDA anticipates awarding multiple contracts and/or other transactions 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 SST Areas of Interest.


Contact Information:
Comments to this announcement, referencing synopsis BARDA-BAA-12-100-SOL-00013 may be submitted to SST-BAA@hhs.gov.


Pre-proposal Conference:
It is anticipated that a pre-proposal conference will be held on Thursday, May 3, 2012, from 2-4pm (EST) at the following address:
200 Independence Avenue S.W.
Hubert H Humphrey Building 7th floor Room 725A
Washington, DC 20201
Instructions regarding access to the meeting and dial-in information will be posted prior to the meeting.


Contracting Office Address:
Office of the Assistant Secretary for Preparedness & Response (ASPR)
Department of Health and Human Services
330 Independence Ave. SW
G640
Washington, District of Columbia 20201
United States


Please contact the Contracting Officer for additional information.


Point of Contact(s):


Carolyn Keeseman, Contracting Officer
Phone: 202-260-0950
Fax: 202-205-6061
Email: Carolyn.Keeseman@hhs.gov


Elizabeth Steiner Elmazahi, Contract Specialist
Phone: 202-205-8926
Fax: 202-205-6061
Email: Elizabeth.Elmazahi@hhs.gov

Attachments

Files attached to this notice, newest first
File Type Posted
Amendment_3.docx DOCX document
BAA PreProposal Conference Slides 7.16.12.pdf PDF
Multi-BAA Pre-Proposal Conference JULY 16 2012 REVISED Posting.pdf PDF
SST BAA 12-100-SOL-00013 Solicitation.pdf PDF
SST Pre-proposal meeting Amendment 4-19-2012.pdf PDF
FOREIGN_VISITOR_INFORMATION_SHEET.docx DOCX document
Pre-proposal_Conference_FBO_posting.pdf PDF

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