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A -- Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss and Vascular Injury Resulting From Acute Exposure to Ionizing Radiation

Solicitation Number: BAA-BARDA-08-08
Agency: Department of Health and Human Services
Office: Office of the Secretary
Location: Acquisitions Management, Contracts, & Grants (AMCG)
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BAA-BARDA-08-08
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Award
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September 16, 2008
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HHSO100200800062C
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$2,725,629
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University of Pittsburgh
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350 Thackeray Hall
Pittsburgh, Pennsylvania 15260
United States
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Added: February 20, 2008
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.

BARDA's mission includes managing the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological, and nuclear agents (CBRN). As part of its CBRN development and preparedness mission, BARDA announces a program to encourage research and development aimed at MCMs specifically addressing the hematopoietic and vascular syndromes resulting from acute radiation exposure from potential terrorist acts with radioactive materials or nuclear weapons, or public health emergencies.



BARDA is using a Broad Agency Announcement (BAA) to advance the development of new CBRN therapeutics, including the development of new indications for already licensed therapeutics, as novel MCMs for the treatment of populations exposed to acute radiation as a result of a nuclear detonation, radiologic dispersive device (RDD, "dirty bomb"), or other radiologic mechanisms, including deliberate contamination. The purpose of this BAA entitled, "Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation" is to fund advanced development for therapies to replenish hematopoietic lineages, recover bone marrow stromal loss, and treat vascular injuries.



It is the intention of this BAA to award contracts to provide funding for Offerors to advance lead candidate products in the development pipeline. Each lead candidate product must be developed to serve as an MCM for injuries sustained from exposure to ionizing radiation. Advanced development funding from BARDA shall assist selected candidate products through clinical Phase 2 and not higher. The research and development areas that are to be funded through this BAA include the following:

1) Research and Development Area 1: Development of MCMs that can replenish the normal hematopoietic profile following lethal hematopoietic dyscrasias from acute exposure to ionizing radiation;

2) Research and Development Area 2: Development of MCMs to replenish bone marrow progenitor cells and the niche environment that together manifest normal functioning hematopoietic cell lineages following lethal hematopoietic dyscrasias from acute exposure to ionizing radiation; or

3) Research and Development Area 3: Development of MCMs that address injury to the vascular system, including intimal integrity, macrophage repair mechanism, vascular leak, endothelial repair, or alteration of angiogenesis, in response to acute exposure to ionizing radiation.



The proposals must outline a well-defined product development plan in the Offeror's Statement of Work (SOW). The SOW must include completion of a Phase 1 clinical trial no later than three (3) years after contract award, unless Phase 1 is completed prior to contract award. This BAA will also support Phase 2 product development activities which further enable progress toward a biologic license application (BLA) or a new drug application (NDA).



It is anticipated that multiple cost-reimbursement, completion type contracts will be awarded for a period of up to three (3) years beginning on or about September 16, 2008. BAA-BARDA-08-08 will be available electronically on or about March 6, 2008 and may be accessed through the Federal Business Opportunities web site.



Responses to the BAA Research and Development Areas will be due on or about April 17, 2008. Any responsible Offeror may submit a proposal for consideration by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-wide numbered note 26.

Added: Sep 17, 2008 3:38 pm
Develop therapies for Acute Radiation Syndrome.
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Solicitation 1

Type:
Solicitation
Posted Date:
March 6, 2008
Description: Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss and Vascular Injury Resulting From Acute Exposure to Ionizing Radiation

Amendment 1

Type:
Mod/Amendment
Posted Date:
April 30, 2008
Description: Amendment No1
Description: Packageing and Delivery Attachment
Description: Security Plan Attachment
:
Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, UNITED STATES
:
Carl A. Newman,
Contracting Officer
Phone: 202-205-1156
Fax: 202-205-8441
:
David K Beck,
Contracting Officer
Phone: 202-260-0453
Fax: 202-205-4520