ADVANCED DEVELOPMENT OF THERAPEUTICS FOR TREATING NEUTROPENIA RESULTING FROM ACUTE EXPOSURE TO IONIZING RADIATION

THIS IS A FORMAL SYNOPSIS OF PROPOSED CONTRACT ACTION NOTICE IN ACCORDANCE WITH FAR 5.2. 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 medical countermeasure development and preparedness mission, BARDA contemplates a five year Cost Reimbursement, multiple award contract for the advanced development and manufacturing of therapeutics on the path to licensure or market approval (i.e., BLA or NDA, respectively) for the indication of treating neutropenia arising from acute exposure to ionizing radiation, (Acute Radiation Syndrome, ARS). This announcement will support ARS product development activities on the path to obtaining a New Drug Application (NDA) or a Biologic License Application (BLA), including: - Manufacturing scale-up supporting consistent lot-to-lot manufacturing. - Clinical trials, if feasible and ethical. - Establishing appropriate animal models, as necessary. - Animal studies leading to pivotal animal efficacy data required to support licensure under the U.S. Food and Drug Administration (FDA) - Animal Rule (Approval of Biological Products when Human Efficacy Studies are not Ethical or feasible" 21 CFR - 601 Subpart H, as well as 21 CFR - 314 Subpart I for New Drugs) . This is not a procurement solicitation. In order to be considered eligible to submit a proposal under this solicitation, the Offeror(s) shall meet the following two mandatory criteria for eligibility: 1) The Offeror shall provide documentation that shows they have met with the appropriate review division at the FDA to consult on the appropriate path for approval of their proposed therapeutic for use in treating neutropenia caused by Acute Radiation Syndrome (ARS). Documentation should include, but is not limited to, a cover page, executive summary, and a table of contents that demonstrates the Offeror's intent to file an IND for ARS. FDA meeting minutes should also be included. 2) The product in question must be a) licensed or in clinical trials for any indication OR b) have an Investigative New Drug (Application) for ARS (IND; as per 21 CFR 312) filed with the Food and Drug Administration (FDA). The proposed product shall not be on clinical hold. Offerors are required to maintain a relationship with the FDA and be on alert for Agency regulatory updates and changes to USG or HHS policies specific to their product development. This requirement is to support product development which demonstrates both safety and efficacy of the product when administered 24 hours or more following exposure to a neutropenia-inducing exposure to ionizing radiation. To that end, non-clinical studies should be designed to show efficacy in abrogating neutropenia in appropriate animal models and that these models support approval or licensure under the FDA Animal Rule Additional details and requirements will be described in the RFP entitled - Advanced Development of Therapeutics for Treating Neutropenia Resulting from Acute Exposure to Ionizing Radiation. The solicitation number RFP HHS-BARDA-09-31, is anticipated to be available electronically through FEDBIZOPPS on or about February 20, 2009. Any responsible Offeror may submit a proposal for consideration by the USG. This solicitation notice does not commit the USG to the award of a contract. Only written or email requests will be accepted directly from potential offerors for this solicitation. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses should be identified with the respective solicitation number RFP HHS-BARDA-09-31, name of company, name of requestor, mailing address, telephone number, fax number, and email address of Point of Contact (POC), should be submitted to the Contracting Office address identified in this notice. The contract award resulting from this solicitation will have an estimated award date of September 2009. A draft RFP of the above referenced solicitation is anticipated to be released for industry comment on or about January 15, 2009. Any written comments or questions on the solicitation are due to the Contracting Office by COB on February 4, 2009.