SPECIAL NOTICE
A -- Advanced Development of Broad-Spectrum Influenza Monoclonal Antibodies
- Notice Date
- 5/14/2015
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), 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
- ZIP Code
- 20201
- Solicitation Number
- HHS-BARDA-15-100-SOL-0015
- Point of Contact
- sherica teshome, Phone: 2022055919, Dorothy McMillan, Phone: 202-260-8541
- E-Mail Address
-
sherica.teshome@hhs.gov, dorothy.mcmillan@hhs.gov
(sherica.teshome@hhs.gov, dorothy.mcmillan@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- SYNOPSIS General Information Document Type: New Notice Solicitation Number: HHS-BARDA-15-100-SOL-0015 Classification Code: A-Research & Development NAICS Code: 541711 - Research and Development in Biotechnology Contracting Office Address U.s Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Development and Research Authority, 330 Independence Avenue, SW Room 640G, Washington, DC, 20201 Description Preparing to address the challenges of natural or man-made health threats is a priority of the U.S. Government. This project supports the advanced development of new monoclonal antibodies with novel mechanisms of action that exhibit broad-spectrum neutralizing activity across Influenza A subtypes, and treat infected individuals with a focus on the severely ill, hospitalized population with the goal of U.S. licensure and a plan for U.S. supply of these monoclonal antibodies during a pandemic. Supported activities may include Phase 2 and 3 clinical studies, process development, manufacturing of clinical and registration lots, assay development and validation, non-clinical testing and regulatory activities. Of the two classes of drugs approved in the United States for treatment of influenza infections, adamantanes and neuraminidase inhibitors (NAIs) both have exhibited vulnerabilities to emergence of resistance and limitations in treatment of the severely ill. While adamantine drugs were initially effective, influenza viruses have evolved over time and virtually all circulating strains are now resistant to these drugs. Neuraminidase inhibitors are effective at reducing symptoms of influenza infection when given within 48 hours of the onset of symptoms. However, recent epidemiological surveillance has identified the emergence of influenza viruses that show reduced sensitivity and resistance to the NAIs. Moreover, novel influenza strains with pandemic potential, such as A(H7N9), have exhibited properties of resistance to all approved drugs in laboratory testing. Widespread dissemination of multi-drug resistant influenza strains would be catastrophic and will remain a concern until new classes of influenza therapeutics are made available. The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) contemplates single or multiple awards of contracts to develop broad-spectrum influenza monoclonal antibody candidates towards FDA licensure. These antibodies, either individually or as a cocktail, will demonstrate broad neutralizing activity against all relevant subgroups of Influenza A leading to therapeutic benefit. Pre-clinical efficacy studies will have demonstrated the potential for treatment at >48 hours of influenza symptom onset. Clinical development should emphasize treatment of severely ill, hospitalized patients as well as evaluation in pediatric populations. The Offeror may request funds for activities that could include process development, testing, manufacturing, clinical development and evaluation of pilot and commercial scale lots of broad-spectrum influenza monoclonal antibodies. Funds may also be used for scale-up development and equipment, but not facility construction or regulatory filing fees. Contracts will be awarded to companies that independently furnish all the necessary services, qualified personnel, materials, equipment, and facilities not otherwise provided by the government as needed to perform the work necessary to develop and file for licensure of a broad-spectrum influenza monoclonal antibody candidate that meets the Key Attributes to include the following: (1) an indication for the treatment of seriously ill, hospitalized patients 6 months and older who are infected with influenza (2) broad-spectrum neutralizing activity across multiple subtypes of influenza A viruses including but not limited to contemporary strains of H1N1, H3N2, H5N1 and H7N9 (3) single dose treatment regimen consisting of a formulation that contains no more than three monoclonal antibodies (4) effective when treatment is initiated within 48-96 hours of influenza symptom onset (72-96 hours preferred). The primary purpose of this acquisition is to fully develop the proposed broad-spectrum influenza monoclonal antibody candidate. The anticipated period of performance will be two and a half to five years or 30 to 60 months. Additional details and requirements will be described in the solicitation. The solicitation, RFP HHS-BARDA-15-100-SOL-0015 will be available electronically through the FedBizOpps on or about June 8, 2015. Proposals will be due a minimum of 45 days after issuance of the RFP. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to the award of a contract. Only written or email requests, directly from the requested, for this solicitation will be accepted. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses to this notice should be identified with RFP HHS-BARDA-15-100-SOL-0015, name of firm, name of requestor, mailing address, telephone number, fax number, email address and should be submitted to the Contracting Office Address identified in this notice. Multiple awards may result from this solicitation with an estimated award date of February 15, 2016. This requirement will be full and open competition for both large and small businesses. Small businesses are encouraged to respond. Point of Contact Sherica Teshome, Contract Specialist, Phone 202-205-5919, Email Sherica.Teshome@hhs.gov - Dorothy McMillan, Contracting Officer, Phone 202-260-8541, Email Dorothy.McMillan@hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/HHS-BARDA-15-100-SOL-0015/listing.html)
- Record
- SN03730818-W 20150516/150514234713-5216d6eacc2f2861d2e4de188a9c341a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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