Procurement and Late-Stage Development of Smallpox Antiviral Drug(s)
Pre-solicitation Notice
Title
Procurement and Late-Stage Development of Smallpox Antiviral Drug(s)
Description:
Smallpox (Variola viridae or VARV, the etiological agent responsible for smallpox disease) is responsible for the deaths of hundreds of millions of people throughout history. An effort spearheaded by the World Health Organization (WHO) led to the eradication of smallpox disease in the 1970s, with the last case of smallpox diagnosed in 1977. While smallpox disease is eradicated, repositories of VARV remain, it is still considered one of the most dangerous human pathogens as it is highly communicable and carries exceptionally high morbidity; the two known repositories are in the Russian Federation and the United States. Furthermore, recent advances in synthetic biology allow for the creation of smallpox viruses from published genomic sequences available to the public.
Medical countermeasures (MCM) against Smallpox are urgently needed should future outbreaks of Smallpox occur. The 2014 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies Smallpox as a high-priority threat as determined by the Secretary of Homeland Security.
Vaccines are no longer administered to the US population (outside of military recruits and first responders) and there are no therapeutic agents available on the market to treat symptomatic smallpox. To counter the threat, the US Government stockpiles both a large quantity of smallpox vaccine intended for pre-exposure prophylaxis (PrEP), and a limited quantity of antiviral therapeutics intended to treat symptomatic patients during the course of a smallpox event. The government has pursued this multi-faceted approach with the goal of being able to rapidly deploy lifesaving therapeutics to an effected population during a smallpox event and to provide sufficient vaccine to protect the population surrounding an effected area or those who are considered at risk of infection.
While there is a licensed vaccine for the pre-exposure prophylaxis against smallpox, there are currently no approved therapeutic antivirals for the treatment of symptomatic smallpox. BARDA is seeking to procure smallpox therapeutic antiviral agents for the Strategic National Stockpile that can be used in the event of an outbreak to treat symptomatic patients.
All proposals submitted to any future solicitations shall have evidence of two formulations of the antiviral (parenteral and nonparenteral), an active FDA IND or licensed product with completed phase I trials for both products, evidence of efficacy in at least two animal models accepted by the FDA for the evaluation of a smallpox medical countermeasure, and the ability of the Offeror to deliver at least one formulation to the SNS upon contract award (e.g. FDA approval, pre-EUA IND on file).
Pre-Solicitation Notice Objective
This Pre-solicitation Notice is issued pursuant to FAR Subpart 5.2. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This Pre-solicitation Notice does not commit the Government to contract for any supply or service whatsoever. Furthermore, AMCG is not at this time seeking proposals, and will not accept unsolicited proposals.
It is anticipated that an RFP may be available electronically through the FedBizOpps website in February 2018 for 45 days with proposals being due in April 2018. Once any RFP is posted we encourage all responsible sources, particularly small businesses, to submit a proposal which will be considered by the agency. It is the Offeror's responsibility to monitor this internet site (www.fbo.gov) for the release of this solicitation as well as any amendments. Potential Offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted.
It is anticipated that one contract award with both cost reimbursement and firm-fixed CLINs will be awarded by July 2018. The anticipated base period of performance for any resultant contract(s) will be for a total of 60 months and up to 10 years with options if exercised. Additional details and requirements will be described in the solicitation.
Furthermore, all respondents must be registered in the System for Award Management (SAM) https://www.sam.gov.
Christine Jihae Park, Contract Specialist, Phone 2024015550, Email christine.park@hhs.gov - Brooke Bernold , Contracting Officer , Phone 2022600690, Email brooke.bernold@hhs.gov
