Next_Generation_Anthrax_Vaccine_Pre-Solicitation_Notice.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Assistant Secretary for Preparedness & Response Washington, D.C. 20024

FEDERAL BUSINESS OPPORTUNITIES

PRESOLICITATION NOICE

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION MAY BE

ISSUED ON A LATER DATE.

Title: Next-Generation Anthrax Vaccine

General Information

Document Type: Pre-Solicitation Notice

Posted Date: May 16, 2016

Solicitation Number: RFP#16-100-SOL-00015

Classification Code: A – Research & Development

NAICS Code:

541 -- Professional, Scientific, and Technical Services/541711 -- Research and Development in Biotechnology

Synopsis

Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillius anthracis, which can cause human disease via gastrointestinal, cutaneous, or inhalation (pulmonary) routes. The 2014 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies anthrax as a high-priority threat as determined by the Secretary of Homeland Security. Strategies to mitigate anthrax as a biothreat against civilian populations include the development of an anthrax vaccine suitable for Post-Exposure Prophylaxis (PEP) as a priority medical countermeasure.

To improve the Concepts of Operations (CONOPs) for an anthrax vaccine, BARDA is seeking a next-generation vaccine capable of reducing the number of vaccinations needed to confer protection in PEP. Characteristics of a new vaccine suitable for a PEP indication include rapid onset of protective immunity in one or two doses and capability for use in conjunction with antibiotics after exposure. The candidate must be further along in advanced research and development (completed phase II) and capable of receiving Emergency Use Authorization (EUA) by the FDA. Improvements such as protection against all forms of anthrax, protection in special populations (children, elderly, and the immunocompromised), and elimination of cold chain storage would be considered additional enhancements for an ideal candidate.

The vaccine at a minimum should be able to protect against inhalation anthrax in one or two doses, have stability for at least four years, have no interference when used in combination with other drugs approved for anthrax, have the capability to be consistently manufactured under GMP conditions, and have a good safety profile in adults 18-65

Any proposed vaccine shall have completed appropriate safety, toxicology, and effectiveness profiles from non-clinical and Phase 1 and 2 clinical trials. The vaccine will need to demonstrate appropriate efficacy and immunogenicity to allow continued progress towards approval for Emergency Use Authorization under the Animal Rule and, ultimately, approval with a Biologics License Application (BLA). Other requirements will include a defined regulatory path, cGMP production capabilities and capability to demonstrate consistency of Phase 3 lots, and, while a Phase 3 trial is not required, a completed Phase 2 trial and acceptable planning and progress into Phase 3 trials will be a requirement.

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 a RFP may be available electronically through the FedBizOpps website on or around June 2016 for 30 days with proposals being due on or around July 2016. 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 any RFP 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 with both cost reimbursement and firm-fixed aspects may be awarded on or around August/September 2016. The anticipated period of performance for any resultant contracts will be for a total of 60 months. Additional details and requirements will be described in the RFP.

Furthermore, all respondents must be registered in the System for Award Management (SAM) https://www.sam.gov.

Contracting Office Address:

Office of the Assistant Secretary for Preparedness & Response (ASPR) Department of Health and Human Services 200 C St. SW Washington, District of Columbia 20024 United States

Points of Contact:

Christopher Scott Contracting Officer Christopher.Scott@hhs.gov Phone: 202-205-8580

Jason Bell Contracting Officer Jason.Bell@hhs.gov Phone: 202-260-1457 https://www.sam.gov/ mailto:Christopher.Scott@hhs.gov mailto:Jason.Bell@hhs.gov