Biodefense Vaccine Enhancement

Additional contract awarded from this BAA (see separate award notice): HHSN272200800051C - Emergent Product Development Gaithersburg, Inc.

NOTE: THIS PRESOLICITATION NOTICE REPLACES THE SAME NOTICE THAT WAS POSTED ON SEPTEMBER 6, 2007, WHICH WAS ACCIDENTALLY DELETED FROM THE FEDBIZOPPS ON THIS DATE.The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. This project will be funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), DHHS, in conjunction with the NIAID, NIH. The NIAID, Division of Microbiology and Infectious Diseases (DMID) has a requirement for vaccine candidate(s) for NIAID Category A or B Priority Pathogens (Part A) or a candidate third generation anthrax vaccine (Part B). The purpose of this solicitation is to fund organizations with demonstrated vaccine product development experience to produce a vaccine candidate either for a NIAID Category A or B Priority Pathogen (PART A) or a candidate third generation anthrax vaccine (PART B). Offerors may propose under both Part A and Part B. Candidate vaccines eligible for support must have demonstrated safety and proof of concept efficacy in an animal model. Offerors must propose a well-defined and feasible Product Development Plan for advancing the vaccine candidate to achieve the following objectives as specified in the Research and Technical Objectives. PART A (Base): Development and update of the Product Development Plan for a NIAID Category A or B Priority Pathogen vaccine candidate (Part A), including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken; manufacturing and formulation process development; manufacturing of pilot lot cGMP material; real time and accelerated vaccine stability studies; conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies and immunogenicity studies; development, qualification and, where necessary, validation of all assays necessary to support product development; rapid immune response with no more than two (2) vaccinations; long-term stability of three (3) years or longer at temperatures of at least 35oC; and a safety profile that meets all existing U.S. Food and Drug Administration (FDA) requirements. PART A Option: May be exercised at the discretion of the Government to provide support for the submission of an Investigational New Drug (IND) Application to the FDA and for the design, conduct, completion and analysis of a Phase 1 clinical trial for contracts awarded to carry out product development activities under Part A for NIAID Category A or B Priority Pathogen vaccine candidates. PART B (Base): Development and update of the Product Development Plan for a third generation anthrax vaccine candidate, including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken; manufacturing and formulation process development; manufacturing of pilot lot cGMP material; real time and accelerated vaccine stability studies; conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies and multivalent immunogenicity interference studies; development, qualification and, where necessary, validation of all assays necessary to support product development; rapid immune response with no more than two (2) vaccinations; long-term stability of three (3) years or longer at temperatures of at least 35oC; development of stabilization technology that is broadly applicable to a variety of vaccines; a safety profile that meets all existing U.S. Food and Drug Administration (FDA) requirements; development, submission, and sponsorship of an IND, including compliance with all regulatory requirements; design, conduct, completion, and analysis of a Phase 1 dose-escalating clinical trial of the multivalent vaccine candidate in healthy subjects ages 18 to 40; and the provision of clinical and non-clinical samples from all studies to NIAID and, for clinical trials, obtaining future use consent from volunteers for their samples. Part B Option 1 may be exercised at the discretion of the Government to provide for performance of activities associated with scale-up, cGMP manufacturing and release of 200,000 doses of the recombinant protective antigen (rPA)-based third generation anthrax vaccine candidate. Part B Option 2 may be exercised at the discretion of the Government to provide for the design, conduct, completion, and analysis of a Phase 2 clinical trial to evaluate further the safety and immunogenicity of the recombinant protective antigen (rPA)-based third generation anthrax vaccine candidate. In response to PART A, offerors may propose multiple NIAID Category A or B Priority Pathogen vaccine candidate but are required to submit a separate proposal for each vaccine candidate. Offerors may also submit separate proposals in response to PART B. It is anticipated that multiple cost-reimbursement, completion type contracts will be awarded for a three-year base period of performance beginning on or about August 28, 2008. PART A Option, if exercised, will extend the PART A contract(s) for an additional one year, for a maximum period of performance of four years. The Options for PART B, if exercised, will extend PART B contract(s) for two years each, for a maximum period of performance of seven years for PART B. It is estimated that the provision of total FTEs per year will be approximately as follows: PART A Base = 13.85 FTEs for a 3-year period; PART A Option 1 = 3.5 FTEs for a 1-year period; PART B Base = 13.85 FTEs for a 3-year period; PART B Option 1 = 3.7 FTEs for a 2-year period; and PART B Option 2 = 9.45 FTEs a 2-year period. Any responsible offeror may submit a proposal which will be considered by the Agency. This Broad Agency Announcement will be available electronically on/about September 21, 2007, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice 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.

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. This project will be funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), DHHS, in conjunction with the NIAID, NIH. The NIAID, Division of Microbiology and Infectious Diseases (DMID) has a requirement for vaccine candidate(s) for NIAID Category A or B Priority Pathogens (Part A) or a candidate third generation anthrax vaccine (Part B). The purpose of this solicitation is to fund organizations with demonstrated vaccine product development experience to produce a vaccine candidate either for a NIAID Category A or B Priority Pathogen (PART A) or a candidate third generation anthrax vaccine (PART B). Offerors may propose under both Part A and Part B. Candidate vaccines eligible for support must have demonstrated safety and proof of concept efficacy in an animal model. Offerors must propose a well-defined and feasible Product Development Plan for advancing the vaccine candidate to achieve the following objectives as specified in the Research and Technical Objectives. PART A (Base): Development and update of the Product Development Plan for a NIAID Category A or B Priority Pathogen vaccine candidate (Part A), including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken; manufacturing and formulation process development; manufacturing of pilot lot cGMP material; real time and accelerated vaccine stability studies; conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies and immunogenicity studies; development, qualification and, where necessary, validation of all assays necessary to support product development; rapid immune response with no more than two (2) vaccinations; long-term stability of three (3) years or longer at temperatures of at least 35oC; and a safety profile that meets all existing U.S. Food and Drug Administration (FDA) requirements. PART A Option: May be exercised at the discretion of the Government to provide support for the submission of an Investigational New Drug (IND) Application to the FDA and for the design, conduct, completion and analysis of a Phase 1 clinical trial for contracts awarded to carry out product development activities under Part A for NIAID Category A or B Priority Pathogen vaccine candidates. PART B (Base): Development and update of the Product Development Plan for a third generation anthrax vaccine candidate, including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken; manufacturing and formulation process development; manufacturing of pilot lot cGMP material; real time and accelerated vaccine stability studies; conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies and multivalent immunogenicity interference studies; development, qualification and, where necessary, validation of all assays necessary to support product development; rapid immune response with no more than two (2) vaccinations; long-term stability of three (3) years or longer at temperatures of at least 35oC; development of stabilization technology that is broadly applicable to a variety of vaccines; a safety profile that meets all existing U.S. Food and Drug Administration (FDA) requirements; development, submission, and sponsorship of an IND, including compliance with all regulatory requirements; design, conduct, completion, and analysis of a Phase 1 dose-escalating clinical trial of the multivalent vaccine candidate in healthy subjects ages 18 to 40; and the provision of clinical and non-clinical samples from all studies to NIAID and, for clinical trials, obtaining future use consent from volunteers for their samples. Part B Option 1 may be exercised at the discretion of the Government to provide for performance of activities associated with scale-up, cGMP manufacturing and release of 200,000 doses of the recombinant protective antigen (rPA)-based third generation anthrax vaccine candidate. Part B Option 2 may be exercised at the discretion of the Government to provide for the design, conduct, completion, and analysis of a Phase 2 clinical trial to evaluate further the safety and immunogenicity of the recombinant protective antigen (rPA)-based third generation anthrax vaccine candidate. In response to PART A, offerors may propose multiple NIAID Category A or B Priority Pathogen vaccine candidate but are required to submit a separate proposal for each vaccine candidate. Offerors may also submit separate proposals in response to PART B. It is anticipated that multiple cost-reimbursement, completion type contracts will be awarded for a three-year base period of performance beginning on or about August 28, 2008. PART A Option, if exercised, will extend the PART A contract(s) for an additional one year, for a maximum period of performance of four years. The Options for PART B, if exercised, will extend PART B contract(s) for two years each, for a maximum period of performance of seven years for PART B. It is estimated that the provision of total FTEs per year will be approximately as follows: PART A Base = 13.85 FTEs for a 3-year period; PART A Option 1 = 3.5 FTEs for a 1-year period; PART B Base = 13.85 FTEs for a 3-year period; PART B Option 1 = 3.7 FTEs for a 2-year period; and PART B Option 2 = 9.45 FTEs a 2-year period. Any responsible offeror may submit a proposal which will be considered by the Agency. This Broad Agency Announcement will be available electronically on/about September 21, 2007, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice 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.