Presolnotice_BAA_2013174.pdf

PRESOLICITATION NOTICE

DEVELOPMENT OF VACCINE FORMULATIONS EFFECTIVE AGAINST NIAID PRIORITY

PATHOGENS

BAA NUMBER NIAID-DMID-NIH-AI-2013174

Presolicitation Notice Information

Introduction

Research supported and conducted by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents, with the exception of the human immunodeficiency virus (HIV).

This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. The NIAID also has a mission to advance the development of new medical countermeasures (MCM) against the biological agents that are most likely to be used in a terror attack on civilian populations.

Description The primary objective of this BAA is to support the advanced development of candidate products which consist of a vaccine component in combination with a technology component (a dry formulation technology) to increase stability and minimize cold chain or preservative requirements. These products will likely be used in post-event settings following the intentional release of NIAID Category A, B and C Priority Pathogens or in response to naturally occurring outbreaks of infectious diseases caused by NIAID Category A, B and C Priority Pathogens (description of priority pathogens located at http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx). Only candidate products against NIAID Category A, B and C Priority Pathogens are eligible under this solicitation.

Proposals with multiple candidate products using the same vaccine component will be considered, however, proposals with one candidate product are preferred. If more than one candidate product is proposed, a down-select to a single candidate product is required as part of the statement of work (SOW).

The dry formulation technology must demonstrate enhanced stability of a vaccine compared to liquid formulation and advancement of vaccine development strategies. Examples of dry formulations may include, but are not limited to, lyophilization, spray drying, foam drying, nanoparticles, dry powders, microneedle patches and other emerging drying technologies. Note that simply drying of an existing liquid vaccine formulation (final drug product under clinical evaluation or licensed vaccine) is not considered to advance the current state of technology.

The candidate product may include (but are not required to include) adjuvants. If the proposed candidate product includes an adjuvant, ideally, enhancement of the immune response (enhanced immunogenicity, decreased time or reduced number of immunizations to achieve protective antibodies and/or increased efficacy) should be demonstrated in an animal model. Anticipated benefits may include production of a protective immune response with 1-2 doses of vaccine.

In this setting, simplicity and efficiency of dry formulation vaccine delivery to, and the effectiveness in, large numbers of patients are also key considerations. Thus, a delivery platform may be http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx included as part of the proposed vaccine candidate. Anticipated benefits may include decreased manpower and time required to prepare and administer the vaccine, and increased compliance among vaccine recipients.

Eligible candidate products include a vaccine component comprised of an agent(s) identified as NIAID Category A, B and C Priority Pathogens in combination with a dry formulation technology. If available, supporting information on the candidate product must be provided and may include immunogenicity or efficacy data, safety and toxicology data, development status and manufacturing capabilities, human safety data in general or associated with known adverse events for the product class, the Regulatory pathway/strategy and FDA feedback. When applicable, candidate products may also include an adjuvant that enhances the immune response (i.e., enhanced immunogenicity, decreased time or reduced number or immunizations to achieve protective antibodies and/or increased efficacy). Adjuvants will be supported as components of the candidate product. Novel delivery platforms that reduce logistical requirements may be components of the candidate product to be developed as well. Cross-cutting dry formulation technologies applicable to more than one vaccine component are also of interest. The requirements for vaccine and technology components are described below.

1. Vaccine Component - The vaccine component is the antigen or immunogen of the candidate product. The vaccine component must satisfy the below criteria for consideration. The offeror shall provide sufficient information to demonstrate that the source of the vaccine component meets the following criteria:

a. Immunogenicity and efficacy in an animal model;

b. Completion of current cGMP manufacturing, including production of a Bulk Drug

Substance (BDS) and Final Drug Product (FDP), as well as lot characterization, release and stability testing using qualified assays;

c. Undergone GLP non-clinical studies for toxicology, as appropriate; and

d. Completed a Phase 1 clinical trial for safety and immunogenicity and demonstrate results that support further clinical development at the time of proposal submission.

2. Technology Component - The technology component is the dry formulation technology (also referred to as a solid formulation technology) in the proposed candidate product. The offeror shall provide sufficient information to demonstrate that the technology component meets the following criteria:

a. Increases duration of stability of a vaccine;

b. Minimizes the need for cold chain or preservative requirements; and

c. Advances the current knowledge and strategies for vaccine development;

methods may include lyophilization, spray drying, foam drying, nanoparticles, dry powders, microneedle patches and other emerging drying technologies.

The proposed candidate product may include an adjuvant and or delivery platform and, if applicable, the requirements are described below:

3. Adjuvant may be included if provided that the following criteria are demonstrated:

a. An enhanced immune response (enhanced immunogenicity, decreased time or reduced number of immunizations to achieve protective antibodies and/or increased efficacy) with proof of concept efficacy data in animal models with the proposed vaccine component/adjuvant combination as compared to the vaccine component alone,

b. Feasibility of attaining a safety profile that meets all existing FDA requirements,

c. Completion of cGMP manufacturing, and

d. Completion of a Phase 1 clinical trial and safety and immunogenicity results that support further clinical development.

4. Delivery platform may be included if provided that the following criteria are demonstrated:

a. Designed to achieve a more rapid or enhanced immune response, or

b. Reduce logistical requirements (decrease manpower and time required to prepare and administer the vaccine, and increase compliance among vaccine recipients).

Capability statements submitted as a result of this announcement should demonstrate the offerors’ qualifications and experience, with particular attention to the appropriateness and adequacy of organizational experience, proposed plans and procedures, availability of personnel, and understanding of problems and deficiencies for a variety of functions, including:

1. Development and updating of the Product Development Plan for the candidate product, including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken.

2. Manufacturing and formulation process development.

3. Manufacturing, characterization and release of pilot lot cGMP material.

4. Real time and accelerated vaccine stability testing over the duration of the contract.

5. Conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies, combination product approvals and multivalent immunogenicity and interference studies, as needed.

6. Development, qualification and, where necessary, validation of all assays and reagents needed to support product development.

7. Development, submission, and sponsorship of an Investigational New Drug (IND)/combination product application, including compliance with all regulatory requirements.

8. Although a resultant contract will not support the design and conduct of Phase 1 clinical trials for vaccine components, the design, conduct, completion, and analysis of a Phase 1 or Phase 2 clinical trial of the candidate product in normal healthy volunteers may be included.

9. 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.

10. The delivery to the NIAID, negotiated at the time of award, cGMP bulk drug substance and/or final product and all necessary supporting documentation/letters of cross-reference required for subsequent regulatory submissions, clinical trials or for any other purpose deemed necessary by the Government.

It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a 5 year period of performance beginning on or about August 13, 2014.

NIAID estimates that multiple contracts may be issued for an aggregate total cost (direct and indirect costs combined) of up to $ 19 million for all awards during the first non-severable phase. Importantly, contract activities will be divided into manageable time frames with initial funding of only the Base Period. Funding of subsequent timeframes will be funded by Options. Each Option will be fully funded when exercised and will be dependent on successful completion of critical predecessor activities, including USG acceptance of associated deliverables when applicable.

The critical predecessor activities should constitute Go/No Go criteria for successor activities. The contract budget will be aligned with the Base Period, Options and associated tasks identified in the Product Development Plan and associated Gantt Chart.

Moreover, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. In no event shall the period of performance proposed by an offeror exceed five years.

All responsible sources may submit a proposal which shall be considered by the Agency. This Broad Agency Announcement will be available electronically on/about June, 3, 2013 and may be accessed through FedBizOpps http://www.fbo.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

http://www.fbo.gov/

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