synopsis schreef:
Offerors must propose a well-defined and feasible Product Development Plan for advancing the vaccine candidate by carrying out the following research and development activities as specified in the negotiated Statement of Work:
1) development and update of the Product Development Plan for a multivalent filovirus vaccine candidate, including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken;
2) manufacturing and formulation process development;
3) manufacturing of pilot lot cGMP material;
4) real time and accelerated vaccine stability studies;
5) conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies and multivalent immunogenicity interference studies;
6) development, qualification and, where necessary, validation of all assays and reagents necessary to support product development;
7) development, submission, and sponsorship of an Investigational New Drug (IND) application, including compliance with all regulatory requirements;
8) 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;
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; and
10) the provision to NIAID of cGMP final container vaccine and all necessary supporting documentation/letters of cross-reference to allow NIAID to perform subsequent clinical trials.