National Institutes of Health

Description

The purpose of this Funding Opportunity Announcement (FOA) is to support translation of advanced HIV-1 vaccine candidates from pre-clinical studies through different phases of process and product development, Current Good Manufacturing Practice (CGMP) manufacturing and regulatory filing to the point of clinical testing. The FOA will support technology transfer, preclinical immunogenicity and optimization studies, process development, analytical assay development, qualification, validation, testing, small scale pilot or engineering runs, CGMP manufacture in partnership with Pharma/Biotech/Contract Manufacturing Organizations (CMO), quality assurance/quality control oversight, fill-finish activities, product release and storage, generation of reference standard, drug substance and drug product stability testing programs, Investigational New Drug (IND)-enabling studies, regulatory submission preparation.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

NIH Grants Information<br/>grantsinfo@nih.gov
grantsinfo@nih.gov