Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has announced the Planning for Product Development Strategy (R34 Clinical Trial Not Allowed) funding opportunity under Funding Opportunity Number PAR-25-099. This Notice of Funding Opportunity (NOFO) supports planning activities aimed at developing comprehensive product development strategies for next-generation treatments for HIV, HIV-associated comorbidities, coinfections, and complications, as well as innovative HIV preventive strategies. The goal is to enable the submission of Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) and facilitate the transition of research findings into tangible drug products. The NOFO emphasizes the importance of establishing a multidisciplinary team with expertise in product development, regulatory affairs, chemistry, manufacturing, and controls (CMC), and preclinical and clinical development. Projects funded under this program are expected to define a Target Product Profile (TPP), identify critical path studies, align preclinical and clinical programs, conduct gap analyses, and address FDA regulatory requirements. Activities should include defining product indications, administration routes, CMC strategies, pharmacology and toxicology assessments, and preliminary clinical protocol designs. Finalized clinical protocols are not expected by the conclusion of the project period. Eligible applicants include higher education institutions, nonprofits with or without 501(c)(3) status, for-profit organizations, state and local governments, tribal governments, faith-based organizations, and foreign institutions or organizations. Both U.S. and non-U.S. entities are eligible, including foreign components of U.S.-based organizations. Program Directors/Principal Investigators (PDs/PIs) must have an active eRA Commons account, and applicant organizations must maintain active registrations with SAM.gov, Grants.gov, and eRA Commons. The funding opportunity allows applications with budgets of up to $225,000 in direct costs per year for a maximum project period of one year. NIAID anticipates funding 2-3 awards in Fiscal Year 2025, with an estimated total funding of $1,000,000. Applications must clearly outline critical milestones, risk management strategies, go/no-go decision points, and plans for a regulatory strategy, including key meetings and submissions with the FDA. Applications will be evaluated based on three primary criteria: Significance and Innovation (impact and novelty of the proposed product), Approach (feasibility and robustness of the proposed planning activities), and Expertise and Resources (the capacity and expertise of the research team). Additionally, reviewers will consider the quality of plans for addressing CMC requirements, pharmacology, toxicology assessments, and alignment between preclinical and clinical development strategies. Key submission dates include an open date of February 13, 2025, with subsequent application due dates aligned with NIH standard deadlines. Applicants are encouraged to submit a Letter of Intent at least 30 days before the application deadline. Applications must be submitted electronically via Grants.gov and tracked in eRA Commons. Non-compliant applications will not be reviewed. For technical and scientific inquiries, applicants may contact designated program officials at NIAID. For assistance with submission processes, the eRA Service Desk and Grants.gov Support are available. The NIAID strongly encourages prospective applicants to consult with program staff during the preparation of their applications to ensure alignment with the NOFO objectives and requirements.