Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)
ID: 349870Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $225K

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/349870

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-029.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)" aimed at supporting the development of comprehensive strategies for next-generation treatments for HIV and related health issues. This grant seeks to facilitate the translation of research findings into drug products, enabling applicants to prepare for Investigational New Drug (IND) applications to the FDA, with a focus on multidisciplinary collaboration among business and clinical experts. The NIH anticipates awarding 2-3 grants totaling $1,000,000 for fiscal year 2025, with individual project budgets capped at $225,000 for a one-year period. Interested applicants can submit proposals starting February 13, 2024, with a deadline of December 4, 2024, and should direct inquiries to grantsinfo@nih.gov for further information.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-029-Full-Announcement.html
    PAR-24-029.html
    The National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID), has announced a new funding opportunity (NOFO) aimed at supporting the development of comprehensive product development strategies for next-generation HIV treatments, associated comorbidities, coinfections, and preventive measures. The R34 Planning Grant allows applicants to strategically plan before submitting Investigational New Drug (IND) applications to the FDA. The opportunity is expected to generate 2-3 awards totaling $1,000,000 for fiscal year 2025, with a maximum budget of $225,000 per year for each project, limited to a one-year period. Applicants must demonstrate multidisciplinary expertise, including involvement from business and clinical experts to develop effective IND-directed strategies. Key dates include the opening date for applications on February 13, 2024, with a submission deadline on December 4, 2024. Specific eligibility criteria encompass a wide range of organizations, including higher education institutions, nonprofits, and for-profit entities. Applications must comply with detailed submission guidelines, including addressing the NIH Data Management and Sharing Policy. Proposals should articulate clear objectives and the strategic alignment of preclinical and clinical activities to promote successful product development and facilitate interactions with potential investors and funding agencies. This NOFO highlights NIH's commitment to advancing research in HIV treatment and prevention.
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