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Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed

US · MD Food and Drug Administration (HHS-FDA) grant unknown #FOR-FD-24-001

Summary

The Food and Drug Administration (FDA) is seeking research proposals to integrate machine learning (ML) techniques with computational fluid dynamics (CFD) models applied to orally inhaled drug products. This is a U01 cooperative agreement mechanism, meaning FDA will have substantial scientific and programmatic involvement during execution. Clinical trials are explicitly not allowed under this funding opportunity. The opportunity was forecasted as of November 2023, indicating it had not yet been formally solicited at time of publication.

What they want

Conduct research integrating machine learning algorithms with computational fluid dynamics (CFD) models to advance the scientific understanding and regulatory evaluation of orally inhaled drug products (OIDPs). Work must be performed under a U01 cooperative agreement with FDA involvement. Clinical trials are prohibited under this opportunity.
Technical requirements
  • Integration of machine learning methods with CFD models
  • Focus on orally inhaled drug products
  • Clinical trials not permitted
  • U01 cooperative agreement mechanism — FDA has substantial programmatic involvement

How they evaluate

Submission: Grants.gov electronic submission (federal grants portal)

Risks & flags

  • Highly specialized scope (ML + CFD for OIDPs) narrows the realistic bidder pool significantly
  • Forecasted status means full solicitation requirements are not yet public — scope could tighten further upon formal release

Market context

inferred from NAICS
R&D in Physical, Engineering, Life Sciences (except Nanotech & Biotech)
NAICS 541715
US market size
$95B
Typical award
$100K – $50M+
Typical buyers
DoDNSFNIHNASADOE
Commonly required
DCAA-compliant accountingITARCMMC L2
Integrating Machine Learning with Computat…
$unknown
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