Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program (X01 Clinical Trial Not Allowed)

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Description

The Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program, administered by the National Institute of Allergy and Infectious Diseases (NIAID) under NIH, offers a mechanism for investigators to request gap-filling preclinical services to support the development of novel therapeutics targeting HIV and HIV-associated co-infections such as hepatitis B virus (HBV), hepatitis C virus (HCV), and Mycobacterium tuberculosis (TB). The program aims to facilitate the advancement of promising therapeutics from early research stages through preclinical development to enable Investigational New Drug (IND) applications.

This program provides access to a range of preclinical services without direct funding awards. Instead, it offers resource access awards (X01 mechanism) that allow researchers to utilize NIH-supported preclinical contract services to fill gaps in their drug development efforts. The program supports projects at various stages of preclinical development, including small molecules, biologics, cellular and genetic therapies.

Available Services

• A) In Vitro Testing and Screening of HIV Compounds

  • High-throughput screening of compound libraries
  • Testing in human peripheral blood mononuclear cells (PBMCs) and cell lines
  • Hit-to-lead optimization studies
  • HIV drug resistance testing

• B) Evaluations in Small Animal Models for HIV, HBV, HCV, and MTB

  • Pharmacokinetic, safety, and efficacy studies
  • Use of xenograft models with human cells/tissues
  • Clinical and laboratory monitoring of animals
  • Immunology, histopathology, imaging, and other supportive assays

• C) Formulation Development and Manufacture of Clinical Dosage Forms

  • Development of alternative dosage forms and improved formulations
  • Analytical assay development and validation
  • cGMP-compliant drug product manufacturing
  • Stability studies

• D) Preclinical Pharmacology and Toxicology

  • Pharmacology studies in animal species
  • GLP-compliant toxicology and safety pharmacology
  • Genotoxicity and off-target toxicity evaluations
  • ADMET studies and development of novel toxicology models

Applicants may submit separate applications for each service area with strong justification. Services in categories A, C, and D typically last up to 12 months, while category B services may extend to 24 months.

Intellectual Property

Applicants are expected to have or be pursuing appropriate intellectual property protections before applying. Agreements regarding intellectual property management will be established prior to initiation of services.

Due Dates

• September 1, 2022
• January 17, 2023
• September 1, 2023
• January 17, 2024
• September 1, 2024
• January 17, 2025

All applications are due by 5:00 PM local time of the applicant organization. Applicants are encouraged to submit early to allow time for corrections.

Funding Amount

• No direct funds are awarded through this program.
• The award provides access to NIH-supported preclinical services.
• Project periods vary by service type: up to 1 year for most services, up to 2 years for small animal model evaluations.

Eligibility

• Eligible Applicants:

  • Public and private institutions of higher education (including HBCUs, Hispanic-serving institutions, tribal colleges, etc.)
  • Nonprofits with or without 501(c)(3) status (excluding institutions of higher education)
  • For-profit organizations including small businesses
  • State, county, city, township, and special district governments
  • Federally recognized and other Native American tribal governments and organizations
  • Independent school districts, public housing authorities
  • Foreign institutions and foreign components of U.S. organizations are eligible

• Eligible Individuals:

  • Any individual with the skills, knowledge, and resources to carry out the proposed research may apply as PD/PI.

• Registrations Required:

  • System for Award Management (SAM)
  • NATO Commercial and Government Entity (NCAGE) Code (for foreign entities)
  • eRA Commons
  • Grants.gov

Application Process

• Applications must be submitted electronically via Grants.gov and tracked in eRA Commons.
• No budget is submitted as no funds are awarded.
• A single specific aim must be provided, directly related to the requested services.
• Research strategy should include background, significance, preliminary data, intellectual property status, work plan, deliverables, material availability, and timeline.
• Letters of intent are encouraged but not required; submit 30 days prior to application due date.
• Applications must comply with SF424 (R&R) Application Guide instructions and program-specific requirements.
• Multiple applications can be submitted for different service areas but must be distinct.
• Clinical trials are not allowed under this FOA.

Additional Information

• Applications will be administratively reviewed; no peer review is conducted.
• Applicants are encouraged to contact scientific/research contacts to discuss potential service requests before applying.
• Intellectual property management agreements will be required if selected.
• The program supports translational research to overcome barriers in drug development for HIV and associated infections.
• The FOA expired January 18, 2025; check NIH Guide for current opportunities.

External Links

• NIH RAPIDD Program FOA (PAR-22-185)
• NIH Grants Policy Statement
• NIH eRA Commons
• Grants.gov
• NIH Guide for Grants and Contracts

Contact Information