NIAID maintains contracts to support the development of emerging HIV therapeutics, vaccines, and non-vaccine biomedical prevention (nBP) candidates. As promising adult and pediatric formulations emerge for the treatment and prevention of HIV and co-infections, there is a critical need to move these candidates rapidly and efficiently into clinical testing.
The services under these contracts are provided on a case-by-case basis and are designed to assist product developers (i.e., Sponsors) in filling key gaps in their product development pathway. These services have enabled the acquisition of preclinical data, development of essential methods, manufacture and characterization of products, fulfillment of regulatory requirements, and completion of studies necessary to advance these products into clinical trials. These contract services have also helped Sponsors obtain critical data and materials to attract additional funding and identify prospective partnerships.
Main Areas of Focus
- To fill specific gaps in a Sponsor’s product development plan that are delaying advancement of an HIV prevention drug formulation or strategy into clinical testing and to product licensure
- To support preclinical/nonclinical activities for the development of drug formulations to treat and prevent HIV and co-infections in pediatric populations
- To address critical issues blocking advancement of a drug formulation or drug delivery system (e.g., in vivo delivery system optimization/verification, dose selection, drug metabolism and transport, pharmacokinetic (PK)/pharmacodynamic (PD) relationships, physiologically based PK modeling, etc.)
Support Services
- Performance of non-Good Laboratory Practices (GLP) and GLP in vitro and in vivo animal safety, toxicity, and pharmacology studies to enable Investigational New Drug (IND) or New Drug (NDA) applications
- Performance of non-human primate and humanized mouse efficacy and PK studies for dose selection and product characterization
- Focused current Good Manufacturing Practice (cGMP) manufacturing to enable IND or Investigational Device Exemption (IDE) required safety and toxicity studies or support first-in-human clinical trials
- Development and performance of analytical methods to support specific IND/IDE-enabling studies
- Physical characterization of drug products and substances to support chemistry, manufacturing, and controls (CMC) submissions
- Quality Assurance/Quality Control oversight and audits of GLP and cGMP activities
- Support for pre-IND/IDE and IND/IDE submissions
- Support for potential workshops and best practices groups to address key gaps in product development for HIV prevention and treatment
These services are provided at no cost to the Sponsor. Sponsors seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors. Data and reports are provided in a format that supports a regulatory filing.
Collaboration Opportunities
- Support for potential workshops and best practices groups to address key gaps in product development for HIV prevention and treatment
- Development of pediatric formulations
Who Can Use This Resource
Sponsors with a defined need or gap that is delaying or blocking further advancement of their product to clinical testing and/or licensure may request services.
Sponsors will need to provide preliminary data and/or regulatory agency input supporting a justification for the requested support.
Sponsors may be required to provide a Target Product Profile (TPP), Product Development Plan (PDP), or regulatory agency recommendation to support their request for services.
If a requested activity is related to an NIH grant award, the Sponsor should demonstrate how the activity will advance the grant objectives and confirm that the activity cannot be supported through rebudgeting or an administrative supplement, if applicable.