The National Institute of Allergy and Infectious Diseases (NIAID) is recompeting a preclinical services contract for activities supporting new diagnostics for infectious disease-causing pathogens and toxins.
The suite of services included in this contract will encompass those activities commonly associated with the development of biopharmaceutical products for treating or diagnosing infectious disease that are required for Investigational New Drug (IND) application and/or Biologic License Application (BLA).
These services are available for therapeutic candidates arising from academia, the private sector or other sources.
While the overall suite of services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of biopharmaceutical product and diagnostic candidates, rather than carry a single product candidate through an entire preclinical development pathway.
These services have helped a wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter a Phase I trial.
NIAID anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) contracts to the organizations that best meet the overall qualifications needed to fulfill the technical requirements of the task areas of this solicitation, which include:
- Product Development Planning and Evaluation
- Analytical Assay Development and Product Characterization
- Process Development and Related Activities
- CGMP Manufacture and Related Activities
- Regulatory Activities and Documentation
- Parent Contract Management Support Activities
Further details are available via Solicitation Number: RFP-NIAID-DMID-NIHAI2015036. The full Request for Proposal is expected to be released July 31, 2015.
