Preclinical services for biopharmaceutical product development

The aim of this solicitation is to create a multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract.

 

The development and introduction of new therapeutic products against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID requires a nontraditional, proactive, and product development-oriented program to provide preclinical product development support for promising biopharmaceutical therapeutic candidates for human infectious diseases or diseases caused by infectious agents. The suite of services included in this IDIQ 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) and/or other FDA submissions including 510(k) application and Investigational Device Exemption (IDE) application. These services are available for therapeutic candidates arising from academia, the private sector or other sources.

While the overall suite of services provided is comprehensive, this resource is intended to be applied to any/multiple product(s) at any/multiple stage(s) requiring access to services in support of a diverse collection of biopharmaceutical candidates, rather than to carry a single product candidate through the entire preclinical development pathway. These services are intended to help 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. Furthermore, the rapid diagnosis of infectious disease-causing pathogens and/or toxins is crucial for implementing proper treatment and patient management. The commercial development of new diagnostics is a high priority. For that purpose, this solicitation includes services supportive of new diagnostics for infectious disease-causing pathogens and/or toxins. This IDIQ will be administered and used primarily to support DMID initiatives as necessary to help the Division accomplish its mission. However, other NIAID programs may initiate Task Orders under this IDIQ as necessary to accomplish their mission.