Preclinical services for biopharmaceutical product development

The development and introduction of new therapeutic products against potential agents of bioterrorism, drug-resistantpathogens, 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 requiresa nontraditional, proactive, and product development-oriented program to provide preclinical product developmentsupport for promising biopharmaceutical therapeutic candidates for human infectious diseases or diseases caused byinfectious agents. The suite of services included in this contract will encompass those activities commonly associatedwith the development of biopharmaceutical products for treating or diagnosing infectious disease that are required forInvestigational New Drug (IND) application and/or Biologic License Application (BLA) and/or other FDA submissionsincluding 510(k) application and Investigational Device Exemption (IDE) application.