BARDA Nonclinical Development Biological Network

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Together with our industry partners, BARDA promotes the advanced development of medical countermeasures (MCM) to protect Americans and respond to 21st century health security threats. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) MCM Review (2010) recommended that PHEMCE partners provide not only financial help to medical countermeasure developers but also technical and regulatory assistance. BARDAs Strategic Plan (2011) set a goal to provide assistance to developers through core assistance programs in critical areas including nonclinical and clinical services to obtain safety and efficacy data supporting MCM development. In May 2011, BARDA awarded multiple contracts using the Indefinite Delivery, Indefinite Quantity (IDIQ) contract mechanism to establish a Nonclinical Development Network in support of the chemical, biological, radiological, and nuclear countermeasures in BARDA's portfolio. The primary goals of the program were to develop well-characterized nonclinical models of infection and/or exposure to priority CBRN threats and ensure these models meet the regulatory requirements supporting MCM product development under the Animal Rule; develop and validate assays to monitor response and bridge animal data to humans; and design and conduct adequate and well-controlled animal efficacy studies intended to provide the primary evidence of effectiveness of candidate MCMs. In 2015 and 2016, the Nonclinical Development Network was expanded, and distinct networks were established addressing chemical agent threats, radiologic and nuclear agent threats, and biological agent threats, respectively. Since 2011, over 100 task orders were issued across these threat area networks. To meet the demands for MCM development and support an ever-increasing need for nonclinical services including those required to address 21st Century Threats and BARDAs innovation activities, this requirement seeks to establish a Nonclinical Services Network of laboratories providing expertise, capacity, and program management across the capability area: Capability Area 1: Animal Model Development and MCM Testing (Biological Agents)