Emergent BioSolutions and the Biomedical Advanced Research and Development Authority (BARDA) are establishing a Center for Innovation in Advanced Development and Manufacturing. The center will facilitate advanced development of chemical, biological, radiological, and nuclear (CBRN) medical countermeasures, ensure domestic pandemic influenza vaccine manufacturing surge capacity, share facility construction costs, and provide workforce development training programs to address the U.S. government’s preparedness priorities and needs.
The contract consists of an eight-year cost-reimbursable, cost-share base period of performance, with a fixed price component, valued at approximately $220 million, with up to 17 additional one-year options that will specify their own period of performance and contract value. The eight-year base period of performance includes:
• securing a pandemic influenza vaccine candidate and obtaining access to all necessary intellectual property rights for facility process development and manufacturing,
• constructing additional facilities to support pandemic influenza vaccine production, and
• obtaining facility licensure to manufacture a pandemic influenza vaccine at the Baltimore facility.
Under the contract, BARDA may issue service task orders for requirements such as CBRN advanced development, pandemic influenza vaccine surge production, facility readiness, and other activities including bulk manufacturing, formulation, filling and finishing, storage, and shipping.
As a designated Center, Emergent is also expected to provide as options under the contract:
• manufacturing and delivery of an influenza vaccine in the event of a pandemic,
• core advanced development and manufacturing services to other commercial partners under contract with the U.S. government for the development of biopharmaceuticals against CBRN threats, and
• a workforce development training program to enhance and maintain the U.S.-based ability to produce identified medical countermeasures.
The establishment of Centers that could provide advanced development and manufacturing capabilities for CBRN medical countermeasures to address national security and to augment public health needs on a cost-effective, reliable, and sustainable basis is a response to the strategic imperative by HHS to have the “nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease.”
This BARDA initiative addresses a gap that was identified during the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) review led by HHS Assistant Secretary for Preparedness and Response and is one of the critical elements in HHS’ forward-looking strategy published in an August 2010 report, The Public Health Emergency Medical Countermeasures Review: Transforming the Enterprise to Meet Long-Range National Needs.
“Emergent is pleased to enter into this long-term public-private partnership with BARDA to help achieve our common goal of strengthening national security and preparedness efforts,” remarks Daniel J. Abdun-Nabi, president and CEO of Emergent BioSolutions. “We are honored by the U.S. government’s continued confidence in us, which is founded on our longstanding track record of being the premier biodefense developer and supplier of medical countermeasures.
“This award underscores Emergent’s core competencies not only in product development and manufacturing but also our expertise in contracting with the U.S. government and navigating the regulatory process,” Abdun-Nabi notes.