Elucidation: Centers for the Innovation in Advanced Development and Manufacturing

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The 2009 influenza pandemic was the main driver for the Centers for the Innovation in Advanced Development and Manufacturing (CIADM). As a new federal government authority, the Biomedical Advanced Research and Development Authority (BARDA), directed by Dr. Robin Robinson, assembled a team of scientists and technicians with a vast array of knowledge and experience in chemical, biological, radiation, and nuclear fields. BARDA’s directive was to enhance preparedness for catastrophic challenges such as an influenza pandemic or other serious threats to the American public.

The CIADM has its origins in the National Strategy for Pandemic Influenza (1). This document has three pillars, with Pillar 1 being “preparedness and communication: to establish domestic production capacity and stockpiles in support of our containment and response strategies,” a high-level perspective. However, the first wave of the 2009 influenza pandemic elevated the recognition that the United States had to be much more prepared for a second wave that “identifies critical questions and gaps in the response and suggests additional opportunities for mitigation” (2). The other two pillars are “surveillance and detection” (Pillar 2) and “response and containment” (Pillar 3).

This 2009 pandemic and its eventual outcome (insufficient vaccine to avert a second wave of influenza) caused biomanufacturers to focus on the need to make doses of vaccine much more rapidly. With the pandemic declining and the lessons learned, the time was appropriate to address the factors that may have prevented this outcome. To prevent significant morbidity and mortality for the next pandemic, seven major categories were recommended (2):

  • coordination (appoint a single person in the White House to coordinate decision making)
  • scenario (develop and disseminate a few specific planning scenarios that federal, state, local, and private entities could assess their capabilities)
  • surveillance (provide important, reliable, and timely information)
  • response (focus on decisions that could reduce instances of severe disease and death such as accelerating delivery and use of vaccines)
  • barriers (overcome legal, social, and financial barriers)
  • communication (overcome inadequate communication among states, health workers, and the general public)
  • future preparedness (improve vaccine production, antiviral drug development, and health surveillance).

As a major effort by the federal government to improve the timing of vaccination for the 2009 pandemic, the CIADM solicitation (3) was posted on 2 March 2011 and issued on 30 March 2011. This initiative to establish CIADM by BARDA was one of five key initiatives issued by the US Department of Health and Human Services (4). The CIADM solicitation provided guidance. After three rounds of questions and responses and two amendments, the one-on-one communication sessions within the government were held in late June 2011. Two more amendments were issued, and the proposals were finally due on 21 July 2011.

Once the proposals were received from the bidders, a series of internal procurement milestone meetings were conducted with oral presentations made by the various bidders on 9–10 August 2011. A Technical Evaluation Panel (TEP) developed the mechanism used for these various reviews. The TEP comprises government employees from BARDA, FDA, NIH, and contractors familiar with the subject matter. Numerous TEP meetings were held initially to evaluate various proposals and to determine whether they met the five mandatory criteria for evaluation. For example, one mandatory criterion was to surge manufacturing capacity for pandemic influenza vaccine production and other threats. The five mandatory eligibility criteria had to be met when the proposal was submitted, and if satisfactory, then the technical evaluation phase was initiated.

The numerous meetings held were between July 2011 and 15 June 2012, when the financial awards were made. In addition, awarders were required to provide documentation of how they would meet each of the four statements of objectives (SOO) (3). One SOO was to establish public–private partnership to construct/retrofit US-based, commercial-scale, biopharmaceutical facilities that support advanced development and manufacturing of medical center measures.

After the selection process for the bidders met all mandatory criteria, the bidders were also required to meet the competitive financial range. Three bidders were selected to provide overlapping capabilities that could provide the United States Government (USG) with the best value. Those who were selected would also support the Department of Defense portfolio.

The financial summary provided about US$400 million from USG cost share for the three offerors and a $194 million cost share by the offeror. In addition to the requirement for supplying pandemic vaccine, the three offerors would provide a range of core services such as the manufacture of recombinant proteins, monoclonal antibodies, vaccines, blood-plasma– derived products, mammalian cells, insect cells, microbial cells, live virus, small molecules, and antibody-like biologics. Evaluation of these services uses a task order request (TOR) that is a competition among the three offerors applying predefined criteria (5).

The concept of CIADM using a public–private partnership has a long history of success in many countries. The National Aeronautics and Space Administration (NASA) has developed a good model within the USG: the Envirocast Vision Touch Table, which is a collaboration between NASA and Northrop Grumman and Storm Center Communications. “Forecasters will use this tool to brief emergency managers, who can perform inquiries in real time on the geographic information system (GIS) data by tapping a computer screen with their fingers” (6).

This USG model demonstrates an effective approach to funding an expensive government program that has many possible applications, including new business models, employment opportunities, and new inventions.

Another example outside the USG highlights the potential for the United States: the Fraunhofer Society, established in Germany in 1949. This group of government-backed research institutes has made Germany a leading “exporter of high-tech manufactured goods” (7). Essentially, the institutes successfully transfer research into applied technology. With the support of President Barack Obama, the United States has begun to create a comparable network: The National Network for Manufacturing Innovations (8). It is hoped that similarly successful collaborations, akin to those seen in Germany, will develop in the United States in the coming decades.

The CIADM leverages a public–private opportunity for resolving complex problems that may not be solved by either government or industry alone. It is an exciting and challenging prospect that will depend upon the support and creativity of many committed individuals and organizations. Working together in this way, the potential is great for both private enterprise and government agencies. The outcomes could be significant.

References
1
National Strategy for Pandemic Influenza. USHomeland Security Council, Washington, DC, November 2005.

2 Report to the President on US Preparations for 2009 H1N1 Influenza. President’s Council of Advisors on Science and Technology (PCAST): Washington, DC, 7 August 2007.

3 Centers for Innovation in Advanced Development and Manufacturing. Solicitation Number 11-100-SOL-00611.

4 The Public Health Emergency Medical Countermeasures Enterprise Review. Transforming the Enterprise to Meet Long-Range National Needs. US Department of Health and Human Services, Assistant Secretary for Preparedness and Response: August 2010.

5 CIADM. TOR 001T: Prepoposal Conference. US Dept. of Health and Human Services: Rockville, MD, 10 July 2014.

6 Jones D, Ambrose S. Public–Private Partnership Yields New Technology for Weather and Emergency Response Operations. NASA Technol. Innov. 15(1) 2009: 31–33.

7 Gummer C. What’s Behind the German Success Story? Public– Private Research Institutes Drive Manufacturing Exports and Serve As Models for a New US Initiative. Wall Street Journal 2 June 2014.

8 Hagerty RH. Why US Manufacturing Is Poised for a Comeback (Maybe). Wall Street J. 2 June 2014.

Michael P. Angelastro is deputy director, R. Thomas Warf is director, and Thor E. Young is program analyst, all at the Manufacturing, Facilities, and Engineering Division of the US Department of Health and Human Services, BARDA. Robert Z Maigetter, PhD, is a senior program manager, Manufacturing, Facilities, and Engineering at Tunnell Government Services, a contractor supporting the office of the HHS/OS/ASPR/BARDA, 330 Independence Avenue SW, Rm 640, Washington, DC 20201; 1-202260-1891; fax 1-202-205-4520; robert.maigetter@hhs.gov.

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