Partnering Against Terrorism Summary of a Workshop (2005) / Chapter Skim
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Panel III: Partnerships Against Bioterrorism
Panel III: Partnerships Against Bioterrorism
Pages 66-86
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From page 66... ...
These include the NRC's Branscomb and Klausner report,13 a blue-ribbon panel of the National Institute of Allergy and Infectious Diseases, the Presidents' Council of Advisors on Science and Technology (PCAST) letter, the President's national strategy on homeland security, and the House and Senate draft legislation for the new Department of Homeland Security.
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From page 67... ...
, especially on their vaccine programs, and then focus more specifically on NIAID's biodefense activities. She would refer often to partnerships, she said, because "one of our assets at NIH is our history of partnering." NIH supports several but not all aspects of the vaccine R&D pipeline, she said, and this necessitates partnerships with other entities that bring needed skills to vaccine development.
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From page 68... ...
Partnering for Vaccine Development The NIH has long maintained robust vaccine development programs, she said, and they have become more robust as a result of post-9/11 activities. Virtually all of the vaccine development of NIH involves partnering in a variety of ways.
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From page 69... ...
A Six-Fold Increase in Funding for Biodefense The Department of Homeland Security, in a document about strengthening the nation, recognized the importance of vaccines, antimicrobials, and a strong infrastructure for medical research. As a result of many factors, including that publication, said Dr.
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70 PARTNERING AGAINST TERRORISM 1,750 Dollars of Millions FIGURE 14 NIH biodefense research funding, FY 20002003. FIGURE 15 Eleven cases of bioterrorism-related inhalational anthrax in the United States, 2001.
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From page 71... ...
Providing homeland security is a continuing need and objective that cannot be reached in a brief burst of activity, no matter how well funded. As the need for research facilities is gradually met, researchers will continue to need flexibility to develop drugs and vaccines, and conduct basic research that makes them possible.
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From page 72... ...
Goals for Biodefense at NIAID The groups set the following goals: · Conduct basic research on the biology of the microbe and host response; · Conduct basic and applied research aimed at developing diagnostics, therapeutics, and vaccines against these agents; · Develop improved vaccines against microbes for which vaccines currently exist but may not be useful for the civilian population; · Develop new vaccines for microbes against which no vaccines currently exist; · Establish needed research resources and make them available to the scientific community. NIH's extramural research grants provide a mechanism to attract not only the academic community but also private firms.
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From page 73... ...
Models for Vaccines Three specific models were evolving around biodefense vaccines. In the first, DHHS awarded a $428 million contract to produce a smallpox vaccine.
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74 PARTNERING AGAINST TERRORISM United States Birmingham, ion certifies FIGURE 17 Smallpox timelines. FIGURE 18 Examples of emerging and re-emerging diseases.
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Just 4 hours previously, she said, NIAID had announced a new contract for the development of an anthrax vaccine. This would be different approach, using a recombinant protective antigen, in which researchers use a fragment of the anthrax agent instead of the whole organism as the antigen.
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From page 76... ...
Before that -- about a decade ago -- companies were excited when genetic sequencing was completed for a number of important bacterial pathogens; this heralded two decades of drug development now regarded as the "golden age of antibiotic discovery." Again, however, results have been disappointing. Even with millions of dollars invested in trying to develop new classes of antibiotics, the products that had reached phase one through three development, and even late preclinical stages, still fell short of completely new classes of antibiotics or new broad-spectrum antibiotics.
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This reality had dampened enthusiasm among firms for investing in antibiotic drug discovery. In fact, she said, a recent competitive analysis indicated that most large pharmaceutical companies and many smaller companies had actually reduced their activity in this area.
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No single institution or sector could address the challenges alone. In addition, partnerships were needed in order to share the high financial risks, particular in the area of antibiotic drug discovery, and to pool dispersed knowledge about health risks.
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The question of liability, in particular, is extraordinarily complex in relation to human health and biothreat agents, both because of the animal model rule and the inability to gather sufficient data to show safety and efficacy in humans. If anti-trust issues that preclude company consortia could be resolved, the resulting partnerships could provide working relationships that allow risks and expertise to be shared.
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From page 80... ...
In the bioterrorism area, she said, whether for protection, vaccine manufacture, or passive immunization, "it's clear that we have a target set of organisms we need to be working on and some very specific results we're looking for to provide protection for individuals."
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From page 81... ...
As adverse reactions were identified, by almost anyone, sufferers were able to go to the compensation program for relief instead of to the legal system. The value of this system was that during the mid-1980s, when law suits became prevalent, fewer vaccine companies were lost than had been feared.
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From page 82... ...
In this model, NIAID announced a partnership agreement with a private vaccine production and support contractor, Science Applications International Corporation (SAIC)
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Kerr said that the new Department of Homeland Security planned an entity called HSARPA, the Homeland Security Advanced Research Projects Agency, under the Undersecretary for S&T. HSARPA, he said, would be "the systems equivalent of DARPA, but with many of the procurement issues and problems put aside." HSARPA would be the "major facilitator to couple the research and development testing and evaluation enterprise with the actual entities, whether they be in the private sector or in academia, and the actual end-users." 19An adjuvant is an immunologic agent that increases an antibody response.
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Dr. Kerr replied that the initial budget should be thought of as "an administrative settingup period in which the actual roadwork and technological and administration will be set in place." Dr.
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Without them, she said, companies would not support the innovation that is required. This was a lesson that had been learned through the experience of the vaccine industry -- that innovation is essential, "especially if we take into account the National Security Council's warning that infectious diseases in general are the most serious threat for humanity over the next two decades." The finding of this report, released 3 years ago, had become even more urgent, she said, because it was written before the anthrax attacks.
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From page 86... ...
It's a fascinating concept to see whether we can interact with them as they're doing their mission for the DoD." A questioner referred to the expense of developing drugs by current processes, and asked whether new techniques such as robotics would reduce the cost and time of drug development, and what public-private mechanisms might advance development of these new robots.
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