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Countering Bioterrorism The Role of Science and Technology (2002) / Chapter Skim
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4. Policy and Implementation
Pages 45-52

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From page 45...
... The recommendations listed below, which support and facilitate the R&D priorities outlined in previous sections of this report, are offered in that spirit. DEVELOP SCIENTIFIC AND TECHNOLOGICAL HUMAN RESOURCES The public and private sectors should explore new funding mechanisms that select for the best ideas and the most productive scientists, that offer great flexibility, and that provide the freedom to pursue bioterrorism-related research in a protected environment (i.e., not subject to 1- or 2-year budget fluctuations or constraints)
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From page 46...
... Protected environments that foster innovation must be developed to support a cadre of leaders, scientists, engineers, policy experts, and strategic thinkers. These designated research organizations should address both classified and unclassified issues, and special mechanisms for rapid funding should be created to support external research efforts as the needs and opportunities emerge.
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From page 47...
... An oversight standards laboratory would have the capacity to evaluate biosensors and diagnostic systems for infectious diseases, develop taxonomies of syndromes and data classifications, improve the quality of the expanding DNA and protein databases, validate methods, develop reagents, create internal standards for diagnostic comparisons for the scientific community, and evaluate methods and standards for personal protective equipment and decontamination. FACILITATE DEVELOPMENT OF THERAPEUTICS AND VACCINES: ENGAGEMENT OF INDUSTRY Government has a vital role to play in basic research on countering biological warfare agents through its own institutions, many of which have enormous expertise that has long been brought to bear in the fight against infectious diseases.
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From page 48...
... Through public-private partnerships, create research, development, and manufacturing capacities to produce diagnostics, therapeutics, vaccines, and devices to counter terrorism and an oversight laboratory to evaluate, prepare, and standardize methodologies. Traditional market mechanisms for the development of new diagnostics and vaccines are failing with regard to pubic health generally and response to bioterrorism in particular, where the principal market is likely to be federal and state governments.
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From page 49...
... For development of broad-spectrum antibiotics and antivirals, federal funding should encourage the large pharmaceutical and biotechnology companies to enter the field with the expectation that at least some drugs developed for bioterrorist threats will have dual use that is, they may be applicable to common infectious diseases as well. Such encouragement for undertaking R&D on new drugs against bioterrorism agents could take the form of streamlined grant mechanisms, financial incentives, and regulatory changes.
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From page 50...
... Human diseases caused by many of the CDC Category A agents are so poorly understood at present that meaningfully defining such criteria for the Animal Rule will be difficult. For some agents for example, smallpox appropriate animal models are lacking, and many existing animal models are poorly characterized with respect to lesion character and disease progression.
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From page 51...
... POLICY AND IMPLEMENTATION 51 Clearly, in an emergency, someone or some agency has to be authorized to decide, for example, that INDs may not be required, that the informed consent process can be modified, that companies might have to be indemnified, or that companies might have to exchange information or work together, which would require a waiver of antitrust law. The factors that go into such decisions should be discussed by government and industry, and possible approaches recommended to federal agencies.
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Key Terms

  • animal models
  • infectious diseases
  • rapid funding
  • national orphan
  • human efficacy

  • biological warfare
  • bioterrorist threats
  • challenge doses
  • poorly characterized
  • vaccine centers

  • warfare agents
  • orphan vaccine
  • oversight standards
  • standards laboratory
  • countering bioterrorism

  • nih grants
  • intensively interacting
  • own institutions
  • rapid access
  • bring vaccines

  • simply acting
  • ultimately facilitates
  • otherwise rare
  • diagnostic comparisons
  • evaluate diagnostic

  • human diseases
  • allows rapid
  • disease characteristics
  • scientific limitations
  • sister agencies


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