Biotechnology, Public Health, and National Security

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Since its inception in the 1970's, the biotechnology industry's mission has been to improve and save human lives. The industry has followed through on that commitment with more than 120 new drugs and vaccines, plus another 350 in late-stage clinical development. Biotechnology has also been used to benefit the environment, with new crops that reduce pesticide use and industrial enzymes that cut chemical waste and energy consumption in manufacturing. Now, BIO and its members are responding to the call to develop products for national and homeland defense - vaccines, therapeutics, diagnostics, rapid response systems and decontamination enzymes aimed at neutralizing the agents of biological warfare.

Since the September 11 terrorist attacks, BIO has been meeting with government officials and our members to explore how we can best address our nation's urgent public health needs. A recent survey shows that many biotech companies are already working on defense projects, or are developing technologies that can be used for both conventional health care and for defense against biological agents. Some companies have technologies "on the back burner" - i.e., not under active development - that could be developed for defense. As we enter the biotechnology century, we must think about and develop even more biological solutions to our public health and national security challenges.

Policy

  • BIO has a long-standing policy of opposing the use of biotechnology to develop weapons of any sort that contain pathogens or toxins aimed at killing or injuring humans, crops or livestock.
  • Appropriate uses of biotechnology include products and services to inoculate citizens against infectious agents that may be used in an attack, to detect biological or chemical attacks, and to diagnose and treat those who may have been exposed to a biological or chemical attack.

The Biotechnology Industry: A Strategic Asset

  • Many U.S. biotechnology companies are actively developing biological defense technologies. Some companies are working on defense-specific technologies under contracts with the federal government. Many more are working on technologies that can be used for both conventional health care and biological defense, such as antivirals and antibiotics.
  • Biotechnology companies have a number of technologies, including vaccines, therapeutics and diagnostics, that can be enlisted to fight bioterrorism.

Vaccines

  • Vaccines of varying efficacy and convenience exist for anthrax, smallpox, plague and tularemia, and vaccines are in development for other infectious agents that may be used in biological assaults. The major challenges in vaccine technology are to improve their safety, to develop vaccines against a variety of infectious agents (including new strains), to shorten the time needed to establish immunity (some vaccines require multiple boosters to be effective), and to be able to produce them in large quantities. Biotechnology companies are working to solve these problems with new vaccines based on improved delivery technologies and discoveries made through genetic research. <
    • Researchers are using live attenuated vaccine vector technology to induce rapid protection. Applications include a third-generation anthrax vaccine. This strategy has the flexibility to address a number of different bioterrorism agents and can elicit a long-lasting immune response after a single oral dose.
    • Agricultural biotechnology researchers are working on fruits and vegetables genetically engineered to contain vaccines. Such foods could protect large populations in a very short period of time.
  • Vaccines of varying efficacy and convenience exist for anthrax, smallpox, plague and tularemia, and vaccines are in development for other infectious agents that may be used in biological assaults. The major challenges in vaccine technology are to improve their safety, to develop vaccines against a variety of infectious agents (including new strains), to shorten the time needed to establish immunity (some vaccines require multiple boosters to be effective), and to be able to produce them in large quantities. Biotechnology companies are working to solve these problems with new vaccines based on improved delivery technologies and discoveries made through genetic research.

Therapeutics

  • Monoclonal antibodies. In the late 1990s, monoclonal antibodies came of age with the introduction of new products to treat cancer, rheumatoid arthritis and cardiovascular conditions, and to prevent a severe viral infection in premature infants. These products bind to specific undesirable molecules or cells, often destroying them in the process. They can be used like antibiotics or antivirals, as a way to kill viruses or bacteria; they can also be used to detect the presence of infectious agents or to clear bacterial toxins from the bloodstream. And, like vaccines, they can confer immunity against biological agents.
    • Monoclonal antibody-based "test strips" are in development that may provide a 15-minute diagnostic system for infections, including anthrax and smallpox.
    • An antibody combination that attaches to anthrax toxin and clears it from the body is also under study. The technology could be applied to other biowarfare threats, such as dengue fever, Ebola and Marburg viruses, and plague.
  • Monoclonal antibodies. In the late 1990s, monoclonal antibodies came of age with the introduction of new products to treat cancer, rheumatoid arthritis and cardiovascular conditions, and to prevent a severe viral infection in premature infants. These products bind to specific undesirable molecules or cells, often destroying them in the process. They can be used like antibiotics or antivirals, as a way to kill viruses or bacteria; they can also be used to detect the presence of infectious agents or to clear bacterial toxins from the bloodstream. And, like vaccines, they can confer immunity against biological agents.
  • DNA- or RNA-based therapeutics against viruses and bacteria. Researchers are applying genomics and proteomics technologies to discover weaknesses in viruses and bacteria that can be targeted with a new generation of antibiotics and antivirals. Such weaknesses include proteins or segments of RNA essential to an infectious organism's survival or replication. Projects are under way targeting both.

    In a similar vein, the Defense Advanced Research Projects Agency (DARPA) has funded projects that entail rapid DNA analysis, followed by the rapid synthesis of drugs that can bind, or disable, segments of DNA crucial to an infectious organism's survival.

    Researchers have completed genome sequences for numerous infectious agents, including the bacteria that cause malaria, stomach ulcers and food poisoning, as well as organisms responsible for hospital-acquired infections, cholera, pneumonia and chlamydia. Recently, the genome sequence was completed for a potential biowarfare agent, the organism responsible for bubonic plague (Yersinia pestis).

  • Drug delivery technology. These technologies can make urgently needed medications easier to distribute and ingest on the battlefield or during a civilian crisis. Medications could even be stored in a soldier's backpack.

    • A lozenge containing interferon, a drug that currently can be given only by injection, is under study. A lozenge is easy to use, safe and can be stored at room temperature for two years.
    • Some drugs or vaccines could be applied to patches to allow for quick distribution, easy storage and easy administration.
  • Drug delivery technology. These technologies can make urgently needed medications easier to distribute and ingest on the battlefield or during a civilian crisis. Medications could even be stored in a soldier's backpack.

  • Detection and diagnosis

    • DNA detection and analysis platforms. As we are seeing in the anthrax scare, we need to be able to rapidly determine whether a person has been exposed to an infectious agent, and we also need capabilities for detecting these agents in the environment. Some devices have been developed already for these purposes, and others are in the pipeline.
      • DARPA provided funding for a portable detection device that can analyze DNA from a sample to detect the presence of a pre-selected infectious agent in 30 minutes. Such devices speed diagnosis and allow it to be performed anywhere, without the need to ship samples to labs.
      • Portable biosensors have been developed to detect the exact DNA sequences of pathogens in the atmosphere. Such rapid detection systems provide the precious time necessary for evacuation, vaccination or other prophylactic measures necessary to save lives.
    • DNA detection and analysis platforms. As we are seeing in the anthrax scare, we need to be able to rapidly determine whether a person has been exposed to an infectious agent, and we also need capabilities for detecting these agents in the environment. Some devices have been developed already for these purposes, and others are in the pipeline.
    • Other approaches:
      • Remediation technologies. Specialized enzymes can be sprayed over contaminated areas, rendering infectious agents harmless.
      • Barrier strategies. These strategies center on the creation of molecular barriers to infection. One company, for example, is developing molecules that adhere to entry sites on mucosal membranes to prevent the absorption of viruses and bacteria into the bloodstream.
    • Although the spotlight is on bioterrorism, the biotechnology industry is developing products that may have utility in treating injuries and illness resulting from conventional attacks as well. Artificial skin products, for example, were deployed to treat burn victims of the September 11 attacks. Other biotechnology products with potential applications in an emergency include blood products (such as blood replacement and purification products now in development) and surgical products. Under battlefield conditions, soldiers are vulnerable to naturally occurring infections such as influenza. The biotechnology industry is addressing such illnesses with vaccines (including some under development that could be taken orally or as a nasal spray), antivirals and antibiotics.
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