Preparedness for Pandemics and Biodefense

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In the wake of the September 11 terrorist attacks, BIO surveyed the industry and found that many biotech companies were already working on defense projects or developing technologies useful for both conventional health care and for defense against biological, chemical and radiological/nuclear agents. Biotechnology companies are also developing novel approaches to prepare for a pandemic, including the development of new vaccines, antivirals and diagnostic and detection tools.

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, chemical or radiological/nuclear attacks, and to diagnose and treat those who may have been exposed to such attacks.

A Strategic Asset

Many U.S. biotechnology companies are actively developing medical countermeasure 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 conventional health care, pandemics and biological defense, such as antivirals, antibiotics, and diagnostic tools.

Recognizing the important value that the biotechnology industry has in developing bioterror countermeasures, President Bush announced in January 2003 the Project BioShield initiative, which would fund new programs at the National Institutes of Health designed to spur countermeasure development. The Project Bioshield Act was signed into law in July 2004 and authorizes $5.6 billion in procurement funding for medical countermeasures against chemical, biological, radiological or nuclear attacks. Similarly, the President approved $3.3 billion in FY 2006 and an additional $2.3 billion in FY 2007 for the Department of Health and Human Services for development and procurement of medical countermeasures against a potential influenza pandemic. Biotechnology companies have products and platforms, including vaccines, therapeutics and diagnostics, that can be enlisted to prepare our nation for man-made and natural emergencies. In addition, drug-delivery technology can make urgently needed medications easier to administer on the battlefield or during a civilian crisis. Medications could even be stored in a soldier's backpack.

VACCINES AGAINST WEAPONIZED PATHOGENS
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 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), to be able to produce them in large quantities, improve ease of administration, and make them even safer. Biotechnology companies are working to solve these problems with new vaccines based on improved delivery technologies and discoveries made through genetic research.

Examples:
Researchers are exploring new vaccine technologies, including 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 may elicit a long-lasting immune response after a single oral dose.

By manipulating an immunotoxin-hybrid molecule used to kill tumor cells in lymphoma patients, researchers have created a vaccine that has been shown to protect mice against ricin, an extremely potent toxin, without significant side effects.

Agricultural biotechnology researchers are working on fruits and vegetables genetically modified to contain vaccines. Such foods could protect large populations in a very short period of time.

MONOCLONAL ANTIBODIES Monoclonal antibodies can be used like antibiotics or antivirals, as a way to treat viral and bacterial infections; 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.

Example:
An antibody combination that attaches to anthrax toxin and clears it from the body is under study. The technology could be applied to other biowarfare threats, such as dengue fever, Ebola and Marburg viruses, and plague.

DNA- OR RNA-BASED THERAPEUTICS
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.

RNAi, or RNA interference, is another exciting technology. RNAi technologies aim to "silence" targeted genes to prevent the manufacture of disease-causing proteins. RNAi could apply to a number of infectious diseases related to national preparedness.

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, and for potential biowarfare agents, such as the organism responsible for bubonic plague (Yersinia pestis).

BATTLEFIELD EPIDEMICS
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), antivirals and antibiotics.

DETECTION AND DIAGNOSIS
As we saw in the anthrax scare of 2001, 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.

Example: Portable detectors. DARPA provided funding for a portable detection device that can analyze DNA from a sample to detect the presence of a preselected 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.

Other Approaches

Remediation technologies
Specialized industrial 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.

Nonbiological attacks and emergencies
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.

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