Trends and Considerations in Global Infectious Disease Drug Dev | Page 12

For the first time, substantial funds are available from various

Figure 10. Let’s

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federal agencies not only for basic science research, but also for
drug development costs through Phase III. In addition, the Biomedical
Advanced Research and Development Authority (BARDA) and the
Departments of Defense Homeland Security support the development
and procurement of bio-terrorism and pandemic infectious disease
countermeasures. To improve their ability to prevent or treat security
threats, they want a drug marketed for other indications that can be
readily supplied in case of a bioterrorism attack.
Barriers to antimicrobial drug development are being reduced in the
US and EU. Recently, the Generating Antibiotic Incentives Now (GAIN)
act required the FDA to provide extended patent exclusivity for specific
new antimicrobial drugs and new guidance to develop drugs for
specific multidrug-resistant bacteria. The European Medicines Agency
(EMA) issued similar new guidance encouraging antimicrobial drug

Rapid Diagnostic Tests

development. Fortunately, multidrug-resistant bacteria are still

Improved diagnostics can make a significant difference in advancing

relatively rare, with few exceptions. Standard clinical trials, which

infectious disease trials. New polymerase chain reaction (PCR)-based

are indication-focused, not pathogen-focused, will enroll 20-30 patients

tests help identify pathogens rapidly, speeding diagnosis. Since treat-

for every one MDR pathogen.

ments for antibiotic-resistant infections are a current focus of research,
rapid diagnostic tests for MRSA in skin infections are now available to

Public and private partnerships have also been formed to stimulate

detect staph DNA in as little as an hour instead of days, providing many

innovation in antibacterial research and development. For example,

answers about patients’ condition before enrolling them. The tests can

GlaxoSmithKline received funding from the Wellcome Trust Se