Public Health Emergency - Leading a Nation Prepared
Before antibiotics existed, surgeries and infections we view today as simple could be life-threatening. Although we have antibiotics today, some bacteria have become resistant to those antibiotics, and simple infections once again can become serious threats to health. Lacking a market incentive to develop new antibiotics, innovation in this area has stagnated, and there have been no new antibiotics developed for decades. This rise of antibiotic resistance poses one of the greatest modern threats to public health, and now ASPR is playing a leading role in addressing this global threat.
For the past 10 years, BARDA has worked to form innovative, flexible partnerships and make sound investments in products that can be used to fight the threat of antibiotic resistant bacteria. Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections.
In a business environment where companies are increasingly walking away from the development of new antibiotics, BARDA is rebuilding the antibiotic development pipeline. BARDA has built a robust portfolio with nine companies that are developing 14 candidate antibiotic products and two diagnostic tools.
Over the next year or two, BARDA will begin to graduate programs out of development and into the commercial marketplace, providing desperately needed options for clinicians to treat these resistant infections.
But we understand that one business model, one country and one approach will not fix this global, complex problem. BARDA is leading innovative international partnerships like CARB-X and using unique business models like the Antimicrobial Resistance Diagnostic Challenge to forge alliances and support innovative solutions that help combat the threat of antibiotic resistance.
The rise of antibiotic resistant infections threatens modern medicine and public health. Some estimates report that if nothing is done, deaths from antibiotic resistant infections worldwide will surpass cancer deaths by 2050.
The pace of new drug development is not keeping up with the threat. There has not been a new class of antibiotics developed for infections caused by gram negative infections in over 45 years and there are relatively few antibiotics in advanced development.
Developing antibiotics creates some unique business challenges. Antibiotic development offers relatively low profit margins compared to other types of drug development. In an attempt to prevent overuse, doctors only prescribe the strongest and most effective products as a last resort. As a result, many companies have left antibiotic development to pursue other products that offer greater returns on investment. In 1990, there were at least 18 large pharmaceutical companies actively developing antibiotics. Today there are four.
BARDA is working to overcome these scientific and business challenges as they fight antibiotic resistance.
The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator
(CARB-X) was created to help address the threat of antibiotic resistance. CARB-X is one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products.
CARB-X includes seven partners in the United States and the United Kingdom, and is backed with half a billion dollars in funding. CARB-X partners are working together to set up a diverse portfolio with more than 20 high-quality antibacterial products. These partners will operate together under a common strategic framework to identify and develop these antibacterial drugs, vaccines, and diagnostics, all of which are preclinical stages of development, which means they have not been tested yet in people. CARB-X anticipates making its initial investments in early 2017.
BARDA has established a series of portfolio partnerships, strategic alliances with companies that are developing new antibacterial drugs that support multiple candidates simultaneously. These partnerships allow for resources and candidate antibiotics to be adjusted in real time.
BARDA has funded four portfolio partnerships since 2013 with GlaxoSmithKline, AstraZeneca, Roche, and the Medicines Company. These partnerships are helping to mobilize industry to pursue research and development of new antibacterial drugs.
The majority of antibiotics are given before a medical professional can tell if drugs are needed or can help the patient heal. Doctors don’t have diagnostics that can tell them if the disease is a bacteria or a virus, so they often prescribe antibiotics when they are not needed. Overuse of antibiotics is a major cause of antibiotic resistance.
To address this need, BARDA and NIH are sponsoring a prize for the development of a new tool to diagnose whether a patient's infection is caused by bacteria or by a virus. The Antimicrobial Resistance Diagnostic Challenge is a $20 million federal prize competition seeking innovative, rapid point-of-care laboratory diagnostic tests to combat the development and spread of drug resistant bacteria.
We want people to get the right treatment. With real-time detection, healthcare providers would be able to identify infecting pathogens and resistance factors within hours, rather than the two to three days or longer that the standard microbiological culture processes require. These diagnostic tests would help doctors make more informed clinical choices.
Despite all of BARDA’s efforts to address antimicrobial resistance, significant market challenges remain. The low commercial returns for antibiotics do not engender robust private sector investment, which has led to diminishing research programs for new antibacterial drugs.
Until the challenges of the antibiotic market are fixed, BARDA remains committed to forming public-private partnerships to support innovation in antibacterial drug development.
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