The Problem

Antibiotic Resistance: The world is on the cusp of the post-antibiotic era

Antibiotics and other antimicrobial agents have been used successfully for more than 70 years to treat a broad range of infectious diseases. As a result of the ever-growing use of antibiotics, many infectious organisms are becoming resistant to those antibiotics. Many experts have proclaimed that we have entered the post-antibiotic era.

In fact, many bacteria are resistant to most, if not all, currently used antibiotics and this resistance is spreading. Unless new approaches to treating infectious diseases are developed, infections that are easily treated today will be life-threatening in the near future.

According to the CDC, at least 2 million people become infected with antibiotic-resistant bacteria each year in the United States. At least 23,000 patients die as a direct result of these infections.

In response to this growing crisis, governments and health organizations worldwide are launching initiatives to spur research and development into new antimicrobial solutions.

“The evolution of antibiotic resistance is now occurring at an alarming rate and is outpacing the development of new countermeasures capable of thwarting infections in humans.”

President Barack Obama

“Antibiotics are a very serious public health problem for us, and it’s getting worse. Resistant microbes outstrip new antibiotics. It’s an ongoing problem. It’s not like we can fix it, and it’s over. We have to fight continued resistance with a continual pipeline of new antibiotics and continue with the perpetual challenge”

Dr. A. Fauci, Former Director, National Institute of Allergy and Infectious Disease (NIAID)

“The more we look at drug resistance, the more concerned we are… It is the end of the road for antibiotics unless we act urgently.”

Dr. Tom Frieden, Former Director CDC

“The problem is so serious that it threatens the achievements of modern medicine. A post-antibiotic era

in which common infections and minor injuries can kill; is a very real possibility.”

World Health Organization

Global Initiatives to Address Antibiotic Resistance

Generating Antibiotics Incentives Now Act (2012 GAIN Act)

Incentivizes the development of new antibiotics in response to the growing threat of antibiotic resistance and a lack of antibiotic product development.

Targets of the Act include Gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant S. aureus (VRSA), vancomycin-resistant Enterococcus (VRE).
Also targeted by the Act are antibiotic-resistant Gram-negative bacteria such as Pseudomonas aeruginosa, Acinetobacter baumannii, and the carbapenem-resistant enterobacteriaceae (CRE), such as Escherichia coli and Klebsiella pneumoniae.

National Action Plan for Combating Antibiotic-Resistant Bacteria

Issued by President Barack Obama, the Plan addresses drug-resistant threats that affect the U.S. and the world.
Goal is to slow the emergence of resistant bacteria, and accelerate surveillance, diagnostics, research and development.
Key target: Gram-negative bacteria.

Review on Antimicrobial Resistance

British program to promote research and development of new antibiotics by the pharmaceutical industry.
Includes a $2 billion global innovation fund.

European Initiatives

European public–private partnerships for the development of new strategies to tackle antibiotic resistance

National Action Plan for Combating Antibiotic-Resistant Bacteria

By Dave Muoio

The Department of Health and Human Services announced Thursday morning a $300 million commitment to supporting a public-private antibiotic-resistant bacteria accelerator over the next decade.

Called the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the accelerator was jointly launched in 2016 by HHS’ Biomedical Advanced Research and Development Authority (BARDA), the National Institute of Allergy and Infectious Diseases (NIAID) and global health charity Wellcome.

The Boston University-led program funds and offers technical, regulatory and business support to private companies in the early stages of developing new products to address antimicrobial-resistant infections.

“Antibiotic resistance continues to grow at an alarming rate worldwide, killing an estimated 1.27 million people each year and affecting the U.S. and global economies,” HHS Assistant Secretary for Preparedness and Response Dawn O’Connell said in a statement. “To save lives and keep pace with that growing threat, we need to accelerate the development and delivery of innovative and effective antibiotics. CARB-X partners are responding to this challenge by reinvigorating the pipeline of early-stage [antimicrobial-resistant] candidates to help fight deadly infections.”

CARB-X is the world’s largest accelerator of its kind, having funded the advancement of 92 such products, according to HHS. To date, 11 funded antibiotic-resistant infection treatment or prevention products have made it to human clinical trials while four diagnostics have moved to validation and verification.

HHS’ $300 million includes $20 million that will be provided to CARB-X this year, according to the department. Wellcome has also signed on to provide as much as $70 million over the next three years.

The program has received a total of $503 million in public and private investments since its launch, with BARDA and Wellcome providing $200 million and $155 million, respectively. Other backers include the U.K. and German governments and the Bill & Melinda Gates Foundation.

According to the announcement, CARB-X will be using its new money to support companies in its existing portfolio and open new funding rounds for its accelerator.

“We are grateful for the leadership and commitment demonstrated by BARDA, NIAID and Wellcome in addressing the global challenge of [antimicrobial-resistant] bacteria,” Kevin Outterson, executive director of CARB-X and professor of law at Boston University, said in a statement. “We now know that [antimicrobial resistance] kills more people each year than HIV or malaria, and a similar number to tuberculosis. With today’s funding announcements, CARB-X will continue to support early-stage research and development for new antibacterial therapies, preventives and diagnostics.”

Antibiotic-resistant infections are responsible for more than 35,000 annual deaths and more than $4.6 billion in spending each year within the U.S. alone, according to the Centers for Disease Control and Prevention. The World Health Organization has declared antimicrobial resistance among the top 10 global public health threats.