HHS forges unprecedented partnership to combat antimicrobial resistance

To address one of the greatest modern threats to public health — antibiotic resistance — the U.S. Department of Health and Human Services (HHS), the Wellcome Trust of London, the AMR Centre of Alderley Park (Cheshire, United Kingdom), and Boston University School of Law will create one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products.

Made possible through a cooperative agreement, the partnership promotes innovation and could provide hundreds of millions of dollars over five years to increase the number of antibiotics in the drug-development pipeline.

The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, represents a global innovation project for antibiotic products research and development. CARB-X brings together multiple domestic and international partners and capabilities to find potential antibiotics and move them through preclinical testing to enable safety and efficacy testing in humans and greatly reducing the business risk, which can make advanced development more attractive to private sector investment.

The Biomedical Advanced Research and Development Authority (BARDA), within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), and the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health will join the Wellcome Trust and the AMR Centre in joint oversight of the project. Two U.S. non-profit life science accelerators — Massachusetts Biotechnology Council in Cambridge, Massachusetts (MassBio), and the California Life Sciences Institute (CLSI) of South San Francisco, California, will provide support for early-stage antibiotic development projects.

ASPR’s BARDA will draw on its extensive experience of successfully advancing promising medical countermeasures through late-stage development and provide $30 million during the project’s first year and up to $250 million during the five-year project.

The AMR Centre, a public-private initiative formed in February 2016 to drive the development of new antibiotics and diagnostics, aims to provide $14 million to support CARB-X projects in year one and up to $100 million over five years. The Wellcome Trust, a global charitable foundation focused on biomedical research, will contribute further funding and its expertise in overseeing projects of this kind.

NIAID, which leads the U.S. government in biomedical research on infectious and immune-mediated diseases and developing better means of preventing, diagnosing and treating these illnesses, will provide in-kind research support, including preclinical research expertise, to projects that CARB-X supports. NIAID will also provide technical support related to early-stage antibiotic drug discovery and product development.

“Increasingly, it is becoming clear that partnerships of global reach and efficiency are needed to address complex problems like antimicrobial resistance,” said Dr. Richard Hatchett, acting BARDA director. “The establishment of CARB-X is a watershed moment; governments, academia, industry, and nongovernment organizations have come together to operate under a common strategic framework to tackle a monumental public health threat of our time.”

“Antibiotic resistance is a major public health problem that will only get worse without the creation of new antibiotic drugs to combat bacterial infections,” said NIAID Director Anthony S. Fauci, M.D. “NIAID is enthusiastic about being a part of this effort to accelerate the discovery and development of a new generation of life-saving antibiotics.”

Modeling private-sector innovation accelerators:

In the private sector, start-up companies with innovative ideas can turn to venture capitalists, or accelerators, who provide the necessary funding for the research and development, and business savvy to turn the ideas into successful products. CARB-X will provide funding for research and development, and technical assistance for companies with innovative and promising solutions to antibiotic resistance.

The end goal of CARB-X is to move promising antibiotic candidates through early stages of research and development, so that they merit private or public investment for advanced development and earn approval by the U.S. Food and Drug Administration and/or the Medicines and Healthcare products Regulatory Agency of the United Kingdom.

“Our hope is that the combination of technical expertise and life science entrepreneurship experience within the CARB-X’s life science accelerators will remove barriers for companies pursuing the development of the next novel drug, diagnostic, or vaccine to combat this public health threat,” said Joe Larsen, Ph.D., acting BARDA deputy director. “In the same way BARDA’s investment model has proven successful in advancing countermeasures through late-stage development, we believe this international partnership can identify promising candidates in the early stages of development that may offer treatment options for drug-resistant bacterial infections.”

CARB-X Accelerators:

CARB-X will be headquartered at the Boston University School of Law in Boston, Massachusetts, where the CARB-X executive team will be led by Kevin Outterson, a leading health law researcher and collaborator in global projects to address antibiotic resistance who will serve as the principal investigator on the cooperative agreement. The executive team will be compromised of experts with decades of experience in drug development, including in the area of antibacterial drugs.

The four CARB-X accelerators are:

Wellcome Trust, which will provide guidance for product developers covering a range of skillsets, including medicinal chemistry, biology, pharmaceutic formulation and clinical development. The Wellcome Trust also will help monitor project progress and provide feedback and guidance through each milestone. It also provides business development support.
The AMR Centre, which will provide funding, capacity and capability to support programs for CARB-X product developers, and pre-clinical expertise in chemistry, analytical, microbiology, drug metabolism and pharmacokinetics, and pharmacology.
MassBio, which will offer selectees access to capital and mentoring. This includes evaluating and providing feedback on commercial feasibility; identifying strengths, weaknesses, opportunities and threats; and teaming up to furnish industry-specific business advice for innovative ideas in therapeutics, diagnostics, medical devices and health information technology.
CLSI, which will partner with MassBio to provide business support and mentoring services to developers selected for funding. CLSI also will work to share best practices with the Wellcome Trust and AMR Centre, expanding the scope of business support services globally.

Also under the cooperative agreement, RTI International, a nonprofit institute headquartered in Research Triangle Park, North Carolina, will be a CARB-X partner. RTI will provide research support services to product developers in the partner accelerators, and build and run the computing systems to identify, track and monitor all research programs, including real-time dashboard management information systems.

Additionally, the Broad Institute of MIT and Harvard in Cambridge, Massachusetts, will build an antibiotics chemistry hub that product developers can access.

Identifying promising candidates to address antibiotic resistance:

Starting in September 2016, CARB-X will review applications for sub-awards to determine the most promising products to support. The agencies and organizations providing funding to CARB-X, namely BARDA, will have a final say in which projects are supported under the cooperative agreement.

Interested companies can visit the CARB-X page on phe.gov or www.carb-x.org for more information.

About the U.S. government partners:

Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threat agents, pandemic influenza, and emerging infectious diseases.

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. NIAID conducts and supports research—at the National Institutes of Health, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.

To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov. Additional information about NIAID, including news releases, fact sheets and other NIAID-related materials, is available on the NIAID website.

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