The AMR Centre is to join the world’s largest public-private partnership focused on tackling the growing health threat posed by antibiotic resistance.
CARB-X – Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (www.carb-x.org) – is a new organisation that will rejuvenate the pipeline of anti-microbial drugs and diagnostics.
CARB-X will coordinate R&D funding of at least $350 million over the next five years, allowing CARB-X to deploy significant resources to address the unique set of scientific and commercial challenges that antimicrobial resistance (AMR) creates.
The AMR Centre, which is based at Alderley Park in Cheshire, is one of five organisations in the partnership.
The Biomedical Advanced Research Authority (BARDA), within the U.S. Department of Health and Human Services is to provide $30 million in grants to CARB-X during the first year and up to $250 million over five years.
The AMR Centre is expected to receive up to $14 million in matched funding from CARB-X in year one – and $100 million in total over the next five years. The combination of its own resources and the contributions from CARB-X means that the AMR centre expects to be able to focus $200 million on a range of R&D projects. These financial resources will be used to help small and medium sized businesses progress their R&D projects into clinical trials.
The Wellcome Trust, a global charitable foundation focused on biomedical research, will also contribute funding, along with its expertise in overseeing projects of this kind.
Within Europe antibiotic resistance already claims 25,000 lives a year, but fatality rates are expected to rise dramatically. A recent review for the UK government, led by leading economist Lord O’Neill, concluded that AMR has the potential to be responsible for 10 million extra deaths globally each year by 2050 – more than currently claimed by cancer.
“The creation of CARB-X is one of the most important steps yet in terms of rethinking how we deal with AMR and the partnership will have an impact around the world,” said Dr Peter Jackson, steering group chairman of the AMR Centre. “We share the same goal of accelerating a new pipeline of treatments and diagnostics by working on new drug development programs. We will do this in our own labs as well as in collaboration with other organisations, in particular providing support to small and medium‑sized businesses and research institutes which have exciting new approaches to AMR.”
CARB-X grew out of President Obama’s 2015 Combating Antibiotic Resistant Bacteria (CARB) initiative and will address several goals laid out in the US Federal CARB National Action Plan.
“Our hope is that the combination of technical expertise and life science entrepreneurship experience within CARB-X’s life science accelerators will remove barriers for companies pursuing the development 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.”
The international partnership will support a suite of products through early preclinical development to a stage where they can be taken forward by private or public investment.
Led by executive director and principal investigator Kevin Outterson, the N. Neal Pike Scholar in Health & Disability Law and Professor of Law at Boston University, the CARB-X partners will pool their comprehensive scientific, technical, business and legal expertise to help supported companies navigate the maze of regulatory steps, studies and data collection required for new drugs and other products to gain approval by US and/or European regulators.
Dr Jeremy Farrar, Director of the Wellcome Trust, said: “Drug-resistant infections are already costing lives all over the world. Many drugs that we have too often taken for granted no longer work, presenting one of the biggest threats to our future global health and economic security. A problem of this scale can only be tackled through coordinated international effort to curb our massive overuse of existing antibiotics, and to accelerate the development of new ones. I hope our new transatlantic partnership marks the beginning of a wider global effort to prevent untreatable bacterial infections from claiming millions of lives.”
Chris Oglesby, chairman of Manchester Science Partnerships, said: “CARB-X is setting out a bold vision to protect humanity from the most serious bacterial threats by accelerating antibacterial product development.
“Its geographical scope is unlimited and the brief simply to fund the best science for the most innovative products, wherever they may be found. Some of that work will undoubtedly happen here. The North of England has always been a place of innovation and discovery. More than 20 new drugs have been developed at our Alderley Park campus including new antibiotics. Some CARB-X projects will be developed at Alderley Park within the AMR Centre but the funding could also benefit other companies and organisations both inside and outside of our organisation. There is strong capability in terms of people and laboratory resource in our region. CARB-X itself has already spoken of collaboration, innovation and urgency as some of its key valves. These are principles that we share at MSP – and we wish the new venture every success in delivering on its important objectives.”
The full list of CARB-X partners include:
- AMR Centre is a public-private initiative based in Alderley Park, Cheshire, UK to support development of new antibiotics and diagnostics and aims to provide matched funding for CARB-X projects, along with R&D support and business mentoring services
- The Biomedical Advanced Research and Development Authority (BARDA), within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) who 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 program
- Wellcome Trust is a global charitable foundation in London, UK. It is a major funder of biomedical research, with significant experience in infectious diseases and investment in early stage antibiotic R&D. In addition to providing funding, Wellcome will bring expertise in overseeing high quality international research projects
- Boston University School of Law in Boston, Massachusetts, will host the CARB-X executive team which will include experts with decades of experience in antibiotic drug development, including John Rex, Senior Vice President at Astra Zeneca. Starting January 1, 2017, Barry Eisenstein (formerly of Cubist and currently at Merck) will join CARB-X
- The National Institutes of Health’s National Institute of Allergy and Infectious Disease (NIAID) leads the U.S. government in determining the causes of infectious and immune-mediated diseases and developing better means of preventing, diagnosing and treating these illnesses. NAID will provide in-kind services, including preclinical services, to projects that CARB-X supports. NIAID also is providing technical support for CARB-X from their internal subject matter experts in early stage antibiotic drug discovery and product development
- MassBio in Cambridge, as an extension of the successful MassCONNECT program, and California Life Sciences in the Bay Area will provide world‑class business support and mentoring services to innovative product developers selected for funding. The two accelerators will also share best practices with the Wellcome Trust and AMR Centre, expanding the scope of business support services globally
- The Broad Institute of MIT and Harvard in Cambridge, Massachusetts will host a new inter-disciplinary Collaborative Hub for Early Antibiotic Discovery. This hub, aimed at early drug discovery, will work with multiple academic programs to advance promising antibiotic candidates that the CARB-X initiative can pursue
- RTI International, an independent, nonprofit institute headquartered in the Research Triangle Park in North Carolina will provide research support services to product developers in the partner accelerators, as well as build and run the computing systems to identify, track and monitor all research programs, including a real-time dashboard management information systems. RTI will evaluate all CARB-X operations, sharing best practices across all partners and supporting continuous quality improvement.
Beginning in September, CARB-X will begin reviewing applications to determine the most promising products to fund. Decisions will be made by its Scientific Advisory Board, with input from the agencies, including BARDA and NIAID, and the partners, including the AMR Centre and the Wellcome Trust. Applicants should check the website (www.carb-x.org) for updates.