In recognition of the growing recognition of the threat of antimicrobial resistance, the Bill & Melinda Gates Foundation and the British government are joining the CARB-X (Combatting Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) project, a BU-based public-private partnership two years ago by the US Department of Health and Social Services (HHS) to provide financial, scientific and business support to small businesses focused on drug-resistant bacteria. The Gates Foundation is committed to invest $ 25 million over three years to support scientific research into the development of new vaccines, preventive agents and other antimicrobial products, particularly for low and middle income health care needs. The UK Government is providing up to $ 27 million in similar work through its Global Antimicrobial Resistance Innovation Fund. CARB-X, which is overseen by Executive Director Kevin Outterson, a School of Law Professor of Law and N. Neal Pike Scholar in Health and Disability Law and an expert in pharmaceutical markets, is the world's leading public-private partnership for the early development of innovative antibiotics, vaccines, and other products to combat the global threat of superbugs
The commitments provide more than $ 500 million for the total funding that CARB-X will receive for developing products to protect against bacterial infections caused by super bacteria. CARB-X's existing funding partners include the Biomedical Advanced Research and Development Authority (BARDA), part of HHS, which has pledged $ 250 million over five years; the Wellcome Trust, a UK-based global charity that has pledged $ 155.5 million over five years; and the National Institute for Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, which has pledged $ 50 million in preclinical services over five years.
"We are in a race against superbugs and it will take leadership, vision and sustained efforts to move forward," says Outterson. "We are deeply grateful for this new partnership with the British Government and the Bill & Melinda Gates Foundation, building on the leadership of the US government [BARDA and NIAID] and the Wellcome Trust."
"The threat of antimicrobial resistance highlights the importance of prevention – which we believe is the key to saving lives," said Sue Desmond-Hellmann, CEO of the Gates Foundation. Gates funding "will drive the development of vaccines and novel biologics, including monoclonal antibodies, to avert drug-resistant diseases and protect the lives of children and young children, especially in low- and middle-income countries."
"Superbugs are already killing hundreds of thousands of people around the world," says England's chief physician Sally Davies. "Working together [with the Gates Foundation and CARB-X’s other partners] will be a tremendous force against this escalating threat."
"We are honored that these two powerhouse organizations are joining us in this fight to accelerate global antibacterial innovation," says Rick Bright. BARDA Director
Tim Jinks, head of the Wellcome Drug-Resistant Infections Priority Program, cites funding from the Gates Foundation and the UK government as a "major boost" and hopes other countries and partners will follow suit. "Without further investment and collaboration," he says, "we will have a hard time delivering the new therapies needed worldwide to protect and save lives and undermine super-bacteria that undermine modern medicine."
Medication-resistant infections cause about 700,000 deaths worldwide each year. according to the World Health Organization (WHO), with an estimated 23,000 of these deaths in the United States. As antibiotic resistance progresses at the current rate, these numbers are expected to increase significantly within a generation.
Researchers say it takes at least a decade and many millions of dollars to develop a new antibiotic or vaccine an early preclinical link to the market is less than one percent. In fact, since 1962, there are no approved classes of antibiotics for the most dangerous types of bacteria – Gram-negative -. The pharmaceutical industry has stepped out of business with the development of new antibiotics and antimicrobials, mainly due to lack of financial incentives. Small biotech and pharmaceutical companies are struggling to attract private investors to the early stages of developing new antibiotics.
The CARB-X funding should – together with the scientific and economic expertise of the partnership – help companies to obtain projects in the first clinical phase tests, if they have a much greater chance of additional private or public funding for to gain further clinical development. The partnership selects promising early research supported by a competitive review process led by a group of senior scientists who form the scientific advisory board to the partnership. Outterson, who has no seat on the board and works with tight-knit staff in offices on the 12th floor of LAW, says 94 percent of CARB-X funding goes directly to research and development. "We try to be entrepreneurial, lean and flexible," he says.
"Obtaining additional funding for CARB-X, especially on this scale and from those lenders, is an indication of the importance of the kind of work that CARB-X is doing," says Gloria Waters, vice president and associate Propost the University of Research. "It is also a strong endorsement of the unique funding model and public-private partnership that Kevin and his team have put together."
The partnership, which focuses on companies targeting the most serious bacterial infections, includes 5 clinical development products and 33 preclinical development sites in the United States and half a dozen other countries. According to Outterson, there are nine new classes of antibiotics, six novel diagnostic devices, one vaccine and more than a dozen non-traditional products, including microbiome approaches.
"CARB-X has become a major source of antibiotic development," says Dr. Allan Coukell, senior director of health programs at the Pew Charitable Trusts, which looks at efforts to combat antibiotic resistance, including the pipeline for new antibiotics. And he adds that CARB-X "helps companies make good decisions early in the development phase by providing companies with scientific expertise in test protocols."
With the support of CARB-X, Entasis Therapeutics, a small Waltham based company, was founded, Mass., Launched an antimicrobial product in the first phase of the clinical trial and another project for a new class of antibiotics against Gram-negative bacteria are directed in the discovery phase. "Innovation is a long way off," says Manos Perros, president and CEO of Entasis. "When you have a small business, it's in the earliest stages when the return is farther away and the risk is higher that the need for support is greatest."
"CARB-X focuses on what matters "What makes you invest as much money as possible in the scientific and clinical development of the companies that finance them," says Perros. "They want us to be successful. There is an exploration of science, of strategy, of the way we solve problems that inevitably arise in research and development.
More than 400 companies in the United States and other countries have so far submitted projects to CARB-X for funding In April 2018, CARB-X issued in its most recent round of awards to the Achaogen biopharmaceutical company in South San Francisco, California, for $ 2.4 million to develop a novel antibiotic to treat gram-negative infections
CARB-X is "very well organized and highly regarded," says Kenneth Hillan, Achaogens president for Research and Development. "They can bring things together so that each organization can not stand alone. Much of this is Kevin's leadership. Few people would have the tenacity to bring these organizations together and navigate between all partners.
The next round of CARB-X funding will be launched on June 1, 2018. The scope of funding includes vaccines and other projects that meet the criteria of the Gates Foundation and the UK Government
The two new partnerships were signed on On the occasion of the opening of the Global Research and Development Center for Antimicrobial Resistance, the Global AMR R & D Hub will contribute to international funding and collaboration for research on 22 May at the 71st World Health Assembly, the WHO decision-making body in Geneva and development of antimicrobial drugs.