Combating antibiotic resistance on a global scale.
Today’s bacteria are developing resistance to many of our current antibiotics, even the most powerful ‘last resort’ drugs. Effective new treatments are urgently needed, but development of antibiotics has not kept pace with the rate that resistance is developing. Unless we act now, experts predict that by 2050 drug-resistant bugs could kill someone on the planet every three seconds.
The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), which is headquartered at BU Law, brings together leaders in industry, philanthropy, government, and academia with the aim of rejuvenating the antimicrobial pipeline for the next 25 years. 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.
Led by executive director and principal investigator Kevin Outterson, BU Professor of Law and the N. Neal Pike Scholar in Health & Disability Law, the CARB-X partners will pool their broad scientific, technical, business and legal expertise to help grantees 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. CARB-X aims to deliver a growing portfolio of promising new antibiotics, diagnostics, and vaccines to tackle the threat posed by untreatable 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.
The Biomedical Advanced Research Authority (BARDA), within HHS’ Office of the Assistant Secretary for Preparedness and Response, will provide $30 million in research and development funding through CARB-X during the first year and up to $250 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.
- The Biomedical Advanced Research and Development Authority (BARDA), within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will draw on its extensive experience of successfully advancing promising medical countermeasures through late-stage development and provide up to $250 million during the five-year program.
- Wellcome Trust, a global charitable foundation in London, UK, 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 will host the CARB-X executive team which will be led by Executive Director Kevin Outterson, a leading BU health law researcher and collaborator in global projects to address antibiotic resistance. The team includes 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. NIAID 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, as an extension of the successful MassCONNECT program, and the California Life Sciences Institute 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 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 will provide technical and regulatory 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 to identify and share best practices across all partners and supporting continuous quality improvement.