Kevin Outterson
Move over NASA. Make room, cancer. Another moonshot is being launched, this time to find new antibiotics to treat drug-resistant bacteria.
The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a collaborative accelerator, a public-private partnership that joins philanthropic organizations, government research and funding agencies and university researchers to find, fund and speed to market promising new therapies, diagnostics and vaccines to attack multi-drug-resistant bacteria. The collaborative brings together more acronyms than an army battle map, international drug research expertise and as much as $350 million in funding to tackle this looming crisis.
(According to the Centers for Disease Control and Prevention, at least 2 million Americans become infected with bacteria resistant to antibiotics, claiming 23,000 lives annually. The World Health Organization has predicted a “post-antibiotic era” that would allow once commonly cured infections again to kill millions.)
The international collaborative includes: the U.S. Biomedical Advanced Research and Development Authority (BARDA); Britain’s philanthropic Wellcome Trust and the UK’s R&D Centre for Antimicrobial Research (AMR Centre); Boston University; MassBio in Cambridge, Massachusetts; the California Life Sciences Institute in the Bay Area and the National Institutes of Health’s National Institute of Allergy and Infectious Disease (NIAID).
The Broad Institute of MIT and Harvard will host CARB-X and RTI International will provide technical and regulatory support services to the partner accelerators and will build and run the computing systems to identify, track and monitor all research programs.
BARDA will commit $30 million in research and development funding the first year and up to $250 million over five years, while the AMR Centre will provide $14 million to support CARB-X projects in year one and up to $100 million over five years. The Wellcome Trust will provide additional funding and oversight experience.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“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 of the next novel drug, diagnostic, or vaccine to combat this public health threat,” said Acting BARDA Deputy Director Joe Larsen.
RTI Project Leader Doris Rouse said Research Triangle Park, North Carolina-based RTI will help identify compounds, perform due diligence and create a pre-clinical development plan addressing key issues.
“We’ll also be helping with pre-drug investigation,” Rouse explained. “We look at the strengths and weaknesses of the proposed products and work with owners of compounds to develop plans for development and contracting out to research organizations.”
Rouse said CARB-X will guide the proposed products from bench to bedside, advance them and “demonstrate their safety so that small companies or universities can attract companies that will take those compounds to market.”
In addition, RTI has developed a website with a dashboard available only to the participants to allow researchers and administrators to track the progress of the selected compound submissions and their funding status. It will also enable collaborative partners to share best practices.
Boston University law professor Kevin Outterson, who serves as the collaborative’s executive director and principal investigator, said CARB-X will consider “anything therapeutic, whether a vaccine, something preventative or diagnostic,” Outterson explained.
“It has to have an impact on unmet medical needs targeting drug resistant bacteria. We’re leaving it wide open. Everyone has a sense of the research going on out there. We’ll be evaluating projects when they come in and then score and fund the best of them,” Outterson said.
He said CARB-X is designed to reduce overlap, improve coordination and accelerate the process.
“The whole reason for establishing this is to develop a higher quality product coming into human clinical trials,” Outterson said. “The scope is pre-clinical.”
He said the CARB-X participants have met with the U.S. Food and Drug Administration to explore designing clinical trials for a single-species antibiotic that would meet European and U.S. standards.
“The FDA is actually thinking about these issues years in advance of an application sitting in its inbox,” he said.
Photo: Jackie Ricciardi for Boston University Photography
