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As part of its ongoing effort to speed-up the response to the COVID-19 epidemic, the Bill and Melinda Gates Foundation is funding a new initiative dedicated to identifying, assessing, developing, and scaling-up treatments for the virus.
The newly-formulated COVID-19 Therapeutics Accelerator—which is being funded by The Gates Foundation, London-based research charity Wellcome, and Mastercard—will play a catalytic role in accelerating and evaluating new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the longer-term.
Currently, there are no broad-spectrum antivirals or immunotherapies available for the fight against emerging pathogens, and none approved for use on COVID-19.
The Gates Foundation and Wellcome are each contributing up to $50 million, while the Mastercard Impact Fund has committed up to $25 million to catalyze the initial work of the accelerator. The Gates Foundation's funding is part of its up to $100 million commitment to the COVID-19 response announced last month.
The foundation's $100 million commitment is also being used to finance public health responses in the greater Seattle area and protective measures for at-risk populations in Africa.
"Viruses like COVID-19 spread rapidly, but the development of vaccines and treatments to stop them moves slowly," said Mark Suzman, chief executive officer of the Bill & Melinda Gates Foundation. "If we want to make the world safe from outbreaks like COVID-19, particularly for those most vulnerable, then we need to find a way to make research and development move faster. That requires governments, private enterprise, and philanthropic organizations to act quickly to fund R&D."
The COVID-19 Therapeutics Accelerator will work with the World Health Organization, government and private sector funders and organizations, as well as the global regulatory and policy-setting institutions to focus on drug pipeline development through manufacturing and scale-up. By sharing research, coordinating investments, and pooling resources, these efforts can help to accelerate research.
This kind of collaboration was a key lesson from the 2014 Ebola outbreak. By providing fast and flexible funding at key stages of the development process, the Accelerator will de-risk the pathway for new drugs and biologics for COVID-19 and future epidemic threats, ensuring access in lower-resource countries.
The COVID-19 Therapeutics Accelerator will operate jointly as an initiative of the funders, drawing on expertise from inside and outside their organizations, and will also pursue several aspects of the development cycle to streamline the pathway from candidate product to clinical assessment, use, and manufacturing.
To identify candidate compounds, the Accelerator will take a three-pronged approach: testing approved drugs for activity against COVID-19, screening libraries of thousands of compounds with confirmed safety data, and considering new investigational compounds and monoclonal antibodies. Drugs or monoclonal antibodies that pass initial screening would then be developed by an industry partner.
The biotech and pharmaceutical industries will be critical partners, bringing their compound libraries and clinical data to the collaboration and lending commercialization and other expertise that will be required to scale up successful drugs and monoclonal antibodies. In parallel to the development of the COVID-19 drug pipeline, the Accelerator will work with regulators to align criteria and develop manufacturing capacity with industry. An accelerated pathway to bringing effective treatments to patients is around one year for products that have current regulatory approval or candidates with existing clinical data. The timeline would be longer for compounds further upstream in the pipeline that have limited existing clinical data.
Dr. Jeremy Farrar, director of Wellcome said: "Science is moving at a phenomenal pace against COVID-19, but to get ahead of this epidemic we need greater investment and to ensure research co-ordination. The Therapeutics Accelerator will allow us to do this for potential treatments with support for research, development, assessment, and manufacturing.
"COVID-19 is an extremely challenging virus, but we've proved that through collaborating across borders we can tackle emerging infectious diseases," he added. "We must strive to strengthen efforts in the face of COVID-19, and in doing so, continue to make sure advances are accessible and affordable to all. Investing now, at scale, at risk and as a collective global effort is vital if we are to change the course of this epidemic. We welcome others to join us in this effort."
While antiviral drugs are approved to lessen the severity of seasonal flu and treat HIV, among other viral diseases, none have demonstrated efficacy against the current epidemic. One reason for the lack of effective treatments is that products may not have an immediate market, which can slow or prevent their research and commercial development. The COVID-19 Therapeutics Accelerator is designed to help by bringing together resources and expertise to lower the financial and technical risk for academia, biotech, and pharmaceutical companies, while ensuring that these products are accessible and affordable to people in low-resource settings. The expertise of pharmaceutical companies will be critical in identifying, researching, and commercializing successful drugs.
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