Frequently Asked Questions
Is the COVID-19 Therapeutics Accelerator a physical organization? Who runs it?
The COVID-19 Therapeutics Accelerator (CTA) is an initiative benefitting from the expertise and resources of accelerator donors as well as external experts. It draws on the talents of individuals with backgrounds in drug and monoclonal development, chemistry, manufacturing, and controls (CMC), supply chain, information management, and regulatory affairs to enable resource deployment with an end-to-end approach for therapeutics development, manufacturing, and equitable access. This governance model allows CTA to begin its work immediately and help enable quick decision-making.
How will this initiative change the landscape of who is involved in the effort to develop COVID-19 treatments?
Several companies and academic institutions are currently working with the Coalition on Epidemic Preparedness Innovations (CEPI) on the development of COVID-19 vaccines, but there is to date little coordinated approach to antiviral therapy development. Ongoing efforts do not span the full range of activities necessary to achieve impact and access to patients globally. That’s the reason CTA has been created, to coordinate resources and efforts to build a drug pipeline and to remove key bottlenecks for academics, pharmaceutical companies and biotechs who have the expertise that will be needed to advance promising candidates through to commercialization. A lesson learned from the Ebola outbreak of 2014 was the need to de-duplicate and optimize the efforts of various research institutions working on finding effective therapeutics. This realizes better use of resources and has the possibility to accelerate the time to delivery of an approved, effective product at scale.
How quickly will this accelerator enable delivery of an effective product? When could we see first use in the field?
CTA will work on multiple fronts to speed up resources deployed for the development of therapeutics. One arm of investments will fund trials of registered drugs that have approval and safety and efficacy data in another indication. Another arm will fund the screening of compounds from existing libraries that have human safety data for activity against COVID-19. Discovery efforts will focus on identifying a broad-spectrum anti-coronavirus drug candidate with the ideal profile suitable for treating all infected individuals. And there will also be an effort to develop monoclonal antibodies that could be used for treatment or prophylaxis, but this would be further in the future. By funding adaptive clinical trials that employ cutting-edge methods, we hope to accelerate the development cycle while maintaining the highest safety standards.
How much total funding is needed to get effective antivirals for COVID-19?
That will depend, in part, on which candidate compounds move forward based on initial screenings. Products that have stringent regulatory approval and/or significant clinical data will be faster and will require less clinical development than new investigational compounds or those compounds with less safety or efficacy data. Decisions will be made on a case-by-case basis.
What’s the role of governments? How are private sector funders involved in this work?
Governments are funding drug discovery and development, as well as other aspects of the COVID-19 response. Through CEPI, government funders are contributing to the development of new vaccines, an effort that requires additional funding. CTA seeks to enhance coordination between the various groups, including those funded by governments, working to develop drugs active against COVID-19. The private sector can provide fast and flexible funding to kick-start efforts and to remove bottlenecks that could delay time to market for potential drugs effective against COVID-19.
How is this effort different than other efforts?
The COVID-19 Therapeutics Accelerator is distinct from other similar efforts including:
- Focused on securing prompt and affordable access of products in LMICs
- End to end focus, including manufacturing and scale-up
- Agile and flexible funding processes, including at-risk to accelerate
- Payout has no geographic restrictions
- Focused on pre- and post- exposure prophylaxis for high-risk individuals as well as mild/moderate disease treatment
What criteria will compounds be screened on?
Compounds will be screened in vitro and via subsequent small animal model models for efficacy, dose, and tolerability that is standard in pharma R&D as early indicators of potential success. They will also be screened on technical profile and considerations such as complexity of manufacturing and other factors affecting feasibility. Given the global access focus, there is additional consideration of suitability for low-resource settings, such as route of administration and supply chain needs (e.g. storage). Finally, exclusivity and intellectual property are important considerations, particularly openness of originator to global access agreements for products under patent.