Accelerating Research, Advancing Hope

We are evaluating a comprehensive spectrum of candidates including: 1) marketed and late-phase development agents, including immunomodulators, 2) novel antibodies, and 3) anti-virals.

Our approach leverages:

• Adaptive trial models allow for more efficient and informative outcomes to be achieved with no impact on scientific rigor. These trials require only a single, limited group of patients on control treatment, they shorten time required to test potential treatments, and allow additional therapies to be added or removed throughout the trial.
• Sharing information in real time – via a secure master repository of de-identified, anonymized clinical trial data – helps our members uncover insights quickly. This high level of transparency across companies allows us to track epidemiology, identify high-risk populations, and measure intervention success while informing trial design, recruitment, additional therapeutic approaches, and drug safety considerations.
• Rapidly crowdsourcing evaluation of 40 early-stage candidates submitted to BioCentury’s COVID-19 Resource Center helps avoid duplicating efforts and offers promising candidates expert feedback and connections with funders.

We have multiple working groups operating in parallel, with a focus on:

• Approved and late-stage candidates: Members are investigating use of marketed and products used for treatment of other disease states, which due to their mechanism of action may have potential treatment effect in patients with COVID-19. Adaptive platform trials enable multiple therapies to be tested simultaneously and protocols to be modified in real-time based on outcomes observed. This approach may help us to:
  • Understand the mechanisms that hold the greatest promise and eliminate those that do not;
  • Serve the global need faster if positive results are seen;
  • Give hope to sick patients in clinical trials; and
  • Reveal drug combinations that mitigate the lethality of COVID-19 symptoms.
• Pre-clinical repurposing: Our members have contributed more than 1,900 candidates from their own pipelines to rapidly analyze their cytopathic effect (i.e. potential to impact the novel coronavirus) and advance the most promising approaches from lab to clinic. We are running active control panels and simulations to understand which platforms are most effective. We are working at accelerated speed: instead of months, the process is occurring in weeks.
• Rapidly crowdsourcing evaluation of 40 early-stage candidates submitted to BioCentury's COVID-19 Resource Center helps avoid duplicating efforts and offers promising candidates expert feedback and connections with funders.

The need to address COVID-19 is urgent and undeniable. Our efforts are complementary to other accelerators, NGOs, and governmental initiatives—and several of our members have engagement with, and candidates involved in, other programs. We are communicating and sharing our efforts across regions, regulators, and other development efforts, which is key to avoid duplication and inefficiencies as the world races to find therapies for COVID-19.

COVID R&D Alliance members are also coordinating with other bodies, including National Institute of Health (NIH), the Bill & Melinda Gates Foundation, U.S. and European trade groups and regulators, among others, to maximize our collective efforts.

Our work is focused on finding treatments through shared expertise, data, and evaluation of drug candidates. A win for one, is a win for all. The world is counting on us.

Many of our members are posting de-identified clinical trial data in a secure master repository to enable greater levels of transparency and sharing to facilitate insights more quickly. With respect to COVID-19 Clinical Trial data, we are working with TransCelerate’s existing DataCelerate platform to enable our member companies to share data from ongoing and planned COVID-19 studies, as well as findings from past trials. The platform uses de-identified, anonymized clinical data shared voluntarily by member companies and, in some instances, converted into harmonized data models. The platform is compliant for protecting privacy while still helping to power insights.

Once available, COVID R&D Alliance plans to share the aggregate and patient-level data for investigational products, as well as standard of care best practices. We will be transparent with our successes and failures, as we all benefit from understanding mechanisms that hold the greatest promise and eliminating those that do not.

BioCentury’s COVID-19 Resource Center will be an additional information sharing resource to disseminate learnings to the greater public health and development community.