Safe and effective therapeutics are critical when responding to a viral outbreak. But as the COVID-19 pandemic starkly highlighted, the pipeline of therapeutics for diseases with pandemic potential is bare.
Establishing a global therapeutics development coalition is a vital next step to invigorate the therapeutics pipeline and drive advocacy for increased investment and coordination of end-to-end therapeutics development, READDI CEO James Rosen and co-authors write in an Aug. 30 PLOS Global Public Health article, "The case for a Global Therapeutics Development Coalition: building a therapeutics pipeline for pandemic and endemic diseases." A consolidated effort by stakeholders across academia, government, international organizations, civil society and the private sector would avoid duplication, eliminate waste and present a unified front to potential funders.
Rosen and his co-authors invite interested stakeholders to consider how they can contribute toward the ultimate goal of developing two Phase-2 ready therapeutics for virus families of pandemic potential.
Antiviral therapeutics reduce mortality, morbidity and overcrowding in hospitals. They offer a frontline defense while vaccines are being developed, tested and rolled out. And therapeutics are essential for diseases for which vaccine development is challenging and lengthy — or for populations who are unwilling or unable to get vaccinated.
However, among the World Health Organization's priority pathogen families with pandemic potential, there are only approved therapeutics available for COVID-19 and Ebola Zaire and few candidates for other viral families of concern in development.
A critical lack of funding for therapeutics R&D, before and during the recent pandemic, hampered efforts to develop a timely therapeutic armamentarium for COVID-19. During the first year of the COVID-19 pandemic, 20 times less was spent globally on therapeutics R&D compared to vaccines ($4.6bn versus $91bn), and the therapeutics pillar of the Access to COVID-19 Tools (ACT) Accelerator received less than 10% of donor funding, compared to nearly 70% allocated to COVID-19 Vaccines Global Access (COVAX) for vaccines. The first oral antivirals did not become available until 20 months after the first COVID-19 vaccines, which were authorized for use in under a year.
"In future health emergencies we may not be so lucky, meaning therapeutics may well be all we have," the authors write. After four decades of HIV research, for example, there is still no HIV vaccine. Antiviral therapeutics turned HIV-AIDS from a death sentence to a chronic manageable disease.
READDI is a core implementation partner in the IPPS's 100 Days Mission, embraced by the G7 and G20 in 2021 to ensure the global availability of diagnostics, therapeutics and vaccines within the first 100 days of a pandemic threat. READDI is co-leading the Therapeutics Development Coalition effort, along with the International Pandemic Preparedness Secretariat (IPPS), WHO, Drugs for Neglected Diseases initiative (DNDi), IFPMA, Unitaid, INTREPID Alliance, Medicines Patent Pool and 100 Days Mission Therapeutics Working Group.
The Therapeutics Development Coalition's goal — two Phase-2 ready therapeutics for priority pathogens — mirrors READDI's goal. Like READDI, the coalition is focused on virus families of pandemic concern and developing broad-spectrum compounds. Equitable access must be embedded throughout the therapeutics development value chain, the authors write.
"READDI is collaborating with colleagues in discovery and development to ensure that a robust antiviral pipeline is comprised of potential therapeutics that will be affordable and accessible to everyone who needs them, where they need them, when they need them. Creating a coalition is a critical step toward meeting these goals," says Rosen, who co-authored the article with eight others, including the co-chairs of the IPPS Science and Technology Expert Group: epidemiologist Shingai Machingaidze; and Dr. Victor Dzau, president of the National Academies of Sciences, Engineering and Medicine.
