One of the most critical initiatives we can do to be better prepared against viral disease outbreaks that could become the next pandemic, is to build a broad and deep pipeline of vaccines, therapeutics and diagnostic products, or Medical Countermeasures (MCMs).

The Intergovernmental negotiations in Geneva to define the PABS (Pathogen Access and Benefit Sharing) Annex, must remain focused on delivering on the key objectives set out in the Pandemic Agreement, including in Article 12 “to strengthen, facilitate and accelerate research and innovation, as well as the fair and equitable sharing and distribution of benefits.”

We see a significant effort on improving equitable access – described as benefit sharing in the PABS – but very little on research and innovation in discussions to date and this is where we have focused our remarks.

The INTREPID Alliance was set up by the Heads of R&D of leading pharmaceutical companies in 2022 to help accelerate the R&D pipeline for antivirals. They recognized that the antiviral pipeline was weak during the COVID-19 pandemic and that industry has a key role to play. Antivirals are essential tools for managing outbreaks – improving patient outcomes, reducing hospitalizations and disease burden, and helping reduce transmission.

INTREPID Alliance includes leading pharmaceutical companies active in antiviral R&D – both large and small – and those not active in antiviral R&D, but that still wanted to contribute their relevant expertise and resources. Our Board and Scientific Advisory Board include leading scientists and experts in the field who have successfully delivered new antivirals, willing to collaborate pre-competitively because we know that the R&D process is challenging and requires dedicated scientific effort over many years. Success rates are relatively low and investments needed significant.

Who Will Do the Research & Development?

A key question for MCMs is who is doing the R&D work. Our view is that we must work together in an ecosystem that brings the best from academia, government institutions and in the private sector, both smaller biotechs and larger companies. The trade association, BIO, is a core member of INTREPID and ensures biotechs are integrated into the mission. Such collaborations have produced groundbreaking science in virology and antiviral development.

But science is not the problem. It is the low level of investment in antiviral R&D, due to uncertain economics and lack of market demand. Almost all the companies that have invested in R&D for products for previous outbreaks have lost money – including the many program failures, but also some that successfully developed an MCM – even some for COVID-19. There are ways to address this together: consider the creation of new economic incentives similar to those developed for antibiotics and the use of stockpiling of MCMs. The PABS system will not solve it, but we all need to make sure that PABS doesn’t make the economic challenges worse.

INTREPID Is Contributing in Three Key Ways

Firstly, in supporting the R&D ecosystem for antivirals. We are launching this week an open-access Antiviral Toolbox to help all researchers around the world to make progress. It includes a curated platform that provides a set of tools and publications, including a Registry of Antiviral Compound Libraries – from leading academic, private research and government-sponsored institutions – to help catalyze the identification and development of small-molecule antivirals.

We are working with the International Pandemic Preparedness Secretariat (IPPS) and others to launch a new Therapeutics Coalition in January 2026 under France’s G7 Presidency. We appreciate the active engagement of funders in this effort, as substantial public funding is needed, such as the recent $100m VITAL award announced by the U.S. Biomedical Advanced Research and Development Authority (BARDA). We are also working with researchers and other stakeholders in the North and South to strengthen the global coalition of the willing to accelerate progress.

Secondly, we are working to embed into the Regulatory system the lessons learned during COVID-19 that can facilitate approvals of new antivirals. We actively participated in the European Medicines Agency workshop last summer and are launching a new workstream to follow up with Regulators globally. This will be critical in speeding up our response to future outbreaks.

Thirdly, we have published a comprehensive overview of the R&D pipeline for antivirals, which is being used as a resource by many stakeholders – including Health Emergency Preparedness and Response (HERA), World Health Organization (WHO), IPPS, and BARDA – as a baseline of the key gaps that need to be filled. It shows that the pipeline is weak in most of the 12 viral families identified by the WHO as high-risk pathogens.

Ninety percent of clinical development activity is being led by biopharmaceutical companies. The work is concentrated on COVID-19 and to some extent influenza. A lot of R&D work is needed for all other viruses. We need to be clear who will do the work and how the PABS agreement will facilitate and accelerate it.

For example, there are no compounds in clinical development for paramyxoviruses – which include outbreaks of Nipah and Hendra viruses that we see currently in India, Bangladesh and Australia. Four compounds are in preclinical stages for these viruses, but we know most will not reach patients, maybe none. And who will do the work to take them forward?

There are 3 compounds in development for the Flavivirus family – even though we see diseases like dengue, zika and West Nile (WNV) expanding their geographical coverage, including this year in European countries such as Spain (dengue) and Germany and Italy (WNV) as well as France and Italy where the Togavirus chikungunya has outbreaks and for which there are no compounds in clinical development. The U.S. and China also have outbreaks of dengue, WNV and chikungunya. Nine flavivirus compounds are in preclinical evaluation, but again, who will do the work to take them forward?

Similarly for poxviruses (2 compounds) – recently found in the U.S., Ireland, Italy, Netherlands, Spain, Greece and Portugal – arenaviruses (which include Lassa – 4 compounds) and so on. The full set of data for the other 8 viral families is on the INTREPID website.

Collaborative R&D Ecosystem to Grow the Pipeline

In summary, there are 27 clinical compounds spread across the 12 families we cover (excluding coronavirus). We would expect no more than a dozen new compounds to be approved in the coming 5-8 years. In order to be confident that the pipeline is likely to offer effectiveness against all key pathogens, we estimate a need to increase the number of compounds in development by a factor of 5-10-fold.

To respond effectively to emerging infectious diseases, every type of preparedness must be in place – effective surveillance, a broad pipeline of diagnostics, vaccines and treatments, education for the public, and capacity and planning for the healthcare system. If any part is missing, we risk a slow or failed response to the next outbreak. We recognize that few, if any, of the viruses we track are likely to spread far and fast enough to cause a pandemic but having treatments available would not only reduce the significant localized disease burden but also give a greater likelihood that future pandemics will also be covered.

That is why we are calling on the Government negotiators to develop a PABS System that helps scientists collaborate globally, that facilitates – and doesn’t penalize – companies that contribute to this R&D effort and that grows the R&D pipeline, rather than taking money away from the needed investment.

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Disclaimer

The INTREPID Alliance is a not-for-profit consortium of innovative biopharmaceutical companies and associations committed to accelerating antiviral research, aiming to ensure that we have a stronger pipeline and are better prepared to respond to future pandemic and endemic threats.

As part of our efforts, the INTREPID Alliance publishes and maintains the Antiviral Toolbox to be a non-promotional resource with the purpose of knowledge-sharing and to support better pandemic preparedness. The Antiviral Toolbox includes the Registry of Antiviral Compound Libraries, a registry of compound libraries designed to facilitate research. These registries are third-party resources and have been developed independently of, and at arm’s length, from INTREPID Alliance and its members. The INTREPID Alliance is not responsible for their content. The INTREPID Alliance also publishes and maintains a centralized list of promising investigational compounds. These compounds have been selected based on objective, scientific criteria, using publicly available sources, and at arm’s length from commercial influence of our member companies. See criteria listed in the report “Antiviral Clinical Development Landscape and Promising Clinical Compounds.” The designation of certain compounds as promising is based upon currently available information, and exclusively upon an assessment against these criteria. “Promising” is not a promotional claim. Candidate compounds have not been assessed by regulatory authorities to be safe and efficacious for the treatment of disease in humans. Our content is designed to be factual, informative, and non-commercial. It is not designed or intended to advertise or promote any pharmaceutical product or therapy or to advance the commercial interests of any company.

ABOUT THE INTREPID ALLIANCE

The INTREPID Alliance aims to accelerate the development of new treatments for emerging viral pandemic agents through facilitating early science and R&D, policy and advocacy, and stakeholder engagement. Led by a not-for-profit consortium of innovative biopharmaceutical companies and associations and working with the public, private and not-for-profit sectors, INTREPID works to bridge key gaps and unmet needs to ensure delivery of antiviral solutions to viral pathogens with the greatest pandemic potential.

INTREPID was launched in March 2023 at a high-level summit bringing together more than 100 thought leaders in virology and global health. For a read-out from the summit and additional information, visit www.intrepidalliance.org.

CONTACT

Nina M. Hill, Ph.D., Head of Secretariat, INTREPID Alliance, [email protected]