James Anderson is the Chair of the INTREPID Alliance and the Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), a leading global organization representing pharmaceutical companies. In his role at IFPMA, James spearheads efforts to address critical global health challenges, including antimicrobial resistance, pandemic preparedness, and non-communicable diseases. He drives policy development, fosters collaboration between public and private sectors, and leads initiatives designed to strengthen global health security.

In this interview, James shares insights into the INTREPID Alliance’s mission to accelerate antiviral innovation and improve understanding of their pivotal role in protecting communities from new and known viral threats. He discusses lessons learned from COVID-19, the progress toward ambitious antiviral development goals, and practical steps stakeholders can take to ensure the world is better equipped to face the viruses that pose the greatest risk of leading to the next endemic or pandemic.

What is INTREPID Alliance’s overall mission and what sparked its formation? Who are the Alliance members and how do they support this mission?

INTREPID stands for International Readiness for Preventing Infectious Viral Disease – a global alliance of private sector partners committed to working with public and philanthropic stakeholders to accelerate the development of antiviral medicines to prepare for future pandemics and emerging viral threats. The mission came out of the recognition during the COVID-19 pandemic that antivirals are a critical, yet underdeveloped, part of the preparedness toolbox. While vaccines and diagnostics received enormous attention, antivirals didn’t get the same level of investment or coordination and played a somewhat lesser role as a result.

The Alliance members bring together expertise across the drug development pipeline – from discovery and early-stage biotech innovation to clinical development, manufacturing, regulatory affairs, and global distribution. This includes experience from big pharma, biotech, contract research organizations, governments, and funders, all working collaboratively to tackle the scientific, technical, and commercial challenges of antiviral development.

The COVID-19 pandemic exposed major gaps in the world’s readiness to respond to fast-moving, emerging threats. What are some of the most critical lessons that we learned from that experience and what changes do we need to make to protect us from repeating history?

The pandemic highlighted the importance of being prepared with multiple tools – vaccines, diagnostics, and therapeutics – that can be rapidly deployed. One of the biggest lessons is that antivirals need to be part of the equation from the start, not an afterthought. COVID-19 showed us that having safe and effective antivirals as rapidly as possible can help reduce severe disease and hospitalizations, even while vaccines are being rolled out. One antiviral was shown to be effective against COVID-19 within 100 days of the outbreak.

The value of small-molecule antivirals is not only that they have the potential to save lives, reduce the severity and duration of disease, and alleviate the strain on our hospitals and healthcare workers, but they also play a crucial role in our broader public health strategies. Antivirals are versatile in their ability to fight against a wide array of viral infections – in other words, they can target a specific virus or be designed as broader-spectrum agents. They can also be used prophylactically to prevent disease transmission among high-risk populations. This is the case with HIV. Antiviral therapies can also move through established supply chains at affordable costs and at a global scale to reach the people who need them. Given how rapidly viruses can spread throughout the interconnected global network of communities, equitable access must be prioritized so that low- and middle-income countries aren’t left behind.

During the COVID-19 pandemic, we also learned about the challenges of rapidly scaling clinical trials, regulatory pathways, and manufacturing capacity under pressure. For future outbreaks, having predefined and streamlined emergency regulatory processes, ready clinical trial networks, and flexible manufacturing platforms can help to mobilize our existing resources with speed and agility.

The ability to control and mitigate the impact of viral diseases using antivirals should not be underestimated.

Tell me more about the work INTREPID has underway through its Landscape analysis & publications. How is the world doing in terms of our readiness to respond to new and emerging potential viral threats?

Mapping the antiviral pipeline through these reports helps us understand where progress is being made and where significant gaps remain. It’s critical to know which viral families have candidates in development and which don’t, so that we can direct resources efficiently – for our preparedness efforts and in the event of a crisis.

Right now, while there has been encouraging activity in some areas – like COVID-19 and influenza – we are still a long way from where we need to be in terms of preparedness. As reported in INTREPID’s 4th Edition Landscape, if we back out COVID-19, there are only 27 compounds in the late-stage research pipeline to tackle the 12 viral families that have the greatest risk of leading to a pandemic or endemic. When we remove those compounds indicated for influenza, this number drops to 17.

This leaves many viral families underrepresented in development efforts, and we know that many of the existing compounds will not make it through development. The pipeline needs to be broader and deeper, with more candidates reaching clinical stages, so that when an outbreak happens, we have potential treatments identified and/or ready to deploy.

Given your global view, how do you see public-private partnerships or new approaches evolving to get us where we need to be?

Currently, we are working with the International Pandemic Preparedness Secretariat (IPPS) and other partners to bring together a broader coalition focused on building out the different capabilities required to effectively prevent, protect, and combat emerging and future viral threats.

These are groups that are already working on surveillance, diagnostics, vaccines, antiviral therapies, and public education with the aim of meeting the 100 Days Mission goal to have two ‘Phase 2 ready’ therapeutic candidates for each high-risk viral family as identified by the World Health Organization.

We think this is a promising way to join forces with the expertise, funding, and capacity needed to drive efforts in a productive direction and potentially thereby increase the focus and the attractiveness for investment in future development.

Today, most of the funding comes from the public sector or from philanthropic organizations hoping to help catalyze investment to reach a state of stability and thereby attract private investment. Private funding can play a role, but will require some kind of new economic model with incentives that don’t currently exist, because there is no market before an outbreak starts. Whether they’re venture capital or bigger companies investing in these areas, they need to expect to make some kind of sustainable return.

Can you talk about the role of smaller biotech companies in antiviral innovation vs. larger pharmaceutical players? Are there unique advantages or challenges for each?

It’s worth noting that within the Landscape analysis, we found that almost 90% of the antiviral compounds in development were coming from the private sector. A mix of both large and small biopharmas and biotechs, and by number, more of those are still led by smaller companies.

Many of them do partner with the larger companies over time, but that’s not unique in this area. That’s simply how drug discovery and development are done. The key difference is in the funding. Big companies are looking to invest in promising science and areas that have been derisked. For small companies, they need a runway to prove their technologies and solutions are headed in the right direction. Particularly in a challenging funding environment, which we are in now, there is an even wider chasm between the two.

What is at risk is the loss or shelving of potentially effective new therapies due to a lack of investment. What is truly at risk are the potential lives lost when – not if – the next pandemic occurs. And then there are the tremendous economic costs and social impact that we’re seeing as a result of the pandemic we lived through just five years ago.

We need to find a way to catalyze the funding required to bridge this chasm.

What would you like to see as the next steps from policymakers, the investment community, and other funders to help ensure we’re not caught unprepared for the next pandemic?

The critical thing that we need to do is to find ways to work across the public and private sectors in partnership, and in ways that provide a winning scenario for all parties. We need this in the areas of investment and funding, and also in the development of frameworks that bolster our rapid response capabilities related to regulatory processes, clinical trials, manufacturing, and supply chain that can be used in the event of an outbreak.

We look at antibiotics as an example here because that’s another area where the level of R&D investment has declined over many years, and yet there’s a real public health need as the bacteria become resistant to current antibiotics.

And what is good is that many governments around the world, including the UK and the EU, recognize that some kind of economic interventions are needed because the normal market dynamics simply don’t work for antibiotics. For example, CARB-X, a global consortium of governments and foundations, is helping to stimulate early-stage antibiotic R&D with funding, expert support, and acceleration tools.

It’s a good step, but we’ve been working on that for over 10 years. We’re just starting to try and go down a similar pathway for antivirals.

On various levels, the private and public sectors are collaborating to coordinate government calls for antiviral research funding and are applying new approaches, such as advanced purchase commitments to help ignite investment.

The work of the IPPS with its Therapeutics Coalition is building such a foundation by bringing together key partners, including the INTREPID Alliance, to define shared objectives. Together, we have created a governance mechanism where we’re leveraging each other’s capabilities in a constructive way to define a path forward aimed at accelerating and strengthening our global preparednes and security from new and known threats.