Infectious Diseases: Learning from the Past and Investing in the Future

Let’s face it: we are in a transformative moment. The pandemic, in many ways, changed the infectious disease landscape as the public, institutional, and governmental response mobilized in an unprecedented way. The US Government announced just last week they will provide $3B-plus into COVID-19 research to develop antiviral pill within a year. So how do we sustain this momentum to maintain innovation, investment, and growth so we don’t experience another 2020?

In the twenty-plus years I’ve spent as a commercial pharmaceutical leader (ten of which focused on infectious disease), the conversation has revolved around investment. Historically speaking, infectious disease funding has been notoriously small because the business case was hard to articulate.

Furthermore, the infectious disease product development and commercialization process posed long-time challenges for pharma companies to navigate — particularly when it came to resource allocation for treatment options. This needs to change.

Earlier this year, I participated in a panel that discussed the trends in pharma commercialization and the impact COVID has had on those trends and as we return to “normal,” I wanted to share some of the insights from the front line in the hopes that we do not forget the lessons we’ve learned.

Utility

There is an argument (especially since COVID) that anti-infectives could and should be viewed as a utility where governments play a larger part in the support and funding of these agents. Anti-infectives, more than any other area of medicine, form the foundation of modern medicine, and as such, are the unsung heroes — but as we saw prior to the pandemic, these acute therapies were rarely prioritized because of a low ROI for businesses compared to other chronic therapy areas. Viewing anti-infectives through the lens of a public utility would be a move in the right direction.

Regulation

Over the last year, the rapid progress that we saw was due — in large part — to greater regulatory flexibility that was based on the acknowledgment that difficult-to-obtain large data sets are not necessary in order to move forward with approvals. Being open to smaller data sets and/or surrogate markers and then following up with post-approval commitments and larger safety databases (that are not necessarily in the patient population) would go a long way to attracting the investment needed for progress to continue.

Investment

Among other things, money — in the form of investment — played a large part in combating the threat of COVID. A small portion of that investment would go a long way in improving the commercial situation for the development of much-needed antivirals, antibacterials, and antifungals.

Historically, incentives in this area have focused on “push” incentives, which assist with R&D expenses but do nothing to improve the commercial situation once a product is approved. Pull incentives that do assist with the commercial reality post-approval should be considered — either delinking the payment from the utilization, an insurance-type model, or separating the payment for an antimicrobial from the cost of the inpatient therapy so it doesn’t put the hospital at risk for a financial loss. As we contain the pandemic, some of the money used should be allocated to fund those changes and initiatives.

Diagnostics

As we saw with COVID, countries that had a strong diagnostic infrastructure benefitted in terms of their economy and a decreased loss of life. Diagnostics in this space — particularly for bacterial and fungal infections — are based on legacy technologies and systems. Investment in diagnostics needs to continue and additionally, it plays a significant role in antibacterials and potentially antifungals. Furthermore, increased focus and funding on novel diagnostics, as well as their rapid development and uptake in clinical practice, would make a huge difference in ensuring and safeguarding global health.

Where We Are

Over the last several decades, the commercial realm for anti-infectives has gotten harder — not easier — and this has stymied innovation in the space. We should take the lessons of COVID to heart. This is a marathon, not a sprint. Let us not forget that the mRNA was decades in the making prior to COVID and it was because of the investment previously made that it was able to become a timely solution.

Moving forward, we need continued regulatory support and flexibility, governmental funding for research and development, expanded diagnostics, and continued investment across infectious diseases — such as all viral, fungal, and bacterial. We cannot afford to lose our momentum when it comes to the threat of infectious diseases.