Tackling infectious disease with innovative R&D approaches

Patrice Hugo, PhD is Chief Scientific Officer at Q2 Solutions, a clinical trial laboratory services organization. In this guest blog for Pharma IQ he writes about the global rise in infectious disease and how scientists should approach the development of new treatments.

There is a renewed interest in vaccine research and development (R&D), the development, approval and clinical success mRNA vaccines and an increased focus on where the next serious infectious disease might come from. Stakeholders across the industry are rethinking their approach to the field and considering revising the design of vaccines for challenging infectious diseases, for example HIV.

Infectious diseases know no boundaries and continue to be a growing public health concern regardless of geographical location, which is the case for two examples of note. The incidence of Dengue has grown dramatically in recent years with approximately 100–400 million infections annually. More recently the Monkeypox virus, although endemic in several Central and West African countries, has recently seen cases recorded widely across Europe, the Americas, Australia and Asia.

Biopharmaceutical companies have growing numbers of vaccine candidates at various stages of clinical development for treating multiple infectious diseases. What best practices should they consider implementing when approaching new vaccine programs utilizing the experience gained during the Covid-19 pandemic?

Partnerships underpin success

There have been paradigm shifts in how multiple stakeholders from industry, non-profit organizations and government bodies worked together during the Covid-19 pandemic. This was vital to allow safe and efficacious vaccines to be developed, approved and administered to billions of people at an unprecedented pace.

Key non-governmental organization partnerships, such as the Coalition for Epidemic Preparedness Innovations (CEPI), established a global network of laboratories during the pandemic to accelerate vaccine development. This approach transferred standardized viral functional methods and reagents globally to multiple laboratories at speed.

Thinking beyond Covid-19, new partnerships are emerging between industry and leading bodies who recognize the importance of public health and safety, such as the UK Health Security Agency (UKHSA) and the Bill & Melinda Gates Foundation (BMGF). These can help ensure the right technical expertise is in place to build public confidence in the processes and work undertaken.

These partnerships continue to promote and expedite advances in research, enabling the use of laboratory techniques and technology – including the development of humoral and cellular assays. They continue to expand upon how we approach efficacy testing for both new infectious diseases and those currently without effective vaccines.

A centralized laboratory network is also being replicated by the BMGF, however, the need for assay standardization is fundamental to this approach.

Assay libraries can save time and unlock advances

Standardizing laboratory vaccine assays allows researchers to rapidly identify and compare competing vaccine candidates and can also accelerate the response to new variants. Some contract research organizations (CROs) have been working to create laboratory assay libraries for infectious disease vaccine efficacy testing.

This includes libraries for multi-drug and extensively drug-resistant tuberculosis. It helps ensure the standardization and quality control of highly technical and time-consuming assays, and viruses such as Ebola with immunoassay and functional antibody assessments, which could help speed up vaccine development.

At Q2 Solutions, we have a broad portfolio of hundreds of assays covering a wide array of potential infectious diseases, which can inform strategies and ensure sponsors have timely access to the right assays for clinical trials.

By leveraging both the breadth and depth of their experience, CROs can also build on previous assay work undertaken. For example, coronavirus assays that were developed for Covid-19 can be adapted and ‘recycled’ for use with other novel infectious diseases, ensuring a head start.

Using assays to compare new viral strains

With Zika virus, traditional assays have been impeded by cross-reactivity issues, making it difficult to distinguish between other viral strains. Therefore, there is a tremendous need for a Zika serologic screening panel that can determine if subjects have been previously infected by similar viruses and their likely response to a vaccine.

Studies funded by the Biomedical Advanced Research and Development Authority (BARDA) are underway, using new serological assays for determining a feasibility assessment of human serum to test for equivalency.

In the longer term, there is a need for the development of a focused set of standardized assays for sponsors across markers of vaccine performance including robustness, accuracy and precision. They could allow for more exact comparisons between candidates for an infectious disease and ultimately result in more informed recommendations from regulators.

Efficient R&D requires innovation

For organizations looking to expedite their progress in infectious diseases, investment and support is needed. Where that investment is made, however, can have a significant impact. A CRO with specialized workstreams and resources can act as an extension of sponsor laboratories, becoming an expertise-provider as well as a challenger.

Several infectious diseases require a biosafety level 3 (BSL-3) laboratory for research, including West Nile virus and Chikungunya virus. CROs equipped with BSL-3 laboratory facilities are vital to the industry. They provide vaccine manufacturers with the flexibility to perform assays and handle infectious diseases that may be transmitted through the air while operating with the efficiency and control needed for preclinical to late-phase trials.

SARS-CoV-2 virus, which causes Covid-19, originally had to be studied in BSL-3 laboratories. By using immunotools, SARS-CoV-2 pseudotype particles where the viral replication gene was knocked out, eliminating the biohazard potential. This could be studied in the more accessible BSL-2 laboratories to assess the efficiency of antibodies generated by vaccination using neutralization assays.

Decentralized clinical trials

Likewise, in remote-monitoring scenarios where diseases may be highly infectious or span a wide geography, decentralized trial services are becoming increasingly prevalent.

Remote recruitment and data collection as well as options for collecting patient samples close to, or at home in clinical trials can increase accessibility and reduce patient burden.

This approach can optimize patient engagement and timelines. During the Covid-19 pandemic we saw a rise in self-testing, which points to the public being open to self-collection for future laboratory testing that will improve convenience.

Alongside this, central lab services complement this approach for sponsors to ensure consistency of testing specimens, offering long-term solutions for global infectious disease trials. Support can range from supply of specimen collection kits, courier networks and project management to expedited trial data processing, where speed is critical.

A multi-faceted approach offers hope

Thoughtful expertise and careful collaboration among infectious disease specialists, immunologists, virologists and vaccine experts must always be applied early in the design phase.

Ultimately, a multi-faceted approach that harnesses the principles of partnership, technology and scientific expertise can help drive innovation to tackle infectious diseases and anticipate potential pitfalls.

Infectious diseases continue to pose serious dangers, but effective vaccine development can offer hope to millions around the world who continue to live under threat of infection.

Quick links

• The benefits of remote monitoring for sample storage and lab processes
• Top five countries running the most clinical trials
• Top 10 largest clinical research organizations

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