Striking the balance between R&D for Disease X and common illnesses

The COVID-19 pandemic has brought an increased focus on where the next serious infectious disease might originate. Stakeholders from across the industry, including biopharmaceutical companies, governments, and non-profit organizations, are rethinking their pandemic readiness, and there is a new focus on the next potential threat of a highly pathogenic new virus or Disease X.¹

If, or when, the next pandemic arises from a highly pathogenic new virus, prophylactic vaccines would need to be deployed at speed to curtail the severity of disease and reduce the threat. However, more common illnesses such as seasonal influenza, which is estimated to result in 290,000–650,000 deaths each year due to respiratory diseases alone, also remain prevalent and thus should not be neglected either.²

So how can companies strike the balance between investing in research and development (R&D) for the next infectious disease that might at the outset have limited geographic reach and commercial potential, alongside more common illnesses that are already widespread?

Targeted investment with additional support

Whether an organization is looking to expedite its progress for Disease X, or other more common infectious diseases, the best approach will focus on targeted investment and support. It is important for biopharmaceutical companies that need to develop either prophylactic vaccines and/or therapeutic solutions, such as antiviral drugs, to work with commercial partners with a solid track record of supporting clinical trials.

A highly focused contract research organization (CRO) with specialized resources and ready-to-go solutions can act as an extension of a sponsor’s laboratories, so sponsors can focus their internal resources on the priorities and remain agile. Such a CRO laboratory partner should have the right infrastructure, along with a skilled and knowledgeable team of scientists with domain experience.

Key areas of responsibility-sharing could include translational science with assays optimization and validation capabilities, a broad library of laboratory assays, decentralized trial services, and central laboratory support, which could apply to both Disease X or more widespread illnesses.

Translational science and innovation

Introducing biomarkers or novel technologies into clinical research is challenging and calls for additional research and evaluation as part of the process. Laboratories working on innovative solutions can address challenges, providing agility and breadth of translational science capabilities and the expertise required to bridge the gap between preclinical and early clinical drug development.

Sponsors can work in collaboration with a CRO to validate the most effective biomarkers, assays, and associated technologies early in the R&D process. This can accelerate the development of therapeutics and expedite the deployment of the right assay format in key geographic locations to support clinical trial study requirements.

Assay libraries can deliver time advantages

CROs with expertise in the field have been working to create efficacy assay libraries with the aim of accelerating vaccine development for more common infectious diseases, including for tuberculosis, Ebola, Zika, and Chikungunya. Our infectious disease portfolio at Q² Solutions is made up of more than 350 assays (including respiratory panel and sequencing, viral load, and serology assays) and covers a broad range of potential infectious diseases that can support timely access to the right assays for clinical trials.

Sponsors do not need to start again in their approach. By leveraging both the breadth and the depth of their experience, CROs can also build on previous assay work undertaken. For example, by adapting and “recycling” coronavirus assays that were developed for SARS-CoV-2 use with other novel infectious diseases, clinical development programs that need to start quickly in response to a new virus could be given a crucial advantage.

Decentralized trial services and central lab support can add value

Harnessing new technologies and platforms can support and optimize R&D. Sponsors can drive efficiencies by leveraging decentralized trial services for both Disease X and more common illnesses, whether that is part of a traditional development program or in a remote scenario where diseases may be highly infectious or spread across a wide geography. For example, remote recruitment and close to home or at-home specimen collection in clinical trials can improve convenience and reduce patient burden. In addition, the use of patient service centers, home phlebotomy, home nursing, and special locations can also support trials to optimize patient engagement and secure timelines.

Central laboratory services can also complement this approach by ensuring consistency of testing specimens and offering sponsors long-term solutions for global infectious disease trials. The range of support available is broad and can include the supply of specimen collection kits, courier networks, and project management to expedite trial data processing, in which speed is vital.

Under careful consideration and by focusing on the right solutions with the right partner, sponsors can depend on their CRO counterparts and take advantage of their expertise within novel infectious diseases to balance alongside their other R&D endeavors. This two-pronged approach can yield benefits by delivering game-changing innovations across multiple therapeutic areas in parallel, so sponsors can optimize their investment and stay ahead.

References

1. Coalition for Epidemic Preparedness Innovations website. 100 days. Available at: https://100days.cepi.net/. [Last accessed: September 2022].
2. World Health Organization website. Global influenza programme – estimate of influenza deaths due to respiratory disease. Available at: https://www.who.int/teams/global-influenza-programme/surveillance-and-monitoring/burden-of-disease. [Last accessed: September 2022].