With a renewed interest in vaccine research and development (R&D), stakeholders across the industry are rethinking their approach to the field.
Biopharmaceutical companies have growing numbers of vaccine candidates for infectious diseases, but what best practices should they consider implementing when approaching new vaccine programs, utilizing the experience gained during the COVID-19 pandemic?
Partnerships underpin success
Paradigm shifts in how multiple stakeholders worked together during the COVID-19 pandemic was vital to allow safe and efficacious vaccines to be developed, approved and administrated to billions of people at an unprecedented pace.1
Key nongovernmental organization partnerships, such as the Coalition for Epidemic Preparedness Innovations (CEPI), established a global network of laboratories to accelerate vaccine development.2 This approach transferred standardized viral functional methods and reagents globally to multiple laboratories at speed.
Thinking beyond COVID-19, new partnerships such as the UK Health Security Agency (UKHSA) and the Bill & Melinda Gates Foundation (BMGF), can help ensure the right technical expertise is in place to build public confidence in the 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. The need for assay standardization is fundamental to this approach, and this is where partnership with a contract research organization (CRO) can help.
Assay libraries can save time and unlock advances
Standardizing laboratory vaccine assays allows researchers to rapidly identify and compare vaccine candidates and can also accelerate the response to new variants. Some CROs have been working to create laboratory assay libraries for infectious disease vaccine efficacy testing. At Q2 Solutions, we have a broad portfolio of more than 250 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.
Efficient R&D requires innovation at multiple stages
Several infectious diseases require a biosafety level 3 (BSL-3) laboratory for research. 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, could be studied in the more accessible BSL-2 laboratories to assess the efficiency of antibodies generated by vaccination using neutralization assays.
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 can increase accessibility and reduce patient burden.
A multi-faceted approach offers hope
Ultimately, a multi-faceted approach that harnesses the principles of partnership, technology and scientific expertise can help drive innovation to tackle infectious disease and anticipate potential pitfalls. A CRO with specialized workstreams and resources can act as an extension of sponsor laboratories, becoming an expertise provider as well as a challenger to support effective vaccine development.
This is a summary of an article written by Patrice Hugo and published on Pharma iQ. Read the full article here, https://www.pharma-iq.com/pre-clinical-discovery-and-development/articles/tackling-infectious-disease-with-innovative-rd-approaches.
Patrice Hugo, Vice President, Chief Scientific Officer, Q2 Solutions
1 Our World in Data website. Coronavirus (COVID-19) Vaccinations. Available at: https://ourworldindata.org/covid-vaccinations. [Last accessed: September 2022].
2 Coalition for Epidemic Preparedness Innovations website. The urgency of now. Available at: https://endpandemics.cepi.net/. [Last accessed: September 2022].