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The COVID-19 pandemic has seen exceptional collaboration amongst key industry partners including pharmaceutical companies, manufacturers, government and academia, and one major result of this alliance has been the extraordinary speed of vaccine development. The time from the release of the SARS-CoV-2 genetic sequence in January 2020 to the submission of the first vaccine Phase 3 clinical trial data for regulatory review (from Pfizer/BioNTech) was just 314 days, compared to an upwards of 10 years for vaccine development in a pre-pandemic scenario. During the race to develop and disseminate a successful vaccine, a central focal point has been effective and efficient relations between sponsors and CROs – ensuring sponsors have had access to the right expertise and technology at the right time.
The importance of effective sponsor-CRO partnerships
Effective partnerships between sponsors and CROs have been (and continue to be) a key part of this shift, especially in supporting to improve immunological assay continuity. We began work with our strategic partner United Kingdom Health Security Agency (UKHSA) to investigate SARS-CoV-2 structural proteins as potential therapeutic targets needed to evaluate the efficacy of vaccine candidates as early as January 2020, and in March 2020 we partnered with BMGF to develop universal preclinical assays for all of their grantees. By October 2020, we had joined the CEPI Centralised Laboratory Network.
The network works with a core set of 6 assays to support clinical development across humoral and cellular responses. Five of the six were created, validated and transferred to the other labs around the world by Nexelis with UKHSA producing the sixth assay. As a result, I’m proud in the knowledge that during the 18 months since the pandemic began, we have supported more than 60 SARS-CoV-2-related development projects, testing more than 50,000 samples per month in Biosafety Level 2 and 3 laboratories.
Looking beyond SARS-CoV-2 vaccines
Collaborative projects for SARS-CoV-2 that go beyond vaccine development are also in full swing. CoVIC is a global, academic-industry non-profit research coalition investigating antibody therapies against SARS-CoV-2 that will address the unmet need for an effective post-infection treatment. Through our partnership with BMGF, Nexelis is a named partner of CoVIC, providing our SARS-CoV-2 pseudo neutralization assay to investigate passive immunization as a potential therapeutic.
In addition, CEPI has gone one step further beyond SARS-CoV-2 – committing to the 100-day pledge at the start of 2021. One hundred days would mark approximately a third of the time that it took the world to develop a SARS-CoV-2 vaccine. The aim of the pledge is to reduce this timeline for other pandemic vaccines by optimizing the capabilities of technology platforms, preparing clinical trial networks to respond to threats quickly, working closely with global regulators, and linking manufacturing facilities to enable efficient production.
Collaboration in clinical development used to mean a partnership between a single pharma, a CRO and leading sites, but the industry is now moving to a whole new level - and much earlier in the clinical development process.
For Nexelis, our involvement in the response to the COVID-19 pandemic has been an excellent reminder of our core belief – that is, accelerating successful clinical development program through strong partnerships formed between sponsor and CRO. This core collaboration is central to ensuring access to the right experts, assays, and technologies at the right time in order to have the best chance of success.
As an industry we simply cannot allow a repeat of the health, social and economic devastation we have seen over the past 18 months. Infectious diseases are transboundary and have an impact on us all, which is why it is crucial we are prepared for the unknown. Vaccines are truly invaluable to containing an infectious disease on a global scale. By joining the CEPI 100-day initiative, we will support their ambitious goal of compressing timelines and delivering a vaccine for Disease X faster than ever before.
We have a unique opportunity take this even further, to transform the clinical development approach for a range of infectious diseases beyond COVID-19, even beyond emerging infectious diseases and certainly beyond vaccines.