- What's Next
- Our Services
- Our Expertise
- About Us
- News & Events
The COVID-19 pandemic has changed the biopharmaceutical industry. Most notably, we’ve seen incredible collaboration between pharmaceutical companies, manufacturers, government and academia, which has significantly sped up vaccine development. Typical vaccine development timelines have averaged 10 years but the time from the SARS-CoV-2 genetic sequence’s release to the submission of the first vaccine clinical trial data for regulatory review was a mere 314 days. This is largely due to contract research organizations (CROs) being able to leverage strategic partnerships with sponsors.
Prior to the COVID-19 pandemic, Nexelis and the UK Health Security Agency (UKHSA) formed a partnership after recognizing their complementary capabilities in assay development and vaccine deployment. Thanks to this relationship, Nexelis and UKHSA played a key role in the fight against SARS-CoV-2.
UKHSA received information about the developing pandemic in early January of 2020 and their laboratories received a SARS-CoV-2 strain just a few days after the genetic sequence was publicly released. This enabled Nexelis to get a head start in assessing the industry’s immediate needs for tools to test drug and vaccine efficacy against the emerging disease. After discussing research and development avenues and potential vaccine targets with UKHSA, Nexelis quickly made the decision to initiate SARS-CoV-2 work.
At the beginning of the race to develop a vaccine, the Bill & Melinda Gates Foundation (BMGF) had more than 30 grantees with vaccine candidates in development. Because each grantee used their own assays, there was concern regarding consistently assessing and comparing their efficacy.
Thanks to a previous successful collaboration with Nexelis, BMGF partnered with our team to develop universal preclinical assays for all their grantees. This helped to make it easier for regulatory bodies to review universal assays.
Shortly after starting the initial strategic project, BMGF designated Nexelis as its referral laboratory and extended the project scope. Nexelis now transfers their assays to various labs within the BMGF network to support preclinical and clinical studies.
As the pandemic continued to spread across the world, the number of vaccine development projects grew. However, different methods, reagents, data collection and analysis tools made it incredibly difficult to accurately compare results.
The Coalition for Epidemic Preparedness Innovation (CEPI) asked Nexelis to support their central laboratory network initiative with their clinical assays, including the production of reagents needed for future clinical testing purposes. This partnership agreement included transferring various ELISAs as well as PNA to several global laboratories selected by CEPI. CEPI then formed a Centralized Laboratory Network that uses a core set of six assays to test humoral and cellular responses. Five of the six assays originated at Nexelis, with UKHSA producing the sixth.
Through the collaboration made possible by CEPI’s Centralized Laboratory Network and the grantees of BMGF, the assays and pseudotyped virus developed at Nexelis have been used in more than 100 vaccine development projects worldwide and contributed significantly to bringing vaccines to market.
Historically, CROs, laboratories and agencies would have competed to develop a response to a disease but the SARS-CoV-2 pandemic instead brought our industry together to find a solution. COVID-19 has had a devastating impact on health, economies and societies across the globe – making it clear that infectious diseases don’t have a boundary.
Thanks to the collective work done in the past two years, our industry has the opportunity to revolutionize how we respond to any health crisis.
To read more about Nexelis’ strategic partnerships, you can read our new ebook “Through A CRO’s Perspective: Innovative, Agile Solutions In Vaccine Efficacy Testing”. This ebook showcases how foundational strategic partnerships between sponsors and CROs are invaluable to transforming how we approach clinical development for infectious diseases, allowing us to prepare for the unknown.