Translating SARS-CoV-2 clinical trial challenges into lasting solutions – Key learnings from the perspective of an end-to-end virology Contract Research Organization

Event information Webinar

Date:    Friday April 30
Time:   10:00 – 11:30
Where: Online webinar

Bringing together expertise across a broad domain of preclinical, clinical trial diagnostics, supply chain and bioinformatics services to support the continuous battle against SARS-CoV-2 

As SARS-CoV-2 continues to spread across the globe, pharma and biotech companies remain committed to find effective vaccines and therapeutics. Communities are still affected and we are far from a manageable situation. With newly emerging variants in the UK, South-Africa and Brazil (B.1.1.7, B.1.351, P.1), the industry is faced with new challenges, especially in relation to clinical trials. If vaccines and anti-virals prove to be less effective against new variants, it is likely that current studies have to be adjusted or renewed. In order to stay ahead of mutations the pharma and biotech communities will need to be able to continuously adapt their vaccine and therapeutic strategies. Therefore, it is essential to incorporate a high level of flexibility in clinical trials. This is applicable to all outsourcing partners in the clinical trial network including commercial laboratory testing facilities. In clinical trial settings we are faced with several challenges:

• Selecting the right SARS-CoV-2 early stage, preclinical models;
• The complexity of developing and validating SARS-CoV-2 assays;
• The availability of agile supply chain infrastructures;
• Transforming clinical trial data into valuable insights.

As there are many different therapeutic and prophylactic approaches against SARS-CoV-2 – such as recombinant viral vectors, recombinant proteins, nucleic acids, live attenuated, mRNA, etc. – there is a need for a wide array of preclinical and clinical trial diagnostic research methods. In addition, the wealth of data generated by SARS-CoV-2 trials has to be processed, analyzed and evaluated, which emphasizes the importance of biostatistical support to generate valuable insights.

Having supported many SARS-CoV-2 clinical trials our scientific advisors, logistical specialists and bioinformaticians will share their best practices on:

• Validated animal models for SARS-CoV-2 challenge studies, immunogenicity and efficacy testing;
• Virology Assays: virus titration (titer: TCID50/mL), antiviral assays (IC50);
• Molecular Assays: qPCR, Next Generation Sequencing, whole genome targeted, including Bio-Informatics;
• Immunological Assays: SARS-CoV-2 Neutralization Assay;
• Clinical trial operational support and global logistics services.

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