Translating SARS-CoV-2 Clinical Trial Challenges Into Lasting Solutions

Life Sciences, Clinical Trials, Drug Discovery & Development,
  • Friday, April 30, 2021 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 90 min

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 finding 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 will 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. Clinical trial settings 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, Viroclinics 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 sequencing, including bioinformatics
  • Immunological assays: SARS-CoV-2 Neutralization Assay
  • Clinical trial operational support and global logistics services

Register for this webinar to gain key insights into SARS-CoV-2 clinical trials, from early stage, preclinical and clinical research to supply chain support and bioinformatics.

Speakers

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Carel van Baalen, Director R&D, Viroclinics

Carel van Baalen was trained in immunology and virology at the University of Utrecht, and he performed his PhD studies at the department of Viroscience, Erasmus MC in Rotterdam. His studies focused on the effectiveness of HIV-specific cytotoxic T cells, which led to applications in clinical immunotherapy trials. In the framework of various subsequent projects at the interface of fundamental science and influenza vaccine trials, he has been working on the development, validation and implementation of novel assays at Viroclinics Biosciences since 2008. In addition to virus-specific serological and cellular assays, he has also worked on novel assays and readouts aim at monitoring virus infection, replication and cell-to-cell transmission as well as at testing the effectiveness of novel antiviral compounds.

Message Presenter
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Rienk Jeeninga, Director Clinical Virology Services, Viroclinics

Rienk Jeeninga studied Biology at the University of Groningen. He performed his PhD studies at the Vrije Universiteit Amsterdam on ribosomal RNA in yeast. He worked as a postdoc at the Amsterdam Medical Center on HIV-1 with a focus on latency mechanisms of the virus. He expanded his work to the influenza field in 2010 to explore on 3D culture systems and human adaptation of influenza viruses. He moved to the department of Clinical Virology Services at Viroclinics Biosciences in 2015 to manage the teams responsible for the serology and cell-based assays.

Message Presenter
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Jeroen Strating, Director Molecular Services, Viroclinics

Jeroen holds a PhD in Cell Biology from Radboud University (The Netherlands). After his PhD, Jeroen studied cellular membranes and how enteroviruses usurp them for 11 years. He joined Viroclinics-DDL in 2019 as manager of molecular assay development (sequencing & RT-PCR). Since June 2020, Jeroen heads the department Molecular Virology Services.

Message Presenter
http://Michiel%20Weber,%20Viroclinics

Michiel Weber, Senior Bioinformatician, Viroclinics

Michiel Weber works at Viroclinics-DDL as a Senior Bioinformatician. With his BSc. and MSc. in Bioinformatics, Michiel worked at Centre for Human Drug Research in Leiden before joining Viroclinics-DDL about 5 years ago. In the clinical trial setting, he developed a strong background in software validation (GAMP-5). At Viroclinics-DDL, Michiel helps to develop high-quality Next-Generation Sequencing software pipelines which provide customers with highly sensitive, accurate data interpretation. Transforming data to the industry reporting standards (CDISC) benefits data submission to regulatory agencies like the FDA for our customers. Michiel is involved in various fields where the sequencing is performed within the company, like viral resistance-monitoring, microbiome profiling, anti-microbial resistance analysis and hybrid assembly using third generation sequencers.

Message Presenter

Who Should Attend?

  • Preclinical Scientists, Managers and Directors
  • Clinical Trial Directors/Managers
  • Supply Chain Specialists
  • Vaccine/Anti-Viral project leads
  • Clinical Development Directors/Managers
  • (Bio)pharmaceutical Researchers/Scientists
  • Chief Scientific Officers/ Medical Directors/ Scientific Project Leads
  • Bioinformaticians

What You Will Learn

In this webinar, participants will learn about:

  • Key insights into preclinical models against SARS-CoV-2
  • Leveraging the latest advances in SARS-CoV-2 assay development
  • The importance of building flexibility and agility in SARS-CoV-2 clinical trial supply chains
  • Optimizing the use of data insights in SARS-CoV-2 clinical trials, through bioinformatics
  • The Athena virology pipeline for the analyses of virology data

Xtalks Partner

Viroclinics-DDL

Viroclinics-DDL builds further on an impressive track record of pandemic related viral targets, including SARS-CoV-1 (2002-2004) and S-OIV (Swine-Origin Influenza Virus, 2009) using validated molecular, cellular and preclinical analyses models. As a virology focused CRO we have extensive expertise with high-demand scenarios. To assist the pharmaceutical, biotech and academic communities with the development of anti-viral medication and vaccines against SARS-CoV-2, Viroclinics-DDL offers a full suite of preclinical, clinical trial diagnostic, bio informatics and global supply chain services.

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