Translating SARS-CoV-2 clinical trial challenges into lasting solutions – Key learnings from the perspective of an end-to-end virology Contract Research Organization
April 30 @ 3:00 pm - 4:30 pm UTC+0
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.
Key Learnings / Take Aways
• 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 bio-informatics.
• Discussion of the Athena virology pipeline for the analyses of virology data.
• Preclinical scientists, managers and directors
• Clinical Trial Directors/ Managers
• Supply Chain Specialists
• Vaccine / Anti-Viral project leads
• Clinical development directors/ managers
• (Bio)pharmaceutical researchers / (Sr) Scientists
• Chief Scientific Officers/ Medical Directors/ Scientific project leads
Carel van Baalen, Director R&D
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, 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.
Rienk Jeeninga, Director Clinical Virology Services
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.
Jeroen Strating, Director Molecular Services
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.
Marc van Pruijssen, Director Global Logistics
Marc van Pruijssen holds a Bsc. In international marketing, as well as management & organizational sciences. He performed an Msc, studying Transport & Logistics at TIAS-NIMBAS in Tilburg. Before joining Viroclinics-DDL in 2020, he has been responsible for a variety of developing supply chain functions and new business set up: supply chain planning, transport and distribution center operations, strategy development, program management and new product introductions.
Next to that he is Board member and VP Marketing of the Council of Supply Chain Management Professionals (CSCMP) Benelux Round Table.
Michiel Weber, Senior Bioinformatician
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 provides 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.