RNA Gene expression signatures (GESs) offer tremendous potential to classify patients into molecular subgroups of relevance for prognostic & predictive utilities. However, GESs with similar biological targets are often developed independently and therefore may not classify identically. This, along with variations in gene expression caused by technical imprecision in the analysis process, has led to uncertainty regarding the suitability of GES for clinical trial stratification.
Almac Diagnostic Services has substantial experience in both the development & analytical validation of RNA based molecular biomarkers so that the assays are both robust and compliant with appropriate global regulatory frameworks for prospective clinical trial stratification.
Speaker
Dr. Katarina Wikstrom, Head of US Operations, Almac Diagnostic Services
Dr. Katarina Wikstrom has worked for over 14 years in the field of translational molecular oncology and holds the position of Head of US Operations at Almac Diagnostic Services. She has overall responsibility for all US laboratory technologies and services supporting biomarker discovery, assay development and validation and product delivery. Since joining Almac in 2009, Dr. Wikstrom has built up a breadth of experience in the biomarker field with particular focus on assay development & validation.
Message PresenterWho Should Attend?
This webinar will be of interest to senior biopharma decision makers with relevant job titles including:
- Director/Head/VP of Translational Medicine
- Director/Head/VP of Biomarker Discovery
- Director/Head/VP of Clinical Development
- Director/Head/VP of CDx Development
- Director/Head/VP of Clinical Trials
- Medical Director
- CEO
- Chief Scientific Officer
- Head of R&D
- Principal Scientist
- Senior Scientist
- Scientist
- Biomarker Lead
What You Will Learn
In this webinar, participants will learn about:
- Key considerations in the development & analytical validation of developing RNA biomarkers suitable for clinical stratification.
- Lessons learned during the development & validation of an in-house developed Next Generation Sequencing (NGS) gene expression signature.
- Supporting evidence for Gene Expression Signature suitability for clinical trials.
- Innovative reporting of GES utilising Almac’s proprietary software solution.
Xtalks Partner
Almac Diagnostic Services
Almac Group
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Our innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. The international company is a privately owned organization that has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.
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Almac Diagnostic Services
Almac Diagnostic Services is a stratified medicine company specialising in biomarker driven clinical trials. Our global laboratories provide tailored diagnostic solutions from biomarker discovery to CDx development & commercialisation, with a collaborative approach and reputation for quality.
We offer clients complete flexibility for their biomarker strategies, supporting all CDx models from single site PMA to IVD kit.
Almac enable assay development across a range of platform & chemistry options and have extensive experience working with multiple disease indications & multiple sample types. We also provide innovative data generation & analysis solutions, utilising Almac optimised workflows, proprietary bioinformatics pipelines & unique reporting tools.
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