In this talk, Almac will explore the realities of running next-generation sequencing (NGS) liquid biopsy panels in biomarker-driven clinical trials from a CLIA laboratory diagnostic provider viewpoint.
Panelists will discuss the opportunities and challenges of NGS liquid biopsy panels and the critical steps involved in ensuring that they are ready for stratification use within clinical trials, as demonstrated by a biotech case study from Almac Diagnostic Services.
Almac Diagnostic Services has experience in both the development & analytical validation of blood-based molecular biomarkers so that the assays are both robust and compliant with appropriate global regulatory frameworks for prospective clinical trial stratification.
Register for this webinar to hear about the opportunities and challenges of NGS liquid biopsy panels.
Dr. Leeona Galligan, VP of UK Operations, Almac Diagnostic Services
Dr. Galligan (PhD, FRCPath) has worked for over 15 years in the field of translational molecular oncology and holds the post of VP UK Operations at Almac Diagnostic Services where she has overall responsibility for all laboratory based technologies and services supporting Almac’s biomarker discovery, development and delivery.
Prior to joining Almac in 2009, Dr. Galligan obtained a PhD in molecular haematology from Trinity College Dublin. She subsequently completed a postdoctoral fellowship on the molecular mechanisms of drug resistance in colorectal cancer at Queen’s University Belfast and has completed a 4 year training programme in specialist haemato-oncology laboratory services. She maintains registration with the UK Health and Care Professions Council as a Clinical Scientist and has been awarded Fellowship of the Royal College of Pathologists (FRCPath) through examination in haemato-oncology and laboratory management.Message Presenter
Who Should Attend?
This webinar will appeal to personnel involved in:
- Biomarker Discovery
- Translational Medicine
- Clinical Development
- CDx Development
- Medical Director/ Head/ VP/ CEO
- Principal/ Senior Scientist
What You Will Learn
- Key aspects of running NGS liquid biopsy panels in biomarker-driven clinical trials
- Challenges of demonstrating adequate analytical performance of the panel
- The importance of adequate specimen collection and stabilisation
- Data analysis pipeline considerations for liquid biopsy panels
The 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 commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5,000 highly skilled personnel across 17 facilities including Europe, the US and Asia.
We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. We will be exceptional, always.
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Almac Diagnostic Services
Who we are:
Almac Diagnostic Services is a stratified medicine company specialising in biomarker driven clinical trials. Our global CLIA and CAP accredited laboratories provide diagnostic solutions from biomarker discovery to CDx development & commercialisation.
Our range of services:
Biomarker Discovery, Assay Development & Validation, CDx Development & Commercialization, Clinical Testing and Sample Management, Supporting Services (Bioinformatics, Biostatistics & Software Development, Quality & Regulatory Support, Project Management).
Why are we different?
- Quality Experience: Discover our collaborative working approach and reputation for high quality data output, garnered over fifteen years working on complex biomarker projects.
- Complete Flexibility: We offer a customised approach across a range of platforms, sample types & disease indications, supporting all CDx models from single / dual site PMA, to IVD kit.
- Innovative Solutions: Specific expertise in NGS and offering clients a range of NGS panel solutions (RNA-Seq, DNA-Seq & Liquid Biopsy) & innovative data sciences support.
Click here to find out more.