Clinical Trial Assay Development & Validation – Strategies for Success

Life Sciences, Clinical Trials, Drug Discovery & Development, Biomarkers,
  • Tuesday, September 14, 2021

Molecular biomarkers offer tremendous potential to classify patients into subgroups of relevance for prognostic & predictive utilities. However, there are many challenges and considerations in translating a biomarker to a molecular diagnostic test (clinical trial assay). When defining the intended use of novel biomarker, decisions including specimen collection, molecular content and platform selection can have a significant impact on a biomarker program.

A strategic approach to the development & analytical validation of clinical trial assays at each stage of clinical validation ensures the highest quality molecular data is acquired in the most efficient way whilst minimising the potential risk of product redesign for biopharma companies.

Almac Diagnostic Services has substantial experience of analytical validation across all stages of diagnostic test development from utilisation in early proof of concept trials through to IVD Companion Diagnostic (CDx) tests, often consulting to help guide biopharma companies through the process.

Register for this webinar to hear a series of case studies that explore the strategic considerations at each stage of the development & validation journey to ensure that assays are both robust and compliant with appropriate global regulatory frameworks for prospective clinical trial stratification.


Dr. Cheryl McFarlane, Almac Diagnostic Services

Dr. Cheryl McFarlane, Assay Development & Validation Manager, Almac Diagnostic Services

Dr. McFarlane, PhD has worked for over 15 years in the field of translational molecular oncology and holds the post of Assay Development & Validation Manager at Almac Diagnostic Services where she has responsibility for assay development and validation activities supporting biomarker discovery, development and delivery for a range of Global Biopharma clients.

Prior to joining Almac in 2015, Dr. McFarlane obtained a PhD from Queen’s University Belfast. She subsequently completed postdoctoral fellowships where she specialized in the identification and validation of novel therapeutic targets in the Ubiquitin Proteasome system.

Cheryl is also a General Supervisor in the clinical laboratory supervising the day-to-day work of all CLIA certified laboratory testing.

Message Presenter

Who Should Attend?

  • Pharma Companies
  • Biotech Companies
  • Relevant to Both Oncology and Non-Oncology Indication Focus
  • Senior Biopharma Decision Makers

What You Will Learn

  • Key considerations in the development & validation of clinical trial assays for clinical stratification
  • The importance of adequate specimen collection & stabilisation
  • Major factors influencing platform selection
  • The requirement of bridging studies and lessons learned
  • Challenges of demonstrating adequate analytical performance of panels
  • Considerations for data analysis pipelines

Xtalks Partners

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.

Click here to find out more.

Almac Diagnostic Services

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.

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