Understanding Biomarker Expression Using Multiplex Immunofluorescence (mIF) with FFPE Access for Clinical Trials

Life Sciences, Clinical Trials, Drug Discovery & Development, Biomarkers, Preclinical,
  • Tuesday, October 11, 2022 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 60 min

Multiplex immunofluorescence (mIF) with artificial intelligence (AI) driven digital image analysis (DIA) provides comprehensive biomarker data while preserving precious samples to advance precision oncology programs. In order to successfully apply mIF and DIA in large-scale clinical trials, comprehensive and rigorous design, development, validation and quality control processes must be implemented to ensure reliable results.

Today’s in situ diagnostic questions can often not be answered by standard immunohistochemistry (IHC) procedures alone. With the emergence of immunotherapies, identification of special sub-populations of cells and their spatial context becomes increasingly important. Preclinical projects and early phase clinical trials demonstrate the value of the massive amount of data that can be generated from multiplex analysis on patient-derived biospecimens. The number of publications citing multiplex staining technology has increased more than threefold in the last decade. In addition to the demand for increased complexity of analyses for scientific reasons, tissue biospecimens have become a scarce and valuable commodity. mIF technologies offer an attractive alternative to singleplex IHC, however, due to the added complexity of mIF evaluations when compared to singleplex IHC, there are many challenges to implementing mIF robustly, especially when using in global clinical trials.

Relevant challenges have recently been overcome and clinical trials were successfully conducted for drug and companion diagnostic developers using mIF technologies by employing strict process standardization, rigorous quality control, artificial intelligence and deep learning guided by expert pathologists during every step.

The assay development begins with the respective singleplex assays to ensure the accuracy of results in the final multiplexed protocol. Quality measures like on-slide controls and continuous monitoring of actual staining and slide scanning quality are applied to ensure consistency and quality throughout the trial. DIA algorithms are developed in parallel to ensure accuracy, precision and build confidence in the final evaluation results.

Register for this webinar to learn more about how to optimize reliability, precision and accuracy of mIF technologies and DIA for robust use in the formulation of innovative biomarker strategies and the execution of global clinical trials.

Speaker

http://Thomas%20Henkel,%20PhD

Thomas Henkel, PhD, Executive Vice President of Science & Innovation, Discovery Life Sciences

Dr. Thomas Henkel currently manages the scientific integration and extension of Discovery’s global tissue biomarker services portfolio. Before joining Discovery, Dr. Henkel was the CEO and co-founder of TARGOS Molecular Pathology GmbH, Kassel, a company focusing on research and development services regarding clinical biomarkers and targeted therapeutics. Targos was established in 2005 and developed into a premium molecular pathology service provider. From 2002 to 2005, he was Head of Biomedical Research at the Klinikum Kassel GmbH, an activity leading to the foundation of TARGOS GmbH. Prior to this, Dr. Henkel was Vice President Research at MediGene AG, Martinsried, which he joined shortly after its foundation in 1995 and led the research programs through an IPO in 2000. From 1993 to 1995 he worked scientifically at Tularik Inc., San Francisco. Dr. Henkel received his scientific education and his diploma in Biology and Biochemistry from the Georg-August- Universität and the Max-Planck Institute for Experimental Medicine in Göttingen. After his graduation he performed scientific work at the Gene Center München, the Hadassah Medical School Jerusalem and the Salk Institute in San Diego. Dr. Henkel holds a PhD in Biochemistry from the Ludwig-Maximilians-Universität München. Dr. Henkel co-authored more than 30 publications, including one of the most cited Annual Reviews in Immunology. He is also the author of 15 patents. Since 2004, Dr. Henkel is a lecturer in Biochemistry at the Universität Kassel. He received business and management training and education in Munich and St. Gallen.

Message Presenter

Who Should Attend?

This webinar will appeal to:

  • Immunotherapy researchers and developers seeking to implement innovative biomarker strategies in any phase of development, especially clinical trial phases of precision oncology programs.
  • Anyone involved in conducting biomarker studies for solid tumor indications, including, but not limited to:
    • Founders/CEOs/CSOs
    • R&D Managers, Directors
    • Biomarker Heads, Directors
    • Principal Scientists
    • Clinical Scientists
    • Research Scientists/Associates

What You Will Learn

Join this webinar to learn:

  • Why multiplex immunofluorescence (mIF) is an important consideration for biomarker strategies in global clinical trials
  • How streamlined access to formalin-fixed paraffin-embedded (FFPE) tissues combined with mIF and digital image analysis accelerate biomarker identification in clinical trials
  • How an approach of integrated mIF assays and digital image analysis (DIA) validation is rooted in a fully Good Clinical Laboratory Practice (GCLP) compliant clinical trial environment

Xtalks Partner

Discovery Life Sciences

Discovery Life Sciences is the company of Biospecimen and Biomarker Specialists, combining the world’s largest commercial biospecimen inventory and procurement network with preeminent multi-omic biomarker service laboratories to accelerate new therapies supported by biomarker and companion diagnostic programs for cancer, infectious disease, and other rare and complex conditions.

Discovery’s expert multi-omic biomarker testing services are optimized for speed and large scale capacity. Our global tissue biomarker service laboratories routinely manage hundreds of global studies and expertly test thousands of biospecimens simultaneously using NGS, IHC, flow cytometry and other advanced technologies.

Driven by leading scientific expertise and innovative use of current technologies, the Discovery team engages and consults with customers to more rapidly overcome obstacles and obtain results to make critical research and development decisions at market-leading speed. We are Science at your Service™!  For more information, visit dls.com.

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