MSACL 2019 US Abstract

Clinical Proteomics Enters Clinical Trials: A Generic GCP-compliant Workflow for the Routine Analysis of FFPE Tissue Samples by Quantitative Mass Spectrometry

Axel Ducret (1), Annette Muehleisen (2) Christian Schmauch (2), Valerie Hindie (3), Maxim Isabelle (3), Michael Schirm (3), Lorella Di Donato (3), Jakob Vowinckel (4), Claudia Escher (4), Corinne Solier (1), Tom Dunkley (1)
(1) Pharma Research and Early Development (pRED), Pharmaceutical Sciences, Roche Innovation Center Basel (Switzerland) (2) TARGOS Molecular Pathology GmbH, Kassel (Germany) (3) Caprion Biosciences Inc, Montreal (Québec, Canada) (4) Biognosys AG, Schlieren (Switzerland)

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Axel Ducret (Presenter) F. Hoffmann-La Roche Ltd

Presenter Bio: Axel Ducret is a protein biochemist by training who has been using mass spectrometry for the characterization and quantification of proteins in complex mixtures. Throughout his career first at Merck Frosst in Montreal (Canada), then at F. Hoffmann-La Roche in Basel (Switzerland), he has applied increasingly more complex proteomics strategies for the discovery and validation of biomarkers in tissue, biological fluids, or other complex biological systems. One of his current fields of interest has been the accurate and specific quantification of proteins from formalin-fixed, paraffin-embedded tissue as an untapped sample collection for retrospective biomarker discovery, enabling the use of mass spectrometry as a bridging technology between discovery and early development in clinical samples.

Relevant Financial Disclosures (within past 24 months) Stock/Bonds F. Hoffmann-La Roche Ltd Salary F. Hoffmann-La Roche Ltd Discussing Products? NO, presenter will NOT present educational content related to products/services of the ineligible company(ies) listed above. Conflict mitigation NOT REQUIRED.

Routine analysis of tissue samples collected during a clinical trial using quantitative mass spectrometry remains challenging: it requires rapid assay development and qualification, robust protocols for sample measurement, while study reporting must be documented following Good Clinical Practice guidelines. We report here on a study performed to mimic as closely as possible a clinical investigation framework documenting a targeted and a discovery proteomics investigation of 30 colo-recto cancer FFPE tissue blocks from human origin. We describe the processes that were developed and reflect on the potential of such analytical strategies to become widespread in the future.