Emmanuel Karouzakis
Director Translational Biomarkers @ Alesta Therapeutics
About
Highly motivated scientist with demonstrated academic and pharmaceutical experience in basic research and drug development in Immunology. As a clinical biomarker leader in Galapagos, I have executed and ensured timely planning, design, implementation, monitoring, analysis, and reporting of biomarkers from early clinical phase I, II through late clinical phase III trials in Immunology according to GxP requirements. In addition, I have conducted 15 years of translational research on Rheumatoid Arthritis (RA) pathogenesis at the University of Zurich with proven a record of publications in medical research peer-reviewed journals. Specialization: Data Science, Machine Learning,Statistics, Biomarker development, R programming, Laboratory, Data management, Clinical study reports, Clinical Study protocols, Informed consent form, genomic and proteomic assay development, PK/PD, clinical trials, multi-omics data ( DNA,RNA,CRISPR, methylation, proteomics),clinical development ------------------------------------------------------------------------------------------------------------------ Clinical Development Scientific Director, Clinical Scientist, Translational Scientist, Senior Scientist, Preclinical Scientist, Clinical Biomarker Leader, Biomarker expert, Computational Biology
Poland
Warsaw
Pharmaceuticals
Research Skills, Biomedical Sciences, Research and Development (R&D), Pre-clinical Studies, Biomarker Development, Team Management, Leadership, Budget Management, Presentations, Oral Communication, Clinical Research Experience, Multi-country, Informed Consent, Data Review, Phase III, Project Management, Communication, Reporting & Analysis, Clinical Trials, Good Clinical Practice (GCP)
Experience

Clinical Biomarker leader
Basel, Switzerland
I am responsible for the following tasks and responsibilities: • Responsible for bi-directional transfer of biomarker knowledge between the Discovery, Safety, and Clinical teams. • Collaborate in a matrix team with the Discovery team toward the identification of new disease relevant biomarkers/pathways and interpretation of the mode of action of Galapagos’ drug candidates, through the analysis of (pre-) clinical biomarker data. • Collaborate with leading academic experts externally, as needed to support the clinical projects in early and late clinical development. • Accountable for development of clinical biomarker strategy needed to drive decision-making regarding safety and efficacy from FIH to late stage (Phase III) development of Galapagos' drug candidates across Immunology therapeutic areas. • Accountable for the clinical biomarker plan document, budgeting of biomarker activities and relevant sections of the clinical protocols. • Contribute to regulatory documents relevant to clinical studies such as Briefing documents, Clinical Study Protocols and Clinical Study Reports. • Accountable for planning of the collection of biomarker samples including 1) selection of relevant specialty vendors, suppliers and technologies and 2) development of the informed consents and laboratory manuals, considering biobanking. • Responsible for biomarker data delivery and bioanalytical reports from external sources, including biomarker vendors. • Collaborate closely with the data scientists to define exploratory analysis plans. • Collaborate in a cross-functional team to analyse and interpret the biomarker data generated from FIH through late Phase clinical trials. • Accountable to the writing of the clinical biomarker data reports. • Contribute to business improvement through development of biomarker related role descriptions, standard operating procedures, and clinical document templates.

Postdoctoral Researcher
Designed and executed postdoctoral projects related to the identification of epigenetic biomarkers using stromal cells clinical cohorts and the study of immunological memory in monocyte / macrophages during rheumatoid arthritis pathogenesis.

Research Assistant
St Georges Medical School
London, United Kingdom
• Responsible for the preparation of dendritic cells cancer vaccines for clinical applications. • Worked in DAVAL international start-up and gained exposure in initial development of an experimental drug for multiple sclerosis.
Education

PhD in Molecular Medicine in the lab of Steffen Gay. The research generate important data about the role of DNA methylation and miRNA expression in rheumatoid arthritis synovial fibroblasts (RASFs) and identify an enzyme responsible for RASFs activation that lead to patent an enzyme inhibitor for RA treatment.
Emmanuel Karouzakis's Contact Information
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