Expertise:Bioanalysis:- Method development and method validation according to regulatory guidelines (ICH M10, CLSI)- Technical knowledge, including LC-MS/MS, protein multiplexing platforms, ddPCR, NGS- Technology transfer Biomarkers:- Biomarker strategy, from exploratory biomarker to validated biomarker in clinical trials- Method development, fit for purpose qualification and validation

Main responsibilities:- Defining & implementing the biomarker strategy for (early) clinical development programs.- Translating preclinical findings into clinically useful biomarker approaches.- Developing go/no go criteria for further clinical development.- Developing, qualifying, and validating analytical assays for use in a clinical setting, according to FDA and EMA guidelines on Bioanalytical Method Validation.- Liaising with internal teams on (pre) clinical strategy and biomarker outcome measures.- Liaising with key opinion leaders and managing vendor contacts.- Participating in preparing clinical protocols and regulatory documents.- Preparing plans for statistical analysis and contributing to interpretation of clinical trial data.

- Lead in assay development ((dd) PCR, protein detection) and FFP qualification for use in clinical programs- Lead in developing standardized procedures for assay development and FFP qualification- Lead in developing procedures for in house clinical sample handling and processing- Safeguarding adherence to GCLP guidelines

- Lead in the selection of biomarker candidates for validation - Lead in assay development (LC-MS/MS, PRM, high sensitivity immunoassays (Erenna platform)) - Safeguarding adherence to FDA and EMA guidelines for assay development and implementation - Data analysis (SPSS, SAS, R) - Managing contacts with external collaborators (academia and biotech industry)

- Identifying and validating biomarkers for early Alzheimer’s disease - Assay development for targets in serum, CSF and (brain) tissue - Mass Spectrometry (nLC-MS/MS, SRM) - Isolation and enrichment strategies (laser capture microdissection, solid phase enrichment) - High sensitivity immunoassays - Supervision of PhD and MSc students

Experience in: - Project management & management of collaborating partners- Biochemistry - Cell Culture - Immunohistochemistry View my thesis at: http://dare.uva.nl/record/426831Project: The role of the unfolded protein response in neurodegenerative diseases. I used a unique combination of human post-mortem brain material, cell and animal models to elucidate the involvement of the unfolded protein response in neurodegeneration. I demonstrated that activation of the unfolded protein response is an early event in tauopathies that precedes the formation of inclusion bodies composed of hyperphosphorylated tau protein.Additional activities: - Coaching and supervision of MSc students - Organisation annual ONWAR graduate school retreat for ~200 participants.

Project: Analysis of the Igf2r imprinted locus in mouse embryonic cells.10 month placement in the laboratory of dr. A. Peters, Department of Epigenetics. Experience in:- Epigenetic regulation - Embryonic development - (Confocal) Microscopy - (Immuno) FISH

Project: Characterization of RNA-protein inclusions in myotonic dystrophy.10 month placement at the laboratory of prof. dr. B. Wieringa and dr. R. Wanders in the RIMLS (Department of Cell Biology) Experience in:- (Immuno) FISH - Sectioning of fresh frozen and paraffin embedded tissue - (Confocal) Microscopy

Project: Characterization of peptide aggregation in living cells.9 month placement at the laboratory of dr. J. Neefjes and dr. E. Reits. Experience in: - (Confocal) Microscopy (Life Cell Imaging/FRET) - Intracellular microinjections - Measuring enzyme activity in life cells

Project: Designing a qPCR based method for the detection of EBV variants in human blood samples.Obtained a ‘Leonardo da Vinci’ scholarshipExperience in:- GCP guidelines and accreditation - qPCR development - Cell culture - Handling human serum & plasma