David Skibinski, PhD PMP

Director, Immunology at Curevo Vaccine
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Seattle Area

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Credentials

  • Project Management Professional (PMP)
    Project Management Institute
    Mar, 2018
    - Oct, 2024

Experience

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Director, Immunology
      • Jun 2023 - Present
    • Principal Scientist, Immunology Services
      • Sep 2020 - Jun 2023

      · Lead assay development, assay qualification, assay validation, assay transfer and clinical sample analysis: o COVID-19 serology assays including in-house ELISA, MSD multiplex and pseudovirus neutralization assays o Biomarker and bioanalytical assays including cell-based neutralizing ADA assays · Authored and implemented SOP framework for vaccine serology assays · Directed the development and validation of automated data processing pipelines, saving hundreds of hours of data… Show more · Lead assay development, assay qualification, assay validation, assay transfer and clinical sample analysis: o COVID-19 serology assays including in-house ELISA, MSD multiplex and pseudovirus neutralization assays o Biomarker and bioanalytical assays including cell-based neutralizing ADA assays · Authored and implemented SOP framework for vaccine serology assays · Directed the development and validation of automated data processing pipelines, saving hundreds of hours of data QC · Reported directly to CSO (Nexelis) and Site Head (Seattle) Show less · Lead assay development, assay qualification, assay validation, assay transfer and clinical sample analysis: o COVID-19 serology assays including in-house ELISA, MSD multiplex and pseudovirus neutralization assays o Biomarker and bioanalytical assays including cell-based neutralizing ADA assays · Authored and implemented SOP framework for vaccine serology assays · Directed the development and validation of automated data processing pipelines, saving hundreds of hours of data… Show more · Lead assay development, assay qualification, assay validation, assay transfer and clinical sample analysis: o COVID-19 serology assays including in-house ELISA, MSD multiplex and pseudovirus neutralization assays o Biomarker and bioanalytical assays including cell-based neutralizing ADA assays · Authored and implemented SOP framework for vaccine serology assays · Directed the development and validation of automated data processing pipelines, saving hundreds of hours of data QC · Reported directly to CSO (Nexelis) and Site Head (Seattle) Show less

    • Staff Scientist, Diabetes Clinical Research Program
      • Jun 2018 - Sep 2020

      · Led mass cytometry analysis to identify and publish early immunological profile of COVID-19 response in humans (Journal of Clinical Investigation 131 (3), e143648 2021) · Coordinated mechanistic/ biomarker studies, and developed clinical trial protocols for TrialNet, an international NIH sponsored clinical trials network · Established new concepts in immunology driven diseases (Diabetes Care 43 (1), 5-12 46 2020) · Led mass cytometry analysis to identify and publish early immunological profile of COVID-19 response in humans (Journal of Clinical Investigation 131 (3), e143648 2021) · Coordinated mechanistic/ biomarker studies, and developed clinical trial protocols for TrialNet, an international NIH sponsored clinical trials network · Established new concepts in immunology driven diseases (Diabetes Care 43 (1), 5-12 46 2020)

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Principal Scientist, Flow Cytometry Lead
      • Oct 2014 - Jul 2017

      · Drove the strategic development of experimental pembrolizumab clinical trials in immune-oncology (RCC, CRC, HCC and nasopharyngeal carcinoma) · Led the development and validation of cytometry based clinical biomarker assays supporting the clinical development of pembrolizumab (in-house and with CROs) · Established and ran the flow cytometry platform (Fortessa, Aria, Canto, Chipcytometry) · Drove the strategic development of experimental pembrolizumab clinical trials in immune-oncology (RCC, CRC, HCC and nasopharyngeal carcinoma) · Led the development and validation of cytometry based clinical biomarker assays supporting the clinical development of pembrolizumab (in-house and with CROs) · Established and ran the flow cytometry platform (Fortessa, Aria, Canto, Chipcytometry)

    • Singapore
    • Research Services
    • 700 & Above Employee
    • Research Scientist, Head Vaccine Platform
      • Mar 2011 - Oct 2014

      · Led the pre-clinical assessment for Singapore’s first pandemic influenza vaccine and supported a successful Phase I clinical evaluation (Scientific reports 8 (1), 1-12 13 2018; Vaccine 32 (39), 5041-5048 52 2014; PLoS One 8 (10), e76571 19 2013) · Led the pre-clinical assessment of other novel viral vaccines against dengue (Vaccine 33 (12), 1474-1482 21 2015) · Led the pre-clinical assessment for Singapore’s first pandemic influenza vaccine and supported a successful Phase I clinical evaluation (Scientific reports 8 (1), 1-12 13 2018; Vaccine 32 (39), 5041-5048 52 2014; PLoS One 8 (10), e76571 19 2013) · Led the pre-clinical assessment of other novel viral vaccines against dengue (Vaccine 33 (12), 1474-1482 21 2015)

    • United States
    • Wellness and Fitness Services
    • Laboratory Head, Head Vaccine Formulation Science
      • Oct 2008 - Aug 2010

      - Established formulation strategy for evaluation of vaccines in pre-clinical studies - Led formulation development of next generation tlr-based vaccine adjuvant Super Alum - Manager of research laboratory including PhD scientists

    • Research Scientist
      • Apr 2006 - Sep 2008

      - Led formulation activities on S. agalactiae and pathogenic E. coli vaccine programs

    • United States
    • Biotechnology
    • 100 - 200 Employee
    • Research Scientist
      • Jan 2004 - Apr 2006

      - Reverse vaccinology based Chlamydia trachomatis and Yersina pestis vaccine research programs

    • Postdoctoral Research Fellowship
      • Jan 2002 - Dec 2003

      - Investigated link between polymorphism in H. pylori vacA gene and human receptor RPTPβ

Education

  • The University of Sheffield
    PhD, Molecular Biology and Microbial Physiology
    1997 - 2001
  • University of Warwick
    BSc (Hons), Microbiology and Virology
    1993 - 1996

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