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July 11, 2013

A Multiplexed Approach for Immunogenicity Assessment Using the New SQiDlite™ System: Case Study Analysis

Speakers for this Event:
  • Jaymie R. Sawyer, Ph.D., Vice-President, Research and Development, SQI Diagnostics   Learn More
  • Robert Massé, Ph.D., Vice-President, Large Molecule Bioanalysis, Algorithme Pharma   Learn More
  • In collaboration with SQI Diagnostics, Algorithme Pharma offers a unique multiplexed immunoassay system to characterize Anti-Drug-Antibody (ADA) using a reporter cocktail of differentially labeled secondary antibodies. The SQI Diagnostics’ SQiDlite™ system combines ADA screening and quantitative capabilities while simultaneously characterizing antibody isotypes (e.g. IgG, IgA, IgE or IgM), and subclasses (e.g. IgG1, IgG2, IgG3 and IgG4).

    In this webinar, we will be presenting a case study on Heparin-induced thrombocytopenia (HIT) antibodies developed in response to heparin, and its low molecular weight analogues using the SQI Diagnostics’ platform. This case study will illustrate the capabilities of the novel SQiDlite™ system in assessing the immunogenicity of a wide variety of biologic therapeutics required in safety and efficacy studies.

    THIS PROGRAM IS INTENDED FOR

    VPs, Directors, Heads, Managers, Scientists, Researchers, Laboratory Professionals, Study Coordinators, Study Monitors involved in:

    • Immunogenicty
    • Bioanalysis
    • R&D Clinical Operations (Pharmacology, Toxicology, Clinical Safety, Clinical Research, Principal Research, Research Investigation, Drug Development)
    • Regulatory Affairs
    • Outsourcing Management
    ABOUT OUR SPEAKERS

    Jaymie R. Sawyer, Ph.D., Vice-President, Research and Development, SQI Diagnostics  


    Dr. Jaymie Sawyer joined SQI Diagnostics as VP of Research and Development in 2010 as an experienced leader in both bead based and planar protein arrays and multiplexed immunoassay development. With a doctorate in genetics from the Univ. of Wisconsin, Dr. Sawyer also has expertise in both hybridoma and phage display antibody discovery.

    As a founding member of Motorola Biochip Systems, Dr. Sawyer was responsible for the inception and development of protein arrays on the Codelink platform as well as developing applications for microfluidic and novel detection technologies. She later moved to BD Biosciences to take responsibility for setting up a fully automated, high throughput screening lab for phage libraries in collaboration with Dyax Corp. As R&D Director with BD Biosciences, Dr. Sawyer was responsible for reagent and assay development and led the Cytometric Bead Array program bringing high value multiplexed research immuno-assays to market.

    Robert Massé, Ph.D., Vice-President, Large Molecule Bioanalysis, Algorithme Pharma  


    Dr. Robert Massé is the Vice-President, Large Molecule Bioanalysis at Algorithme Pharma, where he is responsible for developing an integrated approach to the large molecule business using Ligand Binding technology platforms. He is a seasoned executive with more than 30 years of experience, in Academia and leading bioanalysis laboratories in Contract Research Organizations.

    His current interests include the use of Ligand Binding Assays for the PK/TK bioanalysis of therapeutic biologics, and the assessment of immunogenicity using current and emerging technologies. Dr. Massé has published more than 80 papers in peer-review scientific journals and 219 abstracts related to the metabolism and bioanalysis of small and large molecules.

    OUR XTALKS PARTNERS FOR THIS EVENT

    SQI Diagnostics is a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics. The Company’s proprietary microarray tests and fully-automated systems are designed to simplify protein and antibody testing workflow, increase throughput, reduce costs and provide excellent data quality.

    Founded in 1992, Algorithme Pharma is an established early stage clinical contract research organization (CRO) providing multiple research services for pharmaceutical, biotechnology and generic drug industries. Algorithme Pharma’s facilities include a 6-unit clinic with 224 beds and a 20,000 square foot Bioanalytical laboratory.

    With over 20 years’ experience in clinical research, Algorithme Pharma successfully completes over 200 clinical trials annually in Phase I/IIa and Bioequivalence. Combined with Algorithme Pharma’s active participant list of over 40,000 healthy participants, recruitment levels and timelines far exceed industry standards and ensure on-time study starts. In addition, our network of specialized clinicians and relationships with local hospitals provides access to a wide range of patient populations.

    Furthermore, Algorithme Pharma performs large and small molecule bioanalysis on samples from Preclinical to Phase IV studies. The organization is comprised of almost 500 professionals from the medical and scientific fields who work together to provide quality input into study design, conduct and reporting in a wide range of therapeutic areas.

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