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Biomarkers qualifications: a first step towards companion diagnostic development

Post thumbnail Biomarkers qualifications: a first step towards companion diagnostic development

Biomarker qualification can be a first step towards companion diagnostic development. The European Medicines Agency already has a biomarker qualification process and the US Food and Drug Administration is developing one itself. The two agencies should find a way to harmonise their respective processes and propose clear incentives for companies seeking to use them.

Sabah, Malek, Sylvie Le Glédic, Anne Dupraz-Poiseau
Biomarkers qualifications : a first step towards companion diagnostic development

2011 – SCRIP Regulatory Affairs

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    publication by

    Sylvie Le Glédic, PhD thumbnail
    Sylvie Le Glédic, PhD
    Director, Medical Devices & IVD
    Sylvie Le Glédic is in charge of the design and implementation of global regulatory strategies for the development and registration of in vitro diagnostics medical devices (IVDs).
    Sabah Malek thumbnail
    Sabah Malek
    Senior Regulatory Scientist Medical Devices and In Vitro Diagnostics
    She is responsible for multiple client projects involving the implementation of global regulatory strategies and submissions for the development and marketing of medical devices (MD) and on in vitro devices (IVD).
    Anne Dupraz Poiseau thumbnail
    Anne Dupraz Poiseau
    Executive Vice President
    Responsible for the definition of the Corporate Strategy and Business Development implementation plan. Participation in the structuration of the Company to allow future growth (internal and through acquisition). Managerial and expertise responsibilities and acts as senior Advisor on Advanced Therapies Medicinal Products (ATMPs, in particular on cell and tissue based therapies), combination products (drug/device combinations) and medical devices related projects (incl. e- and m-health).