Contact Person
    Nicole Mastrell

    Event Manager & PA to CEO
    Email: nm@mva.org
    Phone: (M) +45 6141 8634 Linkedin

    Early Drug Development Workshop

    Meet the experts: Ewoud-Jan van Hoogdalem, PRA Health Sciences; Mads Almose Røpke, Leo Pharma; Martin Bonde, Vaccibody; Iftekhar Khan, MHRA; Suzanne Pihl, Ascendis; Nils Piwon, and Jo Hulbert, PRA Health Sciences as we share perspectives in deciding the best early clinical development strategy based on mechanism of action, using adaptive & innovative designs.

    Discussions include rational use of biomarkers in the translational medicine mindset, tailored therapy, and drug evaluation.

    Date: September 27, 2018
    Time: 10:00 – 15:00, registration begins at 9:30
    Venue: D’Angleterre, Kongens Nytorv 34, 1050 Copenhagen

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    Agenda

    9:30 – 10:00

    Registration

    Light Breakfast Buffet

    10:00 – 10:10

    Introductions

    Ewoud-Jan van Hoogdalem, PRA Health Sciences

    10:10 – 10:30

    Drug Development Success by Design

    Ewoud-Jan van Hoogdalem, PRA Health Sciences

    10:30 – 11:00

    Translational Medicine Concepts in Dermatology

    Mads Almose Røpke, Leo Pharma

    11:00 – 11:30

    First-in-Human Evaluation in Patients

    Nils Piwon, PRA Health Sciences

    11:30 – 12:00

    Patient Tailored Vaccinotherapy in Cancer

    Martin Bonde, Vaccibody

    12:00

    Lunch

    13:00 – 13:30

    Using Adaptive Dose Escalation Designs in Phase 1 Clinical Trials: Are they worth it?

    Iftekhar Khan, MHRA

    13:30 – 14:00

    Biomarkers – Challenges vs Standard PK

    Suzanne Pihl, Ascendis

    14:00 – 14:30

    Regulatory Guidance Providing One Pillar for Successful Clinical Drug Development

    Jo Hulbert, PRA Health Sciences

    14:30 – 15:00

    Questions and Answers

    Dessert Buffet

    15:00

    Closing

    Ewoud-Jan van Hoogdalem, PRA Health Sciences