Contact Person
    Nicole Mastrell

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

    From Discovery to Clinic: Creating a Comprehensive and Efficient Development Operation

    The pharmaceutical industry continues to experience decreasing productivity and high levels of attrition. Inflation of molecule physicochemical properties and complexities in clinical trial protocols stand among the main reasons for these trends. The most successful companies can leverage different expertise, manage risks, and follow logical sequences of operations in an integrated manner.

    This event will focus on key considerations for transitioning a molecule from discovery through clinical studies including molecule developability assessment, phase appropriate formulation selection, integration of product development and clinical supply, and creating an appropriate clinical study design.

    Date: March 7, 2019
    Time: 9:30 – 15:00
    Venue: Medicon Valley Alliance, Arne Jacobsens Alle 15 , 2300 Ørestad City, Copenhagen, Denmark, Ground floor

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    Agenda

    9:30

    Registration & Coffee

    10:00

    Welcome
    Andy Maitland, Account Director, Catalent &
    David Zepernick, Head of Communication and Public Affairs, Medicon Valley Alliance

    10:10

    Assessing Molecule Developability Using Pharmacokinetic Modeling

    • Assess developability of NCEs
    • Understand ADME deficiencies that can be improved through drug design or formulation
    • Set target PK profile and starting dose
    • DMPK modeling to guide formulation selection
    • Case studies

    Jan Neelissen, Scientifc Adviser, Science & Technology, Catalent

    10:55

    Drug Product

    • Selection of an optimal formulation: when advanced technologies (solubility enhancing) are required versus simplified approaches (i.e. powder-in-capsule)
    • Formulation and dose form considerations for clinical studies

    Julien Meissonnier, Vice President, Science & Technology, Catalent
    or Rob Harris, Chief Technical Officer, Catalent

    11:40

    Lunch and Networking

    12:30

    Efficient Coordination of Clinical Supplies

    • Best practices to efficiently coordinate clinical supplies: clinical manufacturing, packaging, storage and distribution

    Susie Jelsbak Christensen, Clinical Supply Manager, Symphogen

    13:15

    Clinical Studies

    • Different models of clinical studies and their goals
    • Challenges of executing complex clinical studies

    Gunnar Danielsson, Senior Regulatory Advisor, LINK Medical Research AS

    14:00

    Closing Remarks

    Andy Maitland, Account Director, Catalent

    14:10

    Coffee and Networking

    15:00

    End of seminar

    Following the meeting, all presenters and Catalent’s Science and Technology leaders will be available for private, no-obligation discussions on specific programmes and challenges.

    Organized by:

    In collaboration with: