Smart Drug Development & Design from Candidate to Phase I

    This event will focus on key considerations for transitioning a molecule from discovery to phase 1 readiness including API and formulation development, pharmacokinetics, quality and CMC requirements, and incorporation of clinical supply services solutions to meet protocol, clinical site and patient needs.

    Following the meeting, all Catalent speakers and executives will be available for private, no-obligation discussions on specific programmes and challenges. To request an appointment, please contact Annalisa Zuccotti (az@biorn.org).

     

    9:00 am Registration

    9:30 am WELCOME & INTRODUCTION

    9.45 am "A REFINED DEVELOPABILITY CLASSIFICATION SYSTEM TO ENABLE PRAGMATIC COMPARISON OF DRUG CANDIDATES AND FORMULATION APPROACHES" - tbc

    10.30 am "MODELING THE PHARMACOKINETIC CHALLENGES OF ORAL SMALL MOLECULE DRUGS" by Dr. Jan Neelissen (Catalent Pharma Solutions)

    11.15 am "IMPORTANCE OF API CHARACTERIZATION AND FORMULATION STRATEGIES TO OVERCOME ORAL BIOAVAILABILITY CHALLENGES OF SMALL MOLECULE DRUGS" by Dr. Rob Harris, Catalent Pharma Solutions

    12 pm Lunch

    1 pm "INTEGRATING QUALITY AND CMC INTO EARLY DEVELOPMENT" by Dr. David Elder, Principal Consultant

    1.45 pm "STRATEGIC CLINICAL SUPPLY SOLUTIONS FOR EARLY PHASE CLINICAL TRIAL" by Dr. Carsten Schmidt, Grünenthal Innovation

    2.15 pm Concluding remarks and meet the experts

    Download the program here.

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    Event venue address

    Im Neuenheimer Feld 582 69120 Heidelberg Germany
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