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 (email@example.com).
When: April 4 from 9.30 am to 2.15
Where: Conference Center, Technology Park in Heidelberg
9.30 am Welcome
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
The event is free of charge but registration is required.
About the speakers:
Dr. William Wei Lim Chin, Technical Specialist, Science & Technology, Catalent Pharma Solutions
Dr. Jan Neelissen, Scientific Adviser, Science & Technology Catalent Pharma Solutions
Dr. Rob Harris, Chief Technical Officer, Catalent Pharma Solutions
David Elder, Principle Consultant, David P Elder Consultancy