OVERVIEW

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.

AGENDA

9:00 am – 9:30 am | REGISTRATION & REFRESHMENTS

9:30 am – 9:45 am | WELCOME & INTRODUCTION
Speaker TBC, BioRN
               -Dr. William Chin, Technical Specialist,Catalent Pharma Solutions

9:45 am – 10:30 am | A REFINED DEVELOPABILITY CLASSIFICATION SYSTEM TO ENABLE PRAGMATIC COMPARISON OF DRUG CANDIDATES AND FORMULATION APPROACHES
               -TBD

10:30 am – 11:15 am | MODELING THE PHARMACOKINETIC CHALLENGES OF ORAL SMALL MOLECULE DRUGS
               -Dr. Jan Neelissen, Scientific Adviser for PBPK Modeling, Catalent Pharma Solutions

11:15 am – 12:00 pm | IMPORTANCE OF API CHARACTERIZATION AND FORMULATION STRATEGIES TO OVERCOME ORAL BIOAVAILABILITY CHALLENGES OF SMALL MOLECULE DRUGS
               -Dr. Rob Harris, Chief Technical Officer, Oral Drug Delivery, Catalent Pharma Solutions

12:00 pm – 1:00 pm | NETWORKING LUNCH

1:00 pm – 1:45 am | INTEGRATING QUALITY AND CMC INTO EARLY DEVELOPMENT 
               -Dr. David Elder, Principal Consultant, David P Elder Consultancy

1:45 pm – 2:15 pm | STRATEGIC CLINICAL SUPPLY SOLUTIONS FOR EARLY PHASE CLINICAL TRIAL
               -Dr. Carsten Schmidt, Head Clinical Trial Supply, Grünenthal Innovation 

2:15 pm | CONCLUDING REMARKS & MEET THE EXPERTS Catalent Pharma Solutions
               -Dr. William Chin, Technical Specialist, Catalent Pharma Solutions