Co-hosted with One Nucleus, this webinar will focus on the key considerations for transitioning small molecules from preclinical through clinical development. Experts will discuss the technological aspects of drug development and describe practical approaches to improve bioavailability of poorly soluble drugs.

In addition, the speakers will discuss the ways physiologically-based pharmacokinetic (PBPK) models are used to predict the pharmacokinetics (PK) of drugs in various human populations to support clinical trial design. A review of key regulatory and guideline requirements for early clinical research will also be presented.

Agenda:

Developing Early Formulation: Strategies and Practice
Stephen Tindal, Director, Science & Technology, Catalent

PBPK as a Component of Model-Informed Drug Development
Prof. Amin Rostami-Hodjegan, Professor of Systems Pharmacology & Director of Centre for Applied Pharmacokinetic Research, University of Manchester & Senior Vice President of R&D and Chief Scientific Officer, Certara

Regulatory Considerations for Getting Your Molecule in Early Clinical Trials
Judith Jones, FRSC, Director, Global Regulatory Affairs, Catalent