OpenTox Virtual Conference 2021 Session 5 Summary
Model-Based Approaches to Increase Predictability in Early Drug Development
During this session, we will cover state-of-the-art, model-based approaches in support of translation of preclinical efficacy and safety assessments to clinics. The discussion will be based on case studies and best practices, and we will provide a new perspective on the use of model-based approaches. The following points will be discussed during this session: How can M&S increase predictability in early drug development? How can we leverage model-based approaches and advanced human-relevant in vitro systems for advancing Confidence in Compounds, Safety, Patients, and Prediction Tools? We will also offer a regulatory perspective around these questions.
This session will include some critical consideration of the value of model-based approaches for supporting safety assessments during drug discovery and development and what can be done to translate this to the clinical situation in man.
CV: Since 2012 Thierry Lavé is the Global Head of Project Leaders and Modeling and Simulation Pharmaceutical Sciences, pRED. His organization supports a pipeline of more than 150 projects across the entire value chain, by enabling the discovery and development of safe and effective therapeutics as well as ensuring compliance with regulatory and legal standards.
Thierry is very passionate about translating innovations into portfolio impacts. He has been championing innovative (eg in vitro only) and model-informed approaches to increase the probability of success and enabling the development of compounds that could not be developed with traditional approaches.
Thierry joined Roche in 1992. He received his degree in Pharmacy (1987) and Ph.D. (1992) from Strasbourg University, France. Before joining Roche Thierry worked for 5 years as Internist at the University Hospital in Strasbourg.
During his career, Thierry has been working on all stages of discovery and development and across various therapeutic areas and therapeutic modalities. Thierry has been contributing to a regular flow of publications and external presentations on translational PK/PD, modeling, and simulation over the years. He is the author or co-author of more than 90 papers. Thierry is also teaching at various Universities, such as Strasbourg, Besançon, Basel, Bern.