Recently the FDA and EMA have both included modeling and simulation among their highest priorities to support efficient drug development and facilitate regulatory decision making.
With modeling and simulation, your existing data can be leveraged to provide important insights, design more efficient trials, and used to potentially avoid certain clinical studies, saving money and time.
This webinar will cover modeling and simulation fundamentals, real-world examples, and best practices to implement in your development program. At the end of this webinar attendees should have a better understanding of:
1. Modeling & Simulation / Population PK Fundamentals
2. Pharmacokinetic & Pharmacodynamic Modeling Strategies Across Development
3. Using Modeling & Simulation to Avoid Clinical Trials
Meet the Speakers
Mark Sale, M.D.
Senior Vice President, Pharmacometrics
Mark Sale who has over 20 years of experience and serves as Nuventra’s Senior Vice President of Pharmacometrics. Dr. Sale has extensive experience conducting complex population PK analyses across diverse therapeutic areas and is one of the pharmaceutical industry’s thought leaders in modeling and simulation.
Lauren R. L. Lohmer, Ph.D.
Scientist III, Clinical Pharmacology
Lauren Lohmer has experience in all stages of development, with specific interest in Pediatric Study Plans, Concentration-QT analyses, and other types of modeling and simulation. Dr Lohmer recently worked on four drugs that received FDA approval in 2018 providing key insights and analysis to ensure that these drugs are safe and effective for patients.