Join us on July 31st when Nuventra’s Mark Sale, MD, and Lauren Lohmer, PhD, will lead a webinar titled, “Designing Smarter Clinical Trials with Modeling & Simulation Approaches.” 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:
- Modeling and Simulation / Population PK Fundamentals
- Pharmacokinetic and Pharmacodynamic Modeling Strategies Across Development
- Using Modeling and Simulation to Avoid Clinical Trials
Meet the Speakers
Mark Sale, MD
Senior Vice President, Pharmacometrics
Mark Sale received his MD in 1985 from The Ohio State University and an MS in biostatistics from Georgetown University in 1995. In 1998 Dr. Sale was the Global Director, Research Modeling and Simulation for GlaxoSmithKline prior to starting an independent consultancy in 2006 in population pharmacokinetics, modeling, and simulation. 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 Lohmer, PhD
Scientist III, Clinical Pharmacology
Dr. Lohmer has been with Nuventra for 3+ years and has experience in all stages of development, with a specific interest in Pediatric Study Plans and Concentration-QT analyses. Dr. Lohmer has also worked on 5+ approved drugs, NDAs, INDs, a variety of other regulatory submissions, protocols, PK analyses, and Population PK analyses.