Gaining regulatory approval for drugs targeting conditions that cannot ethically be studied in humans presents a unique challenge for drug developers. Without traditional clinical trial pathways, teams must rely on alternative methods to demonstrate efficacy and support approval.
This webinar will explore how modeling and simulation are used to meet the requirements of the animal rule, a regulatory mechanism that enables drug approval based on animal efficacy data. The featured speakers will provide practical insights into navigating this pathway using real-world examples.
The animal rule permits approval when human trials are unethical or infeasible. In these cases, preclinical data are quantified using mathematical models, and simulations inform clinical dose selection, trial design and the bridging of efficacy between animal models and human exposure data. These tools also guide broader program development and regulatory decision-making.
Attendees will learn:
- When the animal rule is appropriate to use for drug approval
- How modeling and simulation is used to navigate the animal rule
- How to apply the concepts in a real-world example
Register for this webinar to learn how modeling and simulation can help navigate the animal rule in drug development.
Speakers
Jessica K. Roberts, PhD, Senior Director, Pharmacometrics, Allucent
Jessica K. Roberts has over 10 years of professional experience in clinical pharmacology and pharmacometrics. In her current position as Senior Director of Pharmacometrics at Allucent, she is responsible for directing and conducting modeling and simulation analyses and providing strategic advice to clients. Jessica also leads the Quantitative Translational Pharmacology team at Allucent. Before this role, Jessica worked as a Consultant at Metrum Research Group and Cognigen, a division of Simulations Plus. Jessica also worked at St. Jude Children’s Research Hospital before becoming a consultant.
Jessica currently serves as adjunct faculty at the University of Tennessee Health Sciences Center’s School of Pharmacy and as an Associate Editor for the Obstetric and Pediatric Pharmacology Specialty section of Frontiers. Jessica holds a Bachelor’s degree in Biochemistry from Texas A&M University, a Doctorate degree in Pharmacology and Toxicology and a Master of Science in Clinical Investigation from the University of Utah. Jessica also completed a postdoctoral fellowship in Clinical Pharmacology at the University of Utah School of Medicine. To gain a better understanding of the business landscape, Jessica received her Master of Business Administration from Washington University in St. Louis.
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