Stronger Together: Harnessing PKPD and statistical insights for drug development decisions at Eli Lilly and Company

Parag Garhyan Speaker
Global PK/PD/Pharmacometrics, Eli Lilly and Company
 
Sunday, Aug 3: 4:05 PM - 4:30 PM
Invited Paper Session 
Music City Center 
The synergy between PKPD and statistical analyses has become increasingly crucial for timely and informed decision making in the complex drug development process. This presentation will highlight how the integration of PKPD modeling and statistical methodologies creates a robust framework for drug development decisions, driving both scientific excellence and organizations efficiency. We will present recent examples where this collaboration has enhanced our understanding of drug behavior, optimized dose selection and study designs, and improved the quality of go/no-go decisions. We will also discuss practical strategies for fostering effective and timely communication between PKPD and statistics teams, joint analyses planning, unified reporting strategies, synchronized decision making, and stakeholder communication.

Keywords

Pharmacokinetics and pharmacodynamics

Dose response

Clinical Pharmacology

Pharmacometrics

Population modeling

Exposure response