Pharmacometrics as an Emerging Discipline – Application and Utilization to
Improve Decision Making in the Pharmaceutical Industry
Daniel L. Weiner, PhD
SrVP and CTO, Certara Corporation
Adjunct Associate Professor, Division of Pharmacotherapy and Experimental Therapeutics,
School of Pharmacy, College of Medicine, UNC Chapel Hill
Nonlinear mixed effects modeling (NME) has been a mainstream application in the pharmaceutical
industry for over 20 years. Initially NME was applied after an NDA submission was submitted, and was
used to support dosing regimens in special populations (e.g., elderly, pediatric). Despite the advance of
new technologies for identifying molecules for further development, and methods to assess their utility
(e.g. biomarkers) the failure rates of drugs late in clinical development remain persistently high. As a
result, companies are attempting to derive a deeper understanding of the mechanism of action of drugs
and the underlying diseases they are trying to treat. These newer methods, collectively denoted as
Pharmacometrics, utilize deeper biological modeling than previously applied using NME, along with
disease progression modeling, and extensive simulations based on in-silico models of a drug’s
pharmacokinetics and pharmacodynamics; drug development plans; and the individual protocols to be
conducted.
During this talk these topics will be discussed, along with a few case studies illustrating the application of
Pharmacometrics to drug development.