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Seminar: Dan Weiner

Date:
-
Location:
TBD

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.

Event Series: