Pharmacometrics: Implications and Impact in Preclinical to Early Phase Clinical Development
Track
:
Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
Program Code:
332
Date:
Wednesday, June 26, 2013
Time:
10:15 AM to 11:45 AM
EST
Location:
105
CHAIR
:
Royce A. Morrison, MD,MS (SCHNON), Executive Vice-Chair, Quorum Review, Inc., United States
Royce Morrison MD CPI brought over 20 years' internal medicine practice experience to early phase research in 2002. Principal Investigator and protocol author for the range of CP studies, he developed cardiac safety & radiolabeled study capabilities. He is Chair of the CP SIAC Core Committee.
SPEAKER
(S):
Dinah Duarte, PharmD,MSc (SPKAGY), Head, Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED, Portugal
MSc in Regulatory Affairs & Evaluation of Medicines. Specialist in Regulatory Affairs (Portuguese Pharmaceutical Society). CHMP member at European Medicines Agency. Head of Scientific Evaluation Unit - INFARMED, I.P. Portuguese contact Point for “Paediatric Medicines”.
Jogarao V. Gobburu, PhD,MBA (SPKSUP), Professor, School of Pharmacy and School of Medicine, University of Maryland, United States
Dr. Gobburu, Prof., Schl of Pharmacy & the Schl of Medicine, Univ of Maryland, Baltimore. While with the FDA (1999-2011) under his leadership, a Div. of Pharmacometrics was formed. He is a world-recognized scientific leader in the area of quantitative disease models & their application to decisions.
Royce A. Morrison, MD,MS (SPKNON), Executive Vice-Chair, Quorum Review, Inc., United States
Royce Morrison MD CPI brought over 20 years' internal medicine practice experience to early phase research in 2002. Principal Investigator and protocol author for the range of CP studies, he developed cardiac safety & radiolabeled study capabilities. He is Chair of the CP SIAC Core Committee.
Arnab Mukherjee, (SPKNON), Director, Specialty Care Clinical Pharmacology, Pfizer Inc, United States
Description
Increasingly, sponsors' and regulators' decisions in drug programs are being driven by pharmacometric methods. Early phase trials will change to give the right range of data for physiologically- and pharmacologically-based modeling and simulations.