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Wednesday, June 21 • 2:00pm - 3:15pm
#354: Experimental Studies: New Approaches to Study Designs to Facilitate Early Phase Decision Making

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will follow the life of a biomarker from the nonclinical arena to its use in clinical trials. The characteristics of a useful biomarker will be discussed. Examples of protocol designs and statistical analysis approaches that use mechanism of action at the molecular level to inform go/no-go decisions will be discussed.

Learning Objectives

Describe the characteristics of a useful biomarker; Illustrate examples of protocol designs and statistical analysis approaches at the molecular level.


Adam F Cohen, MD, PharmD, FACC, FFPM


Experimental Studies
Adam F Cohen, MD, PharmD, FACC, FFPM

Quantitative Approaches to Design and Analysis of Experimental Medicine Clinical Trials
Gengqian Cai, DrSc

avatar for Jonathan Haddad

Jonathan Haddad

Director, Clinical Statistics, GlaxoSmithKline
20 years experience building & leading Biometrics groups in biotech sector. Experience includes oncology, inflammatory diseases and dermatology.


Gengqian Cai

Director, Statistics and Programming, GlaxoSmithKline
PhD in Statistics from Temple University 14 years of industry experience covering different phases of drug development from pre-clinical to phase III in multiple therapeutic areas Currently Director, statistics leader for Rare Diseases Unit at GSK
avatar for Adam Cohen

Adam Cohen

Chief Eecutive Officer, Centre for Human Drug Research
Bio Adam Cohen (b.1952) graduated in Pharmacy and Medicine from Leiden University. He subsequently joined the department of Clinical Pharmacology of the Wellcome Research Laboratories He obtained a PhD degree from Leiden University (1986). Since 1987 he is director of the Centre for... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session