John Shillingford is a VP Strategic Initiatives for Aptiv Solutions based in Germany. He has over 30 years of Pharmaceutical and Contract Research industry experience working in the USA and across Western, Central and Eastern Europe.
John Shillingford is a VP Strategic Initiatives for Aptiv Solutions based in Germany. He has over 30 years of Pharmaceutical and Contract Research industry experience working in the USA and across Western, Central and Eastern Europe.
Sergei has worked in GlaxoSmithKline (Research Statistics Unit, Philadelphia), USC (Los Angeles) and Institute for Systems Analysis (Moscow). Research interests include optimal design for nonlinear models, including dose-response and PK/PD modeling, nonparametric estimation, statistical computing
1970 Diploma in mathematics,University Karlsruhe,Germany.1970–1992 Boehringer Mannheim,Statistician,clinical trials and preclinical experiments,1987 Head Risk Analysis Therapeutics.1992-2004 PRA, Quality and Process Management, Product Development Services.>2004 consultant,2005 ICDC & 2008 PRESCOS.
Description
This session will look at the Early Phase Team's decision-making processes, use of adaptive designs to facilitate studies, and reduction of study times. An integrated approach with the aim to facilitate rapid development go/no-go decisions.
Learning Objectives: Analyze the decision making processes used to determine Early Phase Drug Development with study designs to facilitate drug development go/no-go decisions Identify strategies to facilitate the acceleration of studies from the volunteer phase into patients for proof-of-concept.