Improving translation of in vivo disease efficacy models
*Peter Ceuppens, AstraZeneca Ian Stuart Peers, AstraZeneca
Keywords: Translation, in vivo, disease efficacy
Translating basic research and pre-clinical experiments into clinically effective proof of concept studies is a key step in developing medicines that address unmet medical needs and deliver benefits to patients.
In the progression from ‘bench-to-bedside’, attrition of new chemical entities attributable to lack of demonstrable clinical efficacy remains as a significant challenge1,2. Attention has focussed recently on the translatability and clinical utility of animal models in predicting the efficacy of novel therapeutic agents in clinical settings 3,4,5,6. In this presentation, six key issues contributing to problems with translation are highlighted.
These are as follows:- • Inconsistent standard of pre-clinical information supporting in vivo efficacy studies • Lack of statistical rigour driving quality of pivotal pre-clinical in vivo experiments • Lack of consistency between pre-clinical and clinical hypothesis, e.g. different disease phases or severity • Lack of evidence of reliability of clinical translation • Decision makers (including investigators, ethical review boards, research sponsors and regulators) have inconsistent views on requirements for pre-clinical studies • Lack of routine retrospective evaluation of the clinical utility of pre-clinical animal models
The presentation will describe suggestions for improving confidence in disease efficacy models along the lines of the 6 areas above. Furthermore, it is suggested that the pre-competitive sharing of reference compound data from specific in vivo disease efficacy models across Pharmaceutical companies and academia would be beneficial.
April 30 - May 22, 2013
Invited Abstract Submission Open
June 4, 2013
Online Registration Opens
August 9 - August 23, 2013
Invited Abstract Editing
August 23, 2013
Short Course materials due from Instructors
August 26, 2013
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC