Role of Pharmacogenomics in Drug Development – An Industry ...

Rosiglitazone in ADPhase III progression enabled by PGx hypothesis• Phase II Results– Results suggest AD patients without an APOE ε4 allele responded betterthan patients who carry either 1 or 2 APOE ε4 alleles– Results are exploratory and do not inform clinical practice, further studiesare required to confirm these findings– No conclusions can be drawn about clinical management of patients with AD• Prospective Phase III hypothesis– Patients without an APOE ε4 allele will show more improvement comparedto patients who carry an APOE ε4 allele– Phase III subjects will be randomised by APOE ε4 allele status(positive/negative)• Efficacy PGx– Associates genetic variation with differences in drug response– Provides the means to classify patients as responders or non-responders– Enables progression in responder subset for otherwise ‘failed’ drugs