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

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ADAS-Cog Score in APOE ε4-Negativevs. APOE ε4-Positive CohortsMean Change in ADAS-Cog Score-2.5-2-1.5-1-0.500.511.522.5Baseline Week 8 Week 16 Week 248mg E4+ 4mg E4+ 2mg E4+ Pbo E4+8mg E4- 4mg E4- 2mg E4- Pbo E4-• Analysis of interaction between APOE carriage status and ADAS Cog change from baseline to Week 24 wassignificant (P
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
Page 1 and 2: Role of Pharmacogenomics inDrug Dev
Page 3 and 4: Variation in medicine response to c
Page 5 and 6: GSK Pharmacogenetic StrategyOngoing
Page 7 and 8: Efficacy PGx: Opportunities• Asso
Page 9 and 10: APOE4 - a susceptibility gene varia
Page 11: ADAS-Cog Score in APOE ε4-Negative
Page 15 and 16: Abacavir and Hypersensitivity (HSR)
Page 17 and 18: Abacavir HSR Prospective PGx study
Page 19 and 20: PPARγ agonist FarglitazarOedema AE
Page 21 and 22: Farglitazar oedema AE PGxSCNN1B Gen
Page 23 and 24: Ethical considerations• PGx is no

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

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