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

More documents

Recommendations

Info

PG Opportunities in the ‘Pipeline’Target selectionPathway analysisResponderpopulationidentificationRisk ManagementPost MarketingSurveillanceEarly risk discharge(tolerability)TargetLeadCandidateFTIHPOCPhase 2Phase 3RegSubmissionLaunchand LCMPredictiveToxicologyExposurePK / dosingResponders:stratify / enrich
Efficacy PGx: Opportunities• Associate genetic variation with differences indrug efficacy response• Provide the means to classify patients asresponders or non-responders• Enable enrichment of subsequent studies withresponders• Enable dose adjustments by genotype• Enable progression in responder subset forotherwise ‘failed’ drugs• More focused, better defined studies
Page 1 and 2: Role of Pharmacogenomics inDrug Dev
Page 3 and 4: Variation in medicine response to c
Page 5: GSK Pharmacogenetic StrategyOngoing
Page 9 and 10: APOE4 - a susceptibility gene varia
Page 11 and 12: ADAS-Cog Score in APOE ε4-Negative
Page 13 and 14: Rosiglitazone in ADPhase III progre
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 ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?