Role of Pharmacogenomics in Drug Development – An Industry ...
Role of Pharmacogenomics in Drug Development – An Industry ... Role of Pharmacogenomics in Drug Development – An Industry ...
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
Efficacy PGx: Opportunities• Associate genetic variation with differences <strong>in</strong>drug efficacy response• Provide the means to classify patients asresponders or non-responders• Enable enrichment <strong>of</strong> subsequent studies withresponders• Enable dose adjustments by genotype• Enable progression <strong>in</strong> responder subset forotherwise ‘failed’ drugs• More focused, better def<strong>in</strong>ed studies
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