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

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Safety PGx: Opportunities• Associate genetic variation with drug inducedadverse events• Provide the means to classify patients’ risk ofdrug induced adverse events• Enable exclusion of ‘at risk’ patients fromsubsequent studies• Enable dose adjustment to reduce exposuredrivenAEs in ‘poor metaboliser’ patients• Potential markers require full evaluation ofperformance characteristics in broad studypopulation to ensure suitability for safetymanagement
Abacavir and Hypersensitivity (HSR)• Abacavir is a nucleoside reverse transcriptase inhibitor fortreatment of HIV infection• Active agent in Ziagen, Trizivir, and Epzicom/Kivexa• Approximately 5% of patients receiving abacavir develophypersensitivity reaction (HSR)– Vast majority of HSR cases are non-serious adverse events andresolve with permanent drug discontinuation– HSR toxicity burden includes excess clinic visits, provision ofalternate antiretroviral drug(s), hospitalizations and rare fataloutcomes• Clinical risk management is highly effective in reducingserious outcomes
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 and 12: ADAS-Cog Score in APOE ε4-Negative
Page 13: Rosiglitazone in ADPhase III progre
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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