Role of Pharmacogenomics in Drug Development – An Industry ...
Role of Pharmacogenomics in Drug Development – An Industry ... Role of Pharmacogenomics in Drug Development – An Industry ...
Farglitazar oedema AE PGx• Based on data emerging after completion of clinicaltrials this study was conducted on stored DNAsamples• Several polymorphisms in SCNN1B were highlysignificantly associated with oedema adverse events inFarglitazar clinical trials• These findings strengthen the hypothesis implicatingrenal sodium handling in the development of PPARγinduced fluid retention and suggest opportunities formanagement (eg, amiloride)• “No samples, no science”
Ethical considerations• PGx is not ‘exceptional’• PGx information is treated the same as otherclinical data– DNA samples are collected following clinicaltrial informed consent– DNA samples for PGx are coded to protectpatient identity• Primary goal of PGx is to investigate geneticvariation relating to drug effects, not to predictlikelihood of developing a disease
- 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 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: Farglitazar oedema AE PGxSCNN1B Gen
Ethical considerations• PGx is not ‘exceptional’• PGx <strong>in</strong>formation is treated the same as othercl<strong>in</strong>ical data<strong>–</strong> DNA samples are collected follow<strong>in</strong>g cl<strong>in</strong>icaltrial <strong>in</strong>formed consent<strong>–</strong> DNA samples for PGx are coded to protectpatient identity• Primary goal <strong>of</strong> PGx is to <strong>in</strong>vestigate geneticvariation relat<strong>in</strong>g to drug effects, not to predictlikelihood <strong>of</strong> develop<strong>in</strong>g a disease
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