Challenges and opportunities of pharmacogenetics in drug development

Personalized Medicine

Volumn 3, Issue 2, 2006, Pages 195-206

  March, Ruth ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

Biomarker; Drug development; Pharmaceutical industry; Pharmacogenetics; Pharmacogenomics; Translational science

Indexed keywords

ABACAVIR; ALPHA 1 ANTITRYPSIN; ARIPIPRAZOLE; ATOMOXETINE; CELECOXIB; CETUXIMAB; CYTOCHROME P450; CYTOCHROME P450 1A2; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GLUCURONOSYLTRANSFERASE; GLUCURONOSYLTRANSFERASE 1A1; GROWTH HORMONE; HLA ANTIGEN; IMATINIB; IRINOTECAN; MERCAPTOPURINE; MODAFINIL; PLACEBO; PROTEINASE; RETINOIC ACID; ROSUVASTATIN; STEM CELL FACTOR RECEPTOR; THEOPHYLLINE; THIORIDAZINE; TRASTUZUMAB; UNINDEXED DRUG; WARFARIN;

BREAST CANCER; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; COLORECTAL CANCER; DRUG ABSORPTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG INDUSTRY; DRUG LABELING; DRUG METABOLISM; DRUG RESEARCH; DRUG RESPONSE; DRUG SAFETY; ETHNIC DIFFERENCE; HEALTH CARE DELIVERY; HUMAN; PHARMACOGENETICS; PRADER WILLI SYNDROME; PRIORITY JOURNAL; PROMYELOCYTIC LEUKEMIA; REVIEW; RISK ASSESSMENT; SINGLE NUCLEOTIDE POLYMORPHISM;

EID: 33646811221     PISSN: 17410541     EISSN: 1744828X     Source Type: Journal    
DOI: 10.2217/17410541.3.2.195     Document Type: Review

References (37)

1. Weaver R, Graham KS, Beattie IG, Riley RJ: Cytochrome P450 inhibition using recombinant proteins and mass spectrometry/multiple reaction monitoring technology in a cassette incubation. Drug Metab. Dispos. 31, 955-966 (2003).
2. Kuwayama H, Luk G, Yoshida S: Efficacy of a low-dose omeprazole-based triple-therapy regimen for Helicobacter pylori eradication independent of cytochrome P450 genotype: The Japanese MACH Study. Clin. Drug Invest. 25, 293-305 (2005).
3. Kim K, Johnson JA, Derendorf H: Differences in drug pharmacokinetics between East Asians and Caucasians and the role of genetic polymorphisms. J. Clin. Pharmacol. 44, 1083-1105 (2004).
4. Gibson N, Jawaid A, March R: Novel technology and the development of pharmacogenetics within the pharmaceutical industry. Pharmacogenomics 6, 339-356 (2005).
5. Marzolini C, Tirona RG, Kim RB: Pharmacogenomics of the OATP and OAT families. Pharmacogenomics 5, 273-282 (2004).
6. Lee E, Ryan S, Birmingham B et al.: Rosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environment. Clin. Pharm. Ther. 78, 330-341 (2005).
7. Mahgoub A, Idle JR, Dring LG, Lancaster R, Smith RL: Polymorphic hydroxylation of debrisoquine in man. Lancet 2, 584-586 (1977).
8. Zineh I, Gerhard T, Aquilante CL et al: Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs. Pharmacogenomics J. 4, 354-358 (2004).
9. Lesko LJ, Woodcock J: Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nature Rev. Drug Discov. 3, 763-769 (2004).
10. Innocenti F, Undevia SD, Iyer L et al.: Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J. Clin. Oncol. 22, 1382-1388 (2004).
11. Huang SM, Goodsaid F, Rahman A, Frueh F, Lesko L: Application of pharmacogenomics in clinical pharmacology. Toxicol. Mech. Methods 16, 89-99 (2006).
12. Harries M, Smith I: The development and clinical use of trastuzumab (Herceptin). Endocr. Relat. Cancer 9, 75-85 (2002).
13. US FDA and CMS in talks on coverage for pharmacogenomics tests. CLINICA World Medical Device and Diagnostic News. December 07, 2005.
14. Johnson D: Gefitinib (Iressa) trials in non-small cell lung cancer. Lung Cancer 41 (Suppl. 1), S23-S28 (2003).
15. Lynch TJ, Bell DW, Sordella R et al.: Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small cell lung cancer to gefitinib. N. Engl. J. Med. 350, 2129-2139 (2004).
16. Paez JG, Janne PA, Lee JC et al.: EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304, 1497-1500 (2004).
17. Eberhard DA, Johnson BE, Amler LC et al.: Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J. Clin. Oncol. 23, 5900-5909 (2005).
18. Bell DW, Lynch TJ, Haserlat SM et al: Epidermal growth factor receptor mutations and gene amplification in non-small cell lung cancer: molecular analysis of the IDEAL/INTACT gefitinib trials. J. Clin. Oncol. 23, 8081-8092 (2005).
19. Speake G, Holloway B, Costello G: Recent developments related to the EGFR as a target for cancer chemotherapy. Curr Opin. Pharmacol. 5, 343-349 (2005).
20. Cappuzzo F, Hirsch FR, Rossi E et al: Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small cell lung cancer. J. Natl. Cancer Inst. 97, 643-655 (2005).
21. Hirsch FR, Varella-Garcia M, Bunn PA et al.: Molecular analysis of EGFR gene copy number, EGFR expression and Akt activation status in advanced non-small cell lung cancer (aNSCLC) treated with gefitinib or placebo (ISEL trial). AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications, Philadelphia, USA, Abstract A268 (2005).
22. Holloway B, Thatcher N. Chang A et al.: Epidermal growth factor (EGFR), K-Ras and B-Raf mutation status and clinical outcome to gefitinib (IRESSA) in a Phase III placebo-controlled study (ISEL) in advanced non-small cell lung cancer (aNSCLC). AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications, Philadelphia, USA, Abstract A269 (2005).
23. Lazarou J, Pomeranz BH, Corey PN: Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 279, 1200-1205 (1998).
24. Pirmohamed M, James S, Meakin S et al.: Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ 329, 15-19 (2004).
25. Mallal S, Nolan D, Witt C et al.: Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse transcriptase inhibitor abacavir. Lancet 359, 727-732 (2002).
26. Hetherington S, Hughes AR, Mosteller M et al.: Genetic variations in HLA-B region and hypersensitivity reactions to abacavir. Lancet 359, 1121-1122 (2002).
27. Hughes DA, Javier V, Ward CC et al.: Cost-effectiveness analysis of HLA B*5701 genotyping in preventing abacavir hypersensitivity. Pharmacogenetics 14, 335-342 (2004)
28. Bridgland-Taylor MH, Hargreaves AC, Easter A et al.: Optimization and validation of a medium-throughput electrophysiology-based hERG assay using Ion Workstrade mark HT. J. Pharmacol. Toxicol. Methods. [Epub ahead of print] (2006).
29. Royal Society: Personalised medicines: hopes and realities. Royal Society, London, UK (2005).
30. Thomas DC, Clayton DG: Betting odds and genetic associations. J. Natl. Cancer Inst. 96, 421-423 (2004).
31. Lohmueller KE, Pearce CL, Pike M, Lander ES, Hirschhorn JN: Meta-analysis of genetic association studies supports a contribution of common variants to susceptibility to common disease. Nature Genet. 33, 177-182 (2003).
32. McCarthy A, Kerr M, Abadie E et al.: Report on the joint EFPIA, DIA and EMEA pharmacogenetics workshop: moving toward clinical application. Pharmacogenomics 5, 731-739 (2004).
33. Thomas SM: Society and ethics - the genetics of disease. Curr. Opin. Genet. Dev. 14, 287-291 (2004).
34. March R, Cheeseman K, Doherty M: Pharmacogenetics - legal, ethical and regulatory considerations. Pharmacogenomics 2, 317-327 (2001).
35. Knudsen LE: Global gene mining and the pharmaceutical industry. Toxicol. Appl. Pharmacol. 207, 679-683 (2005).
36. Anderson DC, Gomez-Mancilla B, Spear BB et al.: Elements of informed consent for pharmacogenetic research; perspective of the pharmacogenetics working group. Pharmacogenomics J. 2, 284-292 (2002).
37. Renegar G, Webster CJ, Stuerzebecher S et al.: Returning genetic research results to individuals: points-to-consider. Bioethics 20, 24-36 (2006).