Translation of biomarkers into clinical utility

Methods in Pharmacology and Toxicology

Volumn , Issue , 2008, Pages 239-251

  Trepicchio, William L ^a   Mulligan, George ^b  

^a MILLENNIUM PHARMACEUTICALS INC   (United States)

^b NONE

Author keywords

biomarkers; clinical trials; pharmacodynamics; pharmacogenomics; translational research

Indexed keywords

ABACAVIR; BIOLOGICAL MARKER; CYTOCHROME P450 2D6; EPIDERMAL GROWTH FACTOR RECEPTOR; GEFITINIB; IMATINIB; TRASTUZUMAB;

BREAST CANCER; CANCER RESEARCH; CHRONIC MYELOID LEUKEMIA; CLASSIFICATION ALGORITHM; CLINICAL STUDY; DISEASE MARKER; DRUG DESIGN; DRUG MECHANISM; DRUG RESEARCH; DRUG RESPONSE; DRUG SAFETY; DRUG SCREENING; DRUG SENSITIVITY; GENE MUTATION; GENETIC VARIABILITY; HUMAN; HYPERSENSITIVITY REACTION; NONHUMAN; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; PATIENT ASSESSMENT; PATIENT CODING; PHARMACODYNAMICS; PHARMACOGENOMICS; PRIORITY JOURNAL; REVIEW; TOXICITY TESTING;

EID: 77949471381     PISSN: 15572153     EISSN: 19406053     Source Type: Book Series    
DOI: 10.1007/978-1-59745-439-1_12     Document Type: Review

References (22)

1. Biomarkers Definitions Working Group (2001) Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmac Ther 69: 89-95.
2. Wagner JA, Williams SA, Webster CJ (2007) Biomarkers and surrogate end points for fit-forpurpose development and regulatory evaluation of new drugs. Clin Pharmacol Ther 81:104-7.
3. Trepicchio WL, Essayan D, Hall ST, Schechter G, Tezak Z, Wang SJ, Weinreich D, Simon R (2006) Designing prospective clinical pharmacogenomic (PG) trials: meeting report on drug development strategies to enhance therapeutic decision making. Pharmacogenomics J 6:89-94.
4. Trepicchio WL, Williams GA, Essayan D, Hall ST, Harty LC, Shaw PM, Spear BB, Wang SJ, Watson ML (2004) Pharmacogenomic data submissions to the FDA: clinical case studies. Pharmacogenomics 5:519-24.
5. Kwon, Y (2001) Handbook of essential pharmacokinetics, pharmacodynamics, and drug metabolism for industrial scientists. New York, Kluwer Academic/Plenum
6. Sarker D, Workman P (2007) Pharmacodynamic biomarkers for molecular cancer therapeutics. Adv Cancer Res 96:213-68.
7. Sarac F, Pehlivan M, Celebi G, Saygili F, Yilmaz C, Kabalak T (2006) Effects of sibutramine on thermogenesis in obese patients assessed via immersion calorimetry. Adv Ther 23:1016-29.
8. Mendrick DL (2007) Current trends and strategic directions in the use of pharmacogenomics to identify translational biomarkers. Curr Opin Drug Discov Devel 10:37-42.
9. Hardiman G (2006) Microarrays technologies 2006: an overview. Pharmacogenomics 7:1153-8.
10. Tao F, Lazarev A (2007) Clinical proteomics: opportunities for diagnostics, pharmaceuticals and the clinical laboratory. Expert Rev Proteomic 4:9-11.
11. Giacomini KM, Brett CM, Altman RB, Benowitz NL, Dolan ME, Flockhart DA, Johnson JA, Hayes DF, Klein T, Krauss RM, Kroetz DL, McLeod HL, Nguyen AT, Ratain MJ, Relling MV, Reus V, Roden DM, Schaefer CA, Shuldiner AR, Skaar T, Tantisira K, Tyndale RF, Wang L, Weinshilboum RM, Weiss ST, Zineh I (2007) The pharmacogenetics research network: from SNP discovery to clinical drug response. Clin Pharmacol Ther 81:328-45.
12. Bartlett JM (2005) Pharmacodiagnostic testing in breast cancer: focus on HER2 and trastuzumab therapy. Am J Pharmacogenomic 5:303-15.
13. Sequist LV, Bell DW, Lynch TJ, Haber DA (2007) Molecular predictors of response to epidermal growth factor receptor antagonists in non-small-cell lung cancer. J Clin Oncol 25(5):587-95.
14. Kalow W, Werner DM (1995) In: Scriver CR, Beaudet AL, Sly WS, Valle D (eds) Pharmacogenetics in the metabolic basis of inherited disease, 7th ed. New York, McGraw-Hill, pp 293-326.
15. Kirchheiner J, Seeringer A (2007) Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes. Biochim Biophys Acta 1770(3):489-94.
16. Lazarou J, Pomeranz BH, Corey PN (1998) Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 279(15):1200-1205.
17. Burczynski ME, Oestreicher JL, Cahilly MJ, Mounts DP, Whitley MZ, Speicher LA, Trepicchio WL (2005) Clinical pharmacogenomics and transcriptional profiling in early phase oncology clinical trials. Curr Mol Med 5(1):83-102.
18. Druker BJ (2002) Perspectives on the development of a molecularly targeted agent. Cancer Cell 1:31-6.
19. Vogel CL, Cobleigh MA, Tripathy D, Gutheil JC, Harris LN, Fehrenbacher L, Slamon DJ, Murphy M, Novotny WF, Burchmore M, Shak S, Stewart SJ (2001) First-line Herceptin monotherapy in metastatic breast cancer. Oncology 61(Suppl 2):37-42.
20. Bild AH, Potti A, Nevins JR (2006) Linking oncogenic pathways with therapeutic opportunities. Nat Rev Cancer 6:735-41.
21. Lamb J (2007) The connectivity map: a new tool for biomedical research. Nat Rev Cancer 7:54-60.
22. Martin A, Nolan D, Almeida CA, Rauch A, Mallal S (2006) Predicting and diagnosing abacavir and nevirapine drug hypersensitivity: from bedside to bench and back again. Pharmacogenomics 7:15-23.