Biomarker Assay Translation from Discovery to Clinical Studies in Cancer Drug Development: Quantification of Emerging Protein Biomarkers

Advances in Cancer Research

Volumn 96, Issue , 2006, Pages 269-298

  Lee, Jean W ^a   Figeys, Daniel ^b   Vasilescu, Julian ^b  

^a AMGEN INC   (United States)

^b UNIVERSITY OF OTTAWA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; PROTEIN; PROTEIN TYROSINE KINASE INHIBITOR; TRASTUZUMAB;

CALIBRATOR; CANCER DIAGNOSIS; CANCER SURVIVAL; CANCER THERAPY; CLINICAL RESEARCH; COMMERCIAL PHENOMENA; COMPUTER PROGRAM; DATA ANALYSIS; DISEASE COURSE; DOSE RESPONSE; DOWN REGULATION; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG MECHANISM; DRUG METABOLISM; DRUG RESEARCH; DRUG SAFETY; ELECTROCARDIOGRAPHY; ENZYME LINKED IMMUNOSORBENT ASSAY; EXPERIMENTAL ANIMAL; GENE EXPRESSION; GENE EXPRESSION PROFILING; GENE MUTATION; GENOMICS; HUMAN; IMMUNOHISTOCHEMISTRY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MATRIX ASSISTED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; NONHUMAN; PHARMACODYNAMICS; POSITRON EMISSION TOMOGRAPHY; PREDICTION; PRIORITY JOURNAL; PROTEIN ANALYSIS; PROTEOMICS; QUALITATIVE ANALYSIS; QUALITY CONTROL; QUANTITATIVE ANALYSIS; RELIABILITY; REVIEW; STANDARD; STATISTICAL ANALYSIS; SURFACE ENHANCED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; THREE DIMENSIONAL IMAGING; UPREGULATION; VALIDATION PROCESS;

ANIMALS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS; DRUG DESIGN; GENOMICS; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; NEOPLASMS; PROTEOMICS; TUMOR MARKERS, BIOLOGICAL;

EID: 33845205234     PISSN: 0065230X     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S0065-230X(06)96010-2     Document Type: Review

References (40)

1. Antal P., Fannes G., Timmerman D., Moreau Y., and De Moor B. Using literature and data to learn Bayesian networks as clinical models of ovarian tumors. Artif. Intell. Med. 30 (2004) 257-281
2. Barker P.E. Cancer biomarker validation: Standards and process: Roles for the National Institute of Standards and Technology (NIST). Ann. NY Acad. Sci. 983 (2003) 142-150
3. Basuyau J.P., Blanc-Vincent M.P., Bidart J.M., Daver A., Deneux L., Eche N., Gory-Delabaere G., Pichon M.F., and Riedinger J.M. Summary report of the standards, options and recommendations for the use of serum tumour markers in breast cancer: 2000. Br. J. Cancer 89 Suppl. 1 (2003) S32-S34
4. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69 (2001) 89-95
5. Bjornsson T.D. Biomarkers applications in drug development. Eur. Pharm. Rev. 1 (2005) 17-21
6. Booth B., Glassman R., and Ma P. From the Analyst's couch. Oncology's trials. Nat. Rev. 2 (2003) 609-610
7. Carney W.P., Neumann R., Lipton A., Leitzel K., Ali S., and Price C.P. Potential clinical utility of serum HER-2/neu oncoprotein concentrations in patients with breast cancer. Clin. Chem. 49 (2003) 1579-1598
8. Crawford E.D. Use of algorithms as determinants for individual patient decision making: National comprehensive cancer network versus artificial neural networks. Urology 62 (2003) 13-19
9. DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., and Celniker A. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20 (2003) 1885-1900
10. DiMasi J.A., Hansen R.W., and Grabowski H.G. The price of innovation: New estimates of drug development costs. J. Health Econ. 22 (2003) 151-185
11. Dubey P., Su H., Adonai N., Du S., Rosato A., Braun J., Gambhir S.S., and Witte O.N. Quantitative imaging of the T cell antitumor response by positron-emission tomography. Proc. Natl. Acad. Sci. USA 100 (2003) 1232-1237
12. FDA. Guidance for industry. Bioanalytical method validation: Availability. Fed. Regist. 66 (2001) 28526-28527
13. FDA Document. Innovation or stagnation: Challenge and opportunity on the critical path (2004). http://www.fda.gov/oc/initiatives/criticalpath/
14. FDA. Guidance for industry. Pharmacogenomic data submissions (2005)
15. Futreal P.A., Coin L., Marshall M., Down T., Hubbard T., Wooster R., Rahman N., and Stratton M.R. A census of human cancer genes. Nat. Rev. Cancer 4 (2004) 177-183
16. Hammond M.E., Barker P., Taube S., and Gutman S. Standard reference material for Her2 testing: Report of a National Institute of Standards and Technology-sponsored Consensus Workshop. Appl. Immunohistochem. Mol. Morphol. 11 (2003) 103-106
17. Hunt S.M., Thomas M.R., Sebastian L.T., Pedersen S.K., Harcourt R.L., Sloane A.J., and Wilkins M.R. Optimal replication and the importance of experimental design for gel-based quantitative proteomics. J. Proteome Res. 4 (2005) 809-819
18. Lambert J.P., Ethier M., Smith J.C., and Figeys D. Proteomics: From gel based to gel free. Anal. Chem. 15 (2005) 3771-3787
19. Lee J.W., Smith W.C., Nordblom G.D., and Bowsher R.R. Validation of assays for the bioanalysis of novel biomarkers. In: Bloom J.C., and Dean R.A. (Eds). "Biomarkers in Clinical Drug Development" (2003), Marcel Dekker, New York 119-149
20. Lee J.W., Weiner R.S., Sailstad J.M., Bowsher R.R., Knuth D.W., O'Brien P.J., Fourcroy J.L., Dixit R., Pandite L., Pietrusko R.G., Soares H.D., Quarmby V., et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development. Pharm. Res. 22 (2005) 499-511
21. Lee J.W., Devanarayan V., Barrett Y.C., Allinson J., Fountain S., Keller S., Weinryb I., Green M., Duan L., Rogers J.A., Millham R., O'Brien R., et al. Fit-for-Purpose method development and validation for successful biomarker measurement. Pharm. Res. 23 (2006) 312-328
22. Leong F.J., and Leong A.S. Digital photography in anatomical pathology. J. Postgrad. Med. 50 (2004) 62-69
23. Lesko L.J., and Woodcock J. Translation of pharmacogenomics and pharmacogenetics: A regulatory perspective. Nat. Rev. Drug Discov. 3 (2004) 763-769
24. Liggett W.S., Barker P.E., Semmes O.J., and Cazares L.H. Measurement reproducibility in the early stages of biomarker development. Dis. Markers 20 (2004) 295-307
25. Listgarten J., and Emili A. Statistical and computational methods for comparative proteomic profiling using liquid chromatography-tandem mass spectrometry. Mol. Cell. Proteomics 4 (2005) 419-434
26. MacGregor J.T. Biomarkers of cancer risk and therapeutic benefit: New technologies, new opportunities, and some challenges. Toxicol. Pathol. 32 Suppl. 1 (2004) 99-105
27. Mire-Sluis A.R., Barrett Y.C., Devanarayan V., Koren E., Liu H., Maia M., Parish T., Scott G., Shankar G., Shores E., Swanson S.J., Taniguchi G., et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289 (2004) 1-16
28. National Committee for Clinical Laboratory Standards. Document EP5-A: Evaluation of Precision Performance of Clinical Chemistry Devices: Approved Guideline. (1999)
29. Paradis V., Degos F., Dargere D., Pham N., Belghiti J., Degott C., Janeau J.L., Bezeaud A., Delforge D., Cubizolles M., Laurendeau I., and Bedossa P. Identification of a new marker of hepatocellular carcinoma by serum protein profiling of patients with chronic liver diseases. Hepatology 41 (2005) 40-47
30. Rafferty B., Rigsby P., Rose M., Stamey T., and Gaines Das R. Reference reagents for prostate-specific antigen (PSA): Establishment of the first international standards for free PSA and PSA (90:10). Clin. Chem. 46 (2000) 1310-1317
31. Ray C.A., Bowsher R.R., Smith W.C., Devanarayan V., Willey M.B., Brandt J.T., and Dean R.A. Development, validation, and implementation of a multiplex immunoassay for the simultaneous determination of five cytokines in human serum. J. Pharm. Biomed. Anal. 36 (2005) 1037-1044
32. Reichert J.M. Trends in development and approval times for new therapeutics in the United States. Nat. Rev. Drug Discov. 2 (2003) 695-702
33. Reyzer M.L., Caldwell R.L., Dugger T.C., Forbes J.T., Ritter C.A., Guix M., Arteaga C.L., and Caprioli R.M. Early changes in protein expression detected by mass spectrometry predict tumor response to molecular therapeutics. Cancer Res. 64 (2004) 9093-9100
34. Srivastava S., and Gopal-Srivastava R. Biomarkers in cancer screening: A public health perspective. J. Nutr. 132 (2002) 2471S-2475S
35. Sweep F.C., Fritsche H.A., Gion M., Klee G.G., and Schmitt M. Considerations on development, validation, application, and quality control of immuno(metric) biomarker assays in clinical cancer research: An EORTC-NCI working group report. Int. J. Oncol. 23 (2003) 1715-1726
36. Wagner J.A. Overview of biomarkers and surrogate endpoints in drug development. Dis. Markers 18 (2002) 41-46
37. Washburn M.P., Wolters D., and Yates J.R.r. Large-scale analysis of the yeast proteome by multidimensional protein identification technology. Nat. Biotechnol. 19 (2001) 242-247
38. Weinstein J.N. Integromic analysis of the NCI-60 cancer cell lines. Breast Dis. 19 (2004) 11-22
39. Westgard J.O., and Klee G.G. Quality management. In: Burtis C. (Ed). "Fundamentals of Clinical Chemistry" (1996), WB Saunders, Philadelphia 211-223
40. Westgard J.O., Barry P.L., Hunt M.R., and Grove T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin. Chem. 27 (1981) 493-501