Are we approaching the post-blockbuster era? Pharmacodiagnostics and rational drug development

Expert Review of Molecular Diagnostics

Volumn 8, Issue 6, 2008, Pages 689-695

  Jørgensen, Jan Trøst ^a  

^a Research and Development   (Denmark)

Author keywords

Blockbuster medicine; Companion diagnostics; Molecular diagnostics; Oncology; Personalized medicine; Pharmacodiagnostics; Rational drug development; Stratified medicine

Indexed keywords

EPIRUBICIN; MARAVIROC; TRASTUZUMAB;

BREAST CANCER; CLINICAL TRIAL; DIAGNOSTIC PROCEDURE; DRUG INDUSTRY; DRUG MECHANISM; HEALTH PROGRAM; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; PHARMACODYNAMICS; REVIEW;

COMBINATORIAL CHEMISTRY TECHNIQUES; DRUG DESIGN; HUMANS; MODELS, BIOLOGICAL; PHARMACOLOGY, CLINICAL; TIME FACTORS;

EID: 56049120143     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.8.6.689     Document Type: Review

References (30)

1. Langreth R, Waldholz M. New era of personalized medicine. Oncologist 4, 426-427 (1999). • First instance of the concept of 'personalized medicine'.
2. Jørgensen JT. From blockbuster medicine to personalized medicine. Personalized Medicine 5(1), 55-63 (2008).
3. Morgan LR, Schein PS, Woolley PV et al. Therapeutic use of tamoxifen in advanced breast cancer: correlation with biochemical parameters. Cancer Treat. Rep. 60, 1437-1443 (2008).
4. Pegram MD, Pauletti G, Slamon DJ. HER-2/neu as a predictive marker of response to breast cancer therapy. Breast Cancer Res. Treat. 52, 65-77 (1998).
5. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med. 344, 783-792 (2001).
6. Jacobs TW, Gown AM, Yaziji H, Barnes MJ, Schnitt SJ. Specificity of HercepTest in determining HER-2/neu status of breast cancers using the United States Food and Drug Administration-approved scoring system. J. Clin. Oncol. 17, 1983-1987 (1999).
7. Fadel H, Temesgen Z. Maraviroc. Drugs Today 43, 749-758 (2007).
8. Whitcomb JM, Huang W, Frasen S et al. Development and characterization of a novel single-cycle recombinant-virus assay to determine human immunodeficiency virus type 1 coreceptor tropism. Antimicrob. Agents Chemother. 51, 5666-5575 (2007).
9. Jørgensen JT, Nielsen KV, Ejlertsen B. Pharmacodiagnostics and targeted therapies - a rational approach for individualizing medical anti-cancer therapy in breast cancer. Oncologist 12, 397-405 (2007).
10. Nielsen KV, Ejlertsen B, Møller S et al. The value of TOP2A gene copy number variation as a biomarker in breast cancer: update of DBCG trial 89D. Acta Oncol. 47, 725-734 (2008).
11. Spear BB, Heath-Chiozzi M, Huff J. Clinical application of pharmacogenetics. Trends Mol. Med. 7, 201-204 (2001).
12. Frye RF. Probing the world of cytochrome p450 enzymes. Mol. Interv. 4, 157-162 (2005).
13. Wolf AC, Hammond ME, Schwartz JN et al. American Society of Clinical Oncology/ College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J. Clin. Oncol. 25,118-145 (2007).
14. Hu SX, Foster T, Kieffaber A. Pharmacogenomics and personalized medicine: mapping of future value creation. BioTechniques 39, 1-6 (2005).
15. Trusheim MR, Berndt ER, Douglas FL. Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers. Nat. Rev. Drug Discov. 6, 287-293 (2007). • Discussion of the concept of stratified medicine in relation to the drug development process.
16. Osler W. The Principles and Practice of Medicine, 1st Edition. D Appleton and Company, NY, USA (1892).
17. Woodcock J. The prospects for 'personalized medicine' in drug development and drug therapy. Clin.Pharmacol. Ther. 81, 164-169 (2007). •• Perspective with respect to personalized medicine and drug development.
18. Ferrara J. Personalized medicine: challenging pharmaceutical and diagnostic company business models. Mcgill J. Med. 10, 59-61 (2007).
19. Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin. Cancer Res. 10, 6759-6763 (2004). • Sample size calculations using the predictive value of human epidermal growth factor receptor 2 in breast cancer.
20. Lee W, Lockhart AC, Kim RB, Rothenberg ML. Cancer pharmacogenomics: powerful tools in cancer chemotherapy and drug development. Oncologist 10, 104-111 (2007).
21. Freidlin B, Simon R. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clin. Cancer Res. 11, 7872-7878 (2005).
22. Garrison LP, Austin MJF. Linking pharmacogenetic-based diagnostics and pharmaceuticals for personalized medicine: scientific and economic challenges. Health Affairs 25, 1281-1290 (2006).
23. Medical News Today. Four studies affirm significance of monogram's Trofile™ HIV Co-Receptor Tropism Assay. www.medicalnewstoday.com/articles/ 63005.php Accessed March 2008.
24. New device approval. Dako TOP2A FISH pharmDx™ Kit - P050045. March 28, 2008. www.fda.gov/cdrh/mda/docs/P050045.html Accessed July 2008.
25. US FDA drug-diagnostic codevelopment concept paper. (Draft.) April 2005. www.fda.gov/cder/genomics/pharmacoconceptfn.pdf Accessed April 2008. • Description of the parallel drug-diagnostic codevelopment model.
26. The CYP450 Gene Family & Drug Metabolism. Roche Diagnostics. www.roche.com/final_cyp_gene_family.pdf Accessed July 2008.
27. Personalized Medicine Coalition (PMC). www.personalizedmedicinecoalition. org/index.php Accessed August 2008.
28. Innovation or stagnation: challenges and opportunity on the critical path to new medical products. FDA, March 2004) www.fda.gov/oc/initiatives/ criticalpath/whitepaper.html Accessed April 2008.
29. Little S. Personalized Medicine - what's in it for big pharma? Drug Discovery World. www.ddw-online.com/data/pdfs/2005personalised%20medicine.pdf Accessed May 2008.
30. Targeted therapies to conquer cancer market by 2015. Pharmaceutical Executive Europe, October 1, 2006. www.pharmexeceurope.com/europharmexec/issue/ issueDetail.jsp?id=10446 Accessed May 2008.