A challenging drug development process in the era of personalized medicine

Drug Discovery Today

Volumn 16, Issue 19-20, 2011, Pages 891-897

  Jørgensen, Jan Trøst ^a  

^a Dx Rx Institute   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ANASTROZOLE; BRCA1 PROTEIN; BRCA2 PROTEIN; CETUXIMAB; CRIZOTINIB; DOXORUBICIN; EPIDERMAL GROWTH FACTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; ERLOTINIB; ESTROGEN RECEPTOR; EXEMESTANE; GEFITINIB; IMATINIB; INFLIXIMAB; LAPATINIB; LETROZOLE; OLAPARIB; PANITUMUMAB; TAMOXIFEN; TAMOXIFEN CITRATE; TRASTUZUMAB; VEMURAFENIB;

BREAST CANCER; CENTRAL NERVOUS SYSTEM; CENTRAL NERVOUS SYSTEM DISEASE; COLORECTAL CANCER; DEPRESSION; DRUG DEVELOPMENT; DRUG INDUSTRY; GASTROINTESTINAL STROMAL TUMOR; HUMAN; LUNG NON SMALL CELL CANCER; MELANOMA; NON INSULIN DEPENDENT DIABETES MELLITUS; PERSONALIZED MEDICINE; REVIEW; SCHIZOPHRENIA; STOMACH CANCER;

BIOLOGICAL MARKERS; DISEASE; DRUG DISCOVERY; HUMANS; INDIVIDUALIZED MEDICINE; MODELS, BIOLOGICAL; MOLECULAR DIAGNOSTIC TECHNIQUES; PHARMACEUTICAL PREPARATIONS; SYSTEMS BIOLOGY;

EID: 80053942714     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2011.09.010     Document Type: Review

References (39)

1. R. Langreth, and M. Waldholz New era of personalized medicine - targeting drugs for each unique genetic profile Oncologist 4 1999 426 427 (Pubitemid 29508743)
2. J.T. Jørgensen New era of personalized medicine: a 10-years anniversary Oncologist 14 2009 557 558
3. Cleveland Clinic Medical Innovation Summit (2009) October 5-7, 2009, http://www.clevelandclinic.org/innovations/summit2010/summit09/news.html Accessed January 2011
4. Lundbeck A.S. (2010) Lundbeck launches new research and development strategy, September 22, 2010, http://www.lundbeck.com/investor/releases/ ReleaseDetails/Release-1445988-EN.asp Accessed January 2011
5. A. le Grand Intervention research in rational use of drugs: a review Health Policy Plan 14 1999 89 102 (Pubitemid 29280990)
6. T.O. Nielsen Immunohistochemical and clinical characterization of the basal-like subtype of invasive breast carcinoma Clin. Cancer Res. 10 2004 5367 5374 (Pubitemid 39100473)
7. T. Sørlie Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications Proc. Natl. Acad. Sci. U.S.A. 98 2001 10869 10874 (Pubitemid 32878711)
8. J.T. Jørgensen Pharmacodiagnostics and targeted therapies - a rational approach for individualizing medical anti-cancer therapy in breast cancer Oncologist 12 2007 397 405 (Pubitemid 46698717)
9. C.A. Hudis Trastuzumab - mechanism of action and use in clinical practice N. Engl. J. Med. 357 2007 39 51 (Pubitemid 47026733)
10. V. Roy, and E.A. Perez Beyond trastuzumab: small molecule tyrosine kinase inhibitors in HER-2 positive breast cancer Oncologist 14 2009 1061 1069
11. H.J. Burstein Neratinib, an irreversible ErbB receptor tyrosine kinase inhibitor, in patients with advanced ErbB2-positive breast cancer J. Clin. Oncol. 28 2010 1301 1307
12. S.T. Lee-Hoeflich A central role for HER3 in HER2-amplified breast cancer: implications for targeted therapy Cancer Res. 68 2008 5878 5887
13. J.T. Jørgensen Are we approaching the post blockbuster era? - Pharmacodiagnostics and rational drug development Expect. Rev. Mol. Diagn. 8 2008 689 695
14. K.L. Cheung The estrogen and progesterone receptors - setting the scene for pharmacodiagnostics J.T. Jørgensen, H. Winther, Molecular Diagnostics - The Key Driver of Personalized Cancer Medicine 2010 Pan Stanford Publishing 21 42
15. H.J. Lerner Phase II study of tamoxifen: report of 74 patients with stage IV breast cancer Cancer Treat. Rep. 60 1976 1431 1435 (Pubitemid 8055855)
16. J.T. Jørgensen, and H. Winther The development of the HercepTest - from bench to bedside J.T. Jørgensen, H. Winther, Molecular Diagnostics - The Key Driver of Personalized Cancer Medicine 2010 Pan Stanford Publishing 43 60
17. A. Tutt Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial Lancet 376 2010 235 244
18. J. Balmaña BRCA in breast cancer: ESMO clinical recommendations Ann. Oncol. 20 Suppl. 4 2009 19 20
19. C.K. Anders, and L.A. Carey Biology, metastatic patterns, and treatment of patients with triple-negative breast cancer Clin. Breast Cancer 9 Suppl. 2 2009 73 81
20. Maraviroc (Selzentry) Full Prescribing Information. Revised November 2009: http://www.accessdata.fda.gov/drugsatfda-docs/label/2009/022128s002lbl.pdf
21. D.D. O'Rielly, and P. Rahman Pharmacogenetics of rheumatoid arthritis: potential targets from susceptibility genes and present therapies Pharmacogenomics Pers. Med. 3 2010 15 31
22. C.L. Verweij Anti-TNF therapy in RA - towards personalized medicine? Nat. Rev. Rheumatol. 7 2011 136 138
23. Innovative Medicines Initiative (2010) Call for proposals. Version-04, October 2010, http://www.fp7.org.tr/tubitak-content-files//266/IMI/Call3- TopicsText-Final.pdf Accessed March 2011
24. M.I. McCarthy Genomics, type 2 diabetes, and obesity N. Engl. J. Med. 363 2010 2339 2350
25. Board Institute Diabetes Genetics Initiative. http://www.broadinstitute. org/scientific-community/science/projects/diabetes-genetics-initiative/ diabetes-genetics-initiative Accessed March 2011
26. B.B. Spear Clinical application of pharmacogenetics Trends Mol. Med. 7 2001 201 204 (Pubitemid 32822891)
27. NEWMEDS. http://www.newmeds-europe.com/en/news.php Accessed March 2011
28. J. Lehar High-order combination effects and biological robustness Mol. Sys. Biol. 215 2008 1 6
29. H. Kitano Systems biology: a brief overview Science 295 2002 1662 1664 (Pubitemid 34202893)
30. L. Hood Systems biology: integrating technology, biology and computation Mech. Ageing Dev. 124 2003 9 16 (Pubitemid 36262894)
31. Microsoft Research. http://research.microsoft.com/en-us/groups/biology/ Accessed March 2011
32. The Microsoft Research - University of Trento Centre for Computational and Systems Biology. http://www.cosbi.eu/ Accessed March 2011
33. The Lancet Where will new drugs come from? Lancet 377 2011 97
34. A. Mullard 2010 FDA drug approvals Nat. Rev. Drug Discov. 10 2011 82 85
35. R.L. Schilsky Commentary: tackling the challenges of developing targeted therapies for cancer Oncologist 15 2010 484 487
36. AstraZeneca Newsroom: AstraZeneca and Dako sign agreement to develop companion diagnostics for cancer treatments. http://astrazeneca-usa.com/about- astrazeneca-us/newsroom/all/8146364?itemId=8146364 Accessed April 2011
37. H. Winther, and J.T. Jørgensen Drug-diagnostic co-development in cancer Pharm. Med. 24 2010 363 375
38. M.R. Trusheim Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers Nat. Rev. Drug Discov. 6 2007 287 293 (Pubitemid 46505879)
39. J. Woodcock Assessing the clinical utility of diagnostics used in drug therapy Clin. Pharmacol. Ther. 88 2010 765 773