Translational research in the pharmaceutical industry: from bench to bedside

Drug Discovery Today

Volumn 11, Issue 17-18, 2006, Pages 833-838

  O'Connell, Damian ^a   Roblin, David ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; MONOCLONAL ANTIBODY; TRASTUZUMAB;

ALZHEIMER DISEASE; ATTENTION DEFICIT DISORDER; BREAST CANCER; CANCER PATIENT; DRUG DESIGN; DRUG INDUSTRY; DRUG RESEARCH; DRUG SAFETY; DRUG TARGETING; FOOD AND DRUG ADMINISTRATION; FUNCTIONAL MAGNETIC RESONANCE IMAGING; FUNCTIONAL PROTEOMICS; GENE MAPPING; GENOMICS; HUMAN; HYSTERESIS; MANAGED CARE ORGANIZATION; MAXIMUM TOLERATED DOSE; MEDICAL DECISION MAKING; PROGNOSIS; REVIEW; SIGNAL NOISE RATIO; SIGNAL TRANSDUCTION; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; STRUCTURAL PROTEOMICS; TRANSCRIPTOMICS; VALIDATION STUDY;

ANIMALS; BIOLOGICAL MARKERS; DRUG DESIGN; DRUG INDUSTRY; HUMANS; MEDICINE; RESEARCH;

EID: 33747804614     PISSN: 13596446     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drudis.2006.07.009     Document Type: Review

References (36)

1. Kola I., and Landis J. Can the pharmaceutical industry reduce attrition rates?. Nat. Rev. Drug Discov. 3 (2004) 711-715
2. Food and Drug Administration (2004) Innovation or stagnation? Challenge and opportunity of the critical path to new medical products. Revised version. (http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html)
3. Benjamin G.A., and Lumley C.E. Industry success rates 2003 (2003), CMR International
4. DiMasi J.A. Risks in new drug development: approval success rates for investigational drugs. Clin. Pharmacol. Ther. 69 (2001) 297-307
5. DiMasi J., et al. The price of innovation: new estimates of drug development costs. J. Health Econ. 22 (2003) 151-185
6. Tufts Center for the Study of Drug Development Backgrounder 2001: How New Drugs Move Through the Development and Approval Process (http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=4)
7. Gilbert J., et al. Rebuilding Big Pharma's Business Model, In Vivo, the Business & Medicine Report. Windhover Information 21 (2003)
8. Gobburu J.V.S., and Marroum P.J. Utilization of pharmacokinetic-pharmacodynamic modeling and simulation in regulatory decision-making. Clin. Pharmacokinet. 40 (2001) 883-892
9. Lesko L.J., et al. Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans. J. Clin. Pharmacol. 40 (2000) 803-814
10. Reigner B.G., et al. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffmann La Roche. Clin. Pharmacokinet. 33 (1997) 142-152
11. Littman B.H., and Williams S.A. The ultimate model organism: progress in experimental medicine. Nat. Rev. Drug Discov. 4 (2005) 631-638
12. Hall J.E. The promise of translational physiology. Am. J. Physiol. 283 (2002) L235-L236
13. Danhof M., et al. Mechanism-based pharmacokinetic-pharmacodynamic modeling-a new classification of biomarkers. Pharm. Res. 22 (2005) 1432-1437
14. Greaves P., et al. First dose of potential new medicines to humans: how animals help. Nat. Rev. Drug Discov. 3 (2004) 226-236
15. Smith M.K., et al. Implementation of a Bayesian adaptive design in a proof of concept study Pharmaceut. Statist. 5 (2006) 39-50
16. Lehmann F., et al. Integration of Translational Research in the European Organization for Research and Treatment of Cancer Research (EORTC) Clinical Trial Cooperative Group Mechanisms. J. Transl. Med. (2003) 1:2
17. Ferber G. Biomarkers and proof of concept. Methods Find. Exp. Clin. Pharmacol. 24 Suppl. C (2002) 35-40
18. Frank R., and Hargreaves R. Clinical biomarkers in drug discovery and development. Nat. Rev. Drug Discov. 2 (2003) 566-580
19. Lipton H.L., and Duke K.S. Experiences with pharmacy benefit management programmes in the U. S. A. In: Dukes M.N.G., et al. (Ed). Drugs and Money - Prices, affordability and cost containment (2003), IOS Press 111-118
20. Gund P., et al. Editorial overview: whither the pharmaceutical industry?. Curr. Opin. Drug Discov. Devel. 8 (2005) 296-297
21. Vogel R.J. Pharmaceutical pricing, price controls, and their effects on pharmaceutical sales and research and development expenditures in the European Union. Clin. Ther. 26 (2004) 1327-1340
22. Almarsdottir A.B., and Traulsen J.M. Cost-containment as part of pharmaceutical policy. Pharm. World Sci. 27 (2005) 144-148
23. Alabaster V., and the in vivo Pharmacology Training Group. The fall and rise of in vivo pharmacology. Trends Pharmacol. Sci. 23 (2002) 13-18
24. Mankoff S.P., et al. Lost in translation: obstacles to translational medicine. J. Transl. Med. 2 (2004) 14
25. Crowley Jr. W.F. Translation of basic research into useful treatments: how often does it occur?. Am. J. Med. 114 (2003) 503-505
26. Lesko L.J., and Woodcock J. Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nat. Rev. Drug Discov. 3 (2004) 763-769
27. Johnson K., et al. Pharmacogenomics: integration into drug discovery and development. Curr. Top. Med. Chem. 5 (2005) 1039-1046
28. De Laurentiis M., et al. Targeting HER2 as a therapeutic strategy for breast cancer: a paradigmatic shift of drug development in oncology. Ann. Oncol. 16 (2005) 7-13
29. Byrd J.C., et al. Select high-risk genetic features predict earlier progression following chemoimmunotherapy with fludarabine and rituximab in chronic lymphocytic leukemia: justification for risk-adapted therapy. J. Clin. Oncol. 24 (2006) 437-443
30. Banks R., and Selby P. Clinical proteomics-insights into pathologies and benefits for patients. Lancet 362 (2003) 415-416
31. Musante C.J., et al. Small- and large-scale biosimulation applied to drug discovery and development. Drug Disc. Today 7 Suppl. (2002) S192-S196
32. Lee J.W., et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23 (2006) 312-328
33. Ilyin S.E., et al. Biomarker discovery and validation: technologies and integrative approaches. Trends Biotechnol. 22 (2004) 411-416
34. Colburn W.A. Biomarkers in drug discovery and development: from target identification through drug marketing. J. Clin. Pharmacol. 43 (2003) 329-341
35. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69 (2001) 89-95
36. Rolan P. The contribution of clinical pharmacology surrogates and models to drug development-a critical appraisal. Br. J. Clin. Pharmacol. 44 (1997) 219-225