OPINION Assessing the translatability of drug projects: what needs to be scored to predict success?

被引：83

作者：

Wehling, Martin ^{[1
]}

机构：

[1] Heidelberg Univ, Univ Med Mannheim, Dept Clin Pharmacol Mannheim, D-68169 Mannheim, Germany

来源：

NATURE REVIEWS DRUG DISCOVERY | 2009年 / 8卷 / 07期

基金：

美国国家卫生研究院;

关键词：

GASTROESOPHAGEAL-REFLUX DISEASE; PHARMACEUTICAL-INDUSTRY; TRANSLATIONAL MEDICINE; SCIENCE;

D O I：

10.1038/nrd2898

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Drug development projects have high attrition rates, often because efficacy and safety issues have not been foreseen. More effective prediction of 'translational success' could therefore have a key role in addressing the widely acknowledged problems with weak drug development pipelines. Here, I discuss how a scoring system to systematically assess key determinants of translational success, such as biomarkers and animal and human data, could help identify deficiencies and potential improvements, and increase the reliability of portfolio risk estimates.

引用

页码：541 / 546

页数：6

共 27 条

[1]

*BIOM CONS, 2009, BET CELL FUNCT S

[2] Qualification of biomarkers for drug development in organ transplantation [J].

Burckart, Gilbert J. ;

Amur, Shashi ;

Goodsaid, Federico M. ;

Lesko, Lawrence J. ;

Frueh, Felix W. ;

Huang, Shiew-Mei ;

Cavaille-Coll, Marc W. .

AMERICAN JOURNAL OF TRANSPLANTATION, 2008, 8 (02) :267-270

[3]

Coron E, 2007, CURR OPIN GASTROEN, V23, P434

[4] Translational science: past, present, and future [J].

Curry, Stephen H. .

BIOTECHNIQUES, 2008, 44 (02) :II-VIII

[5]

*EUR ADV TRANSL RE, 2008, MED TRANSL BAS RES D

[6]

*EUR MED AG, 2008, MED EM SCI

[7] Recommendations for standards regarding preclinical neuroprotective and restorative drug development [J].

Feinklestein, SP ;

Fisher, M ;

Furland, AJ ;

Goldstein, LB ;

Gorelick, PB ;

Kaste, M ;

Lees, KR ;

Traystman, RJ ;

Albers, GW ;

Anwer, UE ;

Ashwood, T ;

Barone, FC ;

Basta, SL ;

Bogousslavsky, J ;

Buchan, AM ;

Cady, WJ ;

Chan, PH ;

Clemens, JA ;

Cox, BF ;

Craddock, RE ;

Cramer, SC ;

del Zoppo, GJ ;

Dielrich, WD ;

Elliott, P ;

Faden, AI ;

Feuerstein, GZ ;

Ginsberg, MD ;

Gold, M ;

Greene, WL ;

Hall, ED ;

Hsu, CY ;

Hunter, AJ ;

Lai, M ;

Lesko, LM ;

Levy, DE ;

Li, FH ;

Locke, KW ;

Lodge, D ;

Lowe, D ;

Marcoux, FW ;

McCulloch, J ;

McDermott, J ;

Meibach, R ;

Messersmith, EK ;

Moseley, M ;

Moskowitz, MA ;

Mueller, AL ;

Munro, F ;

Nudo, RJ ;

Oeda, J .

STROKE, 1999, 30 (12) :2752-2758

[8]

Food and Drug Administration, 2004, CHALL OPP CRIT PATH

[9]

Food and Drug Administration, 2006, CRIT PATH OPP REP

[10] A variant of the gene encoding leukotriene A4 hydrolase confers ethnicity-specific risk of myocardial infarction [J].

Helgadottir, A ;

Manolescu, A ;

Helgason, A ;

Thorleifsson, G ;

Thorsteinsdottir, U ;

Gudbjartsson, DF ;

Gretarsdottir, S ;

Magnusson, KP ;

Gudmundsson, G ;

Hicks, A ;

Jonsson, T ;

Grant, SFA ;

Sainz, J ;

O'Brien, SJ ;

Sveinbjornsdottir, S ;

Valdimarsson, EM ;

Matthiasson, SE ;

Levey, AI ;

Abramson, JL ;

Reilly, MP ;

Vaccarino, V ;

Wolfe, ML ;

Gudnason, V ;

Quyyumi, AA ;

Topol, EJ ;

Rader, DJ ;

Thorgeirsson, G ;

Gulcher, JR ;

Hakonarson, H ;

Kong, A ;

Stefansson, K .

NATURE GENETICS, 2006, 38 (01) :68-74

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