eprintid: 20112
rev_number: 11
eprint_status: archive
userid: 1589
dir: disk0/00/02/01/12
datestamp: 2016-02-17 10:39:23
lastmod: 2024-03-24 18:43:39
status_changed: 2016-02-17 10:39:23
type: article
metadata_visibility: show
creators_name: Wendler, Alexandra
creators_name: Wehling, Martin
title: Translatability scoring in drug development: eight case studies
subjects: ddc-610
divisions: i-61900
abstract: Translational medicine describes the transfer of basic in vitro and in vivo data into human applications. In the light of low rates of market approvals for new medical entities, better strategies to predict the risk of drug development should be used to increase output and reduce costs. Recently, a scoring system to assess the translatability of early drug projects has been proposed. Here eight drugs from different therapeutic areas have been subjected to a retrospective test-run in this system fictively located at the phase II-III transition. The scores gained here underline the importance of biomarker quality which is pivotal to decrease the risk of the project in all cases. This is particularly evident for gefitinib. The EGFR mutation status is a breakthrough biomarker to predict therapeutic success which made this compound clinically acceptable, and this is plausibly reflected by a considerable increase of the translatability score. For psychiatric and Alzheimer's drugs, and for a CETP-inhibitor, the lack of suitable biomarkers and animal models is reflected by a low translatability score, well correlating with the excessive translational risk in these areas. These case studies document the apparent utility of the scoring system, at least under retrospective conditions, as the scores correlate with the outcomes at the level of market approval. Prospective validation is still missing, but these case studies are encouraging.
date: 2012
publisher: BioMed Central
id_scheme: DOI
ppn_swb: 165716022X
own_urn: urn:nbn:de:bsz:16-heidok-201126
language: eng
bibsort: WENDLERALETRANSLATAB2012
full_text_status: public
publication: Journal of Translational Medicine
volume: 10
number: 39
place_of_pub: London
pagerange: 1-11
issn: 1479-5876
citation:   Wendler, Alexandra ; Wehling, Martin  (2012) Translatability scoring in drug development: eight case studies.  Journal of Translational Medicine, 10 (39).  pp. 1-11.  ISSN 1479-5876     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/20112/1/12967_2011_Article_1021.pdf