Goh J.-Y.,Association of the British Pharmaceutical Industry ABPI |
Weaver R.J.,Institute Of Recherches Internationales Servier Iris |
Dixon L.,Association of the British Pharmaceutical Industry ABPI |
Platt N.J.,Association of the British Pharmaceutical Industry ABPI |
Toxicology Research | Year: 2015
We examined the use of in vitro (including in silico) techniques in preclinical safety testing by the pharmaceutical industry between 1980 and 2013 to determine patterns, drivers and challenges in uptake. Data were collected via a survey sent to the Association of the British Pharmaceutical Industry (ABPI) member companies from the Nonclinical and Biological Discovery Expert Network (NaBDEN) requesting the number of compounds screened using in vitro and in silico tests at 5-year intervals between 1980 and 2005 then yearly from 2008 onwards. A utility score from 1 (poor) to 5 (excellent) for each assay was also requested. Four pharmaceutical companies and 3 contract research organisations (CROs) responded to the survey, providing >895000 data points across all years and all assays. Overall, there was a steady increase in the use of in vitro tests by the pharmaceutical industry between 1980 and 2013; indeed >20% of all in vitro tests reported were conducted in the last year of the survey window (2013) and >70% of all in vitro tests reported were conducted since 2010. Use of in vitro tests peaked at >190000 tests per annum in 2012; >99% of this usage was in the three main areas reported of ADME, safety pharmacology and genotoxicity. Trends and step changes in uptake were most notable in the three main areas of ADME, safety pharmacology and genotoxicity and may be explained by the timing of adoption of the relevant International Committee on Harmonisation (ICH) guidelines. Trends in uptake may also be explained by perceptions of utility where scores varied from poor (Eye Irritation - flourescein leakage) to excellent (Genotoxicity - Ames and Skin irritation - EpiSkin/Epiderm). In summary, the data show a large increase and a continuing upwards trend in development and adoption of in vitro alternatives to animal testing in pharmaceutical drug development providing new opportunities to improve success rates coupled with a strong commitment to the 3Rs. © The Royal Society of Chemistry 2015.
Cunningham S.,Association of the British Pharmaceutical Industry ABPI |
Partridge N.,Association of the British Pharmaceutical Industry ABPI |
Platt N.,Association of the British Pharmaceutical Industry ABPI |
Toxicology Research | Year: 2015
This project explored the impact of the pharmaceutical industry's contribution to published papers relevant to the 3Rs (reduction, refinement and replacement of the use of animals in research) nearly half a century after the publication of the Principles of Humane Experimental Technique (Russell and Birch 1959). Specifically, the PubMed database was used to search for all papers with an explicit 3Rs objective that were published during the years 2002, 2007 and 2012. Overall, 433 papers with a 3Rs objective were identified in the 3 time periods analysed; there was little change in the total number of published papers in the first two time periods tested (2002, 2007) but this was followed by a substantial (55%) rise in the latter time period (2012). Within this total of 433 papers, the number of published 3Rs papers with industry involvement increased from 20 (2002) through 30 (2007) to 39 (2012). Additionally, the proportion of 3Rs papers involving academia and industry collaboration increased from 40% in 2002 to 61.5% in 2012; the number of multiple affiliation papers also rose during the time period. Other notable trends were the increase in contract research organisation (CRO) involvement in 3Rs research and a slight increase (10%) in the latter time period in those papers describing and presenting original data rather than review/discussion papers. In summary, the reduction, refinement and replacement of animal testing in pharmaceutical drug development depends upon continued and increased collaboration; the data reported herein clearly demonstrate an increased contribution by the pharmaceutical industry to the 3Rs objective along with increasing collaborative efforts between industry and academic institutions. This journal is © The Royal Society of Chemistry 2015.