Animal studies provide essential information, not available through other methods, about the effects of a potential new therapy on disease and the living body. Regulatory authorities around the world also require safety data from pre-clinical testing in animals before a new medicine can be tested in humans (clinical trials).
We are committed to applying the principles of the 3Rs (replacement, reduction and refinement of animal studies) across our research activity. Wherever possible, we use non-animal methods such as cell culture, computer modelling and high-throughput screening that eliminate the need to use animals early in drug development, or reduce the number needed. We also work to refine our existing methods, so that animals are exposed to as little discomfort and stress as possible.
In 2007, we used approximately 271,000 animals in-house, a decrease on 2006 (276,000 animals). In addition, approximately 13,500 animals were used by external contractors, an increase on 2006 (12,000). Approximately 95% of the animals we used in 2007 were rodents, 4% were fish and amphibians and the remaining 1% included dogs, rabbits, primates, pigs and ferrets. . We also use genetically modified mice and rats to better understand the genes involved in human disease. In 2007, these accounted for 13% of our total rodent use.
The number of animals involved in our scientific studies reflects the size of the pre-clinical portfolio and the complexity of the diseases under investigation. As we continue to expand our discovery research our ongoing challenge is to ensure that our animal use is minimised without compromising the quality of the data. The growth of our early development portfolio during 2007 reflects the effort we are putting into improving the quality and productivity of our research, and we believe that, without our active commitment to the 3Rs, our animal use in discovery research would be much greater. AstraZeneca’s acquisition of MedImmune in June 2007 accelerated our strategic aim of building a major presence in biopharmaceuticals – medicines derived from biological molecules, for example antibodies. Our entry into this new area of science builds on our long-established skills in small molecule research and drug development, and strengthens our potential to develop the next generation of medicines that offer better results for patients.
In biopharmaceutical research, primates are in most cases the only relevant animal model. In anticipation of our increased use of primates, therefore, during 2006/7 we developed a specific global standard for their use and care. Based on the principles of the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, our new standard applies globally to drive consistent practice across our primate research.
Following the acquisition, we are working closely with MedImmune, to make sure that our two companies’ standards are aligned. Given the scope and complexity of the task, this will take time and therefore in 2007, MedImmune’s performance details are not included in the scope of this report.
The welfare of all the animals that we use continues to be a top priority. Compliance with all relevant external legislation and regulatory requirements is considered a minimum baseline and underpins our own global standards of animal welfare. Qualified veterinary staff are involved in the development and implementation of our animal welfare programmes, and everyone working with laboratory animals is trained and competent in their allocated responsibilities. As well as mandatory inspections by government authorities, we have a formal programme of internal inspections every two years by our own, highly qualified staff. External organisations that conduct animal studies on AstraZeneca’s behalf are also expected to comply with high ethical standards, and members of our staff conduct a programme of inspections of contractors to ensure our expectations are being met.
During 2007, we set up a cross-functional, cross-territorial task force to review the way in which we manage our animal research worldwide. Our research and development organisation has been undergoing significant change in recent years and we wanted to ensure that our global commitment to leading innovation continues to be underpinned by a consistent approach to the associated animal studies.
We have indicators in place to support our drive for continuous improvement in the 3Rs and animal welfare worldwide. Each of our animal research sites is required to have a Site Improvement Plan in place, updated annually, and each site must demonstrate their overall progress against the objectives in their Plan each year. These objectives vary from site to site and can include improved animal housing conditions, less stressful or less invasive research techniques, and improved research study design leading to reduced animal use. All of our sites demonstrated positive progress against their Improvement Plans during 2007. 100% of scheduled internal peer review inspections and 91% of the planned inspections of external contractors were completed. During 2007, the review done by the task force described above led to the decision to develop a Global Improvement Plan and to begin its roll-out in 2008 to promote a consistent approach across all our research sites.
Examples of our commitment to the replacement, reduction and refinement (the 3Rs) of animal use | > In 2007, we completed our investment of over £40 million in facilities for housing and care of dogs in the UK and Sweden. These investments are in line with the most recent scientific consensus on how best to refine dog husbandry in a laboratory setting. They will provide state-of-the-art kennels, stimulating environments and outdoor playgrounds in which the dogs will be able to socialise with each other and with the staff who care for them.
> We increasingly use non-invasive imaging techniques such as ultrasound and MRI (which are also used for human diagnosis) to study the effects of new medicines on the progress of disease in living animals. Our scientists have been instrumental in developing an innovative ultrasound method that enables them to "look inside" a mouse's arteries and follow the effects of potential medicines on the development of atherosclerosis in 'real-time', in the same animal, over its whole life. This method helps to improve the scientific accuracy of the studies, and reduces the number of animals needed to obtain the required data.
> Databases that capture information on the properties of existing medicines and other similar compounds can help scientists to predict, at an early stage, how new compounds are likely to behave in the human body. This enables earlier, more informed choices about which compounds to take forward for further development – which in turn helps to avoid any unnecessary animal testing on compounds likely to fail. We use a range of such databases, and in 2007 increased predictive power by rolling out across all sites the most comprehensive pharmacological profiling database currently available – BioPrint®, licensed from Cerep. |
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