Our performance
Responsible business plan: Animal research
Objectives
Continued engagement with external partners on the implementation of AstraZeneca global standards for non-human primate housing and care.
Ensure that regional annual improvement plans continue to be developed in line with global improvement plans for managing our ethical approach to animal research which informs regional plans.
Formalise a plan for strengthening current governance framework for assuring Good Statistical Practice (GSP) in animal research.
Targets
>60% of external providers of AstraZeneca non-human primate research studies are operating to AstraZeneca standards; 2013 target: 100%)
AstraZeneca China to have an annual improvement plan.
All committed annual improvement plans are in place.
An AstraZeneca Good Statistical Practice (GSP) global standard, underpinning the Bioethics Policy is developed, reviewed and adopted.
The AstraZeneca global 3Rs award is open and (a) winner(s) announced.
3Rs virtual conference held to share best practice.
One new 3Rs initiative adopted as global best practice.
% of non- human primate studies placed with external providers during 2011 conducted to AstraZeneca’s required standards of care and housing.
% compliance with GSP standard for internal and externally placed AstraZeneca animal work.
A global 3Rs virtual conference each year to communicate the winning entry(s).
At least one peer reviewed 3Rs publication each year.
Achieved
59% of non- human primate studies placed with external providers during 2011 conducted to AstraZeneca’s required standards of care and housing.
Annual improvement plan in place in China.
All committed annual improvement plans in place.
2 global 3Rs awards made.
3 peer reviewed 3Rs publications.
1 3Rs initiative adopted as global best practice
More work needed
GSP standard developed and approved, but not rolled out in 2011. Roll-out planned for 2012. This meant that we could not measure compliance in 2011 in line with our stated KPI. Compliance monitoring will accompany roll-out in 2012.
Global 3Rs virtual conference deferred to early 2012.
Objectives
Continued engagement with external partners on the implementation of AstraZeneca global standards for non-human primate housing and care.
Ensure that regional annual improvement plans continue to be developed in line with global improvement plans for managing our ethical approach to animal research which informs regional plans.
Identify opportunities through dialogue with external partners worldwide for continuous improvement activities both within and outside AstraZeneca.
Targets
>80% of external providers of AstraZeneca non-human primate research studies are operating to AstraZeneca standards, including AstraZeneca -SIMM preclinical safety alliance. 2013 target: 100% of all suppliers operating to our standards.
All committed internal improvement plans in place.
Roll-out of AstraZeneca Good Statistical Practice (GSP) global standard and associated compliance monitoring.
Standard operating procedures or guidance underpinning the GSP standard introduced throughout R&D.
The AstraZeneca global 3Rs award is open and (a) winner(s) announced.
3Rs virtual conference held to share best practice.
One new 3Rs initiative adopted as global best practice.
% of non- human primate studies placed with external providers conducted to AstraZeneca’s required standards of care and housing.
% compliance with GSP standard for internal and externally placed AstraZeneca animal work. 2012 % will provide baseline for future reporting.
One new 3Rs initiative adopted as global best practice.
At least one peer reviewed 3Rs publication each year.
In 2011, AstraZeneca used approximately 381,000 animals in-house (408,000 in 2010). In addition, approximately 17,000 animals were used by external contract research organisations on our behalf (21,000 in 2010). Around 76% of the animals used in 2011 were rodents, 22% were fish and the remaining 2% included chickens, dogs, rabbits, ferrets, primates, pigs, goats and sheep. We also used genetically modified mice to understand better the genes involved in human disease. In 2011, these accounted for approximately 16% of our total rodent use (internally and externally). Our use of zebra fish at our UK based environmental unit increased by 9% in 2011 as we continue to progress use of animals of a lower species.
The number of animals we use will continue to vary because it depends on a number of factors including the amount of pre-clinical research we are doing, the complexity of the diseases under investigation and the regulatory requirements.
Improvement plans
Our Global Improvement Plan provides a common framework for our business regions to use to develop individual improvement plans that are specific to their geographies and research activity. These Regional Improvement Plans drive continuous improvement at both a regional and site level in North America, Sweden, UK and India. An improvement plan for China was introduced during 2011 and will continue to evolve during 2012.
Our Global Improvement framework focuses on the key areas of: the 3Rs, the appropriateness and use of existing and new animal models; the use of statistical input into the design, analysis and interpretation of studies; global standards of care and use, and governance and management. The framework requires the development of regional objectives and measures that address these areas. At a global and regional level, progress must be demonstrated against the objectives and all plans are reviewed annually and updated where necessary.
Strengthening governance
We developed and adopted a global standard for Good Statistical Practice (GSP) during 2011, with a planned roll-out in 2012. The standard will ensure that statisticians are involved in the planning and conduct of animal research to deliver high quality experimental study design and data analysis. Compliance monitoring will accompany roll-out in 2012.
Consistent standards internally/externally
59% of our externally placed non-human primate studies are meeting AstraZeneca standards (narrowly missing our 2011 target of 60%). These standards are based on principles now embedded into EU law. We will continue to progress towards our 2013 target of 100% of our studies being conducted in facilities meeting AstraZeneca required standards.
Recognising and sharing best practice
Our global 3Rs award is one of a range of scientific innovation awards that are given to employees demonstrating best practice in the research and development of new medicines. In 2011 two global awards were made - one to a team in our biologics part of the business and one to a team in the small molecules Safety Assessment function. Read more.
Peer review publications in 2011
Opportunities to minimise animal use in pharmaceutical regulatory general toxicology: A cross company review published in Regulatory Toxicology and Pharmacology 61 (2): 222-229
Toxicity studies in animals are carried out to identify the intrinsic hazard of a substance to support risk assessment for humans. In order to identify opportunities to minimise animal use in regulatory toxicity studies for small molecule pharmaceuticals, a working group was set up by the National Centre for the Reduction, Refinement and Replacement of Animals in Research and the Laboratory Animal Science Association (NC3Rs/LASA) comprising toxicologists that carry out these studies in the UK. Data on study design were collected and analysed and this information demonstrated some variation in the number of animals used in general toxicity and carcinogenicity studies. Based on this analysis, recommendations have been made on how small changes to current practice could further reduce the number of animal that are used in regulatory toxicity studies in the future.
The design of chronic toxicology studies of monoclonal antibodies: Implications for the reduction in use of non-human primates
The UK’s National Centre for the Replacement, Reduction and Refinement of Animals in Research (NC3Rs) has been working with the pharmaceutical and biotechnology industry, independent research and contract research organisations and regulators on the use of non-human primates (NHPs) in the development of monoclonal antibodies (mAbs) and has established an international expert working group with representatives from these sector. The group has shared anonymised data in order to identify stages of the development process offering opportunities for the reduction in use of NHPs. Data from the participating organisations shown in this paper indicates variation in practice in sub-chronic and chronic toxicology studies using NHPs. This includes variations in the number of such studies conducted, study duration, group sizes, number of dose groups, and numbers of animals used in recovery. This information has been used to develop practical guidance and make recommendations on the use of science-based rationale to design studies using fewer animals taking into account the current regulatory guidance. used in short and long term chronic toxicology studies.
BioMedical Engineering OnLine an integrative pharmacological approach to radio telemetry and blood sampling in pharmaceutical drug discovery and safety assessment
A publication in Biomedical Engineering on line describes a system for integration of automated blood sampling and telemetry that enables simultaneous collection of physiological parameters such as heart rate with blood and urine samples for determination of drug concentrations and other biochemical measures in the same rat. The system offers unique advantages over traditional between group study designs that include improved data quality (e.g. multiple physiological and biochemical responses from the same animal) and significantly reduced animal use.
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Animal research
We are committed to the responsible use of animals and the welfare of the animals we use is a top priority.
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