Responsible business plan: Animal research
We are committed to embracing, promoting and embedding scientific and technical best practice in animal research.
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.
>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.
One new 3Rs initiative adopted as global best practice.
At least one peer reviewed 3Rs publication each year.
85% of non- human primate studies placed with external providers conducted to AstraZeneca’s required standards of care and housing.
All committed annual improvement plans in place.
1 global 3Rs award made.
> 10 peer reviewed 3Rs publications.
1 x 3Rs initiative adopted as global best practice.
6 x global virtual 3Rs conferences held.
Standard operating procedures (SOP) and guidance documents underpinning the Global Good Statistical Practice (GSP) Standard developed and launched.
60% of studies at R&D sites which have a GSP SOP were assessed and were found to be compliant; 40% were not assessed.
In 2012, we used approximately 304,000 animals in-house (381,000 in 2011). In addition, approximately 14,000 animals were used by external contract research organisations on our behalf (17,000 in 2011). Around 86% of the animals used in 2012 were rodents, 13% were fish and the remaining 1% included ferrets, dogs, rabbits, primates, chickens, pigs, and sheep. We also used genetically modified mice and rats to understand better the genes involved in human disease. In 2012, these accounted for approximately 10% of our total rodent use.
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.
Our Global Improvement Plan has provided 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 drove continuous improvement at both a regional and site level in North America, Sweden, UK, India and China (where the improvement plan introduced in 2011 continued to evolve during 2012). The Global improvement framework, which will continue to focus on the 3Rs, has been revised for 2013 to include the scientific justification for use of animals in the research of innovative medicines.
During 2012, we developed, launched and began implementation of standard operating procedures and guidance documents to underpin our new Global Good Statistical Practice Standard, developed in 2011. These SOPs and guidance apply to our internal animal research and the launch included extensive training programmes for relevant scientists, technical staff and managers across the organisation. Also during 2012 we began measurement of compliance with the Standards. 60% of studies at R&D sites which have a GSP SOP were assessed and were found to be compliant; 40% were not assessed. This will provide the baseline for driving and monitoring progress going forward. SOPs and guidance documents for external work will be developed in 2013.
Also in the year, the responsibilities of our previous Science Policy & Practice Council were transferred to our Research and Development leaders who have accountability for our R&D functions. The leaders make any top level decisions around our R&D policies and bioethical principles, and are advised in this respect by our recently formed Bioethics Advisory Group (BAG). BAG is made up of AstraZeneca subject matter experts from all the areas covered in our Bioethics Policy, alongside our Chief Medical Officer, Vice Presidents from Regulatory, Compliance and Science Policy, and a senior legal counsel. BAG will also consult external bioethics experts on new and emerging issues, as required. The combined accountabilities of senior leaders and BAG further strengthen the leadership and direction on R&D ethical policies and practice.
Consistent standards internally/externally
85% of our externally placed non-human primate studies are meeting AstraZeneca standards (2012 target: 80%). 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 2012 one global award was made to a team in our small molecules part of the business. Four entries were highly commended, two in our small molecules business, one in our biologics part of thebusiness and one from our UK environmental unit. Find out more
Peer review publications in 2012
Capilliary Microsampling of 25 µ blood for the determination of toxicokinetic parameters in regulatory studies in animals. Bioanalysis (2012) 4(6), 661-674
A new technique, capilliary microsampling (CMS), has been developed by AstraZeneca for the determination of drug /metabolites in plasma using only a few µ of blood. The small sample volumes allow toxicology endpoints and drug exposure to be measured in the same animals.
In line with this publication AstraZeneca hosted a one day external meeting on microsampling which was also reported in Bioanalysis (2012), 4(23), 2775-2779
Refinement of the Charcoal Meal Study by Reduction of the Fasting Period. ATLA 40, 99-107, 2012
A reduction in the fasting time in rats and mice for charcoal meal studies is a refinement leading to less aggressive behavior in mice, thus allowing group housing. It requires no additional expenditure on equipment or time and no additional training of technicians.
Effects of the anti-androgen, bicalutamide, in a reduced life-cycle study with the fathead minnow (Pimephales promelas) Aquat Toxicol 114-115: 31-38
This paper describes a significant modification to a regulatory study , which provided robust data for the environmental risk assessment and was accepted by the regulators. It used 50% fewer fish in 35% less time.
Does structural enrichment for toxicology studies improve zebrafish welfare? Applied Animal Behaviour Science 139(1): 143-150
This paper examined the enrichment requirements of zebrafish and showed that anthropomorphic desire to include items in the fish tank does not necessarily improve welfare measures.
Go back to...
We are committed to the responsible use of animals and the welfare of the animals we use is a top priority.Read more
Our top priority is to make sure that that those taking part in our studies are not exposed to any unnecessary risks.Read more