Amgen's Mission & Ethical Use of Animals in Research

Amgen's mission is to serve patients. The safety of the patients that we serve and who take our medicines is of fundamental importance to us. At this time, the use of animals in biomedical research and in the development of novel medicines is indispensable, both for regulatory and scientific reasons. Specifically, we, like all biopharmaceutical companies, are required by the regulations to evaluate the safety and efficacy of new medicines in animals before introducing them into humans for clinical trials. Critical decisions regarding the use of animals in research are made by cross-functional teams of scientific and veterinary experts who balance scientific knowledge and regulatory requirements with considerations of ethical and social values. When we need to use animals in our research programs, we are committed to acting ethically, responsibly, and providing for their health and well-being. 

Commitment to the Ethical Use of Animals in Research

Amgen's Commitment

As an innovative leader in the discovery and development of human therapeutics, we aim to improve the quality of human life through our mission to serve patients. Animal research continues to play a vital role in the search for novel and improved medicines to treat human diseases. We recognize that animal research is a subject of ethical concern for the public and we take our responsibility extremely seriously. We also recognize that laboratory animal research has proven to be indispensable to the identification, development, and manufacturing of innovative therapeutics to treat and prevent diseases in humans. We are committed to the ethical and responsible treatment of all animals used in the discovery and development of medicines to fight serious illnesses in humans such as cancer, kidney disease, neurologic disorders and inflammatory diseases.  Amgen specifically commits to the principles of Reduction, Refinement and Replacement in the use of animals in research, as well as to the elimination of use of chimpanzees.

Animal Welfare

Animal research is a very sensitive topic and involves ethical issues which should be reviewed and discussed openly on an ongoing basis.  Part of our ethical responsiblity in accomplishing our mission is our commitment to conducting animal research in compliance with international, national, regional and local laws and regulations.   Additionally, we aim to meet or exceed standards of industry-specific accrediting bodies. 

The welfare of all the animals we use in research is a top priority and an equally important part of our ethical responsibility.  High quality veterinary care is provided by our staff of board-certified laboratory animal veterinarians who have specific training, education and expertise in the management and care of research animals.

All employees who work with animals are mandated to participate in training programs and have their competency assessed before being allowed to use animals. Additionally, these employees must undergo continuing mandatory training and ongoing assessments of their competency in order to continue working with animals.

Animal Research Oversight

Amgen conducts numerous non-animal experiments to make critical decisions about advancing drugs in the pipeline before conducting research in animals.  Research animal studies are only used to answer critical strategic scientific questions or to fulfill regulatory requirements.  We try to employ multiple strategies to provide extensive internal monitoring and oversight throughout every animal study.  The welfare of every animal we work with in research is a top priority and an ethical responsibility we take very seriously. 

3Rs

The drive to reduce, refine or replace animals has been a major focus of the biomedical research community for the last sixty years. As a key element of Corporate Social Responsibility, we are committed to the ethical use of animals in research by adhering to principles known as the 3Rs: Reduction, Refinement and Replacement. Each year, new technology and developments are made that bring us closer to our goal of finding better, more accurate predictors of safety and efficacy while reducing our use of animals.  To promote the use of 3Rs and communicate their importance to Amgen, an internal 3Rs Award Program was established in 2011, recognizing outstanding examples of fulfilling the commitment to these principles.

Our employees follow the guiding principles of the 3Rs when decisions are made that require the use of animals in research projects.

  • Reduction – use the absolute minimum number of research animals as necessary in studies to attain quality science and obtain valid results.
  • Refinement - whenever possible, eliminate or minimize impact to animals by reducing potentially painful or invasive procedures by implementing state-of-the-art practices to promote animal welfare.
  • Replacement – always look for alternative, non-animal-based research methods where possible by using non-animal systems (for example, cell cultures, computer modeling, bacterial assays, simulation models, etc.).
  • We have voluntarily made the decision to not conduct research in chimpanzees as part of the development of our medicines. Advanced research methodologies allow us to use alternative methods that replace the need to use chimpanzees. It is possible that from time to time, we will acquire technology or molecules that have been developed using research in chimpanzees. In these cases, we strive to take steps to rapidly transition research into alternative models. 

External Business Partners

We hold our External Business Partners (ie, contract research organizations, academic institutions and animal vendors) to equally high quality standards of care and use. Additionally, we strive to hold these partners accountable for the same regulations, standards and guidelines that govern our internal animal care and use programs. When working with third parties, we perform a range of animal welfare audits or due diligence activities to ensure that their training and competency assessment processes meet our standards. Whenever possible, we use facilities accredited by the AAALAC, International. AAALAC, International accreditation serves as an independent quality mark, validating that the standards of the Guide for the Care and Use of Laboratory Animals are being met.

Animal research protocols conducted by External Business Partners must be reviewed and approved by the External Studies Ethical Review Committee and animal studies may not begin with External Business Partners until they have been assessed and evaluated. All agreements with External Business Partners include terms and conditions regarding our expectations for animal care and use as well as regulatory compliance. External Business Partners who do not maintain compliance with the regulations and our internal policies, standards and guidelines are subject to contract termination.

Public Outreach and Education

We collaborate and partner closely with organizations and working groups that educate the public about the use of animals in research such as California Biomedical Research Association, National Association for Biomedical Research and The Foundation for Biomedical Research. In addition to providing funding for these organizations, we also provide funding for Chimp Haven. Chimp Haven is a nonprofit organization that was established as the National Chimpanzee Sanctuary. This species-specific facility was designed to provide a home for chimpanzees that are retired from biomedical research, the pet trade and the entertainment industry. The funding that we provide to this institution supports the care and well-being of nearly 200 chimpanzees that are retired at Chimp Haven.

Accrediting Bodies

Our programs and facilities are subject to unannounced regulatory reviews and inspection by the federal government.  Our corporate standard for animal welfare is compliance with laws and regulations for animal research; specifically compliance with the guidelines of the Guide for the Care and Use of Laboratory Animals ("The Guide"). Additionally, our US programs are accredited by the AAALAC, International and our Canadian programs are accredited by the Canadian Council on Animal Care (CCAC). AAALAC, International and CCAC accreditations are voluntary, peer review assessments and evaluations by private nonprofit organizations that promote the humane treatment of animals in science. AAALAC, International and CCAC accreditation are considered by many the "gold standard" for the care and use of laboratory animals in biomedical research.

3Rs Award Program

In alignment with our commitment to advance the 3Rs, we established an internal 3Rs Award to reward and recognize our employees' progress in this arena. This program was launched in 2011 to support the 3Rs philosophy and is presented annually to the individual or team of scientists that develop new techniques to support one or more of the 3Rs principles. Awards have been given for refinements to a rodent model of bone biology, replacing the use of an animal assay with a non-animal assay for inflammatory diseases, and refinement and reductions in the number of animals used to understand pharmacokinetics and drug metabolism.

A specific example of how we applied the 3Rs was recognized with the 3Rs Award in 2012.  Our dried blood spot (DBS) micro-sampling technique collects and analyses very small volumes (a droplet) of blood or plasma from rodents in pharmacokinetic and drug metabolism studies. DBS makes blood collection less stressful for rodents and translates into refinement and reduction, because less blood is taken from fewer animals to achieve the same scientifically valid results as standard blood collection.

In another example of refinement, we developed and implemented an industry-leading imaging sciences department that utilizes innovative imaging modalities (MRI, CT, PET and Optical) to allow our scientists to view cancers and other diseases in animals in a non-invasive manner while monitoring the long-term effectiveness of new treatments.

Multiple Strategies

We have developed policies, standards and guidelines governing appropriate animal research practices to assure broad, company-wide compliance with all policies and standards for the ethical use of animals in research.  These documents are regularly reviewed to assure they remain current with or exceed the best practices in the industry.

We have a committee of laboratory animal veterinarians, scientists with animal research experience, nonscientists and independent external representative(s) from the local community that are responsible for the oversight of the animal care and use program.  The Institutional Animal Care and Use Committee is charged with discussing, approving and monitoring all Amgen animal research activities.  They accomplish this by reviewing all proposed animal studies, inspecting all internal animal facilities and investigating, if necessary, any animal welfare concern brought forward by employees or the public.  The Committee regularly communicates with and periodically provides status reports to the Institutional Official regarding animal welfare compliance.

Training Programs

Our Code of Conduct requires that our employees and those that conduct animal research on our behalf comply with our Global Laboratory Animal Care and Use Policy. This policy describes our commitment beyond regulatory and accrediting agency compliance and defines the ethical standards, principles and guidelines governing all our animal research and development activities globally. Our Global Laboratory Animal Care and Use Policy mandates that all research involving animals within our corporation or on its behalf be carried out responsibly and humanely, that the principles of the 3Rs (replacement, refinement and reduction) be applied, and that in vivo studies are only conducted when alternative methods are not available to accomplish research goals or regulatory requirements.

High Quality Veterinary Care

Veterinary professionals consult and assist our scientists on animal-related research activities. All our laboratory animals are monitored for signs of health and well-being by trained and qualified laboratory animal science professionals who are certified by the American Association for Laboratory Animal Science or the Canadian Association for Laboratory Animal Science. Employees involved in our laboratory animal organization are required to keep their training and competency up to date and must continually work on developing and refining their skills in working with animals.