Commitment to the Ethical Use of Animals in Research | Amgen

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

Executive Summary

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering and developing innovative human therapeutics. As part of that mission, Amgen is ethically and legally obliged to rigorously evaluate the efficacy, safety and quality of potential new medicines. While many of these evaluations can be accomplished by techniques that do not require the use of animals, given the present state of scientific knowledge, testing innovative new medicines in animals is frequently critical to their evaluation and is required by regulatory authorities worldwide. Amgen's Policy on the Ethical Use of Animals in Research requires that any research involving animals is conducted only after rigorous ethical review thus ensuring that we provide the highest level of care possible to all animals used and that a scientifically appropriate and validated alternative to the use of animals is not available. Similarly, for any third-party organization we engage to conduct animal-based research on our behalf, Amgen requires them to adhere to this Policy and to comply with all applicable laws and regulations.

Amgen's Commitment to Alternatives to Animal-Based Research

Amgen is fully committed to the development and use of scientifically validated alternative testing methods that are acceptable to regulatory authorities and do not compromise patient safety. Amgen is engaged internally and in cross-industry efforts aimed at developing and refining new in-vitro testing and predictive systems that hold promise for future reduction of animal usage. As part of these activities, Amgen works directly with global regulatory authorities to increase the recognition and acceptance of alternative models where such methods can be used appropriately.

Amgen's Commitment to the Ethical Use of Animals in Research

While progress continues to be made in the development of alternative models, evaluation of new medicines in animals remains critical to their evaluation and required by global regulatory authorities. Integral to Amgen's commitment to high ethical standards in the care and usage of all research animals, Amgen strongly embraces the principles of Reduction, Refinement, and Replacement (3Rs).  Amgen has a long-standing 3Rs Award Program to recognize and reward our scientists who find new and better ways to advance these ethical principles. The 3R's principles we embody are as follows:

  • Reduce animal usage by designing experiments to ensure the minimal number of animals are used to meet the stated scientific objective.
  • Refine procedures to enhance animal welfare by deploying state of the art in vivo translational technologies and by understanding the impact of animal welfare on scientific outcomes.
  • Replace animal research and testing by accelerating the development and use of non-animal models and tools, based on the latest science and technologies, to address important scientific questions.

In addition to the 3Rs, Amgen's commitment for the responsible use of animals mandates that the:

  • Institutional Animal Care and Use Committee (IACUC, US), Animal Care Committee (ACC, Canada) or other country specific oversight bodies are charged with discussing, approving, and monitoring all Amgen animal research activities.  The committees are composed of Amgen scientists and non-scientists as well as independent, uncompensated community representation to assure a balanced review. This is accomplished by assessing and approving all proposed animal studies, inspecting all internal animal facilities and programs of veterinary care, post-approval monitoring, and investigating, if necessary, any animal welfare concern brought forward by any person.  As a full committee, they have the authority to halt or terminate any animal research activities.
  • Amgen appoints an Institutional Official (IO, US) and Senior Administrator (Canada), who are ultimately responsible for all activities involving the use of research animals
  • The IACUC and ACC report independently to the IO. These committees regularly communicate with and periodically provide status reports to the IO or Senior Administrator regarding animal welfare compliance.  Veterinary care is provided by AVMA accredited veterinarians and credentialed veterinary technicians with expertise in laboratory animal care and use. These professionals monitor health and welfare and provide timely intervention to prevent or minimize animal discomfort, distress and/or pain.
  • All employees who work with animals must undergo mandatory and regular training designed to develop and refine their skills in working with animals, to promote adoption of new and improved research methods and best practices, and to ensure Amgen's compliance with all relevant regulations and standards.
  • All Amgen owned animal facilities are accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC International) or the Canadian Council on Animal Care (CCAC); both are voluntary and provide rigorous periodic review against the highest industry standards.
  • All External Business Partners (EBPs), e.g., research animal vendors and contract research organizations, where we have externally placed animal studies follow the same standards mandated internally. We have a robust proactive monitoring process to ensure their compliance.


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.