Commitment to the Ethical Use of Animals in Research
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.