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Drug Development

From Discovery to New Medicines
Before safe and effective medicines and treatments for disease can be produced, we must understand the disease process by looking at animal models to find answers to the question “what is going wrong?” Therefore, scientists can use the similar physical functions animals share with humans. We share genetic structure, develop the same way, and have the same kinds of organs (heart, brain, lungs, kidneys, etc.) and physical systems (circulatory, reproductive, digestive, nervous) that function very similarly. These models guide science toward data driven decisions for treatments of human and animal diseases.

Prior to the clinical trial phase conducted in humans, critical laboratory research (what is known as “in vivo” or preclinical safety studies) is conducted with animals. In these studies, potential new medicines are tested to evaluate how those medicines work in a living organism. In this way, animals have contributed to lifesaving treatments in cancer, diabetes, vaccines, high blood pressure and neurological disorders, to name a few.

Animals have contributed to lifesaving treatments in cancer, diabetes, vaccines, high blood pressure, and neurological disorders, to name a few. (Photo credit: Michael Blann / DigitalVision / Getty Images)
(Photo credit: fotografixx / E+ / Getty Images)

Commitment to High Standards for Ethical Research With Animals

Individually and together, pharmaceutical, biomedical, and animal health organizations work to advance new ways of discovering and developing medicines without the use of animal research, such as through the IQ Consortium for Innovation and Quality in Pharmaceutical Development Microphysiological Systems Affiliate. While many significant advancements in non-animal alternatives have been achieved and continue to be developed, there are still many areas where animals are needed in order to understand complex diseases and discover and develop new treatments. We are committed to setting and meeting high standards of animal welfare and ethical oversight for all work with research animals.  All activities with animals must follow stringent requirements set by government and regulatory authorities.  These requirements typically include independent audits, including unannounced visits to observe animals, the people working with the animals, and review relevant records. Above and beyond these requirements, pharmaceutical, animal health, and biomedical organizations voluntarily invite additional outside review of their animal care and use programs and facilities, as well as commit resources to 3Rs programs that further enhance animal welfare.

Research involving animals is highly regulated.

In the United States, institutions conducting research must follow regulations at a national/federal level, as well as any state or local regulations that apply. These regulations require that research animals have access to specially trained veterinarians who must be available 24 hours a day, 365 days a year to support their health and well-being. Additionally, the regulations require establishing an ethical review board to review and approve all proposed studies with animals prior to starting a study and require regular monitoring after the studies begin.

  • The United States Department of Agriculture (USDA) is sanctioned with the Animal Welfare Act & Regulations (AWA), which regulates the treatment of animals in research and requires regular unannounced visits by USDA veterinarians. The AWA also requires exercise programs for dogs and environments that promote the psychological well-being of primates.
  • The National Institute of Health (NIH) Office of Laboratory Animal Welfare (OLAW) follows the Public Health Service Policy on Humane Care & Use of Laboratory Animals, which requires “institutions to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities” when conducting research using federal grant money.
  • Most pharmaceutical and research institutions voluntarily choose to participate in additional independent accreditation and assessment by AAALAC International. The accreditation process includes an extensive review including in person inspections to assess the quality of the institution’s animal care and use program by AAALAC International appointed evaluators. These evaluators assess the institutions’ adherence to the Guide for the Care and Use of Laboratory Animals (Guide) and encourage adoption of best practices of animal care and ethical oversight.
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