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Helping Patients Live Better Lives

A joint project of the the Institutional Officials Consortium (IOC) and Foundation for Biomedical Research (FBR)

Overview

How Biomedical Discovery Takes Place

Before safe, effective medicines and treatments for disease can be produced, we must first understand biological and/or disease processes. Scientists look to animal models to find the answer to critical questions such as “what is going wrong?” and “how can we help?” Scientists make use of similarities in structure and function that animals share with humans to understand diseases and other conditions and to create new and safe therapies for humans and animals.

Before clinical trials in humans can begin, untested new therapies must first be shown to be effective, i.e. to help the patient as intended, and to be safe for human or animal patients. Animal models are used during early drug development to determine if the new medicine is effective at treating the disease in question (Drug Discovery). This step is necessary despite the many scientific advancements to date since there is still much unknown about the complex biological systems of humans and animals. Following thorough computer and laboratory (in vitro) screening of thousands of initially promising new molecules, only a small number will advance to the next phase of development (Nonclinical Safety). Preclinical evaluation examines how safe these molecules are for humans and/or animals.

Regulations

The drug development process is complex and rigorous, moving through phases of discovery, safety and efficacy, and eventually human clinical trials in accordance with government regulations (FDA). To ensure the safety of human and animal patients, all countries around the world have drug evaluation and approval processes that include contributions from animals and humans.

Animal research is highly regulated through U.S. government agencies (USDA, OLAW) and by governmental agencies across the globe. Moreover, many pharmaceutical companies exceed the government requirements for animal welfare by achieving voluntary accreditation by AAALAC International, an intensive formal third party animal welfare assessment that evaluates institutions on adherence to the Guide for the Care and Use of Laboratory Animals and other published animal welfare standards, as well as through internal standards and practices.

Animal research has made human and animal lives better around the world. IOC members embrace our responsibility for ethical and humane animal welfare and to the patients relying on science to deliver safe and effective medicines to improve lives. We endorse strong policies to ensure animal research and the 3Rs are aligned with our values and know that there remains much to be done for patients still in need.

Work With FBR for a Better Shared Future

No one should be without the treatment they need to live a happy, healthy life. Let’s work together to reduce diseases and injuries and make Americans healthier.

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