Exploring Animal-Free Biomedical Research
Siobhan Gilchrist (J.D. ’06) serves as district leader for Congressional District 5 for the Humane Society of the United States to advance animal welfare policies across Georgia and nationally. In October, she helped to develop a half-day symposium, Exploring New Technologies in Biomedical Research, sponsored by the Human Toxicology Project Consortium (HTPC) and Emory University School of Law.
The symposium was designed to raise awareness of innovative biomedical research alternatives to animal testing, such as stem cell and organ-on-chip technologies, and others mechanisms for developing predictive models of human diseases. The audience included scientists, lawyers, and faculty and students across the university. New approaches to drug development are needed because more than 90 percent of drugs fail in clinical trials. The failures largely occur because the drugs prove ineffective in humans or show toxicity in humans that was not predicted in animal trials.
Patti Zettler, Georgia State Law associate professor of law, and former legal counsel at the Food and Drug Administration, presented at the symposium on the drug and device approval process and the regulatory changes that might be necessary to bring these technologies into clinical trials. One challenge for implementing the use of new technologies for preclinical testing of medical products, Zettler explained, is demonstrating to the FDA that the science supports using the technologies as a means of determining when a medical product is safe enough for research in humans.
“I hope this symposium can serve as a model to raise awareness about the inadequacy of animal testing and the benefits of alternative models of drug development,” Gilchrist said. “Such education can help change the mindset of future researchers, regulators, and attorneys in how we test new drugs.”