FDA awards UAMS $1.2 million to improve drug-safety testing

LITTLE ROCK — The Food and Drug Administration has awarded a three-year $1.2 million contract to the University of Arkansas for Medical Sciences to study new approaches for testing drug safety by accounting for gene mutations that can cause patients to have adverse reactions to drugs.

Alison Harrill, assistant professor in the department of environmental and occupational health in the Fay W. Boozman College of Public Health at UAMS, leads a project titled The Diversity Outbred: A Tool to Improve Preclinical Safety Testing and Pharmacogenomics Analysis.

People respond in different ways to the same dose of a given drug. In recent years, there have been fewer drugs getting approved for use, but the spending has increased, with costs of more than $1 billion to get a drug on the market, largely as a result of safety concerns, Harrill said. This study will help predict which drugs carry a safety risk early in development before they reach the market. Harrill hopes that through this research, drugs can move more quickly to the market so people can get needed medication sooner.

By identifying a drug’s reaction with specific gene mutations, the research can improve the understanding and prediction of adverse drug and chemical reactions in humans. It will allow medicine to be personalized and to know what works with a person’s specific DNA.