Merrie Mosedale, Ph.D., has been selected as one of five recipients of the 2017 Burroughs Wellcome Fund Innovation in Regulatory Science Award. The award provides $500,000 over five years for research into new methodologies and innovative approaches in regulatory science.
Mosedale’s research proposal is titled, “Development of an In Vitro Platform for the Evaluation of Genetic Susceptibility Factors Associated with Adverse Drug Response.” William Valdar, Ph.D., associate professor of genetics at the UNC School of Medicine, is a co-investigator on it.
“The funding will allow me to pursue an exciting and truly novel area of research focused on incorporating genetics into the safety assessment of new drug candidates,” Mosedale said. “I am also thrilled to have the support of the Burroughs Wellcome Fund, which includes outstanding career and professional development opportunities.”
According to Mosedale, genetics are a key factor determining whether an individual has an adverse reaction to a drug, but standard toxicology models used to assess drug safety don’t account for these effects.
“Using genetically diverse mouse populations offers a promising approach to overcoming this problem, but doing so relies on studying large numbers of animals, making it a time-consuming, expensive and somewhat limiting method,” Mosedale said.
Mosedale plans to address these limitations by translating a mouse-population-based approach into a cell-culture platform that will allow for its rapid and cost-effective implementation at all stages of drug development. She said the use of an in vitro model would also improve the content, throughput and reproducibility of this resource. According to Mosedale, the method of cell culture she will use should also improve the phenotypic relevance of the model while decreasing the number of cells required overall.
The Burroughs Wellcome Fund has identified innovation in regulatory science as an important underfunded area. Ultimately, the fund wants to support research that will inform the decisions of the U.S. Food and Drug Administration and other regulatory health agencies, the organization’s website said.
Mosedale says she is honored to have received the award and believes the platform she proposes will be of great interest to drug developers and regulators alike.