LSIPR 50: Daniela Verthelyi—Safety first

According to Daniela Verthelyi of the US Food and Drug Administration (FDA), the development of therapeutic proteins and peptides has improved the lives of countless patients, but there are still numerous challenges ahead, including those relating to bioavailability and immunogenicity.

Verthelyi, who is chief of the immunology laboratory at the FDA, works with researchers, reviewers and research-reviewers to address questions of product immunogenicity for the Office of Biotechnology Products and other areas of the FDA.

She also helps develop new approaches to address immunogenicity risk for peptides, heparins, and other complex products, as well as contributing to the writing of industry guidance documents that outline the FDA’s current thinking.

An important part of Verthelyi’s team’s work is to improve understanding of what product attributes can induce adverse effects by “modulating the immune system”.