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Finding therapies that are safe, effective and available requires hard work and putting patients first, according to Daniela Verthelyi of the FDA, who discusses her role as chief of the immunology laboratory at the government agency.
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.
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Daniela Verthelyi, FDA, immunology laboratory, US Food and Drug Administration, therapeutic proteins, peptides, product immunogenicity