PPTA Co-Sponsors Public Workshop

On Sept. 17-18, 2015, PPTA co-sponsored a U.S. Food and Drug Administration (FDA) public workshop, New Methods to Predict the Immunogenicity of Therapeutic Coagulation Proteins, with the National Institutes of Health (NIH) National Heart, Lung, and Blood Institute and the National Hemophilia Foundation, on the NIH campus in Bethesda, Maryland, USA.

The workshop focused on genetic determinants of immunogenicity, uses of genetic information, preclinical assessments of immunogenicity, studies of previously untreated patients, and immune tolerance induction, and followed a European Medicines Agency workshop on hemophilia registries on July 1-2, 2015, in London, UK. The workshop agenda was developed by a steering committee comprised of the co-sponsors (including PPTA) and other stakeholders, and included presentations and panel discussions by PPTA, member and non-member companies, regulators, patient advocates, and clinicians.

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