“Predictive Immunogenicity for Better Clinical Outcomes” is a collaborative workshop hosted by the University of Maryland Centers of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA) that will be held Oct. 3-4, 8:30 a.m. to 5 p.m. each day, at the FDA’s White Oak campus in Silver Spring, Md. (10903 New Hampshire Ave., Building 31-The Great Room).
Protein therapeutics have continued to gain an increasing share of the pharmaceutical market and provide medical interventions for some of the most complex and intractable diseases. Immunogenicity, the propensity of a therapeutic protein to induce immune responses, principally by development of antibodies, may affect safety and/or efficacy and is thus an important concern in the development and regulation of protein therapeutics. Patients, regulators and the biopharmaceutical industry are affected by immunogenicity. Recently, the U.S. Food and Drug Administration and the European Medicines Agency have released guidance documents for industry focusing on immunogenicity.
This timely public workshop will present advances in the development of technological tools for predictions of immunogenicity and discussions on how to engage relevant stakeholders in application of these tools during drug development.
For more information, visit this webpage.