This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.
Why Should You Attend:
Immune responses in the patient population during clinical trials or post-market are a serious issue facing biologic therapeutics. Regulatory agencies expect biopharmaceutical/pharmaceutical companies to fully assess the potential for immunogenicity in large molecule therapeutics. Understanding agency expectations should allow a reasoned and risk-based approach to assessing potential problems with immunogenicity.
This webinar will provide a general overview of immunogenicity while also addressing specific topics on development and validation. Included in the discussion are understanding and establishing the initial screening method and method to assess neutralizing antibodies.
Areas Covered in the Webinar:
Who Will Benefit:
Duration: 3 Hours
Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.