Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
Instructor:
Gwen Wise Blackman
Product ID: 705019
- Duration: 180 Min
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.
Learning Objectives:
- Understanding expectations for testing for immunogenicity
- Understanding the impact of immunogenicity
- Designing a solid strategy to assess immunogenicity
- Developing a method suitable for validation
- Designing the validation protocol
- Selecting an appropriate cut-point
- Testing samples
- Confirmatory methods
- Checking for neutralizing antibodies
Areas Covered in the Webinar:
- Method Development Strategies
- Validating the methods
- Risk-based approach
- Data analysis during sample analysis
- Confirmation assays
- Importance of pre-clinical data
- Problems and pitfalls to avoid
Who Will Benefit:
- Executive management
- R&D investigators
- Product development
- Validation Scientists
- Pre-clinical and clinical
- Regulatory affairs
- QA/ QC
- Consultants
- Training
Gwen Wise Blackman
Manager, Salix Pharmaceuticals
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), and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Immunogenicity, Technology Transfer from client sites, and Quality Assurance. Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
