Impact of Recent Changes to FDA Immunogenicity Draft Guidance
The FDA released an update to the Draft Guidance for Assay Development & Validation for Immunogenicity Testing of Therapeutic Proteins in April 2016. This webinar will outline the changes between the April 2016 draft document and the previous version from December 2009. In depth discussion on current industry standard and what it means to the industry will be covered. The webinar will also outline statistical analysis requirements for cut point determination and do’s and don’ts, including a case study on distribution analysis when dealing with a tailed/skewed data population.
What will you learn?
- Changes to the Draft Guidance for Assay Development & Validation for Immunogenicity Testing of Therapeutic Proteins
- Current industry standard and what the changes mean to the industry
- Statistical analysis requirements for cut point determination and do’s and don’ts
- A case study on distribution analysis when dealing with a tailed/skewed data population for cut point determination
Who should attend?
- Scientists in the clinical or preclinical drug development space
- Diagnostic and post marketing scientists and professionals
- Bioanalysis professionals in CRO, Biotech and pharmaceutical industry
Vice President of Pharmaceutical
Jamil Hantash is a seasoned chemist that brings a wealth of operational and scientific experience in both small and large molecule bioanalyses. He has many publications and webinars with high impact on the field of bioanalytical science. In 2007, Mr. Hantash was part of the leadership team at the bioanalytical laboratory at Millipore (now part of Eurofins.) He served as Senior Lab Manager for large molecule bioanalysis at Covance. At Inventive Health and Tandem (part of LabCorp), he served as a Senior Technical Director where his role was to manage the bioanalysis lab. Mr. Hantash serves as Vice President of the Pharmaceutical Services division of Intertek.
Ronald R Bowsher, PhD
Partner & CSO
B2S Life Sciences LLC
Dr. Bowsher has worked in the pharmaceutical/biotechnology and CRO industries for 40 years. He received his M.S. and Ph.D. degrees in Biochemistry at the Indiana University School of Medicine. Currently, he serves as a Senior Advisor at AIT Bioscience, is President at B2S Consulting and CSO at B2S Life Sciences, a laboratory specializing in the production and life-cycle management of custom biological-based reagents, and protein ADME. In 2003, Dr. Bowsher retired after 30 years at Eli Lilly. He has over 200 research publications, been a consultant to more than 100 companies and was elected as an AAPS Fellow in 2004.
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