KCAS Webinar Archive: Impact of New FDA Guidance on Bioanalytical Testing on Drug Development

Original Time and Date of Webinar:
Thursday, May 30, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Event Overview:
In this webcast, learn how the FDA Bioanalytical Method Validation Guidance (May 2018), the FDA Immunogenicity Testing of Therapeutic Protein Products (January 2019), and the February 2019 draft International Conference on Harmonisation (ICH) Bioanalytical Method Validation M10 guidelines have changed or are poised to change the landscape of outsourcing bioanalysis to support drug development. Additionally, the webinar covered gaps in bioanalytical method validation guidance to support drug development most notably flow cytometry support of gene therapies.

The webcast highlighted the areas of each guidance that indicate a change of thinking from previous documentation provided by the agency. Experts discussed the practical side of execution of these updated parameters, where appropriate, and the impact the documents may have on the scope and time line for outsourcing of bioanalytical analysis.

Key Learning Objectives:

  • What is new in FDA’s May 2018 Bioanalytical Method Validation Guidance?
  • What is new in FDA’s January of 2019 Immunogenicity Testing of Therapeutic Protein Products?
  • What is new in the February 2019 draft of the International Conference on Harmonisation (ICH) Bioanalytical Method Validation M10 guidelines?
  • What actions should bioanalytical testing labs take to adapt to these new guidelines?

Speakers:

Franklin Spriggs, Director, Biopharma Services, KCAS Bioanalytical and Biomarker Services

Stephanie Bull, RQAP-GLP, Quality Assurance Team Lead, KCAS Bioanalytical and Biomarker Services

Marsha Luna, Director, Pharmaceutical Services, KCAS Bioanalytical and Biomarker Services

 

Click here to download a PDF of the presentation slides

Click the video below to view the webinar as it was presented on May 28, 2019.

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