Symposium: Regulatory Implications for Bioanalysis 2

Moderator(s)

• DJ

  Darshana Jani, Ph.D.

  Sr Director
  Moderna Therapeutics
  Cambridge, Massachusetts

Presentations:

• 9:00 AM – 9:30 AM MT

  Unraveling CGTP Compliance: Part 1- Biomarker Assay Selection and Pitfalls
  

  Speaker: Stephanie A. Pasas-Farmer, PhD (she/her/hers) – BioData Solutions LLC
• 9:30 AM – 10:00 AM MT

  Unraveling CGTP Compliance: Part 2- Comparative Study Fabry Associated Biomarkers
  

  Speaker: Josephine Y. Fang, PhD (she/her/hers) – Takeda
• 10:00 AM – 10:30 AM MT

  NAb Assays for ADC: Killing or Not Killing?
  

  Speaker: Weifeng Xu, Ph.D. – Merck & Co., Inc.
• 10:30 AM – 11:00 AM MT

  How Would the European In Vitro Diagnostic Regulation 2017/746 (EU IVDR) Impact Regulated Bioanalysis?
  

  Speaker: Don (Zhandong) Zhong, PhD (he/him/his) – Denali Therapeutics