Symposium: Regulatory Implications for Bioanalysis 1

Moderator(s)

• 

  Manish Kumar, PhD (he/him/his)

  Associate Director
  Daiichi Sankyo

Presentations:

• 9:00 AM – 9:30 AM MT

  Comparison of Different Platforms for Evaluating Cellular and Humoral Immunogenicity
  

  Speaker: Yanshan Dai, PhD (he/him/his) – Bristol-Myers Squibb
• 9:30 AM – 10:00 AM MT

  Challenging Current Immunogenicity Assessment: Clinical Case Studies for 1-Tiered Approach
  

  Speaker: Ching-Ha (Vicky) Lai, PhD (she/her/hers) – Regeneron Pharmaceuticals Inc
• 10:00 AM – 10:30 AM MT

  Collaborative Training Initiatives for Strengthening Regulatory and Laboratory Systems
  

  Speaker: Chaitanya K. Koduri, MTech (he/him/his) – US Pharmacopeia
• 10:30 AM – 11:00 AM MT

  The Road to IVD Companion Diagnostics – Pathways to IDE
  

  Speaker: Luke Armstrong, PhD (he/him/his) – BioAgilytix