Biomarkers and Precision Medicine Community (BPMC)

Putting Biomarker Assay Validation in Context (of Use) – Real World Challenges and Solutions

• Provide clarity on COU and FFP, how they are related to each other, and their relationship to biomarker assay validation
• Communicate key areas of alignment and challenges identified over the last 2-3 years of focused discussion on COU, uniting perspectives from both EBF and AAPS
• Panel discussion with perspectives from BA/biomarker science, stats, & regulatory points of view regarding the challenges and associated solutions

Discussion Leaders:

• Lauren Stevenson (Immunologix)
• Philip Timmerman (EBF)

Panelists:

• Robert Nelson (Covance)
• Viswanath Devanarayan (GSK)
• Devangi Mehta (Immunologix)
• Steven Piccoli (SPARC)
• Abbas Bandukwala (FDA)
• John Allinson (Immunologix)
• Kyra Cowan (Merck KGaA)
• Linda Terry (Immunologix)
• Jo Goodman (Astra Zeneca)

Organized by:  Lauren Stevenson (Immunologix), Carmen Fernandez-Metzler (PharmaCadence)