Bioanalytical Community

Minutes from Discussion

1. New leadership additions:
   • Mark Wissel (Chair)
   • Tim Lochmann (Vice-Chair)
   • Jason Pennucci (Secretary)
2. Membership engagement
   • Opportunities still available - although an ongoing task for all members
3. Sample Analysis white paper topic and approach
   • Topics for inclusion discussed:
     • ISR, retest and reporting strategies
     • How does study size, modality impact testing approach
     • CGT versus circulating (serum, plasma) PK reporting differences
     • Once outline agreed - for sub-teams to address sections
     • LIMS
4. Discuss / Decide on approaches for advancing other topics discussed on 12NOV
   • OSD to discuss sample analysis, regulatory input, considerations for multiplexing (1 year post Hays CGT)
     • Use of LIMS - what LIMS are being used - experiences/considerations
     • Next Steps
       • Jason P to reach out to Sanjeev B to get on OSD schedule - early 2025
       • Darshana J will provide rough outline for team review Dec 2025
       • Kate H to move forward questionnaire/request for input re: LIMS systems used (PCR and compatibility with other bioanalytical platforms) - input requested from team on best approach (Excel in PCR work group Teams)