12th GCC Closed Forum for Bioanalysis

Apr 9, 2018,

Freedom Ballroom

  • Recent Findings/483s - Share your issues if you have faced recent findings from regulators

    Topic Moderator: Nicki Hughes
    Speakers/Individual Topic Leaders: Allan Xu, Bruce Stouffer, Rafiq Islam, Maria Caturla, Nicki Hughes

  • Critical reagent characterization and handling for both bioanalytical assays and biomarker assays

    Topic Leaders: Paul Rhyne, Chris Beaver

  • Oligonucleotides in bioanalysis - Recent increase in Oligonucleotides outsourcing. Best approach from a CRO point of view

    Topic Leaders: Bruce Stouffer, Jessica St. Charles, Eric Tewalt

  • "What would you do?” - A session with case studies where you have faced dilemma’s, approaches being used and advice and feedbacks from other CRO members

    Topic Moderator: Chad Briscoe
    Speakers/Individual Topic Leaders: Bruce Stouffer, Franklin Spriggs, Kelly Colletti, Chad Briscoe

  • Challenges of Method Transfer for both LCMS, Hybrid LBA/LCMS and LBA

    Topic Leaders: Chad Briscoe, Nicki Hughes

  • Certificate of Analysis (CoA) - Current quality of CoA? Are CoA more standardized now? Is there a big difference between CoA for LM and SM? What can we do to impact the vendors?

    Topic Leader: Roger Hayes

  • HRMS in Regulated Bioanalysis - How many CRO within GCC are using HRMS in Regulated Bioanalysis? Any feedback from Regulatory Agencies on Regulated studies submitted?

    Topic Leaders: Stephanie Cape, Pat Bennett

  • Classification of Commercial Kits to Support Regulated Bioanalysis - develop a set of GCC recommendations for kit manufacturers to consider undertaking the development of tiered “regulated kits.”

    Topic Leaders: Rafiq Islam, Masood Khan

  • Integrating Flow Cytometry in Bioanalysis and its standardization - Increased interest in Flow Cytometry in CRO since it is a technology used more and more in clinical trials from exploratory to secondary endpoints

    Topic Leaders: Pat Bennett, Vellalore Kakkanaiah