Bioanalytical Community

The second day started with Part 1 of morning Plenary for Emerging Platforms, New Challenges moderated by @#FuminLi, Biollege LLC.  

The talks in this session focused on Immune Monitoring Biomarker Strategies for Gene Therapies from @Kristen Kahle SparkTx where she described the role of T cells and its alignment with adverse events.  @Iris Xie #Merck & Co. outlined the differences between capillary and venous blood draws and robustness and precision of analytes and potential interference due to cells and other matrix associated factors.  The talk by @BarryJones Crinetics Pharmaceuticals went over the HRMS and support of regulated bioanalysis in his talk titled HRMS in Regulated Bioanalysis – Ace in the Hole or Jack of All Trades).  A detailed comparison of Quantitative vs. Digital PCR and selection and advantages and disadvantages of each platform was covered by @Russell Soon Russell, BioMarin Pharmaceuticals.
The PK assessments from a blood microsample vs conventional blood draw derived venous sample in Cynomolgus monkeys and its equivalence was a great example of micro-sampling from @Ying Wang Pfizer.  The challenges and need for Microsampling from a patient and clinical study and investigator perspective was provided by @Melanie Anderson, Merck and Co, Inc. The morning session ended with a talk on use of gyros platform to support bioanalysis from antibodies to AAV by @Manny Lozano Gyros Protein Technologies.

Afternoon plenary session moderated by @Brad Roadcap Merck and Co. Inc covered the challenges associated with transgene detection for AAV5 based gene therapy in Hemophilia A.  The use of FVIII activity as a reliable predictor of efficacy was shared by @Christian Vettermann Biomarin.  This was followed by a talk on implementing cellular immunogenicity assessments for sample collection and logistics of handling and analyzing for cell-based therapies from @ Kevin Lang PPD.

The Day 2 ended with a rapid-fire session moderated by @Amanda Hays Bioagilytix with talks ranging from Harnessing Nanoflow LC-MS to Maximize Sensitivity for Analysis of Bio-therapeutics in a High-throughput by Bioanalytical Laboratory by @Nicholas Saichek, LabCorp 
Drug Development to Advances in At-home Microsampling Kits for Liquid Blood Collections by @Greg J. Sommer, Labcorp, a streamlined Biomarker Assay Qualification in a Rare Matrix on the Ella Platform by @Jennifer A. Getz, Genentech and Streamlining Immunogenicity Assay Development with Binding Measurements by @Krisna Duong-Ly, Merck & Co., Inc.

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The second day started with Part 1 of morning Plenary for Emerging Platforms, New Challenges moderated by @#FuminLi, Biollege LLC.  

The talks in this session focused on Immune Monitoring Biomarker Strategies for Gene Therapies from @Kristen Kahle SparkTx where she described the role of T cells and its alignment with adverse events.  @Iris Xie #Merck & Co. outlined the differences between capillary and venous blood draws and robustness and precision of analytes and potential interference due to cells and other matrix associated factors.  The talk by @BarryJones Crinetics Pharmaceuticals went over the HRMS and support of regulated bioanalysis in his talk titled HRMS in Regulated Bioanalysis – Ace in the Hole or Jack of All Trades).  A detailed comparison of Quantitative vs. Digital PCR and selection and advantages and disadvantages of each platform was covered by @Russell Soon Russell, BioMarin Pharmaceuticals.
The PK assessments from a blood microsample vs conventional blood draw derived venous sample in Cynomolgus monkeys and its equivalence was a great example of micro-sampling from @Ying Wang Pfizer.  The challenges and need for Microsampling from a patient and clinical study and investigator perspective was provided by @Melanie Anderson, Merck and Co, Inc. The morning session ended with a talk on use of gyros platform to support bioanalysis from antibodies to AAV by @Manny Lozano Gyros Protein Technologies.

Afternoon plenary session moderated by @Brad Roadcap Merck and Co. Inc covered the challenges associated with transgene detection for AAV5 based gene therapy in Hemophilia A.  The use of FVIII activity as a reliable predictor of efficacy was shared by @Christian Vettermann Biomarin.  This was followed by a talk on implementing cellular immunogenicity assessments for sample collection and logistics of handling and analyzing for cell-based therapies from @ Kevin Lang PPD.

The Day 2 ended with a rapid-fire session moderated by @Amanda Hays Bioagilytix with talks ranging from Harnessing Nanoflow LC-MS to Maximize Sensitivity for Analysis of Bio-therapeutics in a High-throughput by Bioanalytical Laboratory by @Nicholas Saichek, LabCorp 
Drug Development to Advances in At-home Microsampling Kits for Liquid Blood Collections by @Greg J. Sommer, Labcorp, a streamlined Biomarker Assay Qualification in a Rare Matrix on the Ella Platform by @Jennifer A. Getz, Genentech and Streamlining Immunogenicity Assay Development with Binding Measurements by @Krisna Duong-Ly, Merck & Co., Inc.