Specialized Workshop Th1 - Thursday May 09, 2024: 7am to 5:30pm
"AGENDA - Advanced Strategies for Ligand-Binding Assays"
| 07:00am-08:00am: | Start your day at WRIB with Networking Continental Breakfast in the Exhibit Room |
Session 1: LBA in Gene Therapy: Innovative Approaches in LBA for Total Antibody/Neutralizing Antibody (TAb/NAb) Assays Supporting GT Trials
Chair: Dr. Carolina Owen, Director, LBA & Biomarkers, AbbVie| 08:00am-08:20am: |
Ms. Liching Cao, Senior Director Bioanalytical Operations, Sangamo "Overcoming drug interference for detection of anti-transgene protein antibodies after gene therapy treatment" |
| 08:20am-08:40am: |
Dr. Andria Culbert, Associate Director, Regulated Bioanalysis, Spark "GTx Transgene Protein and Enzyme Activity Assays: Case Studies & Regulatory Aspects" |
| 08:40am-09:00am: |
Dr. Kay-Gunnar Stubenrauch, Lead Genomic Medicine, Bioanalytics and Biomarkers, Roche "Development of a novel Immune Complex (IC) Assay to detect total anti-AAV2 antibodies (TAb)" |
| 09:00am-09:20am: |
Dr. Richard Hughes, Scientific Director, Immunoassay, Resolian "Considerations for development and validation of bioanalytical assays for enzyme therapeutic products" |
| 09:20am-10:05am: | Networking Coffee Break with Morning Snacks in the Exhibit Room |
| 10:05am-10:25am: |
Ms. Liching Cao, Senior Director Bioanalytical Operations, Sangamo
Dr. Andria Culbert, Associate Director, Regulated Bioanalysis, Spark Dr. Kay-Gunnar Stubenrauch, Lead Genomic Medicine, Bioanalytics and Biomarkers, Roche Dr. Richard Hughes, Scientific Director, Immunoassay, Resolian "Panel Discussions on LBA in Gene Therapy: Innovative Approaches in LBA for Total Antibody/Neutralizing Antibody (TAb/NAb) Assays Supporting GT Trials" |
Session 2: LBA in Immunogenicity: Super Sensitive ADA/NAb LBA, Strategies on ADA LBA Formats and Singlicate Validation
Chair: Dr. Seema Kumar, Senior Director, Head of DMPK & Bioanalysis, Pioneering Medicines| 10:25am-10:45am: |
Dr. Shalini Gupta, Senior Director, Translational Safety & Bioanalytical Sciences, Amgen "Super-sensitive NAb Assays: Are they Adding Value to Understanding the Impact of Clinical Immunogenicity?" |
| 10:45am-11:05am: |
Dr. Rita Martello, Scientific Director, EMD Serono "ADA Assay Format and Impact on Performance: a Case Study" |
| 11:05am-11:25am: |
Ms. Susana Liu, Associate Director, Biologics Clinical Assay Lead, Pfizer "A Data Driven Strategy and Case Study of Singlicate Ligand Binding Assays: PK and ADA Sample Analysis" |
| 11:25am-11:45am: |
Dr. Shalini Gupta, Senior Director, Translational Safety & Bioanalytical Sciences, Amgen
Dr. Rita Martello, Scientific Director, EMD Serono Ms. Susana Liu, Associate Director, Biologics Clinical Assay Lead, Pfizer "Panel Discussions on LBA in Immunogenicity: Super Sensitive ADA/NAb LBA, Strategies on ADA LBA Formats and Singlicate Validation" |
Session 3: LBA Critical Reagents: Enhanced Approaches for Characterization of CR/PC for Biomarker & ADA/NAb Assays
Chair: Ms. Alison Joyce, Senior Director, Discovery Bioanalytical and Critical Reagents, Pfizer| 11:45am-12:05pm: |
Dr. Kun Lu, Associate Director, Critical Protein Reagent Group, Regeneron "Rigorous characterization of complex ligands is essential for the consistent performance of bioanalytical assays" |
| 12:05pm-01:05pm: |
Sit-down Networking Lunch on the 2nd Floor Note: Lunch Desserts and Coffee/Tea are served in the Exhibit Room |
| 01:05pm-01:25pm: |
Dr. Kimberly Reese, Associate Director, GlaxoSmithKline "Enhancing Neutralizing Antibody Assay Performance Through Considered Reagent Optimization" |
| 01:25pm-01:45pm: |
Dr. Yi Wen, Senior Director, Clinical Immunogenicity, Eli Lilly and Co. "Key Consideration to Generate Suitable Surrogate Positive Controls (PC) to Enable Smooth ADA LBA Development/Validation" |
| 01:45pm-02:05pm: |
Dr. Kun Lu, Associate Director, Critical Protein Reagent Group, Regeneron
Dr. Kimberly Reese, Associate Director, GlaxoSmithKline Dr. Yi Wen, Senior Director, Clinical Immunogenicity, Eli Lilly and Co. "Panel Discussions on LBA Critical Reagents: Enhanced Approaches for Characterization of CR/PC for Biomarker & ADA/NAb Assays " |
Session 4: State-of-the-art Integrative Bioanalysis by Leveraging Multiple Platforms: LBA, Mass Spec and PCR
Chair: Dr. Graham Yearwood, Senior Scientific Director, Translational Sciences and Diagnostics, Bristol Myers Squibb| 02:05pm-02:25pm: |
Dr. Samuel Pine, Global Head of Bioanalysis & Immunogenicity, DMPK, Sanofi "A Balanced Diet of Bioanalytical Techniques: Integrated Approaches for the Bioanalysis of Complex Modalities" |
| 02:25pm-02:45pm: |
Ms. Kelly Coble, Director of Bioanalytical Sciences, Boehringer Ingerheim "Non-Traditional Immunocapture-LC/MS Method Development for Nonclinical and Clinical PK Methods for an On Demand Cytokine" |
| 02:45pm-03:05pm: |
Dr. Valerie Clausen, Director, Bionalytical Sciences, Alnylam "Hybridization ELISA for Quantification of siRNA and Metabolites" |
| 03:05pm-04:05pm: |
Networking Break with Afternoon Snacks, and Wine and Beer Reception in the Exhibit Room |
| 04:05pm-04:25pm: |
Dr. Samuel Pine, Global Head of Bioanalysis & Immunogenicity, DMPK, Sanofi
Ms. Kelly Coble, Director of Bioanalytical Sciences, Boehringer Ingerheim Dr. Valerie Clausen, Director, Bionalytical Sciences, Alnylam "Panel Discussions on State-of-the-art Integrative Bioanalysis by Leveraging Multiple Platforms: LBA, Mass Spec and PCR" |
Session 5: 2024 White Paper in Bioanalysis
| 04:25pm-05:30pm: |
Dr. Carolina Owen, Director, LBA & Biomarkers, AbbVie Dr. Seema Kumar, Senior Director, Head of DMPK & Bioanalysis, Pioneering Medicines Ms. Alison Joyce, Senior Director, Discovery Bioanalytical and Critical Reagents, Pfizer Dr. Graham Yearwood, Senior Scientific Director, Translational Sciences and Diagnostics, Bristol Myers Squibb "Recommendations on Ligand Binding Assays and Panel Discussions for 2024 White Paper in Bioanalysis" |
