Main Workshop DAY 1 - Tuesday May 07, 2024: 7am - 5:45pm
"AGENDA - Ligand-Binding, Cell-Based, and Molecular Assays"
| 07:00am-08:00am: | Start your day at WRIB with Networking Continental Breakfast in the Exhibit |
Session 1: Immunogenicity Assays and Regulatory Expectations
Chair: Dr. Albert Torri, Vice President, Bioanalytical Sciences, Regeneron| 08:00am-08:20am: |
Dr. George Gunn, Senior Director, Head of Immunogenicity, GlaxoSmithKline "How many times should an ADA sample be tested before trusting the result?" |
| 08:20am-08:40am: |
Dr. Michael Partridge, Senior Director, Regeneron "Highly Sensitive and Drug Tolerant Immunogenicity Assays: What is the Clinical Context?" |
| 08:40am-09:00am: |
Dr. Johann Poetzl, Head Bioanalytics, Sandoz "Biosimilar Immunogenicity and Advanced Approaches to Demonstrate Similarity" |
| 09:00am-09:20am: |
Dr. Susan Richards, Vice President, Translational Medicine and Early Development, Sanofi "Hypersensitivity reactions: Bioanalytical approaches to assess immunogenicity related mechanisms" |
| 09:20am-10:05am: | Networking Coffee Break with Morning Snacks in the Exhibit |
| 10:05am-10:25am: |
Dr. George Gunn, Senior Director, Head of Immunogenicity, GlaxoSmithKline
Dr. Michael Partridge, Senior Director, Regeneron Dr. Johann Poetzl, Head Bioanalytics, Sandoz Dr. Susan Richards, Vice President, Translational Medicine and Early Development, Sanofi "Panel Discussions on Immunogenicity Assays and Regulatory Expectations" |
Session 2: Biomarker Development, IVD/CDx Assays and BAV
Chair: Dr. Laura Joglekar, Executive Director, Translational Sciences & Diagnostics, Bristol Myers Squibb| 10:25am-10:45am: |
Dr. Rachel Palmer, Head of Biomarkers and Clinical Bioanalysis, Sanofi "The Rise of Olink" |
| 10:45am-11:05am: |
Dr. Huaping Tang, Executive Director & Global Head of Immunoassay Bioanalysis and Biomarkers, GlaxoSmithKline "Cross validation of PK/PD assays - application of the principles of the ICH M10 guidance" |
| 11:05am-11:25am: |
Dr. Kristina McGuire, Executive Director & Head of Precision Medicine and Companion Diagnostics, Regeneron "Managing Change: Impact of Device and LDT Regulations on Testing Landscape for Patient Care and Clinical Trials" |
| 11:25am-11:45am: |
Dr. Gerard Sanderink, Global Head Biomarkers and Clinical Bioanalyses, Sanofi "Recent Experience with IVDR implementation for Biomarkers in clinical studies in the EU and changes for LDTs in the US." |
| 11:45am-12:05pm: |
Dr. Rachel Palmer, Head of Biomarkers and Clinical Bioanalysis, Sanofi
Dr. Huaping Tang, Executive Director & Global Head of Immunoassay Bioanalysis and Biomarkers, GlaxoSmithKline Dr. Kristina McGuire, Executive Director & Head of Precision Medicine and Companion Diagnostics, Regeneron Dr. Gerard Sanderink, Global Head Biomarkers and Clinical Bioanalyses, Sanofi "Panel Discussions on Biomarker Development, IVD/CDx Assays and BAV" |
| 12:05pm-01:05pm: |
Sit-down Networking Lunch on the 2nd Floor Note: Lunch Desserts and Coffee/Tea are served in the Exhibit Room |
Session 3: Gene Therapy and Cell Therapy Assays
Chair: Mr. John Smeraglia, Vice President Integrated Bioanalysis, AstraZeneca| 01:05pm-01:25pm: |
Dr. Uma Kavita, Director, Regulated Bioanalysis, Spark "Bioanalytical Assays in AAV Gene Therapy-Beyond the Mundane" |
| 01:25pm-01:45pm: |
Dr. Kate Peng, Senior Director, BioAnalytical Sciences, Genentech "Bioanalytical considerations of developing an individualized mRNA-based cancer vaccine" |
| 01:45pm-02:05pm: |
Dr. Yanmei Lu, Vice President, Biomarker and BioAnalytical Sciences, Sangamo "Development of a Sensitive ddPCR Assay to Detect CAR-Tregs in Whole Blood to Support Clinical Trials" |
| 02:05pm-02:25pm: |
Dr. Uma Kavita, Director, Regulated Bioanalysis, Spark
Dr. Kate Peng, Senior Director, BioAnalytical Sciences, Genentech Dr. Yanmei Lu, Vice President, Biomarker and BioAnalytical Sciences, Sangamo "Panel Discussions on Gene Therapy and Cell Therapy Assays " |
Session 4: Vaccine Clinical Assays
Chair: Dr. Ivo Sonderegger, Head of Clinical Bioanalysis, Takeda| 02:25pm-02:45pm: |
Dr. Ingrid Scully, Executive Director, Head of Clinical Immunology, Pfizer "What are you measuring? Considerations on assay format for vaccine immune threshold assessment" |
| 02:45pm-03:05pm: |
Dr. Katrina Nolan, Director, Vaccine Regulated Bioanalysis, Merck "Serotyping Streptococcus pneumoniae: Modernized Approaches for the Regulated Environment" |
| 03:05pm-04:05pm: |
Networking Break with Afternoon Snacks, and Wine and Beer Reception in the Exhibit |
| 04:05pm-04:25pm: |
Dr. Victor Hou, Senior Director, Head of Infectious Disease, Clinical Biomarkers, Moderna "Antibody Response to the Updated mRNA COVID-19 Vaccines in the United States: Results From the DisCOVEries 2 Study" |
| 04:25pm-04:45pm: |
Dr. Ingrid Scully, Executive Director, Head of Clinical Immunology, Pfizer
Dr. Katrina Nolan, Director, Vaccine Regulated Bioanalysis, Merck Dr. Victor Hou, Senior Director, Head of Infectious Disease, Clinical Biomarkers, Moderna "Panel Discussions on Vaccine Clinical Assays " |
Session 5: 2024 White Paper in Bioanalysis
| 04:45pm-05:45pm: |
Dr. Albert Torri, Vice President, Bioanalytical Sciences, Regeneron Dr. Laura Joglekar, Executive Director, Translational Sciences & Diagnostics, Bristol Myers Squibb Mr. John Smeraglia, Vice President Integrated Bioanalysis, AstraZeneca Dr. Ivo Sonderegger, Head of Clinical Bioanalysis, Takeda "Recommendations on Immunogenicity Assays, Biomarker IVD/CDx Assays, Gene/Cell Therapy and Vaccine Assays and Panel Discussions for 2024 White Paper in Bioanalysis" |
Note: Recommendations related to Specialized Workshops M1, M2, T1, Th1, Th2, F1, F2 are shared during M1, M2, T1, Th1, Th2, F1, F2 Specialized Workshops
