Specialized Workshop T1 - Tuesday May 07, 2024: 7am to 5:45pm
"AGENDA - Advanced Strategies for Mass Spectrometry Assays"
| 07:00am-08:00am: | Start your day at WRIB with Networking Continental Breakfast in the Exhibit Room |
Session 1: Biomarker Assays Advanced Strategies for Method Development/FFP BAV: FFPE Tissue, GIP Panel and Low Abundant Proteins
Chair: Dr. Allena Ji, Senior Director, Global Diagnostics, Chiesi| 08:00am-08:20am: |
Mr. John Meissen, Associate Director, Biomarker Development, Astra Zeneca "LC-MS FFPE Tissue Analysis Supports Mouse Model Relevance for anti-STEAP2 CAR-T On-Target/Off-Tumor Toxicity Assessment" |
| 08:20am-08:40am: |
Mr. Joe Palandra, Associate Director, Mass Spectrometry Clinical Bioanalysis, Takeda "Use of Hybrid Immunoaffinity MS (IA-MS) for the Measurement of Gluten Peptides in Urine" |
| 08:40am-09:00am: |
Dr. Naiyu Zheng, Scientific Associate Director, Bristol Myers Squibb "Strategies for De Novo Assay Development to Quantify Low Abundant Endogenous Protein Biomarkers by Immunocapture-LC-MS/MS for Clinical Applications" |
| 09:00am-09:20am: |
Mr. John Meissen, Associate Director, Biomarker Development, Astra Zeneca
Mr. Joe Palandra, Associate Director, Mass Spectrometry Clinical Bioanalysis, Takeda Dr. Naiyu Zheng, Scientific Associate Director, Bristol Myers Squibb "Panel Discussions on Biomarker Assays Advanced Strategies for Method Development/FFP BAV: FFPE Tissue, GIP Panel and Low Abundant Proteins" |
| 09:20am-10:05am: | Networking Coffee Break with Morning Snacks in the Exhibit Room |
Session 2: Hybrid Assays (IA-MS) for PK: Advanced Strategies for ADC, Glycoproteins, Biotransformation and ICH M10 FFP Validation
Chair: Dr. Haibo Qiu, Director, Regeneron| 10:05am-10:25am: |
Dr. Lawrence Linzhi Chen, Bioanalytical Group Leader & Senior Research Fellow, Boehringer Ingelheim "Assessing in vivo critical quality attribute of biotherapeutics by mass spectrometry: high mannose impact on PK" |
| 10:25am-10:45am: |
Dr. Adam Vigil, Senior Director, Preclinical & Translational PK/PD, Regeneron Ms. Wei Wei, Senior Scientist, Boehringer Ingelheim "Immunocapture-LC/MS investigation of the biomodification of a novel multi-domain therapeutic protein" |
| 10:45am-11:05am: |
Dr. Megan Cooley, Associate Director, Bioanalytical Services, ICON "Continued lessons for the validation of hybrid LC-MS/MS assays" |
| 11:05am-11:25am: |
Dr. Lawrence Linzhi Chen, Bioanalytical Group Leader & Senior Research Fellow, Boehringer Ingelheim
Dr. Adam Vigil, Senior Director, Preclinical & Translational PK/PD, Regeneron Ms. Wei Wei, Senior Scientist, Boehringer Ingelheim Dr. Megan Cooley, Associate Director, Bioanalytical Services, ICON "Panel Discussions on Hybrid Assays (IA-MS) for PK: Advanced Strategies for ADC, Glycoproteins, Biotransformation and ICH M10 FFP Validation" |
Session 3: New Small Molecules Challenges and Ultra Sensitivity Mass Spec in Discovery & Regulated Bioanalysis
Chair: Dr. Christopher Kochansky, Director, DMPK, Exelixis| 11:25am-11:45am: |
Dr. Estelle Maes, Director, Non-Regulated Bioanalysis, AbbVie "The Real-World Challenge: Enabling MS-Based High-Throughput Global Bioanalysis to Support Drug Discovery" |
| 11:45am-12:05pm: |
Dr. Yongjun Xue, Scientific Director, Bioanalysis, Bristol Myers Squibb "1-beta-Hydroxydeoxycholic Acid as an Endogenous Biomarker in Human Plasma for Assessment of CYP3A Clinical Drug-Drug Interaction Potential" |
| 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: |
Ms. Elizabeth Hyer, Associate Director, Bioanalytical, Labcorp "Accessible Techniques for Targeting Decreasing LLOQs in Regulated Bioanalysis" |
| 01:25pm-01:45pm: |
Dr. Dawn Dufield, Scientific Officer, Mass Spectrometry, KCAS "Development and Fit-for-Purpose Qualification of Small Molecule Biomarker Panels by LC-MS/MS - Examples and Case Studies" |
| 01:45pm-02:05pm: |
Dr. Estelle Maes, Director, Non-Regulated Bioanalysis, AbbVie
Dr. Yongjun Xue, Scientific Director, Bioanalysis, Bristol Myers Squibb Ms. Elizabeth Hyer, Associate Director, Bioanalytical, Labcorp Dr. Dawn Dufield, Scientific Officer, Mass Spectrometry, KCAS "Panel Discussions on New Small Molecules Challenges and Ultra Sensitivity Mass Spec in Discovery & Regulated Bioanalysis " |
Session 4: High Quality/Throughput Tissue Measurements to support Oligonucleotides and Biomarkers
Chair: Dr. Lin Tao, Associate Director, Sanofi| 02:05pm-02:25pm: |
Mr. Jay Johnson, Principal Scientist, Quantitative Biomarkers and Biomeasures, Pfizer "Automated Tissue Preparation Strategies for Protein Biomarker Bioanalysis: Recent and Ongoing Developments for Increasing Speed, Accuracy, and Transferability" |
| 02:25pm-02:45pm: |
Dr. Wenkui Li, Director, Bioanalytics, Novartis "Importance of sample preparation in LC-MS bioanalysis of ASOs / siRNAs" |
| 02:45pm-03:05pm: |
Dr. Xiaonan Tang, Vice President, Bioanalytical Services, Frontage "Challenges in LC-MS-Based Bioanalysis of Tissue Samples: Considerations and Case Studies" |
| 03:05pm-04:05pm: |
Networking Break with Afternoon Snacks, and Wine and Beer Reception in the Exhibit Room |
| 04:05pm-04:25pm: |
Dr. Aihua Liu, Senior Director, Bioanalysis, Resolian "Ultra-Sensitive LC-MS Assay Development for Oligonucleotides in Tissue: Overcoming Challenges" |
| 04:25pm-04:45pm: |
Mr. Jay Johnson, Principal Scientist, Quantitative Biomarkers and Biomeasures, Pfizer
Dr. Wenkui Li, Director, Bioanalytics, Novartis Dr. Xiaonan Tang, Vice President, Bioanalytical Services, Frontage Dr. Aihua Liu, Senior Director, Bioanalysis, Resolian "Panel Discussions on High Quality/Throughput Tissue Measurements to support Oligonucleotides and Biomarkers " |
Session 5: 2024 White Paper in Bioanalysis
| 04:45pm-05:45pm: |
Dr. Allena Ji, Senior Director, Global Diagnostics, Chiesi Dr. Haibo Qiu, Director, Regeneron Dr. Christopher Kochansky, Director, DMPK, Exelixis Dr. Lin Tao, Associate Director, Sanofi "Recommendations on Mass Spectrometry Assays and Panel Discussions for 2024 White Paper in Bioanalysis" |
