Main Workshop DAY 3 - Thursday May 09, 2024: 7am - 5:45pm

"AGENDA - Mass Spectrometry, Chromatography, and Sample Preparation"

07:00am-08:00am: Start your day at WRIB with Networking Continental Breakfast in the Exhibit

Session 1: New Regulatory Challenges and Concerns in Mass Spec Bioanalysis for Novel Modalities, PCS and NHP Studies

Chair: Dr. Timothy Sikorski, Director, LC-MS Bioanalysis and Biomarkers, GSK
08:00am-08:20am: Dr. Mark Qian, Global Head of Bioanalytical Sciences and Immunogenicity , Takeda Pharmaceuticals
"New mass spectrometric quantitative assays for pro-antibody drugs and oligonucleotides"
08:20am-08:40am: Mr. Mike Baratta, Senior Director & Head of Mass Spectrometry Clinical Bioanalysis, Takeda
"Evaluation of Pre-Analytical Variables to Enable Patient Centric Sampling"
08:40am-09:00am: Dr. Hiroshi Sugimoto, Director, Nonclinical Biomarker , Takeda
"Integrative bioanalytical strategy to support the NHP biodistribution study"
09:00am-09:20am: Dr. Mark Qian, Global Head of Bioanalytical Sciences and Immunogenicity , Takeda Pharmaceuticals
Mr. Mike Baratta, Senior Director & Head of Mass Spectrometry Clinical Bioanalysis, Takeda
Dr. Hiroshi Sugimoto, Director, Nonclinical Biomarker , Takeda
"Panel Discussions on New Regulatory Challenges and Concerns in Mass Spec Bioanalysis for Novel Modalities, PCS and NHP Studies"
09:20am-10:05am: Networking Coffee Break with Morning Snacks in the Exhibit

Session 2: TE/PD Biomarkers and Free & Drug Bound Soluble Targets Measurements/Quantification by Mass Spec

Chair: Dr. John Wojcik, Executive Director, Translational Molecular Biomarkers, Merck
10:05am-10:25am: Dr. Yu Tian, Director, Quantitative Proteomics and Omics Technology, AbbVie
"Mass-Spec Based Proteomics and Multi-Omics in Pharmaceutical R&D"
10:25am-10:45am: Dr. Yeoun Jin Kim, Senior Director, Translational Proteomics , Astra Zeneca
"Assessing target engagement by targeted proteomics in clinical setting"
10:45am-11:05am: Dr. Eugene Ciccimaro, Scientific Associate Director, Bioanalysis, Bristol Myers Squibb
"The Tissue Protein Library: An Evolution in LC/MS Protein Bioanalysis"
11:05am-11:25am: Dr. Michael Lassman, Director, Translational Biomarkers, Merck
"Strategy and execution of free and bound target engagement assays to support MK-0616 clinical development"
11:25am-11:45am: Dr. Yu Tian, Director, Quantitative Proteomics and Omics Technology, AbbVie
Dr. Yeoun Jin Kim, Senior Director, Translational Proteomics , Astra Zeneca
Dr. Eugene Ciccimaro, Scientific Associate Director, Bioanalysis, Bristol Myers Squibb
Dr. Michael Lassman, Director, Translational Biomarkers, Merck
"Panel Discussions on TE/PD Biomarkers and Free & Drug Bound Soluble Targets Measurements/Quantification by Mass Spec"

Session 3: Advancements in Oligonucleotides by Mass Spec: Quantification, Metabolite Profiling and Use of Microsampling

Chair: Dr. Jian Wang, Director, Bioanalysis, Crinetics
11:45am-12:05pm: Dr. Wenying Jian, Director, Bioanalytical Discovery and Development Sciences, Johnson & Johnson Innovative Medicine
"Development and Application of Bioanalytical Platforms for siRNA Therapeutics"
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. Long Yuan, Director & Head of Bioanalytical Group, Biogen
"Hybridization LC-MS/MS for siRNA and ASO Quantification: Method Development Strategy and Application in Capillary Microsampling"
01:25pm-01:45pm: Dr. Susovan Mohapatra, Director, DMPK, Stoke
"Strategy and Methods for Evaluating Metabolites to Support Preclinical and Clinical Development of Oligonucleotide Therapeutics"
01:45pm-02:05pm: Dr. Wenying Jian, Director, Bioanalytical Discovery and Development Sciences, Johnson & Johnson Innovative Medicine
Dr. Long Yuan, Director & Head of Bioanalytical Group, Biogen
Dr. Susovan Mohapatra, Director, DMPK, Stoke
"Panel Discussions on Advancements in Oligonucleotides by Mass Spec: Quantification, Metabolite Profiling and Use of Microsampling "

Session 4: Hybrid Assays (IA-MS) - New Applications for Multispecifics, Engineered Antibodies and Complement Proteins

Chair: Dr. Yue Huang, Director, DMPK, Revolution Medicines
02:05pm-02:25pm: Dr. Inna Vainshtein, Executive Director, Bioanalysis, Exelixis
"Comparison of Ligand-binding and Hybrid LCMS methods for evaluation of Antibody-drug Conjugate (ADC) pharmacokinetics (PK) in clinical assays"
02:25pm-02:45pm: Dr. Anton Rosenbaum, Senior Group Director, Integrated Bioanalysis, AstraZeneca
"Biotransformation methodologies and case studies: Comprehensive Biotransformation Profiling of AZD8205, an Anti-B7-H4 Antibody-Drug Conjugate, Elucidates Pathways Underlying its Stability In Vivo"
02:45pm-03:05pm: Ms. Hetal Sarvaiya, Director, Biologics Characterization & Bioanalysis, AbbVie
"Bioanalytical Strategy for In vitro Characterization and In vivo Stability Assessment for Multispecific Antibodies"
03:05pm-04:05pm: Networking Break with Afternoon Snacks, and Wine and Beer Reception in the Exhibit
Reception
04:05pm-04:25pm: Dr. Rachel Green, Director, Bioanalysis & Biomarkers , Complement
"A Novel Targeted LC-MS Assay for Measurement of Multiple Complement Proteins"
04:25pm-04:45pm: Dr. Inna Vainshtein, Executive Director, Bioanalysis, Exelixis
Dr. Anton Rosenbaum, Senior Group Director, Integrated Bioanalysis, AstraZeneca
Ms. Hetal Sarvaiya, Director, Biologics Characterization & Bioanalysis, AbbVie
Dr. Rachel Green, Director, Bioanalysis & Biomarkers , Complement
"Panel Discussions on Hybrid Assays (IA-MS) - New Applications for Multispecifics, Engineered Antibodies and Complement Proteins "

Session 5: 2023 White Paper in Bioanalysis

04:45pm-05:45pm: Dr. Timothy Sikorski, Director, LC-MS Bioanalysis and Biomarkers, GSK
Dr. John Wojcik, Executive Director, Translational Molecular Biomarkers, Merck
Dr. Jian Wang, Director, Bioanalysis, Crinetics
Dr. Yue Huang, Director, DMPK, Revolution Medicines
"Recommendations on Mass Spectrometry, Chromatography and Sample Preparation and Panel Discussions for 2023 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




Agenda at a Glance Agenda at a Glance