AGENDA - Specialized Workshop T1 - Tuesday Sep. 28, 2021: 8am - 5pm

"Mass Spectrometry of Biotherapeutics, Protein Biomarkers and Transgene Proteins: Recent Issues from Discovery to Regulatory Submissions"

Current advancement in Hybrid Assay (IA-MS), innovative Triple Quad sensitivity gain, HRMS (QTOF & Orbitrap) method development approaches, Hybrid assay Bioanalytical Assay Validation for regulatory submission, Transgene Protein bioanalysis & Tissue Assays for Gene Therapy, Latest Mass Spec Approaches and Technology Advancements for quantification of protein Therapeutics/Biomarkers, challenges for Sample Preparation & Immunoaffinity, HRMS bioanalysis for Intact Large Molecule, Biotherapeutics Biodistributions

Opening Lecture

Chair:Dr. Dian Su, Senior Director, DMPK, Mersana
08:00am–08:20am: Dr. John (Jack) Kellie, Scientific Leader & Fellow, GlaxoSmithKline
"Recent Advancements in Mass Spectrometry of Large Molecules at GSK"

Session 1: Protein Therapeutics

Chair: Dr. Dian Su, Senior Director, DMPK, Mersana
08:20am-08:40am: Dr. Y-J Xue, Scientific Director Nonclinical Disposition and Bioanalysis, Bristol Myers Squib
"Mass Spectrometry-based Glycan Bioanalysis for Therapeutic Glycoproteins"
08:40am-09:00am: Dr. Huiyu Zhou, Director BioAnalytical Research & Development, BioMarin
"Advanced Applications of Hybrid Assays and Challenges in Overcoming ADA Interferences"
09:00am-09:20am: Dr. Shawna Hengel, Associate Director DMPK, Seattle Genetic
"Microflow and Ionization sources for Biotherapeutics Bioanalysis - Impact to LLOQ and Selectivity/Specificity"
09:20am-09:40am: Mr. Robert Wheller, Associate Scientific Director LC-MS Bioanalysis, LGC
"Bioanalysis of Biotherapeutics by LC-MS/MS: Focus on Speed, Sensitivity & Robustness in Regulated Assays"
09:40am-10:30am: Dr. John (Jack) Kellie , Scientific Leader & Fellow, GlaxoSmithKline
Dr. Y-J Xue , Scientific Director Nonclinical Disposition and Bioanalysis, Bristol Myers Squib
Dr. Huiyu Zhou, Director BioAnalytical Research & Development, BioMarin
Dr. Shawna Hengel, Associate Director DMPK, Seattle Genetic
Mr. Robert Wheller, Associate Scientific Director LC-MS Bioanalysis, LGC
"Panel Discussions on Recent Advancements in Mass Spectrometry of Large Molecules and Protein Therapeutics "
10:30am-11:10am: Short Break

Session 2: Protein Biomarkers

Chair: Dr. Gene Ciccimaro, Scientific Associate Director Bioanalytics, Bristol Myers Squibb
11:10am-11:30am: Dr. Wenying Jian, Group Leader, Bioanalytical and Pharmacokinetics, Janssen
"Application of Hybrid Assays to Quantify Protein Biomarkers"
11:30am-11:50am: Dr. Lin-Zhi Chen , Senior Research Fellow, Boehringer Ingelheim
"Hybrid LBA/LCMS for Target Engagement Assessment"
11:50am-12:10pm: Ms. Anita Lee, Principal Scientist Translational Biomarkers, Merck
"Development, Validation, and Implementation of a Target Engagement Protein Biomarker Assay"
12:10pm-12:30pm: Dr. Ludovicus Staelens, Director Translational Biomarkers and Bioanalysis, UCB
"High Sensitivity Biomarker Analysis by Mass Spec: Drive for Determination of Low Abundance Protein Biomarkers"
12:30pm-01:10pm: Dr. Wenying Jian, Group Leader, Bioanalytical and Pharmacokinetics, Janssen
Dr. Lin-Zhi Chen, Senior Research Fellow, Boehringer Ingelheim
Ms. Anita Lee, Principal Scientist Translational Biomarkers, Merck
Dr. Ludovicus Staelens, Director Translational Biomarkers and Bioanalysis, UCB
"Panel Discussions on Protein Biomarkers"
01:10pm-01:50pm: Short Break

Session 3: Transgene Proteins & Anti-Drug Antibodies (ADA)

Chair: Dr. Gene Ciccimaro, Scientific Associate Director Bioanalytics, Bristol Myers Squibb
01:50pm-02:10pm: Dr. Haibo Qiu, Associate Director, Regeneron
"Recent Developments in the Quantification of ADA by Hybrid Assays (IA-MS)"
02:10pm-02:30pm: Dr. Hiroshi Sugimoto, Group Lead and Principal Scientist, Takeda
"Opportunities and Challenges of LC/MS-based Transgene Protein Analysis "
02:30pm-02:50pm: Mr. Joe Palandra, Senior Principal Scientist Biomeasures/Biomarker, Pfizer
"Transgene Protein Analysis and Validation Considerations for Clinical Applications"
02:50pm-03:20pm: Dr. Haibo Qiu, Associate Director, Regeneron
Dr. Hiroshi Sugimoto, Group Lead and Principal Scientist, Takeda
Mr. Joe Palandra, Senior Principal Scientist Biomeasures/Biomarker, Pfizer
"Panel Discussions on Transgene Proteins & Anti-Drug Antibodies (ADA)"
03:20pm-04:00pm: Short Break

Session 4: 2021 White Paper in Bioanalysis

04:00pm-04:30pm: Dr. Dian Su, Senior Director, DMPK, Mersana
Dr. Gene Ciccimaro, Scientific Associate Director Bioanalytics, Bristol Myers Squibb
"Recommendations on Mass Spectrometry of Biotherapeutics, Protein Biomarkers and Transgene Proteins: Recent Issues from Discovery to Regulatory Submissions "
04:30pm-05:00pm: Dr. Dian Su, Senior Director, DMPK, Mersana
Dr. Gene Ciccimaro, Scientific Associate Director Bioanalytics, Bristol Myers Squibb
"Panel Discussions on 2021 White Paper in Bioanalysis draft Recommendations "
05:00pm-05:20pm: Short Break
05:20pm-06:20pm: Poster Spotlight Sessions with open access to all attendees




Agenda at a Glance Agenda at a Glance