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Hybrid LC-MS for Protein therapeutics and biomarkers: Recent developments in characterization and quantification

Speakers: Dawn Dufield (KCAS Bio), Hetal Sarvaiya (Stemcentrx Abbvie), Jessy Fan (Amgen), Richard Seipert (Genentech), Yihan Li (Sciex), Suk Hyung (Genentech), Jintang He (Genentech)
Organizers: Keyang Xu and Surinder Kaur (Genentech)
Date: 11/16/2018
Time: 8:45-17:00
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (2)Catalent Pharma Solutions; Q2 Solutions
Vendor show vendors registered to date: (8)Agilent; Alturas Analytics; Intertek; KCAS Bioanalytical & Biomarker Services; QPS; SCIEX; Tecan SP; Thermo Fisher Scientific, SID
Registration deadline:11/16/2018  (it will close sooner if the seating cap is reached)

About the Topic

Hybrid LC-MS assays, combining features from both ligand binding for preferred analyte enrichment and LC-MS for enhanced detection selectivity, have demonstrated the potential as a complementary or alternative platform to conventional LBAs for bioanalysis of protein therapeutics and biomarkers. This novel technology effectively allows characterization and quantification of biological target analytes, including mAbs, ADCs, other complex modalities and tissue biomarkers where no suitable solutions existed previously. 
This specific workshop is aimed to provide the audience a general introduction, as well as recent developments, of this powerful analytical technology. Both bottom-up and top-down approaches in gaining quantitative and qualitative (e.g., major PTMs) information of protein analytes will be described. Advantages and certain limitations associated with this new platform will be discussed.  Recent progress in this field will be highlighted to demonstrate how a variety of analytical challenges are overcome to pave the way for an increasing practical applications of hybrid LC–MS in characterization and quantification of protein therapeutics and biomarkers. Case studies will include immunoaffinity enrichment, protein biotransformations by HRMS, quantification of total antibody and antibody-conjugated payload of ADCs, tissue-based bioanalysis, LC/MS in CMC for specification tests of APIs, considerations for improving the assay sensitivity, as well as outsourcing.
Workshop Agenda:

8:45 am – 9:00 am            PBSS Welcome - Shichang Miao and Keyang Xu

9:00 am – 9:40 am            1. Qualitative and Quantitative Bioanalysis of Protein Therapeutics using Mass Spectrometry- Hetal Sarvaiya

9:40 am - 10:30 am           2. Quantification of Protein Biotherapeutics and Biomarkers Using Surrogate Peptide Approach - Dawn Dufield

10:30 am - 10:50 am        Break & Vendor Show  

10:50 am – 11:30 am       3. Protein/Peptide Immuno-affinity Enrichment (PIE) LC-MS Application in Biomeasures and Biodistribution Studies of Protein Therapeutics - Jessy Fan

11:30 am – 12:50 pm       Lunch   

12:50 pm – 1:30 pm         4. Improving and Utilizing Mass Spectrometry Techniques for the Characterization of Therapeutic mAbs and ADCs                - Richard Seipert

1:30 pm – 2:10 pm           5. Comprehensive Methodologies for High Performance Biotherapeutic Quantitation - Yihan Li

2:10 pm - 2:20 pm            Major Sponsor’s Presentation - Q2 Solutions

2:20 pm - 2:40 pm            Break & Vendor Show  

2:40 pm - 3:20 pm            6. Application of Quantitative Immunoaffinity LC-MS/MS Antibody-Conjugated Drug Assay to Understand Biotherapeutic Stability and Biotransformations - Suk Hyung

3:20 pm - 4:00 pm            7. Characterization of Intact Antibody-Drug Conjugates from In Vivo Samples by Affinity Capture LC-MS - Jintang He

4:00 pm - 4:30 pm            Panel Discussion + Final Remarks - All

About the Speakers

Dawn Dufield
Dr. Dawn Dufield is the Director, BioPharma Services at KCAS. She received her Ph.D. in Chemistry from the University of Kansas. She joined Monsanto in 1997 which transitioned into Pfizer in 2004. She has been with Pfizer and legacy companies for over 20 years. Dr. Dufield has been working in the LC-MS/MS field since 1997. She has extensive experience in developing qualitative and quantitative LC-MS/MS assays for both large and small molecules. She has developed numerous assays using both traditional and immunoaffinity enrichment approaches. She was one of the early pioneers of using immunoaffinity combined with LC-MS/MS to offer additional selectivity which is now commonly referred to as Hybrid LCMS. She currently is a member of the AAPS Mass Spec Protein Bioanalysis Committee (MSPBC) and an active member of ASMS. She has numerous publications and presentations in her field and recently contributed to a white paper on recommendations for validation of LCMS based bioanalytical methods for protein biotherapeutics.

Hetal Sarvaiya (Abbvie-Stemcentrx)
Ms. Hetal Sarvaiya is currently a Senior Scientist III at Stemcentrx Abbvie LLC, leading the research mass-spec group and LC-MS ADC platform team to support a variety of different ADC programs from research to development. She received her Masters in Biomedical Engineering from Virginia Tech. Prior to joining Stemcentrx, Ms. Sarvaiya also worked at Momenta Pharmaceuticals and Merck. She has 12+ years of industry experience in developing LC-MS based methods for qualitative and quantitative bioanalysis of different biotherapeutics modalities (mAbs, bispecifics, fusion proteins, nanobodies, and ADCs), as well as biosimilars. Her research work has also covered proteomics and glycomics platform development to support translational research studies. Recently, her focus is to evaluate the stability of different linker drugs and conjugations as well as develop robust quantitative assays for total antibody and conjugated antibody read-outs from in-vivo pharm/tox studies.

Jessy Fan (Amgen)
Dr. Jessy Fan is currently a Scientist at Amgen. She finished her graduate study in ETH Zurich, Switzerland, focusing on the mechanism of protein glycosylation. She then got her industry exposure as a postdoc at Pfizer, and continued to worked in the PKDM department as a Senior Scientist. She later moved to Amgen in 2016. Dr. Fan has strong and broad expertise in mass spectrometry quantification and characterization of large molecules ( protein/peptide, glycolipid, carbohydrate) and small molecules. Her responsibilities cover designing, executing, and staff training for IND-enabling PKDM activities mainly for protein therapeutics programs, including PK/PD, target engagement, mechanism of action (MOA), biodistribution analysis etc.

William Haskins (Catalent Biologics-West)
Dr. William Haskins is the Director of R&D, Bioanalytical Chemistry at Catalent Biologics-West (formerly Redwood Bioscience). He is an interdisciplinary leader responsible for therapeutic bioconjugates from Research through Phase I/II/III clinical trials. Dr. Haskins has authored or co-authored more than 70 peer-reviewed publications focused on R&D of disruptive technologies for protein diagnostics and therapeutics.

Richard Seipert (Genentech)
Dr. Richard Seipert is currently a Senior Scientist at Genentech. He is a bioanalytical chemist with 10 years of experience in the biotechnology industry. His experience includes mass spectrometry and chromatography based method development, method validation, and control system strategy. He also has experience managing and has served as analytical and technical team leader for several early stage projects in addition to coaching direct reports and mentoring individuals.

Yihan Li (Sciex)
Dr. Yihan Li is currently an Application Scientist at Sciex. She obtained her Ph.D. at University of Washington, working on the development of CE-MS for proteomics research. She then received her postdoc training at Northwestern University where she focused on MS method development for top-down proteomics. Dr. Li worked at the proteomics core facility at University of Hawaii before joining SCIEX in 2015. Her unique experience in both bottom-up and top-down protein characterization and quantification allow her to design various strategies to achieve high sensitivity for both intact quantification and signature peptide analysis.

Suk Hyung (Genentech)
Dr. Suk Hyung is a Scientist in the Bioanalytical Sciences Department at Genentech. Currently, his research has been primarily focused on the development of bioanalytical assays to support antibody-drug conjugates programs utilizing mass spectrometry. These contributions have enabled a better understanding of the stability and biotransformation of ADCs in vivo. Prior to joining Genentech, Dr. Hyung was a postdoctoral fellow at Pfizer and holds a Ph.D. in Chemistry from the University of Cambridge. He has authored more than 20 publications.

Jintang He (Genentech)
Dr. Jintang He is currently a Scientist in the BioAnalytical Sciences department at Genentech. He is responsible for developing high resolution mass spectrometry methods to characterize in vivo biotransformations of antibody-drug conjugates. He received his Ph.D. in Biochemistry from Peking University. He then completed his first postdoctoral training in proteomics at University of Michigan – Ann Arbor, and pursued further training in mass spectrometry at Pacific Northwest National laboratory. Dr. He joined Genentech in 2014 and his research interests include characterization of ADC biotransformation and quantification of protein therapeutics.

2018-12-04, Challenges in Peptide Drug Discovery & Development: Biology, Chemistry, PK, Delivery, Regulatory and Beyond
2019-02-07, Covalent Inhibitor Drug Discovery & Development: Biology, Chemistry, PK, Safety and Case Studies (Jointly with Bay Area PKPD Network)
2019-03-07, Promising therapeutic approaches and transnational medicine from SPARK: an academic-industry collaboration to advance novel therapeutics (A Joint Symposium by PBSS and Stanford SPARK Program)
2019-03-11, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
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