The SSF kicked off July 11with a morning plenary titled "Old Platform New Tricks" with opening remarks from our Chair @Boris Gorovits . The LCMS/MS platform was leveraged to address challenges with novel and complex modalities covered through range of talks in first and second half of the session. The application ranged from detection of low levels of enzymes implicated in inborn errors of metabolism to distinguishing of glycosylated versions of fusion proteins as well as transgene protein expression. The use of mass spec to understand ADME, biotransformation and PK of ADCs followed by the ADA isotyping using LCMS were great presentations highlighting the use of LCMS.
Track 1: Bioanalytical
Morning Plenary: Old Platform, New Tricks Part 1
Moderator: Vibha Jawa, PhD FAAPS, BMS
Enzyme Analysis by LC-MS/MS (Matthew Schultz, Ph.D., Mayo Clinic)
LCMA; Distinguish Endrogenous vs Drug Product (Ines Santos, Ph.D., Bristol Myers Squibb)
Transgene Expression - LCMS (Jason M. Walsh, Ph.D., Pfizer Inc.)
Mass Spectrometry Provides Insights into ADC Drug Development: Case Studies in PK, ADME, and Biotransformations (Violet Lee, Ph.D., Genentech)
Use of LCMS for ADA Isotyping (Li Sun, Ph.D., Merck & Co., Inc.)
Ist plenary was followed by 2 Thought Leadership Presentations
Challenges and Strategies in Developing Hybrid LCMS Methods for Proteins (Ben Nie, Ph.D., BioAgilytix Labs, LLC)
Setting the First Human Dose: Minimizing Variables Across Species (Shane Needham, Ph.D., Veloxity Labs LLC)
The afternoon plenary session moderated by @Amanda Hays focused again on older methods being used to answer novel challenges. The talk on single cell analysis using high parameter flow cytometry highlighted immune monitoring approaches. This was followed by use of Gyros platforms for support of bioanalysis of novel modalities like bispecifics and active and non-active forms of probodies.
The last talk of the session was a thought leadership presentation on comparison of high-resolution mass spectrometric assays compared to conventional ligand binding assays. The day ended with 4 rapid fire talks moderated by @Ines Santos that covered novel assays for PK and PD detections using flow, immunocapture PCR, LCMS and computational biology based immunogenicity risk assessment tools.
Increasing Complexity in Single-cell Analysis: Challenges and Opportunities for High Parameter Flow Cytometry in Clinical Trials (@Enrique Gomez Alcaide, Ph.D., Roche)
Bioanalysis of Novel Protein Modalities (@Alexander Kozhich, Ph.D., Bristol Myers Squibb)
Application of Mass Spectrometry in Uncovering New Biology of Therapeutic Targets (@Eugene Zhen, Ph.D., Eli Lilly & Company)
Choosing HRMS vs. LBA for Bioanalysis (@Adriane Spytko, Q2 Solutions)
Rapid fires
Development of Pharmacodynamic Assay to Measure Intracellular Response Biomarkers Using Peripheral Blood
Mononuclear Cells: Paths and Pitfalls (Eric Cruz, Ph.D., Celerion)
Single PK Method for Active, Mask, and Prodrug Using LC/MS (Emily Werth, Ph.D., Boehringer Ingelheim)
Ultra-sensitive Immuno-capture PCR Demonstrates Rapid Plasma Clearance and Minimal Shedding of Intact AAV5
Vector Capsids (Krystal Sandza, BioMarin Pharmaceutical, Inc.)
Computational Prediction of Biotherapeutic Immunogenicity Risk (Patrick Wu, MD, Ph.D., Genentech)
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Vibha Jawa
Executive Director
Clinical Pharmacology and Pharmacometrics Disposition and Bioanalysis
Bristol-Myers Squibb
Princeton,NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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