Panel discussion: LBA and LC–MS/MS hybrid assays

What will you learn?

• What are the traditional approaches for biopharmaceutical quantification? When would LBA and LC–MS be used?
• Hybridization – is it the new norm?
• What are the pros and cons of hybrid assays?
• Which areas of bioanalysis are they currently being used in? Where might they be used in future?
• What is required for broader adoption of the hybrid technique?
• How do we currently approach acceptance criteria for hybrid assays?

Who this may interest?

• Researchers in drug discovery
• Scientists performing pharmacokinetic studies and regulated bioanalysis
• Biomarker scientists

Speakers

Shivangi Awasthi

Associate Principal Scientist

Merck & Co., Inc (PA, USA)

Shivangi Awasthi serves as an Associate Principal Scientist within the Regulated Bioanalysis group at Merck & Co., Inc. Her primary research focus is the development of sensitive and selective LC–MS methods for precise PK measurements to inform drug exposure, safety and dose selection, thereby driving the efforts to provide life-saving medicines globally.

Linzhi Chen

Senior Research Fellow

Boehringer Ingelheim Pharmaceuticals (CT, USA)

Dr Chen obtained his BS and MSc degrees from Nankai University (Tianjin, China), and PhD degree in organic chemistry from the University of Mons (Belgium). After postdoctoral training at the Pacific Northwest National Laboratory in Washington (WA, USA), he joined 3M Pharmaceuticals (MN, USA) where he became a group leader responsible for metabolism and PK studies. He then joined Boehringer Ingelheim Pharmaceuticals to lead a group primarily responsible for metabolism and bioanalysis in support of drug development. In recent years, his group has been providing bioanalytical support to the development of therapeutic proteins and oligonucleotides as well as viral vector-based gene therapy. His group has developed a number of LC/MS assays for various biotherapeutic proteins such as nanobodies, Fabs, bispecifics and mAbs, siRNA and viral proteins. He was the pioneer of developing and applying immunocapture-LC/MS methodology for simultaneous anti-drug antibody isotyping and semi-quantitation.

His recent research focuses on assessment of in vivo critical quality attributes of biologic therapeutics, target  engagement, biomarker and mechanistic investigation of biotherapeutics and ATMPs. Dr Chen has more than 40 publications in peer-reviewed journals and has served as editorial board member of several scientific  journals and IQ consortium workgroups. Dr Chen has given numerous talks at international conferences and taught various training courses sponsored by the pharmaceutical industry.

Shashank Gorityala, PhD

Associate Director, Large Molecule Mass Spectrometry

BioAgilytix (NC, USA)

Shashank Gorityala has more than 10 years of experience in biological and analytical research. In his current role as Associate Director, he leads a team of scientists on large molecule bioanalysis by LC/MS at BioAgilytix. His team focuses on developing methodologies to offer bioanalytical support for the analysis of biomarkers, biologics, and novel modalities in biofluids and tissues. Shashank graduated from Cleveland State University in Cleveland (OH, USA), with an MS in Analytical Chemistry and a PhD in Clinical Bioanalytical Chemistry. He received academic training on mass spectrometry-based applications in small molecules, biomarkers, proteomics, and untargeted lipidomics/metabolomics at Case Comprehensive Cancer Center (OH, USA). He is passionate about science and innovation to explore opportunities on how LC/MS can interface cross-platform with other techniques to solve complex bioanalytical challenges in drug development and safety.

Barry Jones

Associate Director, Biomarker Bioanalysis

Crinetics Pharmaceuticals (CA, USA)

As the Associate Director Biomarker/Bioanalysis, Barry Jones leads the biomarker and PK measurement strategy for Crinetics Pharmaceuticals (CA, USA) in clinical studies supporting their drug development pipeline for rare endocrine diseases. After receiving his PhD in Physical Chemistry from Binghamton University (NY, USA), Barry managed the University’s Mass Spectrometry Core facility for proteomic research until joining Q² Solutions (then Advion Biosciences) in 2007. Barry led the large molecule LC–MS team at Q² Solutions (NY, USA) prior to starting his current role at Crinetics in 2022. Dr Jones is particularly interested in the application of hybrid immunoaffinity-LC–MS, high-resolution mass spectrometry and low-flow chromatography techniques to regulated bioanalytical methods, as well as the scientific challenges and validation strategies for LC–MS biomarker assays supporting drug development.

John R Perkins

Senior Scientific Advisor

KCAS Bioanalytical and Biomarker Services (KS, USA)

John R Perkins, PhD is the Senior Scientific Advisor with a focus on LC/MS technologies at KCAS Bioanalytical and Biomarker Services, a bioanalytical CRO, serving the pharmaceutical and biopharmaceutical industries based in Olathe, Kansas. Previously, he was at Q² Solutions (NY, USA) and legacy companies for over 24 years working in quantitative LC–MS/MS, principally with small molecules and small molecule biomarkers. His primary focus was on validation and sample analysis processes as well as managing customer relationships in Ithaca NY and Oss, The Netherlands.

Daniel Schulz-Jander

Senior Director, Bioanalysis (Mass spectrometry)

QPS Netherlands (Groningen, Netherlands)

Daniel received his Dipl Chem from the University of Kassel (Kassel, Germany) in chemistry, his Doctor rerum naturalium from the Technische Universität München (Munich, Germany) in environmental chemistry, followed by a post-doctoral fellowship in pesticide metabolism at UC Berkeley (CA, USA). Since then, Daniel’s scientific passion has been in bioanalysis. Starting in biotech at Ligand and Arena Pharmaceuticals (CA, USA), he then moved to Medtronic (CA, USA) where he built a bioanalytical team specializing in drug in tissue analyses. Since February 2022, Daniel is currently the Senior Director of bioanalysis mass spectrometry at QPS Netherlands, where his team supports small and large molecule bioanalysis with LC-MS/MS as well as ICP/MS.