Panel discussion: LBA vs LC–MS/MS

What will you learn?

• Current trends in surrogate matrices and hybrid LC-MS/MS
• The process of validation for non-primary matrices
• The highlights and challenges of selecting matrices for hybrid LC-MS/MS

Who this may interest?

• CROs, pharmaceutical and biotechnology companies focused on LC-MS/MS quantitative bioanalysis
• Mass spectrometrists and bioanalytical chemists
• Academics and students interested in LC-MS/MS

Speakers

  Mackenzie Bentley

Manager of LC/MS Bioanalytical Services

Lenexa, ICON Bioanalytical Laboratory (KS, USA)

Mackenzie Bentley earned her Bachelors in Chemistry in 2014 and her Masters in Business Administration with an emphasis in Business Analytics in 2021 from the University of Missouri – Kansas City. She began her industry career in 2014 in Toxicology developing small molecule assays for drugs of abuse using LC-MS/MS. She later joined the Bioanalytical space where she has served as a lead scientist for small molecule therapeutics assay development and validation. More recently she has emphasized in large molecule LC-MS for biomarkers and hybrid assays for biotherapeutics such as monoclonal antibodies, modified proteins and oligonucleotides. Mackenzie is the Manager of LC–MS Bioanalytical Services for the Lenexa, ICON Bioanalytical Laboratory. She has been with ICON since January 2023. She is responsible for overseeing the Method Validation and Bioanalytical Operations team. She also collaborates with the Method Development team to mentor the scientist on large molecule LC-MS development.

 Laixin Wang

Executive Vice President

Resolian Bioanalytics (Chongqing, China)

Laixin Wang, obtained his PhD from the School of Pharmaceutical Sciences at the Beijing Medical University (China). He conducted post-doctoral training in pharmaceutical chemistry and medicinal chemistry in University of Utah (UT, USA) and Duke University (NC, USA) respectively. Dr Wang started his industry career working for Salus Therapeutics as a senior formulation research scientist for 5 years until its acquisition by Genta Inc (UT, USA). He then started his GLP bioanalytical career at Tandem Labs Salt Lake City (UT, USA). He was an associate laboratory director prior to leaving Tandem and joined NovaBioAssays (MA, USA) as the Vice President of bioanalysis. Dr Wang returned to China in 2017 and started Chongqing Denali Medpharma as a co-founder, CSO and Senior Vice President. Dr Wang is a recognized expert on bioanalysis of oligonucleotide/mRNA and peptide/protein/ADC therapeutics using LC based assays (LC-MS/MS. LC-HRAM, LC-fluorescence, etc.) LBA assays (ELISA, MSD, qPCR), as well as hybrid assays (IP-LC-MS, hybridization LC-MS and IP-qPCR). Dr Wang is also experienced on non-cell-based assays for Nab analysis, including measurement of neutralizing antibodies using competitive displacement/inhibition and quantitative of drug or drug target using LBA or LC-MS/MS assays.

Jian Wang

Director, Bioanalysis/Biomarker

Crinetics Pharmaceuticals, Inc. (CA, USA)

Jian Wang is a Director for Bioanalysis in the Clinical Pharmacology Group at Crinetics Pharmaceuticals, Inc. Prior to his current position, Jian worked as a Senior Principal Scientist at Bristol Myers Squibb (NJ, USA) for 23 years. Jian graduated from Michigan State University (MI, USA) with a PhD in Analytical Chemistry focused on mass spectrometry and later became a Postdoctoral Fellow at the National Institute of Health (MD, USA). Jian offers 25+ years of experience in discovery and regulated bioanalysis in the pharmaceutical industry, managing internal and outsourced pharmacokinetic (PK), biomarker and clinical diagnostic analyses of both small and large molecules in LC–MS, ligand binding and ligand binding-LC–MS hybrid platforms, as well as using in vitro diagnostics. He is the co-coordinator of the Regulated Bioanalysis Interest Group at the American Society for Mass Spectrometry and has served as a sub-team lead of the American Association of Pharmaceutical Scientists ADC bioanalysis committee.

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 (WA, USA), he joined 3M Pharmaceuticals 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 anitbody 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.