Panel discussion: Advancing bioanalytical method development and validation for small molecules in a changing regulatory landscape

What will you learn?

• Method development and validation importance: Get an introduction to bioanalytical methods for small molecules, their critical role in PK/PD studies, FDA submissions, and the structured development process following ICH M10 guidelines.
• Development Strategies: Guidance on selecting appropriate analytical techniques, optimization approaches, and the increasing integration of automation and AI to enhance efficiency and accuracy.
• Technical Challenges: Addressing complex matrices, metabolic interference, stability issues, and the critical transition between preclinical and clinical bioanalysis.
• Industry Landscape: Examination of how regulatory uncertainty, potential FDA structural changes, economic pressures, and manufacturing trends are influencing bioanalytical practices, timelines, and outsourcing decisions.

Who may this interest?

• Scientists/chemists directly involved in bioanalytical method development and validation for small molecules
• Regulatory affairs managers ensuring compliance with FDA and ICH guidelines
• Clinical research associates overseeing clinical trials
• Individuals interested in keeping up to date on US regulatory changes

Speakers

Jian Wang (Panel Chair)
Senior Director of Bioanalysis
Crinetics Pharmaceuticals, Inc.(San Diego, CA, USA)

Jian Wang is a Senior Director of Bioanalysis in the Clinical Pharmacology group at Crinetics Pharmaceuticals, Inc.(San Diego, CA, USA). 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 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.

Jianchao (JC) Chen
Director, Small Molecules
WuXi AppTec (Shanghai, China)

JC is a Scientist specializing in chemistry, chemical engineering and bioanalytical sciences. He holds a Ph.D. in Chemistry from the University of South Dakota (SD, USA) and completed postdoctoral research at the University of Florida (FL, USA) and Princeton University (NJ, USA). His expertise led to roles at Princeton and WuXi AppTec, followed by research positions at GlaxoSmithKline (London, UK), where he contributed to drug discovery and development. Currently, he serves as Director of Small Molecule Bioanalytical Services at WuXi AppTec and Visiting Research Scholar at Princeton University. With experience across academia, biotech and pharma, JC advances bioanalytical method development, regulatory strategies and drug development innovations.

Jennifer Zimmer
Laboratory Director
Alturas Analytics, Inc. (ID, USA)

Dr Jennifer Zimmer is the Laboratory Director at Alturas Analytics, Inc. and has been working in the field of bioanalysis for over 20 years. She received her BA degree in English and Zoology from the University of Idaho (ID, USA) and her PhD in Pharmacology from the University of Colorado Health Sciences Center (CO, USA), working in Dr Robert Murphy’s laboratory on the leukotriene lipid mediator pathway. Her post-doctoral experience in Dr Richard Smith’s laboratory focused on using metabolomics to elucidate disease pathways and to discover novel biomarker targets. Dr Zimmer is responsible for the overall operation of the Alturas Analytics laboratory. She has experience with FTICR, TOF, ion trap and quadrupole instrumentation. She has utilized these instruments for quantitation as well as structure elucidation using HPLC−MS/MS and HPLC−MSn. She oversees the scientific staff and ensures that client deliverables are met while working laterally with the Alturas Analytics, Inc. Quality Assurance Unit to maintain laboratory compliance with all procedures and regulations. Dr Zimmer is an active participant in the Global CRO Council (GCC) and a member of the American Society for Mass Spectrometry.

Ragu Ramanathan
Executive Director, Bioanalysis & Biotransformation
QPS, LLC (DE, USA)

Ragu Ramanathan is an Executive Director in the Global Regulated Bioanalytical Laboratories at QPS, LLC. Ragu earned his B.S. degree in Chemistry from the University of Southern Mississippi (MS, USA) and a Ph.D. degree in Analytical/Physical Chemistry from the University of Florida (FL, USA). Ragu completed his postdoctoral training at Washington University (MO, USA) (1995-1997) and afterwards ventured into the application of mass spectrometry at several pharmaceutical research and contract research organizations, including Analytical Bio-Chemistry Laboratories (MO, USA), Schering-Plough Research Institute (now Merck; NJ, USA), Warner-Lambert (now Pfizer; NY, USA), Bristol-Myers Squibb (NY, USA) and Vertex. Ragu has published over 80 peer-reviewed research papers and over 15 book chapters in pharmaceutical bioanalysis, drug metabolism, metabolite identification, ion-molecule reactions, clinical biomarkers, oligonucleotides, antibody-drug conjugates and high-resolution mass spectrometry.

Long Yuan
Director & Head, Bioanalytical Group
Biogen (MA, USA)

Long Yuan is currently the Director and Head of the Bioanalytical group in the Department of Drug Metabolism & Pharmacokinetics at Biogen. He leads a group of scientists and provides bioanalytical support for diverse modalities including small molecule drugs, oligonucleotides, biologics and AAV gene therapies, in drug discovery and development. Long received his B.S. in Medicinal Chemistry from Fudan University (Shanghai, China), and his Ph.D. in Medicinal Chemistry from the College of Pharmacy, University of Illinois Chicago (IL, USA). Before joining Biogen, he worked in the Department of Bioanalytical Sciences at Bristol Myers Squibb (NJ, USA). His research focuses on developing bioanalytical methodologies for various molecules, with recent emphasis on oligonucleotides, including ASO, siRNA and antibody-oligonucleotide conjugates. He has published over 50 peer-reviewed papers, including 7 book chapters.