Strategies to Reduce Risk in Multi-Site Assay Cross-Validation

The increasing globalization of drug development programs has driven a growing need for rigorous cross-validation of bioanalytical assays across multiple laboratory sites. As bioanalytical methods become increasingly used for pharmacokinetic, immunogenicity and biomarker assessments, which are key components of clinical studies, ensuring inter-laboratory concordance is essential to maintaining data quality and supporting regulatory submissions in accordance with current regulatory expectations. This webinar outlines practical strategies for achieving successful cross-validation across multi-site programs.

Robust assay cross-validation requires demonstrated equivalence in assay reliability, accuracy and precision across participating laboratories, with consistent performance against established acceptance criteria. Variability introduced by site-specific reagent lots, instrumentation or analyst interpretation can compromise assay comparability and introduce bias into downstream pharmacological or clinical conclusions.

The featured speakers will explore structured assay transfer protocols, approaches for evaluating inter-laboratory comparability using reference standards and quality controls and a review of fit-for-purpose statistical methods, including equivalence testing and bias assessment, for identifying and characterizing inter-site discordance. These strategies aim to support successful drug development programs in meeting both scientific and regulatory expectations for cross-validated assay performance.

Register for this webinar to learn how assay cross-validation strategies can reduce multi-site risk and support reliable bioanalytical data.

Speakers

Lynn Kamen, PhD, Executive Director, Scientific Office, BioAgilytix

Lynn Kamen, PhD, is a Scientific Officer, Executive Director at BioAgilytix. She received her PhD in Immunology at the University of Michigan and completed a postdoctoral fellowship in Immunology at the University of California, San Francisco. Dr. Kamen is an accomplished scientific leader with over 15 years of experience in drug development, with deep technical expertise across large molecules, small molecules and ATMPs. Her experience spans multiple therapeutic areas, including oncology, cancer immunotherapy, immunology, ophthalmology and neurology. Prior to joining BioAgilytix, Dr. Kamen worked at several biotechnology and pharmaceutical companies, playing key roles in numerous global health authority submissions, including INDs, CTAs and post-marketing commitments, and maintains a strong publication record in leading peer-reviewed journals. A collaborative leader and mentor, Dr. Kamen is also an experienced Scientific Communicator, regularly presenting data and insights at international conferences, workshops and webinars and is the Vice Chair of the Science Advisory Committee of AAPS.

Message Presenter

Jessica Weaver, MRes, Associate Director, Scientific Officer, BioAgilytix

Jessica Bridges Weaver brings over 18 years of expertise in pharmaceutical development of upstream and downstream processes and bioanalytical testing in support of Chemistry, Manufacturing and Controls (CMC). Before joining the Scientific Office, she led a team of CMC Scientists as an Associate Director at BioAgilytix. Prior to that, she worked as a Scientific Project Manager for Manufacturing Research and Development for academic and contract organizations. Mrs. Weaver completed her BS in Biological Engineering and a Master’s in Fermentation, both at North Carolina State University.

Message Presenter

Pavan Prathipati, PhD, Manager II, BioAgilytix

Pavan Prathipati, PhD, is a Manager II at BioAgilytix, specializing in LC-MS–based bioanalytical method development, validation and regulated sample analysis. He supports complex drug development programs with expertise in assay optimization, troubleshooting and analytical strategy across multiple therapeutic modalities. Dr. Prathipati brings extensive experience applying mass spectrometry technologies to deliver high-quality, scientifically rigorous data that supports regulatory and development objectives across all phases of drug development.

Message Presenter

Bryan M. Gullick, PhD, Senior Director, Molecular Bioanalysis, BioAgilytix

Dr. Gullick serves as a Director of Bioanalytical Operations at BioAgilytix, where he oversees the molecular programs in Durham. He earned a PhD in Biochemistry from the University of Alabama in Tuscaloosa while researching the role of chromium in Type II diabetes. He has worked in analytical and bioanalytical development throughout his career, leading assay development and validation of small and large molecular entities. Bryan has been leading and managing PCR-based workflows for the past half-decade plus, leading efforts to optimize quality and efficiencies and improve productivity through process improvements and scientific rigor.

Message Presenter

Michael Mullen, Scientist I, BioAgilytix

Michael Mullen is a Scientist I at BioAgilytix, supporting bioanalytical studies through regulated laboratory operations and scientific execution. He contributes to assay implementation, sample analysis and data generation across drug development programs, helping ensure high-quality analytical performance and operational consistency. Michael brings hands-on laboratory experience and a collaborative approach to supporting complex bioanalytical workflows within regulated environments.

Message Presenter

Todd Lester, Senior Director, BioAgilytix

Todd Lester is a seasoned Biotechnology and Pharmaceutical Project Management professional at BioAgilytix with extensive experience leading complex bioanalytical studies across drug development programs. He oversees technical strategy, study execution, data interpretation and reporting, helping ensure scientific rigor and regulatory compliance. Todd brings broad GxP expertise and deep knowledge of FDA and EMA expectations, particularly in immunogenicity assessment strategy and bioanalytical program management

Message Presenter