Date to be announced
Contact us for more infoTRAINING TIMES
Gain a clear understanding of M10 updates, preclinical vs. clinical validation requirements, and how to align SOPs with current expectations.
Learn how to design, optimise, and validate PK and ADA methods, address matrix effects, and implement advanced drug interference resolution techniques.
Identify and resolve common assay failures, set alert limits, and apply trending and supplemental validation to improve reliability.
Work through case studies on rare disease matrices, comedication impact, and neutralizing antibody methods to apply solutions directly in your assays.
Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in one place - before, during, and after the course.
Receive a digital certificate (also LinkedIn-ready) that verifies your skills in strategic trial planning.
Gain clarity on M10 updates, phase-specific validation requirements, and how to adapt SOPs for preclinical and clinical assay validation.
Learn to develop, optimise, and validate PK assays, including handling matrix effects, comedications, rare disease samples, and critical reagent management.
Master screening, confirmatory, and neutralizing antibody assays, including strategies to overcome drug interference and matrix impact.
Identify common causes of PK and ADA assay failure, apply trending, set action/alert limits, and perform supplemental validations effectively.
Explore innovative tools such as BEAD for drug interference resolution and MSD electrochemiluminescence for improved assay sensitivity.
Designed for professionals who want to enhance their expertise and advance their careers
BioData Solutions, USA, Senior Consultant
Dr. Wise-Blackman is a consultant and project lead at BioData Solutions. Her attention is devoted to providing guidance to small and large biotechnology and pharmaceutical companies in support of drug development. Her work includes supporting regulatory approval of large molecule therapeutics. She has over 24 years of experience in both mid-size pharma companies and contract research organizations. She has led detail-oriented teams to successful completion of client projects. Her focus is on pharmacokinetic (PK), pharmacodynamic (PD) biomarker, immunogenicity, neutralizing antibody, and cell-based assays. Dr. Wise-Blackman earned her Doctor of Philosophy degree in pharmacology from the University of Virginia. She received her Bachelor of Science in Biology from the Massachusetts Institute of Technology. She is a sought-after trainer for bioanalytical method development and validation, technology transfer, and implementing process controls for challenging cell-based assays.
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