Date to be announced
Contact us for more infoTRAINING TIMES
Understanding current regulatory expectations (FDA and EMA Regulatory Expectations)
Identify potential challenges to ADA methods
Practical consideration for development of positive controls
Understanding the complexity of potential interference
Gain knowledge of new technologies to overcome assay interference
Implementing a strategy to overcome challenging methods
Designing ADA methods for modified drugs
Understanding and targeting domain specificity
Working with cut point challenges
Value of in study cut points
Using AI for robust calculation of cut point
Practical guides from selected case studies
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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SynoloStats, USA, Principal
Tara Scherder has over 20 years’ experience in the pharmaceutical and biopharmaceutical industries as a statistician, engineer, and master black belt. Her passion is the powerful combination of science and statistics to increase knowledge, optimize both manufacturing and business processes, and reduce risk. She combines statistical expertise with extensive knowledge of manufacturing platforms/analytical sciences and CMC requirements, always within business and regulatory context to achieve goals. She frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University.
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