Navigating IDE and IVDR Requirements in Drug Development

The use of bioanalytical assays as a means of patient inclusion/exclusion criteria in clinical trials implicates these assays as in vitro diagnostic devices (IVDs) under the newest EU In Vitro Diagnostic Medical Devices Regulation (IVDR), while requiring compliance with Investigational Device Exemption (IDE) requirements in the US. In this webinar, the featured speakers share insights from our interactions with global regulatory agencies, consultants, and sponsors who are pursuing the path to IDE and IVDR in drug development and clinical trials.

Attendees will gain insight into the IDE requirements for assays used as inclusion/exclusion criteria in clinical trials. The speakers will share insights into the pathways to compliance with IVDR and how assays can be used for clinical trial enrollment. Attendees will gain practical knowledge from the speakers’ experience to help accelerate the pathways to IDE and IVDR for patient enrollment.

Register for this webinar to learn how to navigate IDE and IVDR requirements to streamline patient enrollment and clinical development programs.

Speakers

Marco Klinge, PhD, Associate Director of Bioanalytical Operations, BioAgilytix

Marco Klinge, PhD, Associate Director of Bioanalytical Operations at BioAgilytix, brings over a decade of experience in regulated bioanalysis, with specialized expertise in IVD and IVDR-compliant assay development and validation. He has a strong background in biomarker, PK, ADA/NAb and qPCR assays, and an in-depth understanding of GLP, GCP and IVDR regulatory frameworks. Prior to joining BioAgilytix, Dr. Klinge held leadership roles in R&D at EUROIMMUN, where he focused on allergy diagnostics and laboratory automation. He earned his PhD in Biochemistry from the University of Hamburg.

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Luke Armstrong, PhD, Associate Director/Bioanalytical Project Manager, BioAgilytix

Luke Armstrong, PhD, Bioanalytical Project Manager at BioAgilytix, has more than 20 years of laboratory experience in cell-based assay development, ion channel and GPCR research and clinical sample analysis. His expertise includes reagent development, early discovery and GLP toxicology studies. At BioAgilytix, Dr. Armstrong leads the development, qualification and validation of cell-based neutralizing antibody assays for AAV, monoclonal antibody and peptide therapeutics. He supports preclinical GLP studies, CLIA testing and GCP/GCLP immunogenicity analysis. His team has developed assays for over 10 AAV serotypes and obtained IDEs for two AAV NAb assays.

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(Panelist) Natalie Smith, PhD, HCLD(ABB), CLIA Laboratory Director, BioAgilytix

Natalie Smith, PhD, HCLD(ABB), CLIA Laboratory Director at BioAgilytix, offers nearly 15 years of experience in clinical diagnostics with a focus in molecular biology and infectious disease. She earned her PhD in Comparative Biomedical Sciences from North Carolina State University and holds board certification from the American Board of Bioanalysis as a High Complexity Laboratory Director. Dr. Smith has led clinical laboratories across multiple specialties, including bacteriology, immunology and toxicology. She currently oversees CLIA operations at BioAgilytix sites in North Carolina and Boston, ensuring compliance for clinical diagnostics and clinical trial enrollment.

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(Panelist) Amanda Hays, PhD, Scientific Officer, BioAgilytix

Amanda Hays, PhD, Scientific Officer, offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers, flow cytometry and qPCR. She has expertise in guiding programs through all stages in the drug development process. In her current role, she provides global scientific leadership and technical guidance at BioAgilytix. Dr. Hays is the Chair of several AAPS working groups, among other volunteer leadership positions. She earned her PhD in Pharmacology from the University of Kansas Medical Center in Kansas City (KS, USA).

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(Panelist) Rob Nelson, PhD, Scientific Officer, BioAgilytix

Robert Nelson, PhD, provides scientific and regulatory consultation, focusing on BioAgilytix’s EU team and customers, to help guide bioanalysis supporting drug development. Spending over 15 years working in regulated GLP/GCP laboratory environments, Dr. Nelson supports preclinical and clinical drug development programs, with broad experience in bioanalysis, immunogenicity and biomarkers. He joined BioAgilytix from Labcorp Drug Development’s Scientific Affairs team, where he partnered with clients, operations and other scientists to address science, technology and regulatory challenges. Prior to this, he led the bioanalytical laboratory team at Swiss biotech company Novimmune. Dr. Nelson holds a PhD in Molecular Physiology and a BSc with Honours in Pharmacology from the University of Edinburgh.

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(Panelist) Will Williams, MS, Senior Director of Lab Operations, BioAgilytix

Will Williams, MS, Senior Director of Lab Operations at BioAgilytix, leads teams focused on ligand binding assay (LBA) development, validation and sample analysis for ADA, PK, NAb and biomarker applications. He has over a decade of experience with ELISA, MSD, Luminex and Gyrolab platforms, supporting both academic and industry settings. Mr. Williams earned his MS from the University of North Carolina at Greensboro and his BS from the University of North Carolina at Chapel Hill. He brings a deep technical understanding of bioanalytical operations and leadership in regulated lab environments.

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