August 19, 2020—Hamburg, Germany—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has welcomed Marianne Scheel Fjording, Ph.D. to its team as Scientific Officer. Dr. Fjording will be based at BioAgilytix’s European laboratory in Hamburg, Germany and will provide scientific and regulatory oversight to BioAgilytix’s team in the development and implementation of strategies for bioanalytical assay development and regulated assay validation.
Dr. Fjording is an expert in regulated bioanalysis and has more than 25 years of experience in the pharmaceutical and biotechnology industry, with particular expertise developing bioanalytical strategies for biomarkers in early- and late-stage drug development. Prior to joining BioAgilytix, she was Scientific Director at Novo Nordisk, where she was responsible for implementing PK and biomarker assays in clinical trials under FDA and EMA guidelines. Dr. Fjording is currently a member of the Expert Working Group (EWG) for ICH M10 Bioanalytical Method Development. She received her Ph.D. in intracellular signalling and MSc in biochemistry from the University of Copenhagen in Denmark.
“Marianne’s vast GLP/GCP regulatory experience and proven project management capabilities make her an invaluable addition to our scientific leadership team,” said PD Dr. Arno Kromminga, Chief Scientific Advisor at BioAgilytix. “She is an active voice in the industry helping to shape the guidelines we use in the lab every day. She will provide our team with expert regulatory guidance, with a focus on quality and timely results, to ensure the successful execution of all bioanalytical aspects of our customers’ studies.”
“I have always been impressed with BioAgilytix’s depth of scientific talent, as well as their track record for quality, and I’m excited to now work side-by-side with their esteemed scientists,” said Dr. Fjording. “I look forward to helping to continue to uphold and expand the organization’s reputation as a trusted global bioanalytical leader, where emerging and large biopharma companies can confidently place their innovative drug candidates to progress them smoothly through development.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area, the Cambridge area of Massachusetts, and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e. product release testing, stability testing, etc.). BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to many of the top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.