BioAgilytix, a leading global bioanalytical testing laboratory specializing in the bioanalysis of biopharmaceuticals, is pleased to announce the appointment of its new Scientific Officer for BioAgilytix Europe, Dr Lydia Michaut.
Lydia brings a wealth of experience in immunology, genetics, gene therapy and regulated bioanalysis to the company, and is perfectly placed to liaise with clients to ensure that BioAgilytix delivers high quality laboratory services tailored to their specific needs.
Passionate about life sciences, Lydia obtained a PhD in molecular biology and innate immunity from Louis Pasteur University, Strasbourg – where she studied with Nobel Laureate Professor Jules Hoffmann – before taking up a postdoctoral position with the world-renowned developmental biologist Professor Walter Gehring at Biozentrum, University of Basel. After 15 years in academia, Lydia moved to Swiss pharma company Novartis, where she became one of the first members of staff dedicated to the scientific interface between the company and bioanalytical contract research organizations. She also acquired expert knowledge in regulated bioanalysis supporting the clinical development and approval of biological drugs, as well as in bioanalytical strategies specific to gene therapy compounds, such as qPCR and immunogenicity assessments.
A key part of Lydia’s role in the pharma industry has been communication with regulatory authorities, including the European Medicines Agency, the US Food and Drug Administration, the Japanese Pharmaceuticals and Medical Devices Agency, Health Canada and the China Food and Drug Administration. This involved ensuring compliance with the latest guidelines for the duration of a study, and correct completion of all the necessary documentation prior to submission to the relevant authority. A decade of experience in this role has given Lydia an in-depth understanding of what clients look for in a bioanalytical testing laboratory, which will be invaluable in her position at BioAgilytix.
“I have been fortunate to work with some very high caliber scientists, learning a great deal from them. I am thrilled to be joining a forward-thinking company and look forward to putting this knowledge and my experience in the pharma industry to good use in my challenging new role. It’s a very exciting time,” said Lydia.
Global Chief Scientific Officer for BioAgilytix, PD Dr Arno Kromminga, commented: “We are delighted to welcome Lydia to the company as we grow the business. Her expertise and experience in working with regulatory authorities worldwide will be crucial to helping support our clients’ bioanalytical needs.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area 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’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