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Senior Bioanalytical Consultant, Kamondi Bioanalytical Consultancy GmbH
Dr. Szilard Kamondi started his consulting business in the field of large molecule bioanalytics (PK, immunogenicity and soluble biomarkers) in November 2018. Previously he had worked as a Bioanalytical Manager at Roche (2013-2018) where he was responsible for all aspects of bioanalytical activities from nonclinical to post-marketing to support the development of novel biotherapeutics in oncology, ophthalmology, infectious disease, hematology, immunology and metabolism therapeutic areas. As one of the lead experts within the organization for immunogenicity testing related matters in the regulated space, he participated in the AAPS Working Group of ADA Validation and Reporting Harmonization Team. Prior to his role in Roche, he had held different positions at pharmaceutical and biotech companies focusing on biosimilar developments. Szilard holds an M.Sc. in Chemistry and Ph.D. in Structural Biochemistry.
Consultant bioanalysis of large molecules, LMBA
Dr. Arjen Companjen received his PhD in immunology in 2001. Subsequently he was involved in the development of novel vaccines and therapeutic antibodies. After a transfer to the biotech company Crucell, he was concerned with testing and selecting new vaccines. For many years he was responsible at Janssen Vaccines for the development, qualification and validation of bioanalytical assays to support clinical studies. Arjen was also core- and steering-committee member of the European Bioanalysis Forum (EBF) and as such involved in international discussions on regulated bioanalysis. As a bioanalysis expert and owner of the company "Large Molecule Bioanalysis Advise" (LMBA) he gives advice on setting up, qualifying and validating biomarker, PK, PD and ADA assays. Also, he executes technical writing and provides training within the regulated bioanalysis arena.vered styrofoam.