Dirk Stynen (born 1957, Belgian citizen) has a wide professional experience including scientific research, diagnostic assay development, quality system implementation, clinical studies and regulatory affairs. He obtained a Ph. D. degree in Biology and completed Postgraduate Studies in Enterprise Economics. Therefore, he understands all aspects of your business. Furthermore, his fluency in four languages (Dutch, English, French, German) and elementary notions of two more (Italian, Portuguese) will allow efficient communication within and outside Europe.

Dirk Stynen represented Belgium in WG2 of TC140 of CEN (the European Standards Organization), in charge of the development of standards for IVD's.

Accomplishments in Regulatory Affairs, Quality Assurance and Clinical Studies

Between 1994 and 2000, Dirk Stynen founded and extended a new department within Innogenetics N.V. (Belgium), grouping Quality Assurance, Regulatory Affairs, Quality Control, Labeling and Clinical Studies.

During this period, he introduced systems to perform Clinical Studies suitable for product registration, made Innogenetics' labeling multilingual and compliant with European regulations and standards, and achieved Innogenetics' first registrations in major European countries such as Germany, France, Italy and Spain. This included both immunoassays and DNA-based assays for virological markers (HIV, HCV), HLA typing, genetic diseases and bacteriological infections.

Under his management, Innogenetics extended its scope of ISO9001 certification and achieved EN46001 certification. In addition, major actions plans were initiated to meet QSR (21CFR820).

Accomplishments in Academic Research and Diagnostic Assay Development

During his doctoral work at the University of Leuven(Belgium) (1979-1984), Dirk Stynen studied the role of lectins and of other interactions between proteins and polysaccharides in egg formation in insects, using biochemical, immunohistochemical and immunochemical techniques. Work on egg formation, now with a cell biology approach, continued as a postdoctoral fellow (1984-1985) at the University of Pennsylvania (Philadelphia, USA).
At the same university, hands-on experience was gained in a project on the molecular cloning of a T-cell membrane receptor (1986).

Dirk Stynen was R & D Manager in the Belgian affiliate of Sanofi Diagnostics Pasteur from December 1986 to 1993. His group developed immunoassays for microbiological and fungal markers. This work included the development, characterization and production of monoclonal antibodies and their coupling to latex beads. Other projects dealt a.o. with serotyping of bacteria.
During a short period of time he also supervised assay development activities at Innogenetics, such as the development of an ELISA for HIV antigen detection.

Dirk Stynen published results of his research and development activities in 36 papers and made oral presentations at ICAAC and other international meetings.