My career started many years ago as a scientist at the University of Cologne. Atfer my diploma in biology I decided for my PhD to change from the E. coli galactose operon to plant tumor research at the Max Planck Institute for plant breeding research, which I continued in Freiburg. Although I was offered a postdoctoral fellowship I decided to change again to study the Interleukin 1 receptor at the German Cancer Institute in Heidelberg. When I had the opportunity to work on the CD 72 B cell surface antigen at Stanford University I packed up and left for the US. I am particularly proud of my 3 year fellowship from the arthritis foundation. Upon my return I felt that the academic environment was not what I wanted to do and consequently, I went to work for E. Merck in Darmstadt where I gathered experience in the preclinical development of biotech products for cancer therapy. My job at Smith Kilne Beecham Biologicals in Belgium provided the opportunity to look at the next step of drug development, the regulatory procedures. I left because the position at PPTA provided the oportunity to work on all different aspects of pharmaceutical development in the very special field of plasma derived medicinal products and their recombinant analogues. Over 17 years I established several standing committees at PPTA, I repesented the association at regulatory authorities on EU and national level and almost all submissions to the European Medicines Agency, the European Directorate for the Quality of Medicines & Health Care and National Competent Authorities. In my role as the secretariate of the PPTA Expert groups I was the first contact point for regulators and other KOLs.
Senior Consultant Brussels area
Since December 2014
Senior Director Quality and Safety Brussels, Belgien
January 1998 --- November 2014
Secretary for PPTA expert committees (agenda setting, chairing of meetings, preparation of workshops with EU, US ROW regulatory authorities):
Pathogen Safety, Regulatory Affairs, Plasma Master File GMP, Clinical Development, Market Access.
- Preparation of consensus industry comments for regulatory authorities (EU, US, ROW).
- Representation of consensus industry positions with regulatory authorities.
- Coordination of peer reviewed publications.
- Presentations for scientific audiences.
- Development of position papers and press releases
Excellent connections within European Regulatory Network (European Medicines Agency, European Pharmacopoeia, National Competent Authorities), US Food and Drug Agency, World Health Organisation.
Scientific Data Manager Rixensart, Belgien
June 1996 --- December 1997
Preparation of scientific documentation for regulatory approval procedures (Mutual Recognition/ Centralised procedure)
Regulatory oversight of projects in pre-clinical development
Staff Scientist Darmstadt, Deutschland
June 1991 --- May 1996
Establishment of laboratories for molecular biology and cell culture according to German laws for gene technology and radiation protection.
Preclinical development of fusion proteins for targeted tumor therapy.
Evaluation of new concepts for pharmaceutical development.
Postdoctoral Fellow Stanford, Kalifornien, USA
May 1988 --- May 1991
Research on CD72, a B cell surface antigen
3 year fellowship from the Arthritis Foundation
Research Scientist Heidelberg, Deutschland
June 1986 --- May 1988
Functional characterisation of the Interleuki 1 receptor
Attention to detailWillingness to compromiseStrategic thinkingSelf-disciplineProactivityProblem solvingOrganizationInnovative thinkingFlexibilityDependabilityCuriosityCritical thinkingCollaborationCoordinationApproachabilitySelf-confidence
Biochemistry R&DAntibodiesBiological Drug DevelopmentBiopharmaceuticalsBiotechnologyCell CultureDrug regulatory authoritiesDrug Safety and PharmacovigilanceEarly development stageEMAFDAGeneticsGood Manufacturing Practice (GMP)HematologyImmunologyImmunoprecipitationInfectious diseasesKOL managementMarket accessMarketing Authorisation Application (MAA)Marketing approvalPediatrics
Skills and Expertise
Publication of articlesPublish scientific projectsRegulatory documentationRegulatory submissionsResearch at universitiesSearch literature on clinical trialsSolve problemsWrite papersWrite protocolsWriting regulatory documentsWritten presentation
PhD in Plant biology, biotechnology from Max Planck Institute for Plant Breeding Research, Cologne and University of Freiburg in 1986
Master in Biologie, biotechnology from University of Cologne, Germany in 1982
Expert has 18 publications (Will be avalible with full profile)