Ph.D. Director Project Management/
Business Developer Biologics

Dr Frank van Engelenburg has joined Kinesis Pharma as Senior Consultant / Business Developer Biologicals in January 2006. In July 2006, Dr. van Engelenburg was appointed as Project Manager for drug development projects of biotech companies.

From 1995 to 2005 he was Virologist / Account Manager at Sanquin Virus Safety Services of Sanquin Blood Supply Foundation in Amsterdam, the Netherlands. He obtained a broad experience in the development and validation of production processes for several blood products and biologicals in general and in the development and validation of methods to inactivate or remove viruses in particular. He was responsible for the development and validation of virus systems to be used for virus validation studies (total number of systems: 12 systems). He was also responsible for developing optimal experimental designs for virus validation studies including designs for robustness studies. He was Study Director for more than one hundred virus validation studies for more than twenty sponsors inside and outside Europe. He has ample experience with implementation and maintenance of ISO and GLP quality systems. He participated as invited expert for several EMEA, FDA, and WHO meetings. He wrote of a series of study and research proposals for development of virus inactivation methods for blood components and for development and validation of diagnostic and validation methods for prion diseases. He was a project leader for four subsequently sponsored research projects. He was chair of the Sanquin working group on transfusion transmissible infections. He received his Ph.D from Utrecht University in 1994 on the pathogenesis of bovine herpesvirus I infections in particular and on prospects for a glycoprotein E negative marker vaccine and molecular diagnosis in particular.

He holds an M.Sc from the Wageningen University with majors on adsorption of proteins and fungal genetics. He is (co-) author of around 15 articles in peer-reviewed journals. Specific areas of expertise of Dr Frank van Engelenburg: - Design of viral safety steps in downstream processing for biologicals - Robust design of virus reduction steps - Implementation and auditing of quality systems (e.g. ISO and GLP) - Regulatory support for biological safety part of the registration of biologicals - Scientific advise and risk assessment on microbiological contamination including viruses and prions - Ghost writing of scientific reports on viral and prion safety topics

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