CURRICULA VITAE. Dr. V. (Vera) Brinks

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1 CURRICULA VITAE Dr. V. (Vera) Brinks Vera Brinks is postdoctoral researcher at the department of Pharmaceutics at the Utrecht University since Her research topic is immunogenicity of therapeutic proteins. She focuses on the immune mechanisms underlying immunogenicity with an emphasis on protein formulation and stability. Next to that she coordinates studies that assess quality of biosimilar products compared to their originators, and that assess batch-to-batch variations in marketed therapeutic proteins. In 2010 she has been awarded a Veni grant for her research. L. (Linda) Bus-Jacobs MSc, PDEng Janssen Biologics B.V. Leiden, The Netherlands, part of Johnson & Johnson (1999 now): Centocor/Janssen develops and manufactures monoclonal antibodies for the pharmaceutical industry. The facility in Leiden manufactures Remicade, a medicine for the treatment of rheumatoid arthritis and Crohn s disease, and other monoclonal antibodies. Current job: Sr. Scientist within the R&D API Large Molecule group. The main task is to to coordinate all manufacturing support and lifecycle improvement projects of Remicade at three different production sites as Technical Integrator. Management of a group of professionals in the cell culture and purification field. The deliverables of this group are change control and deviation assessments, development and technology transfer of process changes/optimizations, process validation and other manufacturing support such as productivity investigations and support during inspections. Skills: Certified Black Belt in six sigma, coach and trainer in PE (lean, six sigma, DEX), people manager, project management, process engineering, validation, working with process equipment at small and large scale (chromatography, (ultra)filtration), scale up and optimization. Education: Master in Science in Food technology at the University of Wageningen ( ). Main topics were protein purification, biochemistry, molecular biology and fermentation. From , post-graduate program in BioProcess Engineering and Design at the Technical University of Delft. Main topics were large scale protein purification, scale up, bioprocess technology, modeling. Dr. M.H.M. (Michel) Eppink Michel Eppink is Head Downstream Processing at the Biopharmaceutical Division of Synthon BV since His responsibility is the development/upscaling/validation/troubleshooting of purification processes, setting up new analytical screening methods and formulation of the biotechnological products. Next to that he was appointed at the same time as Associate Professor at the Department of Bioprocess Engineering of Wageningen University and Research Centre setting up new technologies in the field of downstream processing for proteins, lipids and carbohydrates. Before this period he worked for 10 years at Diosynth/Organon/Schering-Plough as project-manager/section manager/director in the Downstream Processing setting up purification processes and analytical methods for biotechnological products. His experience in the biotechnology field was gained at the University of Utrecht were he obtained a MSc degree in Biochemistry and his Ph.D was performed at the Wageningen University, Department of Biochemistry in the field of structural/functional relationship of proteins with focus on purification and characterization of proteins.

2 E.R.M. (Ed) Geuns, MSc, PharmD Ed Geuns is Director Regulatory Affairs, Vaccines at Abbott Biologicals B.V. in Weesp, the Netherlands. He was awarded a MSc degree in pharmacy by the University of Leiden, The Netherlands, and a PharmD degree by the University of Utrecht, The Netherlands. From 1990 until 1997 he was (senior) chemical-pharmaceutical assessor for the Medicines Evaluation Board in the Netherlands (MEB) and the European Agency for the Evaluation of Medicinal Products (EMEA) at the Department of Human Drug Registration, Laboratory for Quality Control of Medicines (LGO), a subdivision of the National Institute for Public Health and the Environment (RIVM) in The Netherlands. In 1997 Ed joined the Department of Regulatory Affairs Europe of Solvay Pharmaceuticals B.V. in Weesp, The Netherlands, where he held roles of increasing responsibility. He took his current position within Abbott in November Ed represents Abbott in the Regulatory Working Groups of the European Vaccine Manufacturers (EVM) and the Influenza Vaccines Supply Task Force (IVS) of IFPMA, and he is a member of the British Institute of Regulatory Affairs (TOPRA). Dr. W.M.J. (Wout) van Grunsven Wout van Grunsven is working at Merck Sharp & Dohme (MSD) in Oss, the Netherlands. He is currently Director of the department Cell Culture Process Development of Biotech Operations. He is working within different positions for over 22 years at the Biotechnology department of MSD (former Schering- Plough, Organon, Diosynth). He started at the Cell Culture Development department at Diosynth and gained extensive experience in process development working with human cell lines, CHO, NS0, hybridomas and the baculovirus expression system. Subsequently he was involved in contract manufacturing organization (CMO) activities and was responsible for project management of technology transfer projects for external partners involving cell culture, purification and analytics. The last 4 years he is responsible for late stage process qualification of cell culture processes for the manufacturing of recombinant antibodies and responsible for trouble shooting activities and process support to commercial cell culture manufacturing processes. Wout van Grunsven holds a PhD from the University of Leiden (Identification of diagnostically relevant proteins of the Epstein-Barr virus). This study was performed at Organon Teknika, Boxtel, The Netherlands. Olaf Stamm, Ph.D., MDRA Senior Specialist, Biopharmaceutical Services Charles RiverBiopharmaceutical Serives Dr. Stamm holds a doctoral degree in molecular parasitology and a master degree in drug regulatory affairs from the University of Bonn, Germany. He joined Charles River (formerly NewLab) in 2003 and became responsible for the business development activities in Europe, Asia and the US. Prior to joining Charles River/NewLab he worked for Eurofins Scientific running their microbiological GMP testing laboratories in Switzerland. Most recently Dr. Stamm has focused his work on business development activities and analytical/regulatory consulting for Charles River BioPharmaceutical Services of in Korea and India.

3 A.C.A.J. (Aad) van de Leur MSc Aad van de Leur is working at Synthon Biopharmaceuticals BV, Nijmegen, the Netherlands, since January In his present function of COO he is responsible for all Biopharmaceutical process development activity including process development and manufacturing activities from cell line development to formulation and related analytical development. Before starting at Synthon he worked for over 23 years at different Biotechnology departments at Diosynth and Organon. He started at the cell culture development department were he worked for 8 years being involved in cell culture development, optimization, trouble shooting and production using hollow fiber bioreactors, cell factories, (fed) batch fermentation and perfusion up to 100 L scale. He gained extensive experience working with human cell lines, CHO and hybridomas as well as baculovirus expression systems, virus and parasite production systems. Subsequently he was responsible for more than 10 years for purification process development, optimization, trouble shooting and production of glycosylated proteins and was also exposed to characterization of the related glycan structures. The last 5 years within Organon he was responsible for project management of a significant number of technology transfer projects involving cell culture and purification processes as well as al analytical transfers for external partners and internal projects. During these periods he was involved in multiple regulatory filings for EMA, FDA and Japan. Aad van de Leur holds a BSc degree in Biotechnology and a MSc in chemistry from Utrecht University Dr.ir. M. (Marcel) Ottens Marcel Ottens received his MSc in Chemical Engineering from Groningen University, his Professional Doctorate in Engineering on Process Design from Twente University, and his PhD in Chemical Engineering from Amsterdam University (the Netherlands). He is currently Assistant Professor Bioseparation Technology at the Delft University of Technology and group leader Micro Biosystems Technology. He is Visiting Professor at the Beijing University of Chemical Technology and Editor of Food and Bioproducts Processing. He is Board Member of the Advanced Course Downstream Processing. His current research interests are protein separations; micro bio systems technology & bioprocess miniaturization; fast conceptual bioprocess design; crystallization/precipitation, or more in general phase behaviour, of biomaterials; process chromatography (Simulated Moving Bed technology) of biologicals, and more in general transport phenomena and bioseparation science. Dr. N. (Nienke) Vriezen Nienke Vriezen is the Head of Upstream Development for the Biopharmaceuticals unit at Synthon in Nijmegen. In this capacity she is responsible for the development of cell lines for the production of recombinant proteins, selection and banking of these cell lines, and the subsequent development of the cell culture production process. Prior to this position Nienke Vriezen held various scientific roles at Centocor BV with responsibility for troubleshooting of mammalian cell culture production processes, optimisation of production processes for monoclonal antibodies, technology transfer and process validation. In these roles she was also involved in updates of existing CMC filings for both the EMEA and the FDA, and a contributor to the CMC sections of new filings for both FDA and EMEA. Nienke Vriezen holds a PhD from the Technical University of Delft (Physiology of mammalian cells in suspension culture, 1998), a MSc in Biology from the University of Leiden (1992), and an MBA (2003) and is also trained as a six-sigma black belt.

4 D.M. (Diana) Harris, PhD, Msc, PDEng Diana Harris has been with Janssen Biologics since 2007 and is supervisor of the change control and batch composition group at the Manufacturing department. Janssen Biologics (formerly Centocor, and part of Johnson & Johnson) develops and manufactures monoclonal antibodies for clinical use. The facility in Leiden manufactures Remicade, a medicine for the treatment of rheumatoid arthritis and Crohn s disease, and other monoclonal antibodies. In her current role Diana is responsible for the handling of all change controls issued by manufacturing. In addition, she is the API Technical Owner for Stelara, in which she is responsible for all technical activities related to the API manufacturing of this product across three production sites. Her experience in biotechnology was gained at the Delft Technical University were she followed a postdoctoral training in Bioprocess Technology (PDEng, ) and obtained a PhD on antibiotics production by filamentous fungi at the same university (2008). Previous to het current role Diana worked as a Sr. Engineer, responsible for upstream production performance and continous innovation at Janssen Biologics. Prof.dr. Arnold G. Vulto Hospital pharmacist / pharmacologist, ErasmusMC Rotterdam, The Netherlands a.vulto@erasmusmc.nl Arnold G. Vulto (1952) obtained his pharmacy-degree from Groningen University (The Netherlands) in 1981, with undergraduate studies in Cambdrige (UK). He was trained as a pharmacologist at the Rudolf Magnus Institute for Pharmacology / Medical Faculty at the University of Utrecht and at the Karolinska Institute (Stockholm, Sweden). He specialised in hospital pharmacy at the University Hospital Maastricht, The Netherlands (1988) and obtained his PhD from Utrecht University. In 1988 he was appointed Head of the Hospital Pharmacy of the Veterinary Faculty, University of Utrecht. In 1995 he was appointed Deputy Head / Research director of the Hospital Pharmacy of the Erasmus University Medical Center Rotterdam, where he was awarded an Associate Professorship in pharmacy in In 2004 followed appointment to the chair of Hospital Pharmacy / Practical Therapeutics at the Erasmus University Medical Center. He is responsible for the unit of medical education, professional training and research of the hospital pharmacy, which comprises the clinical trial unit. In this capacity he is the preceptor of the Hospital Pharmacy Specialization Program (with 8 residents in training). Professor Vulto is the (co)author of more than 100 peer reviewed papers in international journals on a wide variety of topics, all around medicines and has been supervising 15 PhD-projects. In 2010 he was elected as a Fellow of the American College of Clinical Pharmacology.

5 From he was member of the Board of Directors of the European Association of Hospital Pharmacists (EAHP); from Chairman of the EAHP Scientific Committee, responsible for the content of the annual 2000-delegate congresses. He was a member of the Steering Committee and chair of the Program Committee of the First Global Conference on the Future of Hospital Pharmacy (August 2008, Basel). In 2010 he received an EAHP award for visionary guidance and leadership in hospital pharmacy. Since January 2004 professor Vulto is Editor in Chief of the European Journal of Hospital Pharmacy Practice and accomplished indexation of this journal (starting 2008). He serves as a member of the Medical Ethical Committee of the ErasmusMC and is a member of several advisory bodies in the field of biotechnology / gene therapy (ZONMW, Dutch Medicines Board). He is the qualified person for biotechnology medicines / ATMP s for the Erasmus MC in Rotterdam. Dr. Corné J.M. Stroop Section Head Method Development & Process Support, MSD, the Netherlands After studying in the Netherlands and France, Corné Stroop received his PhD in Bio-Organic Chemistry in 1999 from Utrecht University, the Netherlands, where he worked on the structural analysis of carbohydrate chains on glycoproteins. He moved to Baltimore, USA, to work on structural studies on carbohydrate vaccines during a postdoctoral NIH fellowship at the Department of Chemistry & Biochemistry of the University of Maryland (UMBC). In 2002, he returned to the Netherlands to work as development scientist in Analytical Biochemistry at NV Organon. From 2003 onwards, he led one of the groups responsible for the analytical development of Organon s biotech projects. In 2006, he set up a 5-year research project with the NIBRT biotech institute in Dublin, Ireland. This collaboration between NIBRT and Organon investigated glycosylation pathways in CHO cells. After the 2007 purchase of NV Organon by Schering-Plough Corporation, Schering-Plough and Merck merged in In the new company (called Merck in the USA and MSD in Europe), a new department for Analytical Development and Validation was formed, in which Corné became the Section Head for Method Development and Process Support. Next to his expertise in protein glycosylation, he focuses on enzyme immunoassays and analytical biochemistry.