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Speakers 
 Dr Michele Antonelli,
Senior Vice President, Manufacturing,
Serono International
Currently Senior Vice President Manufacturing at Serono, Head of Manufacturing Operations and Process Development. Held several position in Serono in General Management and Quality Assurance. Previously Head of Molecular and Cell Biology at Agrobios-Enichem. Graduated in Plant Biology at Bari University- Italy (1983), post graduate studies in Genetics and Molecular Biology at Catholic University in Piacenza Italy (1987). Post-doctoral fellow at Genetics Dept. Iowa State University- Ames (87-89).
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 Dr Sylvio Bengio,
BioSepra Scientific Communications,
Pall Life Sciences
Dr. Sylvio Bengio received his Doctorate in ‘Cellular & Molecular Biology’ from the University of Rouen, France. During this time he also conducted research in the field of Cellular Immunology on ‘Fc Receptors & Regulation of the Complement Response’ at the ‘National Institute of Health & Medicine’ (INSERM).
Since joining industry, Dr Bengio has accumulated over 18 years experience in Downstream Processing and Protein Purification. Working for Pall BioSepra he specialises in Chromatography Process Development, Application of Novel Technologies and Scientific Communications.
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 Dr Ulf Bethke,
VP Operations,
Miltenyi Bioprocess
Dr. Ulf Bethke is member of the board and plant director at Miltenyi Biotec GmbH. He is a pharmacist with a Ph.D. in Biochemistry from the GBF in Braunschweig, FRG. He was 8 years with Biotest Pharma in Frankfurt and was responsible for therapeutic monoclonal antibody production. In 1994 he joined Miltenyi Biotec to set up manufacturing of the therapeutic CliniMACS cell selection system and is now responsible for the manufacturing of clinical products.
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 Dr Marc Better,
Vice President, Technical Development,
Xoma
Marc Better is Vice President, Technical Development at XOMA (US) LLC. XOMA develops and manufactures biopharmaceuticals that target cancer, immunological disorders and infectious diseases at its production facilities in Berkeley, California.
Dr. Better is responsible for Process Development and Clinical Manufacturing activities for XOMA’s products and for a variety of products being developed by XOMA in conjunction with its partners. Line management responsibilities include development and optimization of production cell lines, media development, analytical test method development, cell culture and fermentation, protein purification and formulation, as well as drug delivery.
Dr. Better joined XOMA in 1989, when XOMA merged with INGENE, where he had held research positions since 1984. Dr. Better earned a PhD in Biochemistry from Brandeis University and holds a B.S. in Microbiology from Michigan State University.
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Kasper Bonnevie,
Conceptual Design
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 Dr Crawford Brown,
Chief Executive Officer,
Eden Biodesign
Crawford is CEO of Eden Biodesign (contract development and manufacturing services) and leads Eden Biopharm consulting services now established one of Europe’s largest and most successful specialist biopharmaceutical technical-regulatory consultancies.
In 2004 Eden raised £5m equity capital from an investment syndicate led by Stephens Inc, the largest privately held investment banking firm outside of Wall Street. Additionally, Eden successfully won the European-wide UK government tender to lease and operate the UK National Biomanufacturing Centre a £30 million project sponsored by the North West Development Agency, the European Regional Development Fund and the UK Department of Trade and Industry.
Crawford has been involved with the Biotech sector for over 20 years having held senior positions in product development at Celltech-Medeva Pharma (Liverpool), British Biotech (Oxford) and Wellcome Biotech (Beckenham, Kent). At Medeva, as Director of Product Development, he established one of the UK’s largest product development teams that were the first in the UK to take a recombinant vaccine from the laboratory through to approval by the European Medicines Control Agency (EMEA).
Crawford qualified from Strathclyde University with a BSc in Applied Microbiology and a PhD in Chemical and Process Engineering. He is a Senior Visiting Lecturer on Modular Training for the Bioprocess Industries (MBI) course at the Advanced Centre for Biochemical Engineering. University College, London.
Crawford has completed assignments over the past five years in Denmark, Germany, Switzerland, Netherlands, Australia, India, Japan, South Korea, Taiwan and the USA. The focus of assignments is exclusively biopharmaceutical development including therapeutic and prophylactic vaccines, monoclonal antibodies, gene therapy and stem cell/tissue engineered products.
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 Dr Steven Burton,
Vice President, Research and Development,
ProMetic Bioscience
After gaining his Ph.D. at the Institute of Biotechnology, University of Cambridge, U.K. Dr Burton worked for 17 years in the field of bio-processing and has developed separations materials and purification processes for a wide variety of biological products isolated from natural, recombinant and transgenic sources. Dr Burton joined Affinity Chromatography Ltd (ACL) in 1988 and became Vice President R&D at the time ACL was integrated into Prometic Life Sciences. Dr Burton currently holds the position of Executive Vice President with responsibility for the Enabling Technologies Group.
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 Dr Michael Buschle,
Chief Technical Officer,
Intercell
Michael Buschle, who also cofounded Intercell, is Chief Technical Officer and Head of Industrial Operations at Intercell as well as Managing Director of Intercell Biomedical Ltd.
His scientific and industrial career includes work at the Royal Free Hospital School of Medicine, London, UK, the St. Jude Children's Research Hospital, Memphis, TN, USA and at the pharmaceutical company Boehringer Ingelheim. During his time at Boehringer Ingelheim, he was involved in the development of a cancer vaccine against malignant melanomas. Michael Buschle is the holder of several patents in the field of vaccines and biotechnology.
At Intercell, his responsibilities include manufacturing, process development, production and quality.
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 Dr Bernard Chan,
Head of Biologicals Manufacturing Development,
UCB Celltech
Dr Bernard Chan is Head of Biological Manufacturing Development at UCB (formerly Celltech). He is responsible for supply of biological pipeline products via a strategy of in-house and outsourced manufacturing activities. Previous positions held include Senior Biologicals Manufacturing Development Manager at Celltech, Product Development Manager at Medeva and Project Team Leader at Delta Biotechnology. In these roles, he has worked with a variety of expression systems, including microbial, mammalian and yeast. Dr Chan holds a BSc and PhD in Biochemistry, specialising in molecular biology, and has worked in the Biotech / Biopharmaceutical industry for over 15 years. His achievements include establishing long-term manufacturing alliances, European approval of a recombinant biotech product, involvement in design and construction of manufacturing facilities and co-founding of a start-up biotech company.
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 Dr David Chiswell,
Chairman,
BioIndustry Association
David Chiswell was a founder of Cambridge Antibody Technology (CAT), one of the premier emerging European biotechnology companies, in 1990 and was responsible for operational management from 1990 to 2002 including as CEO from 1996 to 2002. Since leaving CAT, David has been focusing on the development of early stage private biotechnology companies; he is the Chairman of Arrow Therapeutics Ltd. In addition David is an advisor to a number of private equity funds including Nomura private equity, TTP Ventures (Melbourne, UK) and BioComm (Melbourne, Australia).
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 Dr Leandro Christmann,
Director, Transgenic Technology,
AviGenics
Dr. Leandro Christmann received his Doctor of Veterinary Medicine degree from Federal Rural University of Rio de Janeiro in 1987 and a Master of Science in Animal Reproduction from the Federal University of Rio Grande do Sul (Brazil), in 1989. He obtained his PhD in Developmental Biology from the University of Cambridge in 1994.
In 1994, Dr. Christmann joined PPL Therapeutics, where he worked on the development and improvement of mammalian transgenic technologies, including microinjection, ES cells and nuclear transplantation.
Since 1998 he has been at AviGenics Inc, developing new transgenic technologies to allow the introduction of large DNA sequences into the avian genome.
Dr. Christmann has five patent applications pending.
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Mr Dan Couto,
Director, rhSA Programme,
GTC Biotherapeutics
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 Professor Francis Crawley,
Secretary General & Ethics Officer,
European Forum for Good Clinical Practice
Francis P. Crawley is the Secretary General and Ethics Officer of the European Forum for Good Clinical Practice (EFGCP) and a World Health Organization (WHO) Expert in ethics responsible for the coordination of the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). He is a philosopher specialised in ethical, legal, and regulatory issues concerning biomedical research, teaching at several European universities. He has acted as an author or expert for the leading international and European ethics guidelines, as well as for several in-country guidelines in Asia, Africa, the Americas, and Europe. He is currently Chairman of the Ethical Review Committee of the International Network for Cancer Treatment and Research (INCTR), a member of the INCTR Tissues Committee, a member of the Ethics Committee of the European Organization for Research & Treatment of Cancer (EORTC), a member of the joint EMVI-AMVTN Ethical Review Committee, a Permanent Liaison Officer to the International Bioethics Committee of UNESCO, and a Contact Officer for the Council of International Organisations of Medical Sciences. He also served for four years on the UNAIDS Ethical Review Committee. In addition, he is a member of the Working Group on Ethical Principles in Paediatrics, Conféderation Européenne des Spécialistes en Pédiatrie, l’Union Européenne des Médecines Spécialistes, a member of the Steering Committee for the Global Forum for Bioethics in Research, a member of the Committee of Interested Parties of the Centre for the Management of Intellectual Property in Health Research & Development, a member of the European Science Foundation’s Education Working Group, a member of the WHO GCP Guideline Revising Group, and a member of the Steering Committee for the European Commission support project ‘The Development of European Standards on Confidentiality and Privacy in Healthcare among Vulnerable Patient Populations’, as well as the two recently completed projects: ‘Ethical Function in Hospital Ethics Committees’ & ‘Ethical Considerations in Clinical Trial Collaboration with Developing Countries’. He is the Co-facilitator for the Ethics Roundtable at the Africa Centre for Health & Population Studies in South Africa and the Chairman of the GCP Course organised jointly by the EFGCP and the Africa Centre. He is also a member of several regional organizations for ethics in research in Central and Eastern Europe, Asia, Africa, and Latin America. He also serves on several editorial boards for international journals. He is an Honorary Member of the Faculty of Pharmaceutical Medicine, Royal College of Physicians, United Kingdom.
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 Dr John Curling,
Founder,
John Curling Consulting AB
John Curling graduated in chemistry from the University of Sussex, UK and joined Pharmacia in 1967. He was President of Pharmacia’s Process Separation Division until 1990 and has over 35 years of experience in industrial chromatography. John Curling consults on the development of life science purification techniques and products and the adoption of new technologies into downstream processing of proteins and DNA. Focus of work is on blood plasma protein process and product development. He is Senior Consultant to ProMetic BioSciences, a member of the European Working Group Downstream Processing and is on the Board of the ‘‘Recovery Conference Series”.
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 Ms Nicola Dagg,
Partner, Intellectual Property,
Lovells
Nicola Dagg is a partner in the Intellectual Property department with Lovells in London. Nicola has a degree in natural sciences from Cambridge University. Nicola has considerable experience in dealing with the litigious and commercial aspects of matters of a high scientific and technological content and in particular with issues in the pharmaceutical, biotechnology/healthcare industry. Nicola has acted in numerous international patent disputes. Nicola has also advised on mergers and acquisitions for private equity, technology development and licensing, regulatory and advertising matters.
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Dr Monica Darnbrough,
Consultant,
Dti Biotech Directorate
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Dr Guy De Martynoff,
Executive Vice President,
Meristem Therapeutics
Dr Guy de Martynoff currently works as Executive Vice President for Meristem Therapeutics, one of the world leaders in production of Plant-Made Pharmaceuticals and the only European manufacturer in this industry (corn and tobacco). Guy has a strong expertise in molecular biology, immunology, virology as well as in various expression systems and protein purification processes.
After a second post-doc at the European Molecular Biology Laboratory (E.M.B.L., Heidelberg, Germany), he starts his professional career in 1991 for a diagnostic/vaccine project on hepatitis C virus at the biotech company Innogenetics NV (Ghent, Belgium) until 1997, when he joined 4C Biotech (Seneffe, Belgium) as Manager of the Biochemistry Department and then as Scientific Coordinator (cultivation at high densities of mammalian cell lines/production & purification of recombinant proteins). After having briefly worked as Project Manager with bacteria/yeast under GMP conditions at Eurogentec (Liège, Belgium), he developed a more “exotic” industrial and business process as Chief Operating Officer and then as Director of Corporate Development for BioProtein Technologies (Paris, France), one of the few companies worldwide producing therapeutics proteins in the milk of transgenic animals (rabbits).
He holds a Master Degree in Chemistry from the University of Brussels (ULB) where he also attained his PhD in Chemistry/Molecular Biology. Subsequently, he was awarded until 1989 a Post-Doctoral Fellowship at the Department of Molecular Biology in collaboration with Smith-Kline (Rixensart, Belgium) for a project on human papillomaviruses involved in cervical cancer. Aside from his professional engagements, he is also Vice-President of Bioformation (Paris, France), the largest European Institute involved in the Continuing Professional Development in Biology.
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Dr Hartmut Ehrlich,
VP, Global Clinical Research and Development,
Baxter AG
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 Dr Thure Etzold,
Co-CEO,
Lion Bioscience AG
Dr. Thure Etzold joined LION in July 1998 and serves as Chief Executive Officer being responsible for Product Development and Services. Before he came to LION, he was a group leader in the research program at the EBI (European Bioinformatics Institute) in Hinxton, U.K. Prior to the EBI, he was a staff scientist at the EMBL (European Molecular Biology Laboratory) in Heidelberg, Germany. He developed and optimized the Sequence Retrieval System (SRS) for Molecular Biological Databanks by establishing novel methods for accessing and interconnecting various datasources and brought the exclusive commercial right of SRS to LION. He holds a Ph.D. from the Max-Planck-Institut für Züchtungsforschung in Cologne, Germany.
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John Ferbas,
Clinical Immunology,
Amgen
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 Dr Brendan Fish,
Director, Bioprocess Sciences,
Cambridge Antibody Technology
(1998-Present) Cambridge Antibody Technology. Joined CAT as Head of Downstream Processing in November 1998 and was promoted to Director in October 2001. Assumed responsibility for all of Bioprocess Sciencen in sping 2004. Currently in control of all aspects of the development of purification methodologies, formulation and delivery solutions and biochemical and biophysical characterisation of all CAT’s products in relation to their use in commercial pharmaceutical processes. This includes process design and optimisation, formulation and stability studies, comparability and product characterisation, scale-up, process cost modelling, process integration and technology transfer to GMP Production for clinical trial supply.
(1991-1998) Delta Biotechnology Limited. Consulting Scientist. Played a key role in the development of Delta’s biotechnology-based products providing expert opinion and strategies for QA, QC, Production, Marketing, Operations, Regulatory Affairs and Engineering on all aspects of Process Development.
(1989-1991) University of Toronto in Canada. Post-doctoral fellowship working in the School of Nutritional Sciences, studying the anti-nutritional effects of lectins in the diet.
Also held posts as a Reseach Assistant and a Medical Laboratory Scientific Officer.
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 Dr Richard Francis,
Director, Process Development and Technical Suppor,
Protherics
Over twenty years experience in the development and manufacture of biopharmaceutical products. The product types range from antibodies (monoclonal and polyclonal), recombinant proteins, Vaccines and DNA gene therapy products. Has been involved in the development and commercialisation of nine licensed biologics to date and is well versed in the regulatory agency requirements and processes. Has previously held senior management positions at Celltech, Centocor and GSK.
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 Dr Reinhard Glück,
President of Swiss Biotech Association, & Chief Scientific Officer,
Berna Biotech
PROFESSIONAL EXPERIENCE
Current Position: Chief Scientific Officer (CSO), Member of Executive Board of Directors, Berna Biotech Ltd
from 2002: President Swiss Biotech Association
from 2001: President of Etna Biotech, Catania
from 2001: Board of Administration of Pevion GmbH, Berne
from 2000: Director of Research and Development, Member of Executive Board of Directors Berna Biotech Ltd, Berne, Switzerland
1987-2000: Head Virology (Research Production, In-Process Control), Berna Biotech Ltd, Berne, Switzerland
1982: Group Leader Virus Research, Berna Biotech Ltd, Berne, Switzerland
1979-1981: Research Teaching Assistant, University of Berne, Major Advisor, Prof. M. Hess
1976: Research Scientist, Ciba-Geigy AG, Dept. Microbiology, Basle, Switzerland
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 Dr Uwe Gottschalk,
Vice President, Purification Technologies,
Sartorius AG--Biotechnology
Dr. Gottschalk joined Sartorius in 2004 and became Vice President Purification Technologies. Before that he was Head of GMP Protein Purification at Bayer Health Care and responsible for the production of monoclonal antibodies and recombinant proteins from various expression systems. Dr. Gottschalk has a number of publications in the area of Biotechnology and Somatic Gene Therapy and is Head Lecturer at the University of Witten (Germany).
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 Dr James Green,
Senior Vice President, Pre-clinical and Clinical Development Sciences,
Biogen Idec
Dr. Green is Senior Vice President of Preclinical and Clinical Development Sciences at Biogen Idec, Inc., in the USA. Formerly, he was Senior Director, Product Development and Safety Evaluation at Genentech, Inc., and before that Director of Toxicological Research in the Pharmaceutical Division of the Ciba-Geigy Corporation. Dr. Green is a diplomat of the American Board of Toxicology and is a member and past Chairman of the U.S. Pharmaceutical Research and Manufacturers Association’s Drug Safety Subsection Steering Committee, and member of the Biotechnology Expert Working Group. He is also a member of a number of professional societies, including the American Chemical Society, American College of Toxicology, American Society of Toxicology and the American Society of Toxicologic Pathologists. Dr. Green has degrees in biology and toxicology and has presented and published extensively in the area of safety evaluation of biotechnology products.
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John Greenwood,
Director, Regulatory Affairs,
GeneMedix
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 Dr. Frank Hanakam,
VP Process Development,
Micromet AG
Dr. Frank Hanakam is Vice President, Process Development at Micromet AG, Munich, where he leads a group of 20 people.He joined Micromet in 1996 where he started to establish a functional unit for the development of cell lines and production processes of antibodies andrecombinant derivatives for use as immuno-therapeutics. Over the past eight years Dr. Hanakam was furthermore in charge of multiple outsourcingactivities and collaborations with EU- & US-based companies, in the contextof process development, supply and release of clinical trial material, involvingtech-transfers and subsequent process scale-up into the kg-range.In 2002 he received his MBA from the Open University Business School, Milton Keynes, UK.
Prior to joining Micromet he did postdoctoral studies on fluorescence correlation spectrometry at the Max-Planck Institute of Biochemistry,Martinsried, Germany, in collaboration with Evotec, Hamburg, Germany. He received his Ph.D. in cell biology in 1995 from the University of Tuebingen, Germany, with work on functional protein characterization performed at theMax-Planck Institute of Biochemistry.
Dr. Hanakam, biologist by training, earned his MS degree in 1991 from the University of Tuebingen with practical work on antibodies and rt-PA performed at Boehringer Ingelheim, Biberach, Germany.
Dr. Hanakam has more than 13 years of experience in cell culture, protein purification and characterization.
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 Dr Philipp Hess,
President and Founder,
Philipp Hess Associates
Philipp N. Hess is Founder and Managing Partner at PHA – Philipp Hess Associates.
Founded in 1994, PHA provides project and consulting services entirely dedicated to the global biopharmaceutical manufacturing sector with projects in Europe, USA, Latin America, and Far East. Since 1999 PHA is a member of PMSA – Pharmaceutical and Medical Services Associates, Zürich, a strategic marketing and consulting organization with members in 5 European countries and the USA.
From 1988 to 1993 Philipp Hess worked in various positions at Centocor’s Therapeutics Division in The Netherlands and the USA; positions included Head of Logistics and Head of Project Management. He was deeply involved in the manufacturing development of successful monoclonal antibodies such as ReoPro and Remicade and less successful ones like Myoscint and the “textbook failure” Centoxin.
Philipp Hess holds a Doctor’s degree in biotechnology from the Department of Biotechnology at the Swiss Federal Institute of Technology, Zürich, Switzerland and a Master’s degree in chemistry from the Technical University of Munich.
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Dr Kowid Ho,
Pharmaceutical Assessor, Evaluation of Biological Products Department,
AFSSAPS
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Dr Christopher Holloway,
Group Director of Regulatory Affairs,
ERA Consulting
Chris Holloway, Ph.D., Dr.rer.hum.biol.habil., is Group Director of Regulatory Affairs at ERA Consulting, with overall responsibility for the company’s operations in Germany, London, Washington, DC, and Australia. He has worked in regulatory affairs, specializing in biotech products and other biologics, for more than 15 years, since leaving academia where he was Professor of Clinical Biochemistry at Hannover Medical School in Germany. Chris graduated in 1971 and obtained his Ph.D. in 1975, after which he held a Royal Society European Research Fellowship at the Max-Planck-Institute in Germany. He then moved into university, and was awarded the venia legendi in 1982. Chris is particularly interested in regulatory strategies for novel biological therapeutics, interacting wherever possible with regulators to define expedient routes towards marketing authorizations. He has worked on more than 200 different products, contributing particularly towards approaches to manufacturing and control as well as early non-clinical and clinical development. His team has compiled dossiers, and Chris authors expert reports for European submissions. With his scientific background in the field of protein biochemistry and physiological chemistry, Chris has an active interest in concepts of comparability, when production processes are scaled-up or changed. He has been a regular speaker at conferences on this subject.
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 Mr James Hope,
Vice President, Operations,
Bioprocessors Corp.
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 Linda Horton,
Partner and Co-Chair, European Life Sciences Practice,
Hogan & Hartson LLP, Brussels
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 Dr Brendan Hughes,
Director, Development and Technical Services,
Wyeth Medica Ireland BioPharma Campus
Currently Director of Development and Technical Services at the Wyeth Medica Ireland BioPharma Campus in Dublin. Responsible for process development and improvement as well as technology transfers and support to ongoing business and Validation.
Before joining Wyeth, Brendan worked in GlaxoSmithKline in Beckenham, Kent having joined the Wellcome organisation in 1991. In GSK, Brendan led the Analytical Sciences Dept and was project leader for a number of candidate biopharmaceutcals. During his time in GSK, he was an active member of the Q5 group in the ICH process, taking part in the drafting of the virus safety, cell substrates and specification guidelines.
Brendan recieved is BSc and PhD from the National University of Ireland.
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 Anne Hyland,
Chief Financial Officer,
Vectura Group
Anne Hyland is Chief Financial Officer, Company Secretary and Executive Director of Vectura Group plc. Vectura raised £20m through its listing on AIM in July 2004. Anne joined Vectura in March 2002 and prior to its listing she was responsible for raising £12m through three separate fund raisings (debt and private equity). Vectura develops inhaled pharmaceutical products. Before joining Vectura, Anne was Director of Corporate Finance at Celltech Group plc; other positions held at Celltech included Group Financial Controller and Finance Director for the Celltech/Medeva UK Division. Anne joined Celltech following the merger with Medeva PLC where she was Finance Director for the UK Division. Previously she was the Medeva Group Financial Controller where, through a period of rapid growth, she was responsible for managing treasury, tax, internal, and external reporting, and acquisition and disposal activity. She joined Medeva from KPMG, London where she was an audit manager and gained exposure to corporate finance, advisory and due diligence work. She has a Business Studies degree from Trinity College, Dublin and is a Fellow of the Institute of Chartered Accountants, Ireland and a Fellow of the Institute of Taxation, Ireland.
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Dr Christopher Joneckis,
Senior Advisor for Chemistry Manufacturing & Control Issues, Office of the Center Director,
CBER, FDA
Christopher C. Joneckis, earned his Ph.D. in Pharmacology from the University of North Carolina at Chapel Hill. He has over 13 years of research experience on therapeutic proteins and small molecules in the areas of oncology, cell adhesion and vascular disease conducted in academic and government institutions.
He joined the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration FDA in 1994 as a reviewer. In this capacity he reviewed IND and BLA applications and participated in pre-license and biennial facility inspections for a variety of therapeutic products including cytokines, monoclonal antibodies, thrombolytics and somatic cellular products. Christopher C. Joneckis, Ph.D., currently serves as the Senior Advisor For Chemistry, Manufacturing and Control (CMC) Issues, at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. He advises the Director of CBER on a variety of CMC issues for the Center’s regulatory, review and scientific programs and activities. He is involved in the development and implementation of several programs, policies and standards for CMC issues in the Center He is also involved in several Agency working groups drafting CMC and cGMP policy, including the Steering Committee and workgroups of the CGMP For the 21st Century Initiative. He is the Quality Lead for CBER in ICH activities and is a representative on ICH Quality Expert Working Groups including Q6B, CTD-Quality and Q8.
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 Dr Tytti Kärkkäinen,
Vice President, Production,
FIT Biotech
Tytti Kärkkäinen, Phil. Lic, has worked for eight years in research and teaching at the University of Helsinki, Department of Biochemistry and 15 years in diagnostic industry in research and development. She has developed methods leading to ELISA based commecial diagnostic immunoassays as well as several commercial rapid tests for diagnostics. Last three years she has been the vice president for production of FIT Biotech. Her expertise is in the immunochemical methodology, monoclonal antibody characterization, protein purification and diagnostic development and production. She has published 23 research articles, owns one patent and has several patent applications.
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Dr Kurt Kunas,
Senior Research Scientist, Cell Culture Process Development,
Baxter Healthcare Corporation
The Hayward, CA, facility offers contract manufacturing of mammalian cell derived therapeutic proteins including process development, pilot and clinical scale production. Kurt Kunas has been a senior process development engineer at the Hayward facility for three years. He received his Ph.D. in Chemical Engineering from Rice University in 1990 and B.S. in Chemical Engineering from the University of Michigan in 1984.
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 Dr Christian Leist,
Head of Bioprocess and Technology Development, Lea,
Novartis Pharma AG
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 Dr Greg Liposky,
Senior Vice President, Operations,
GTC Biotherapeutics
Gregory Liposky joined GTC Biotherapeutics in 1999 and is Senior Vice President of Operations. Mr. Liposky has over 25 years of experience in the operation of facilities for the manufacture of therapeutic proteins. As Senior Vice President of Operations, Mr. Liposky is responsible for all aspects of operations including manufacturing, logistics, process development, quality and commercial development. In addition, Mr. Liposky is responsible for managing the commercialization program of recombinant human serum albumin. Prior to joining GTC, Mr. Liposky held key positions in the industry including Vice President, Contract Manufacturing for Creative Biomolecules, and Vice President, Bioprocessing for Verax Corporation. Prior to Verax Corporation, Mr. Liposky held positions in manufacturing, research, and quality at Worthington Biochemical Corporation. Mr. Liposky’s experience includes the design, construction, start-up, and operation of a 60,000 square foot biologics manufacturing facility.
Mr. Liposky received his Master's degree in Business Administration from Monmouth University and a Bachelor's degree in Biology from Belmont Abbey College.
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Dr Duncan Low,
Distinguished Fellow, Process Development,
Amgen
Duncan Low has worked with biological separations for over 25 years, joining Amgen in 2003 with a responsibility for technology evaluation and development. Prior to joining Amgen he worked at Millipore for four years as Vice President for chromatography, and at Pharmacia Biotech in a number of international roles in Sweden, the UK, Australia and finally as Vice President Bioindustry in North America. He has had an active focus in process scale chromatography of biomolecules since the early 1980’s and has been involved in the development of many of the chemistries and hardware and software tools currently in use in downstream processing. He graduated from the University of Cambridge with an M.A. in biochemistry and completed a Ph.D. in microbiology at the University of Glasgow.
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Dr John McLennan,
Business Development Consultant,
XOMA (US) LLC
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 Dr Stephen Minger,
Director, Stem Cell Biology Laboratory,
King’s College, London
Dr Stephen Minger is the Director of the Stem Cell Biology Laboratory in the new Wolfson Centre for Age-Related Disorders at King's College London. Dr Minger received his BA in Psychology from the University of Minnesota and his PhD in Pathology (Neurosciences) in 1992 from the Albert Einstein College of Medicine, where he studied with Professor Peter Davies, Resnick Professor of Alzheimer’s Disease Research. From 1992-1994, he was a post-doctoral fellow in the laboratory of Professor Fred Gage, University of California, San Diego, where he first began to pursue research in neural stem cell biology. Additional post-doctoral training was obtained at the University of Kentucky, and in 1995, Dr Minger was appointed an Assistant Professor in Neurology at The University of Kentucky Medical School. He moved his stem cell research programme to Guy’s Hospital in 1996 and was appointed a Lecturer in Biomolecular Sciences at King's College London in 1998. Over the last ten years, his research group has worked with a wide range of somatic stem cell populations, as well as mouse and human embryonic stem (ES) cells. In 2002, together with Dr Susan Pickering and Professor Peter Braude, Dr Minger was awarded one of the first two licenses granted by the Human Fertilisation and Embryology Authority for the derivation of human ES cells. His group subsequently generated the first human embryonic stem cell line in the UK and was one of the first groups to deposit this into the UK Stem Cell Bank. Dr Minger’s research is funded by the UK Medical Research Council, Juvenile Diabetes Research Foundation International, Wellcome Trust, GlaxoSmithKline, and Diabetes UK, amongst others.
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Dr Anthony Mire-Sluis,
Head, Product Quality and External Affairs,
Amgen
Dr Mire-Sluis is currently Head of Product Quality and External Affairs at Amgen Inc. He was previously Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego. He is a member of the WHO therapeutic drug standardization committee, Chairman of the International Association of Biologicals Human Therapeutics Committee, an expert for the International Committee for Harmonization and an editor for the Journal of Immunological Methods.
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Gert Moelgaard,
Vice President, Process and Mechanical,
NNE A/S
Gert Moelgaard is Vice President for Process & Mechanical in NNE, providing projects and services for biotech and pharmaceutical facilities. He graduated from the Technical University of Denmark in 1979 and joined Novo in 1982. He has been part of NNE Management for 10 years and engaged in several major engineering, automation and validation projects within pharmaceutical manufacturing. Gert Moelgaard has been actively involved in several international conferences on PAT, cGMP for 21st Century, automation and computer systems validation.
Gert Moelgaard has been member of the GAMP Forum Steering Committee, Chairman for ISPE's Nordic Affiliate and is the Vice Chairman of ISPE (International Society of Pharmaceutical Engineering) in 2005 and a Board member of IFPAT-MA.
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 Dr Inger Mollerup,
Vice President, Pharmaceutical Development,
Novo Nordisk
Many years of experience in developing processes for manufacture of recombinant proteins within Novo Nordisk. Led process development efforts for recombinant proteins and purification of proteins for clinical trials including processes for rFVIIa, aprotinin, insulin analogues, glucagon, TPO, thrombin and monoclonal antibodies. Responsible for design of GMP pilot plant facilities for purification of proteins. Broad leadership experience covering both line management and global project development.
Current responsibility: Vice President for NovoSeven® Future, Regulatory Affairs.
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 Ms Myriam Monge,
Marketing Director, Europe,
Stedim
Miriam MONGE has worked in the biopharmaceutical industry since 1989. Miriam joined STEDIM SA, France in 1994 where she has been involved in integrating single-use disposable technology within several new facility & retrofit projects in biopharmaceutical companies across Europe. Over this period there has been a strong move towards single-use disposable technology in the industry In 2000 Miriam moved into her role as Marketing Manager. Current missions include:
§ Cooperation with R&D on new technology developments, identification of companies offering complementary expertise for our product development & integration of innovative new technologies into the single-use disposable technology platform
§ Since 2000 ongoing studies in collaboration with Biopharm Services on facility design, process simulation & COG analysis comparing single-use technology with traditional stainless steel equipment. 3 concept facilities have been designed to date with the latest facility design being the most radical integrating all existing innovations in single-use technology into the Pharmadule modular facility approach.
Miriam is a member of the ISPE and PDA and a a regular visitor & speaker at UCL, Londons MBI biomanufacturing training courses. She has published papers in key industry journals such as Pharmaceutical engineering, Genetic engineering news and World Pharmaceutical Developments. A key objective: "To make single-use disposable technology a well accepted standard in the industry"
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 Dr Tina Narendra-Nathan,
Founder & MD,
Bio-Pharma Consultancy
Dr Tina J Narendra-Nathan is the Founder & MD of the Bio-Pharma Consultancy which offers consulting services in Process Development & Regulatory Affairs in the Pharma, biotech & healthcare sectors.
The services provided include Technology Due Diligence through all stages from initial assessment to on-site validation to identify and resolve issues; execute cGMP audits and critical ‘real-world’ QA review on product development through its various stages; perform gap analysis and technology ‘reality-checks; advice & assistance on regulatory strategy and submissions, especially with Expert Reports, Investigators Brochures & Quality Overall Summaries; selection, negotiation of contracts and management of CROs; advice on Quality, validation & sterile engineering issues relating to bio-pharmaceutical facilities;
Products of focus include immuno- & other bio-therapeutics; monoclonal antibodies; gene & cell therapy; blood products; and the areas of focus include molecular & cell biology; protein analysis & characterisation; cell bank testing & characterisation; process validation & virus safety validation studies; formulation & filling operations; scale-up & GMP manufacture; and pre-clinical studies including immunogenicity, PK, PD and toxicology studies;
Previous roles in industry include Head of Biopharmaceutical Development at British Biotech and various Process Development roles at Wellcome Biotech (Head of Fermentation and Senior Purification Process Engineer); Educated at the University College London where both the first and second degree were obtained in the Biochemical Engineering Department.
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 Dr Enrico Polastro,
Vice President,
Arthur D. Little Benelux S.A./N.V.
Dr. Enrico Polastro is a Vice-President of Arthur D.Little Benelux S.A./N.V. He is focusing his consulting practice on strategy development and operation optimization focusing on the pharmaceutical and fine chemicals industry.
During his twenty one years consulting career he has assisted a number of pharmaceutical and fine chemicals companies in formulating effective strategies.
He is the author of over one hundred publications and is a regular speaker at various industry events.
He holds a Ph.D. in bioorganic chemistry from the University of Brussels and The Temple University of Philadelphia as well as a Master in Science of Management from the Boston University.
Prior to joining Arthur D.Little Enrico worked in Research and Development at Monsanto and Solvay, both in Europe and the U.S.
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 Mr William Powlett Smith,
Leader, Health Sciences Group,
Ernst & Young
William’s career with Ernst & Young in the UK has spanned three offices - Edinburgh, London and Reading - and a number of disciplines - audit, corporate finance, entrepreneurial services, as well as a secondment to the UK Government’s Department of Trade and Industry. As a result of his extensive work with biotechnology and pharmaceutical businesses, and his strong international connections, particularly with E&Y’s offices on the east and west coast of the USA and in Germany, he is now the partner responsible for the UK firm’s Health Sciences practice. Until October 1999 William was a member of the BIA’s Board of Directors, and of the BIA Sub-Committee responsible for drafting the BIA’s Code of Best Practice. He was a contributor to, and coordinating partner for, the production of, Ernst & Young’s 1998-2004 European Life Sciences Reports.
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Mr Dirk Reyn,
Executive Director, New Business Development,
Janssen Pharmaceutica
Dirk Reyn (CEO) has a pharmacy degree and is a Master in Business Administration from Northwestern (USA) with 20 years of industry experience. After 10 years in a number of sales and marketing functions with Eli Lilly in Belgium, USA and France, Dirk joined J&J in 1992. After different roles with increasing responsibility, he accepted the International Marketing responsibility for the Gastrointestinal Franchise in 1996. He has been one of the driving forces behind the global marketing and commercial strategy for different GI products between 1992 and 1999. His recent experience include Global Prepulsid Team leader (1999-2001), Director of the J&J CRM (Customer Relationship Management) competence center (2001-2002) and most recently he became responsible for New Business Development for Janssen-Cilag in Europe (2002- today).
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Dr Joe Santangelo,
Director,
SingVax PTE Ltd
Joe Santangelo is a founder, board member and Development Director of SingVax Pte. Ltd (incorporated in 2004), which is a privately held Singapore biotech company focusing on vaccines for human health. Prior to that he served in R&D roles at Microscience Ltd. from its inception as a spin out from Imperial College of Science Technology and Medicine (UK) in 1997. His overall career in microbiology and fermentation spans over 20 years. Joe was born, educated and worked in the United States, before moving to South Africa, Germany and the United Kingdom. He has worked in both academia and industry, and moved to the biotech sector 8 years ago.
Joe has a B.Sc. from the State University of New York, an M.Sc. from the University of Vermont and a Ph.D. from the University of Cape Town. He was awarded an Alexander von Humboldt fellowship (1993) and is a member of various Microbiology and Biotechnology Societies.
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 Dr Mark Schenerman,
Senior Director, Analytical Biochemistry,
MedImmune
Dr. Schenerman is Senior Director of Analytical Biochemistry at MedImmune, Inc. in Gaithersburg, MD. He received his B.S. degree in Medical Technology from the University of Maryland in 1980 and his Ph.D. degree in Biochemistry and Molecular Biology from the University of Florida in 1986. From 1986 to 1988, he completed a postdoctoral fellowship at Cornell University in Biochemistry then joined Bristol-Myers Squibb Company in Syracuse, NY in 1988. As a Research Scientist at Bristol-Myers Squibb, Dr. Schenerman developed and validated methods to support recombinant protein product development and stability testing. Dr. Schenerman spent six years at Bristol-Myers Squibb developing chromatography, electrophoresis, and immunoassay methods for monoclonal antibodies, growth factors, and industrial enzymes before joining MedImmune, Inc. in 1994. As Director of Analytical Biochemistry at MedImmune, Inc., Dr. Schenerman oversees method development, validation and quality control testing for recombinant vaccines and monoclonal antibody products. Dr. Schenerman has published more than 16 articles in peer-reviewed journals and currently serves as an Adjunct Assistant Professor to the University of Maryland at Baltimore where he assists in the training of biotechnology students.
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Jörg Schmidt,
Head of Exploratory Pilot Plant,
Novartis Pharma AG
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 Henk Schuring,
Director, Regulatory Affairs,
Genzyme Europe
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 Andrew Sinclair,
Co-Founder, Managing Director, UK,
Biopharm Services
Andrew Sinclair founded BioPharm Services in December 1998 to develop a technology based services business focused on all aspects of biopharmaceuticals manufacturing. The company has developed software tools and databases for economic analysis and optimisation of bioprocesses and manufacturing operations. It also has developed unique insights into the market biomanufacturing market dynamics. Biopharm Services is six years old it has 12 employees based both in the UK and the US. Andrew Sinclair has over 20 years experience within the biopharmaceutical sector working for manufacturing operations (Lonza, Eli Lilly, GlaxoSmithKline) and contractors (Kvaerner, Jacobs engineering). He has been responsible for design, building and operation of biomanufacturing facilities. Prior to setting up Biopharm Services Andrew was the Director of Engineering and Logistics and Lonza Biologics.
Recent publications include.
In Print Paper ‘A Risk-Based Tool to Access Uncertainty in the Production of Therapeutics using Cell Culture’. Lim, A. C: Washbrook, J.; Sinclair, A.; Fish, B.; Francis, R.; Titchener-Hooker, N. J.; Farid, S. Biotechnol. Prog.
2004 Chapter ‘Worldwide Therapeutic Production Capacity’ Advances in Large Scale BioManufacturing and Scale-Up Production, ASM Press
2004 Paper ‘Biomanufacturing for the 21st Century – Designing a Concept Facility Based on Single Use Disposables’, Andrew Sinclair (Biopharm Services) Miriam Monge (Stedim), BioProcess International
2003 Paper ‘Capacity Availability: Impact on Commercialisation Strategies’, SCREENING - Trends in Drug Discovery, GIT Verlag, May 2003
2002 Paper ‘Quantitative Economic Evaluation of Single Use Disposables in Bioprocessing’, Andrew Sinclair (Biopharm Services) Miriam Monge (Stedim), Pharmaceutical Engineering
2001 Patent “Methods and apparatus for simulating industrial processes”, Sinclair P.A., UK Patent Application GB 2 362 484 A, (43) Date of A Publication 21.11.2001
2001 Paper ‘Biomanufacturing capacity: Current and future requirements’ vol. 8, 1 43-50 Journal of Commercial Biotechnology
2000. "Financial Model for Production of Monoclonal Antibodies Using Transgenic Chickens" Sinclair A, Ransohoff T, Latham P. IBC Symposium, ‘Cost of Goods and Process Modeling’. November 2000
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 Dr Ulrich Steiner,
Business Development Manager, Plant Made Pharmaceuticals,
Bayer HealthCare
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 Professor Beate Stern,
Department of Biomedicine,
University of Bergen
Beate Stern, PhD, Associate Professor at the Department of Biomedicine, University of Bergen, and Chief Scientific Officer and cofounder of the biotech spin-off company UniTargetingResearch AS, Bergen, Norway. Expertise in molecular biology, cell biology and bioinformatics. Fields of current research interest are DNA mobility and mRNA/protein localisation. Former professional activities include science journalism and former affiliations include the Max Planck Institute of Biochemistry, Martinsried, Germany.
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 Dr Thibaud Stoll,
Head Manufacturing Huningue,
Novartis Pharma S.A.S
Mr Stoll is Head of Bioprocessing at the new Novartis biotechnology manufacturing facility, located in Huningue, France. He is responsible for all the cell culture operations, from the seed lab to large-scale production in bioreactors (ca 14.5 m3). He has been a member of the start-up team of this facility from the beginning and as such, has participated to- or managed several activities such as equipment qualification (IQ, OQ, PQ), process transfer and validation, staffing and training of personnel.
Mr Stoll started his professional activities at Genentech, Inc., in cell culture R&D. He was then head of chemical production planning in a chemical plant of Firmenich SA (Switzerland), where he was in charge of planning and coordinating the fermentation and chemical production campaigns for fragrance and aroma compounds, including all the toll-manufacturing activities.
Mr Stoll holds a M.S. in chemical engineering from MIT and a Ph.D. in biochemical engineering from the Swiss Federal Institute of Technology (EPFL) in Lausanne, Switzerland.
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Dr Steve Swanson,
Director, Clinical Immunology,
Amgen
Dr. Swanson is a Director of the Clinical Immunology Department at Amgen, Inc. located in Thousand Oaks, California. This department supports functions including development, validation, and performance of all immunoassays and bioassays for the detection of antibodies directed against Amgen therapeutic proteins. This work includes analysis of preclinical and clinical samples generated to support drug development. In addition, the cellular immunology group in this department investigates cellular interactions through FACS and imaging techniques. Dr. Swanson received his B.A. in Biology and Chemistry from North Central College in Naperville, Illinois in 1977 and his Ph.D. in Microbiology from The University of Iowa in 1987. From 1988 to 1991 he was a Postdoctoral Research Associate in the Microbiology Department at The Ohio State University in Columbus, Ohio. Upon completion of postdoctoral work he joined Schering-Plough Research Institute as a Senior Scientist in the Biotechnology-Bioanalytical Department where he held positions of increasing responsibility from 1991 until 1999 when he joined Amgen. While at Schering-Plough he was responsible for the immunoassay lab which developed and performed assays for quantitation of biotechnology drugs and detection of antibodies directed against those drugs.
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 Mr Bill Thompson,
Consultant,
Rotherwood Associates
After obtaining degrees in biochemical engineering and food technology, Bill Thompson joined the APV Company Ltd working in process development and project engineering.
He joined Celltech Ltd where he managed the Process Engineering Department and was responsible for engineering and installation of all fermentation and downstream processing systems as well as the construction of a complete 40,000 sq.ft. production facility. This included the management of the validation exercise leading to a successful FDA inspection.
He then joined OROS Systems Ltd as Operations Director where he was responsible for design, manufacturing and quality assurance of the company's range of automated chromatography systems.
He is currently a Consultant with Rotherwood Associates. Recent projects have included:
- Design, project management and setup of a new medical device manufacturing facility
- project management of a series of quality and logistics-related projects for a contract biopharm manufacturer,
- the technical oversight of a new recombinant vaccine production facility construction project in the UK,
- process design of a major new vaccines manufacturing facility in Belgium,
- the management of a validation and documentation exercise on a bioprocess manufacturing facility
- the development of document control systems for a quality assurance department.
He has also organised the exhibitions and the conferences for UK Biotech and Biotechnology '94.
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 Dr Robin Thorpe,
Head, Division of Immunology & Endocrinology,
NIBSC
Robin Thorpe PhD, FRCPath, has been Head of the Division of Immunology & Endocrinology at the National Institute for Biological Standards and Control UK (NIBSC) since May 2004 & was previously Head of the Division of Immunobiology NIBSC from 1986. Since joining NIBSC in 1980 he has worked on cytokines, monoclonal antibodies, immunoglobulins and the immunology of infectious agents. Recent interests include the unwanted immunogenicity of biologicals development of improved bioassays for cytokines and cytokine contamination of biological products. He is a Fellow of the Royal College of Pathologists. He attends meetings of the ad hoc Working Party on Biotechnology/Pharmacy which gives advice to the CVMP of the EMEA. He has been a member of the Biologicals sub-committee of the CSM and is also a member of the External Advisory Panel to the CSM. He is a member of the British Pharmacopoeia Commission Committee N, the British Pharmacopoeia Panel of Experts on Blood Related Products and the Working Group on Monoclonal Antibodies of the European Pharmacopoeia. He is the Chairman of the IUIS Standardisation Subcommittee for chemokines and the standardisation and nomenclature committee of the International Cytokine Society. Dr Thorpe has been an author on over 190 publications in scientific journals and books and is an advisory editor for the journal Cytokine and an editorial board member of the Journal of Immunological Methods.
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 Dr Lincoln Tsang,
Partner, Arnold and Porter, Chairman, Regulatory Affairs Advisory Committee,
Bionindustry Association
Dr. Lincoln Tsang practises European and UK domestic law at the London office of Arnold & Porter LLP, an international law firm. His practice covers both contentious and non-contentious matters relating to pharmaceuticals, food, cosmetics and devices. He serves as a non-executive director on the management board of National Institute of Biological Standards and Control; and a member of the British Pharmacopoeia Commission’s Committee on Biological Materials; a member of Cancer Research UK Policy Advisory Committee. He is currently Chairman of the BioIndustry Association’s Regulatory Affairs Advisory Committee. He also advises foreign governments, trade associations and not-for-profit and/or charity organisations on various technical and legal matters pertaining to medicines and devices regulation. He is a former Head of Biologicals and Biotechnology of the United Kingdom Regulatory Authority responsible for a wide range of UK and European policy work. He held memberships and chairmanships of various advisory groups at the European Medicines Agency and at an international level, and has authored a number of regulatory guidelines. He was an advisor to the World Health Organisation (WHO) concerning technical and legal aspects of international trade of biological products. He writes and speaks widely on legal and technical matters relating to pharmaceuticals and life sciences industries.
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Dr Annie Van Broekhoven,
Director Biologicals OP,
Innogenetics NV
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 Dr Johan Vanhemelrijck,
Secretary General,
Europabio
Johan Vanhemelrijck, a Belgian national (b. 1951), is Doctor in Veterinary Medicine (University of Ghent).
He has held regional management positions with Upjohn Animal Health for 13 years, before joining FEDESA, the European Federation for Animal Health Industries.
As the Secretary General of FEDESA from 1989 to 2002, he has represented the veterinary pharmaceutical industry on a wide range of regulatory and policy-making subjects, including the creation of the European Medicines Evaluation Agency (EMEA), the effect of medicines regulation on competitiveness in the US and Europe and the effect of over-regulation on the availability of medicines for animals.
He has chaired the Belgian Association of Veterinary Medicines Industry from 1985 to 1987 and the Belgian association of veterinarians in industry from 1985 to 1989. He is an active member of the European Policy Centre (EPC) Risk Forum group, where he worked in the Risk Forum on the Precautionary Principle on Better Regulation, and currently on Science and Decision making. He has represented industry as a member of the EAG (External Advice Group to the European Commission’s DG Research).
He is Honorary Dean of the Belgian veterinary professional sector.
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Dr Meenu Wadhwa,
Leader,Cytokine and Growth Factor Group,Division Of Immunology and Endocrinology,
NIBSC
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 Dr Wynne Weston-Davies,
Medical & Development Director,
Evolutec Group
After an early career as a surgeon Wynne joined E R Squibb (now Bristol-Myers Squibb) as Associate Director of Clinical Research and has subsequently spent 23 years in the pharmaceutical and biotechnology industries. During this time he has worked or consulted on clinical, preclinical and regulatory affairs for many of the world’s major healthcare companies. He joined Evolutec at its formation in 1998 where he has been responsible for the preclinical and clinical development of Evolutec’s discovery molecules. Under his management Evolutec gained its first IND in October 2002 which allowed it to commence an ongoing clinical trials programme with its lead molecule rEV131. Wynne is also a Non-Executive Director of Healthcare Holdings plc, which floated on AIM in March 2004.
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 Jan-Eric Zandbergen,
Manager, Sterile Productions,
Solvay Pharmaceuticals
Jan-Eric Zandbergen has been with Solvay Pharmaceuticals since 1999 in Manufacturing. The Pharmaceutical Manufacturing facility in Olst, the Netherlands is a production facility for filling liquids in bottles and sachets, formulating and packaging of tablets and filling and packaging of syringes.
Most recently Jan-Eric managed the Solid Dosage Department responsible for formulating, tabletting and coating of tablets. Today, Jan-Eric manages the Department of Sterile Productions responsible for compounding, filling, inspecting, labelling and packaging of both aseptic and terminal sterilized syringes. Two new Isolator filling lines are installed for Solvay’s Influenza Virus Vaccin Influvac® and are also available for contract manufacturing.
Jan-Eric holds a MSc degree from the University of Twente in Mechanical Engineering with emphasis in Biomedical Engineering.
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Dr Pierrette Zorzi-Morre,
Director, Evaluation of Biological Products Department,
AFSSAPS
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