|
|
Speakers 
 Dr Farzaad Abdi-Dezfuli,
Director of Business Development,
UniTargetingResearch
Dr. Abdi-Dezfuli’s background is in preclinical and clinical research with seven years of drug development experience from Eli Lilly and Company. He has several years of experience in commercializing innovative medical/biotech projects from Sarsia Innovation AS. Dr. Abdi-Dezfuli has held various positions within UTR the latest of which has entailed charting the commercial development of the company. Dr. Abdi-Dezfuli received his doctorate from the University of Edinburgh Medical School and has postdoctoral training at Haukeland University Hospital, Bergen, Norway.
|
Dr Henning Afflerbach,
Director, Buisness Development Biopharmaceuticals,
Direvo Biotech
|
 Dr Sven-Oliver Arndt,
Senior Manager Analytical Development / Protein Separation,
Merck KGaA
Sven Oliver Arndt joined Merck KGaA, Germany in 2000. Currently, he holds the position of a Senior Manager in the department of Analytical Development, where he is responsible for the development, validation and QC analytics of protein separation techniques. His current interests and responsibilities include analytical development as well as quality control of biological entities from pre-clinical stages to commercialization.
Dr. Arndt received a Ph.D. degree in biochemistry and immunology from the German Cancer Research Center, Heidelberg, Germany in 1999.
|
Dr Alahari Arunakumari,
Director, Process Development,
Medarex
|
 Dr Otmane Boussif,
Formulation Development Unit Manager, Pharmaceutical Sciences Department,
sanofi aventis R&D
Dr. Boussif has over 12 years experience in development of biogical products. He obtained the PhD in Biophysico-chemistry sciences and the M.S. in Biochemistry and Organic chemistry at Strasbourg University, where he developed the widely used PEI-mediated gene transfer system, known as JetPEI®. After his Ph.D he joined Transgene (Strasbourg) where he developed vectors, based on lipid and polymers, for DNA, peptides and proteins for gene and drug delivery applications. In 2000 he joined Aventis-Gencell (Paris) where he held several positions and led the Preclinical Manufacturing and Formulation group. In 2004 he moved to Laboratoires SERONO S.A. (Switzerland) where he was managing pre-formulation activities within Downstream Processing Department. He recently joined Pharmaceutical Sciences Department of sanofi-aventis R&D as Biotherapeutics formulation unit Manager.
|
 Mr Rene Brecht,
Vice President Process Science and Manufacturing,
ProBioGen
|
Dr Andrwe Buchanan,
Protein Engineering,
Cambridge Antibody Technology
|
 Mr Pete Caldwell,
Partner,
Tefen Europe Ltd.
Mr Caldwell is an Associate Partner with Tefen Europe. Pete has been in management consultancy and operations management since 1994. He has made a major contribution to Tefen’s operational excellence offering development within the life sciences and general manufacturing sectors.Pete’s background and expertise include: operations strategy formulation and deployment, lean manufacturing design and
implementation, lean quality (QC and QA) and organisational effectiveness programs. He has experience consulting across a number of sectors, for clients including Alcatel, AstraZeneca, Boots, Johnson and Johnson, Merck Sharpe and Dohme. Pete holds degrees in Engineering and Management from the Universities of Exeter and Cambridge.
|
Dr Paul Chamberlain,
Senior Director, Biopharmaceutical Development, Development and Regulatory Services,
MDS Pharma
|
 Dr Louis Christian Clauss,
Director, Regulatory Affairs, New Product Development,
Baxter Bioscience
|
Mr Mike Davies,
Manager of Product Characterisation,
Lonza Biologics
Lonza, a chemical and biotechnology company driven by the life sciences, generated sales of CHF 2.52 billion in 2005. Headquartered in Switzerland, Lonza operates 23 production and R&D sites around the world. Its 6400 employees are passionately committed to delivering sustainable value to their customers. Lonza is one of the leading custom manufacturers of chemical intermediates, active ingredients and biopharmaceuticals for the pharmaceutical and agrochemical industries. Further information can be found on our website www.lonza.com.
Within Lonza Biologics I am responsible for the development and application of technologies for protein characterization for both final product and in process samples throughout process development (from cell line construction to BLA submission).
|
 Dr Hans de Haard,
Director of Technology Development,
Ablynx
Prior to joining Ablynx, Dr De Haard was Manager in the Functional Biomolecules group at Unilever Research Laboratories in Vlaardingen. In that position he was in charge of the research program within Unilever concerning applications of camelid single-domain antibodies for several Unilever consumer product groups. Previously he was Project Leader in Antibody Engineering at Organon. He received his PhD from the University of Maastricht and has carried-out post-doctoral research in the area of antibody engineering for diagnostic applications.
|
Dr John Dempsey,
European Technical Specialist,
Invitrogen
|
Dr Laurel Donahue-Hjelle,
Director of Cell Line Development,
Invitrogen BioManufacturing Services
|
Dr Reinoud Driebergen,
Senior Program Director, Established Therapeutic Areas, Global Product Development,
Merck-Serono
|
Dr Dave Estell,
Vice President of Technology,
Genencor International
|
 Dr. Igor Fisch,
CEO,
Selexis SA
Igor Fisch is the Chief Executive Officer of Selexis and Chairman of the Board of Directors. He is an accomplished protein chemist and molecular biologist. After completing his post-doctoral studies at the Medical Research Council in Cambridge, UK, he joined the Center for Biotechnology UNIL-EPFL as a group leader, working in the field of molecular evolution and peptide discovery. In parallel to his research and teaching activities, he received the De Vigier Prize and the NETS Best Prize with training in entrepreneurship both at the EPFL in Lausanne and at the Babson College in Boston, USA.
|
 Dr Sabine Geisse,
Lab Head / Scientific Expert,
Novartis Pharma
Dr. Sabine Geisse is a recognized expert in eukaryotic cell biology with 19 years experience that she gathered with her PhDs in Nutrition and Human Biology at the Justus-Liebig-University in Giessen and Philipps-University in Marburg and as a postdoc at the University of Essen in Germany. She joined Sandoz/Novartis in 1988 within Discovery Technologies and is a scientific expert for Biomolecules Production.
In 2004, she received the Novartis Leading Scientist award.
|
 Dr Tariq Ghayur,
Senior Principal Scientist and Research Fellow,
Abbott Laboratories
Tariq Ghayur received a Ph.D (1986) in Immunology from McGill University, Montreal, Canada. He did his post-doctoral training at McGill (1986-’88) and Dana Farber Cancer Institute (1988-’90). He joined BASF Pharma (1990), which was acquired by Abbott Laboratories in 2000. He has worked on both small molecule and therapeutic antibody discovery programs, mainly defining the biology/pathology of selected targets (target validation) and developing assays for high throughput screening and/or candidate selection. More recently, he has worked on developing novel forms of antibody-based therapeutics. Since 1996 he has initiated and/or worked on several therapeutic antibody programs for treatment of immunological, neurological, and metabolic diseases. From 1998-2004, he led two therapeutic antibody discovery project teams and delivered 2 drug development candidates. During this period, he was also responsible for establishing and maintaining several academic and industrial collaborations. He received Abbott’s “President’s Award” in 2004. Currently, he serves as a Senior Principal Scientist and is a Research Fellow in the Volwiler Society whose membership consists of accomplished Abbott Scientists. He is also a member of a team at Abbott Bioresearch Center (ABC, Worcester) that encourages and enables scientists, at all levels of the organization, to explore novel ideas and initiate new drug discovery programs and/or develop novel technologies.
He holds several patents and is the author of many peer-reviewed scientific publications. In addition to therapeutic antibodies and antibody generation technologies, his areas of expertise are inflammation, lymphocyte biology, cytokine biology and transplantation rejection.
|
 Dr Steffen Gross,
Laboratory Head and Scientific Assessor, Section Monoclonal and Polyclonal Antibodies,
Paul Ehrlich-Institute
Biography:
-1990-1995, Friedrich-Schiller- University Jena, Germany, study in Biology
-1995-1998, Max Planck Research Unit Molecular Cell Biology Jena, Germany, Pursuing a Ph.D. degree (1998), “The PDGF-receptor directed protein tyrosine phosphatases in cell signaling pathways”
-1998-2001 Institute of Cellular Signaling, University Nijmegen, The Netherlands, postdoctoral position, “Characterization of IA-2/IA-2?? two phosphatase-like proteins identified as major auto antigens in diabetes mellitus”, during this time several month working visit at the NIH, Bethesda, Maryland, USA
-2001-2005 Institute for Biochemistry II, University of Frankfurt, Germany, research group leader: “Regulation of the NO receptor soluble guanylyl cyclase by tyrosine phosphorylation”
-2005-present, Paul-Ehrlich Institute, laboratory head and assessor (quality, non-clinical)
|
 Dr Thomas Grunfeld,
Managing Partner,
Sarsia Venture Management
|
 Dr Feroz Jameel,
Principal Research Scientist,
Amgen
Feroz Jameel, Ph.D, is a Principal Scientist in Drug Product Process Development at Amgen Inc, Thousand oaks, CA. He received his undergraduate degree in Pharmacy from Kakatiya University, Master’s degree in Pharmaceutics from University of Delhi and Ph.D in Pharmaceutics from University of Connecticut. He performed his postdoctoral work with Professor Mike J. Pikal where he was involved in the formulation and process design for freeze drying of various proteins, antibiotics and conventional small molecules. In his current role at Amgen he is involved in the development, optimization, scale-up and transfer to manufacturing of formulation, filling and lyophilization processes for biopharmaceutical products. Dr. Jameel is also involved in the development of new technologies to enhance robustness of drug product manufacturing.
|
 Dr Yijia Jiang,
Senior Scientist, Analytical Department,
Amgen
Dr. Yijia Jiang is currently a principal scientist in the Global Cellular and Analytical Resources Department of Amgen Inc. and a team leader of the site biophysical characterization team. Her responsibilities include the biophysical characterization of proteins at all stages of the development process using AUC, SEC-LS, DLS, FTIR and fluorescence spectroscopies etc. and providing regulatory support for the better understanding of protein conformation and protein self associations.
Dr. Yijia Jiang received her B.S. and M.S. degrees from the Chemistry Department of Peking University in China in 1988 and 1991, respectively. She received her Ph.D. from the Chemistry Department of Rice University in 1997, where her research was on the purification and characterization of neplanocin A reductase and the biosynthesis of aristeromycin with professor Ronald J. Parry.
|
 Dr Avinoam Kadouri,
Chief Executive Officer,
Rainbow Biotechnologies
|
 Dr Christian Leist,
Head of Bioprocess and Technology Development,
Novartis Pharma
|
 Mr Andy Lewin,
Business Development Director,
SynCo Bio Partners
Andy Lewin currently heads the Business Development and Project Management functions at SynCo Bio Partners and has more than ten years experience in biotechnology and pharmaceutical development especially within the context of contract research and contract manufacturing organisations.
|
Dr Genevieve Losonsky,
Vice President, Infectious Diseases and Vaccines Clinical Development,
MedImmune
Genevieve Losonsky is MedImmune’s vice president, clinical development, infectious disease. She received a bachelor’s degree in biology and psychology from New York University and a medical degree from SUNY Buffalo. Dr. Losonsky completed her residency in pediatrics at Yale New Haven Hospital, Yale University Department of Pediatrics, and also completed a research and clinical fellowship in infectious diseases at Buffalo Children’s Hospital and a National Institutes of Health fellowship in infectious diseases at Johns Hopkins University.
|
 Dr Michael Marshall,
Principal Scientist, Regulatory Affairs,
Novo Nordisk
Michael Marshall’s current position is Regulatory Specialist in biotech drug substances, including second generation manufacturing processes for insulin and BSE safety issues. He has held research positions in diabetes immunology and biochemistry and holds a Ph.D. in plant lipid biochemistry from the University of Ottawa.
|
 Dr Stuart Pollard,
Senior Vice President and Chief Scientific Officer,
Maxygen
|
Mr Steven Projan,
Vice President, Protein Technologies,
Wyeth
|
 Mr Marc Puich,
Partner,
Tefen USA Ltd.
Mr Puich is a Partner with Tefen USA, responsible for leading and developing Tefen’s activity in the Life Sciences sector, with a primary focus on bioPharmaceutical organisations. With over 9 years of consulting experience, Marc has been focused for the past 8 years exclusively in the pharmaceutical and biotech sectors working on organisational transformations and operations excellence in areas such as supply chain, manufacturing, quality assurance, and quality control. Marc is also the facilitator of the US BioPharmaceutical Operations Excellence Consortium, an industry group that meets 6 times per year to benchmark operations excellence programs.
|
 Dr Andrea Rappagliosi,
Vice President, Health Policy and Governmental Relations, Merck-Serono and Chairman of the Healthcare Council,
EuropaBio
|
 Bruce Rawlings,
Product Manager, BioPharmaceutical Division,
Pall Life Sciences
Bruce Rawlings is a Product Manager in the BioPharmaceutical division of Pall Life Sciences. During his 12 years at Pall he has worked in Quality Assurance and in Pall’s Scientific and Laboratory Services (SLS) providing technical support & training for Pall’s Biopharmaceutical customers. More recently, Bruce has supported the Pall tangential flow filtration (TFF) products as a Technical & System Specialist, Applications Engineer and Product Manager. He is currently the Product Manager for Single Use Systems, focussing mainly on tangential flow filtration technologies and applications.
Bruce has a Master of Science Degree in Advance Manufacturing Technology and a Bachelor of Engineering Degree, both obtained from Portsmouth University.
|
 Dr Inigo Rodriguez-Mendieta,
Head of Analytical Services,
Avacta Analytical
|
Barry Rosenblatt,
Director, Technical Services, Biopharmaceutical Services,
Charles River Laboratories
|
 Dr Claudia Roth,
Process Development and Implementation,
Vetter Pharma
Claudia Roth studied chemical / process engineering at the University of Erlangen (Germany). She undertook her PhD thesis (freeze-drying) at Roche Diagnostics (Mannheim, Germany). Since 2000, she has worked for Vetter Pharma-Fertigung (Ravensburg, Germany). Starting within aseptic production as Assistant to the Head of Production, she took over responsibility for a newly created group within the R&D department (process development and process implementation). The focus of the group is on pharmaceutical process development for prefilled systems (liquid/freeze-dried) and implementation within aseptic production.
|
Dr Arndt Schottelius,
Director, Non-Clinical Drug Development,
Genentech
|
 Henk Schuring,
Director, Regulatory Affairs,
Genzyme Europe
|
 Philippe Stas,
Chief Operating Officer,
AlgoNomics
Dr. Philippe Stas is chief operating officer of AlgoNomics, a Belgium based biotech company specialized in immunogenicity monitoring and assessment. Since 1999, Philippe has been responsible for business development, project management and operations at the company.
From 1990 till 1997, Philippe has been active in antibody engineering, immunology and bioinformatics research at the University of Brussels. After performing bioinformatics research at PE Genscope (a Perkin Elmer company, CA), he joined the team for the creation of AlgoNomics in 1999. Since 2002, the company built out an industry standard for predicting and measuring T-cell driven immunogenicity. Philippe holds an M.Sc.E. in biotechnology, a Master in IT, an MBA in part and is chairman of the Belgian Association of Bioindustries bio.be
|
 Dr Lincoln Tsang,
Partner,
Arnold & Porter LLP
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.
|
 Dr. Victor Vinci,
Head, Bioprocess Operations, Bioproduct Research & Development,
Eli Lilly and Company
Dr. Victor A. Vinci is Head of Bioprocess Operations in Bioproduct R&D at Eli Lilly and Company. As such, he is responsible for operations in the bioprocess pilot-plant which is focused on bringing new protein therapeutics to market by producing active pharmaceutical ingredients intended for clinical trials. From 2002 to 2006, he led efforts involved in the design, commissioning and qualification of a new 200,000 sq ft cGMP bulk process facility. He also led the design of a new staffing model as well as implementation of more effective and compliant operational practices. He is responsible for technical transfer of new bioprocesses from development into the cGMP pilot-plant and collaborates on successful late phase technical transfer. Prior to his current role, he was a Senior Research Scientist at Eli Lilly in culture development and fermentation scale-up work and began his career in 1988 as a senior scientist for manufacturing, science and technology at Merck. Dr. Vinci has published, been an inventor of and presented work in biotechnology as well as recently serving co-editor of a book on mammalian, microbial and plant cell culture. He received his doctorate degree in Microbiology from The Ohio State University.
|
 Dr Emanuelle Voisin,
Principal,
Voisin Consulting
Previously, Emmanuelle managed the R&D operations of Laboratoires Besins Iscovesco in the USA. She was responsible for both clinical and preclinical product development, with particular focus on global development plans, in order to harmonize research efforts across Europe and the USA.
Emmanuelle held a position as Reviewing Pharmacologist and Toxicologist with the US FDA CDER Division of Antiviral Drug Products, where she was in charge of reviewing applications for new AIDS therapies. Prior to joining the FDA, Emmanuelle worked in preclinical drug development at Laboratoires Servier in France.
Her background in academic research was acquired in the USA at the National Institutes of Health in the Neuroscience Branch (NIMH), and in France with national research units of CNRS and INSERM. She earned her Ph.D. in Pharmacology at Institut Gustave Roussy, Villejuif, France, studying the bioactiviation of novel anticancer molecules.
|
Dr Meenu Wadhwa,
Leader,Cytokine and Growth Factor Group,Division Of Immunology and Endocrinology,
NIBSC
|
 Dr Armin Weidmann,
Director, Research and Development,
Morphosys
|
 Professor Rolf Werner,
Corporate Director, Corporate Division Biopharmace,
Boehringer Ingelheim Gmbh
Professor Rolf G Werner is Managing Director of the Corporate Division for Biopharma¬ceuticals at Boehringer Ingelheim GmbH and responsible for the strategic orientation and the worldwide business of biopharmaceuticals. He joined Boehringer Ingelheim in 1973, after obtaining his PhD at the University of Tübingen. In 1990 he was appointed as professor at the Faculty of Biology at the same university. Throughout his time at Boehringer Ingelheim, he has worked in positions of increasing responsibility in the biopharmaceutical division before being promoted to Managing Director in 2000. In January 2004, he received an honorary doctor degree from the University of Chiang Mai in Thailand.
|
 Dr Frank Wolpers,
Industrial Sales Director Europe,
Perbio Science
After studying Process Engineering at the University of Hannover (academic degree "Dipl.-Ing."), I started my job career in 1990 as Junior Sales Engineer with Messrs. Drägerwerk Germany. 2 years later I joined Messrs. DIESSEL GmbH, Germany as International Sales Manger for pharmaceutical production systems. In 2001 I took over the responsibility as Sales Director Pharma & Biotech. In 2002 I joined to B. Braun Biotech International GmbH, Germany as Sales Director Fermentation Projects. I worked worldwide for custom fermentation projects. Since 2004 I’m now working for Perbio Science. I firstly started as Business Development Manager for single use BioProcess Container (BPC). In August I was promoted to the function of the Industrial Sales Director Europe, which I’m still holding today. Part of my responsibilities in the past was the organization of several customer seminars as well as the participation as speaker in different national and international seminars, like VDMA (Germany, USA), APV (Germany), Concept (Germany) and ISPE (Europe).
|
Mr Jean Pascal Zambaux,
Pharmacist and Business Development Manager,
ATMI Lifesciences
|
 Dr Karl Ziegelbauer,
Discovery Europe, Pharma Global Drug Discovery,
Bayer Healthcare
|
|
|
|
