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Conference:
Pre-conference briefing
16 Sept 8am - 5:30pm
Day 1
17 Sept 8am - 5:30pm
Day 2
18 Sept 8am - 5:30pm
Post-conference workshop
19 Sept 8am - 5:30pm
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Meet our speakers...
President and Chief Executive Officer,
Pluristem
Mr. Aberman joined Pluristem in September 2005 and changed the Company’s strategy towards cellular therapeutics. Mr. Aberman has 20 years of experience in marketing and management in the high technology industry. He has held Chief Executive and Chairman positions in Israel, the USA, Europe, Japan and Korea. He has operated within high-tech global companies in the fields of automatic optical inspection, network security, video over IP, software, chip design and robotics. Mr. Aberman serves as the Chairman of Rose Hitech Ltd., a private investment company; and has served in the past as the Chairman of VLScom Ltd., a private company specializing in video compression for HDTV and video over IP and as a Director of Ori Software Ltd., a company involved in data management. Prior to that, he served as the President and CEO of Elbit Vision Systems (EVSNF.OB), which supplies inspection systems for the microelectronic industry.
Mr. Aberman has served as President and CEO of Netect Ltd., specializing in the field of Internet security software and was the Co-Founder, President and CEO of Associative Computing Ltd., which developed an associative parallel processor for real-time video processing. He has also served as Chairman of Display Inspection Systems Inc., specializing in laser based inspection machines and as President and CEO of Robomatix Technologies Ltd. (RBMXF.OB).
In 1992, Mr. Aberman was awarded the Rothschild Prize for excellence in his field from the President of the State of Israel. Mr. Aberman holds a B.Sc. in Mechanical Engineering from Ben Gurion University in Israel.
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Chief Executive Officer,
Antitope
Dr Baker completed a PhD in cellular immunology at University of Birmingham UK and after two postdoctoral positions in Cambridge moved to the biotechnology industry where he has held senior management positions at a number of companies including Biovation, Cellular Technologies Limited and Whatman BioSciences. Dr Baker is a founder and the Chief Scientific Officer of Antitope a Cambridge, UK based company which specializes in the prediction of immunogenicity in biologics.
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Principal Scientific Expert Biologics,
Bayer Schering Pharma
Prof. Andreas Baumann is Principal Scientific Expert for Biologics within Global Early Development at Bayer Schering Pharma in Berlin, Germany, where his responsibilities cover the global preclinical pharmacokinetic development of biologics. He has 17 years experience in drug development in the pharmaceutical industry including small molecules and for the last 7 years focused on biologics. Prior his present obligations he was heading the Research Pharmacokinetic Department at Schering AG.
In parallel, he is Professor of Pharmacology & Toxicology, lecturing at the Faculty of Medicine, University of Greifswald, Germany.
Andreas is a regularly featured speaker in international scientific conferences. He has published more than 40 peer-reviewed scientific articles, scientific text book articles and is co-editor of Pharmacokinetic Challenges in Drug Discovery (Springer, 2002).
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Senior Vice President, Biopharmaceuticals,
Boehringer Ingelheim
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Chief Executive Officer,
Suppremol
Peter Buckel studied Biology at the University Munich with focus on Microbiology and Biochemistry. His diploma and PhD thesis contributed to the regulation of protein synthesis and ribosomal structure and genetics. He started his professional career at Boehringer Mannheim leading a team through the development of recombinant enzymes, antigens and antibodies, applied in diagnostic applications and as research tools. He initiated the first Biopharmaceutical projects within his Biotechnology department, finally leading to market introduction of Reteplase and Recormon, today one of the top selling product of Roche. As Head of Global Research of Boehringer Mannheim he initiated a program called “Molecular Medicine” leading to a network of joint venture companies for cellular services and therapies. After his successful career in Pharma Industry, Peter Buckel served as CEO in Xantos and Atugen, as well as a member in scientific and supervisory Boards in several international Biotech and Pharma companies and for governments in Germany, Ireland and Singapore. In 1996 he was appointed Professor for Biology at the Ludwig-Maximilian-University Munich.
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Dr Louis Christian Clauss,
Director, Regulatory Affairs, New Product Development,
Baxter Bioscience
Dr. Clauss holds a Masters degree in Bio-Pharmacy and a PhD in Pharmacy and in Business Administration (IAE). He was a resident Biologist in public hospitals before moving into the multinational health care industry both in medical devices and pharmaceutical fields (Mérieux, Dow Corning, Boston Scientific, Clintec, B.D® Baxter).
He has over 20 years of experience in international marketing, product development and regulatory affairs.
He leads the development of numerous products, drugs, devices and Biologics such as BioSimilar. He is a member of numerous professional societies like DIA, RAPS (past General secretary, RACS), EUCOMED (past chairman of the FRG), APIMCA (past elected President), among others. He has published more than 40 papers on scientific, regulatory and reimbursement subjects.
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Director Biopharmaceuticals,
NDA Regulatory Science
Gabriele Dallman (Schäffner) is internationally recognised for her long career as a biological scientist with 20 years as a regulator at senior level. Until August 2005 Dr Dallman was Director and Professor, Head of Section of ‘Mono and Polyclonal Antibodies’ at the German Federal Agency for Sera, Vaccines and Blood Products (Paul-Ehrlich-Institute). In this capacity she was responsible for pre- and post approval decisions and batch release of antibody-containing medicinal products including immunoglobulins derived from human plasma, monoclonal antibodies as well as immunosera for human use derived from animal blood.
Dr Dallman has in-depth experience with EU regulatory procedures. She was a member of working groups and working parties of the former CPMP and new CHMP, the EDQM and European Pharmacopoeia. She was deputy CHMP member of the Paul-Ehrlich-Institut and a member of CHMP Scientific Advice Working Party. Thus, she represented the agency’s position also on other product classes such as vaccines including tumor vaccines, gene and somatic cell therapy.
Prior to joining NDA Advisory Board, Dr. Schäffner has been working as Principal Consultant at PAREXEL Consulting with specific focus on recent biological and biotechnological developments for EU and FDA submissions.
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Senior Director, Strategic Managemenet Group,
Pfizer
Nick Davies received his BSc in Biology and a PhD in molecular biology and immunology from Cambridge University before completing his post-doctoral studies at St. Mary's Medical School, Imperial College, London.
He joined Pfizer in July 2005 and his current role is Senior Director and Sandwich Site Head for the Strategic Management Group. Previous to this role, Nick was a strategy consultant for PricewaterhouseCoopers and was responsible for growing and managing a Pharmaceutical R&D consulting business in both Europe and the Americas. His main areas of interest are in developing and implementing strategies and innovative solutions for transforming R&D processes, activities and functions. Prior to becoming a consultant, Nick held a number of roles in the research lines of Novartis and AstraZeneca.
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Senior Executive Vice President, Licensing and Intellectual Property and Chief Intellectual Property Counsel,
Merck Serono
Dr. Giampiero De Luca is the Senior Executive Vice President Licensing and Intellectual Property of Merck Serono International S.A. His current responsibilities include management of Merck Serono’s patent portfolio, oversight of patent-related litigation and coordinating the Intellectual Property Department’s support of the company’s licensing activities. Dr. De Luca began his career at the European Patent Office in 1979 as a Patent Search Examiner and, subsequently, as a Substantive Patent Examiner. He holds a doctoral degree in industrial chemistry from the University of Milan, a Diploma in General Microbiology from the Institut Pasteur and is a chartered European Patent Attorney.
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Chief Executive Officer,
ImmuPharma
Mr. Dimitriou has over 20 years’ experience in the pharmaceutical and biotech industry. His past roles include Senior Director, Worldwide Business Development at GlaxoSmithKline, where his responsibilities included worldwide corporate deals with pharmaceutical and biotech companies. He held a similar role in Europe for Bristol-Myers Squibb. He is also the founder and Chief Executive Officer of ImmuPharma plc. He has a degree in biochemistry from the University of London (Kings College) and an MSc in pathology and toxicology from the Imperial College Medical School of the University of London.
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Senior Principle Scientist and Research Fellow,
Abbott Laboratories
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.
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Chairman and Chief Executive Officer,
Biogenerics Inc
Dr William Haddad is a generic drug manufacturer, a founder of the generic trade association and its chairman/president for over a decade. He was vice chairman and CEO of solid dosage manufacturing for Schein Pharmaceutical, one of the largest generic companies. He initiated and negotiated the Drug Price Competition and Patent Restoration Act (Hatch-Waxman) and helped to organize the team leading to the reducing of AIDS prices in Africa from $12-15,000 a year to less than a dollar a day. He began his studies/hearings/writings on the multinational pharmaceutical companies as an assistant to the late Senator Estes Kefavuer.
Dr Haddad was one of the founders, Associate Director and Inspector General of the Peace Corps and the poverty program (OEO). He worked as an assistant to Robert Kennedy and during the presidential campaign as a liaison between Robert and Jack Kennedy and was Mario Cuomo's campaign manager in his first successful effort to win the governorship in New York.
Dr Haddad won a dozen awards and nominated for the Pulitzer Price as reporter and investigative editor of the New York Post and New York Herald Tribune. For the Tribune he exposed the tetracycline cartel resulting in fines of $200,000,000 and a collapse of the cartel. He held the subpoena power for the New York Assembly and in joint hearings with the US House of Representatives exposed and collapsed the Uranium Cartel. His investigation of the oil companies resulted in several billion dollars in rebates to the States.
As an author, Dr Haddad has written several books. He is currently attempting to create a generic biotech industry where the issues are not scientific, but political.
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Head, Early Stage Licensing,
Merck Serono
Joern-Peter Halle is heading the Early Stage Licensing function at Merck Serono leading the negotiations pre-clinical product opportunities and technologies. His function also includes a Search & Evaluation team looking into external product opportunities in all pre-clinical and clinical development stages in Oncology, Autoimmune & Inflammatory diseases, Neurodegenerative diseases, Fertility, and Endocrinology. His team works in close collaboration with the Merck Serono’s business development and the corporate M&A functions, responsible for negotiation of clinical stage and acquisitions opportunities, respectively. He is a member of the Discovery Review and the Proof of Concept Committees at Merck Serono. Dr. Halle had been Senior Licensing Manager of Merck KGaA since February 2005 with significant contributions to several in-licensing and acquisition projects. Prior to joining Merck, he held management positions in Biotech companies. Dr. Halle has a PhD in molecular biology from the University of Constance.
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Director Clinical Research,
GlaxoSmithKline
Michael Herschel was born in Germany and graduated and obtained his doctorate in Medicine from Heidelberg University in 1977. After his post-doc years at the Harvard Medical School Department of Psychiatry and medical speciality training (he is a board-certified Clinical Pharmacologist), he joined the Pharmaceutical Industry in the 1980s. He has held positions in medicine, marketing and as a project leader with Boehringer Mannheim, Merckle, and Boehringer Ingelheim both at the local operating unit and corporate levels. He also obtained an MBA degree from Brunel University which included a dissertation on project evaluation and decision audits. He holds a Diploma in Pharmaceutical Medicine of the Royal College of Physicians, and is a Fellow of their Faculty. He is Past President of the German Society for Pharmaceutical Medicine.
Dr. Herschel joined GlaxoWellcome Germany as Director Clinical Research in February 1999 where he initiated a major change programme to improve the department’s effectiveness. Since January 2001 he is Director Clinical Research at GlaxoSmithKline Germany.
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Director, Finance and R&D Portfolio Management,
Wyeth
Mark Horn is Director of Finance and R&D Portfolio Management for Wyeth Consumer Healthcare. He has more than 20 years of industry experience. Mark, a Fulbright Scholar, is a frequent contributor at industry conferences. He served as conference chair at the Portfolio Management in Pharma conference in Madrid in February 2008, as session chair at the Drug Information Association annual meeting in Atlanta in June 2007 and as course director for the Pharmaceutical Education and Research Institute (PERI) training program "Project Management in the Research-Based Pharmaceutical Industry" in San Francisco in November 2006.
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Senior Director, Biopharma Technology,
GE Healthcare Biosciences
Dr. Günter Jagschies is in his 24th year with GE Healthcare Life Sciences (former Amersham) and has held senior management positions in sales, marketing, and R&D within the bioprocess division of the company supplying the industry with downstream processing solutions for development and manufacturing. His current role is Senior Director Strategic Customer Relations (R&D) working globally with industrial collaborations and as business advisor for the Life Sciences R&D and Business team. He is based in Uppsala, Sweden.
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Scientific Advisory Board, Sigma-Aldrich and SAFC, and Chief Executive Officer,
Rainbow Biotechnologies
Dr Kadouri is the chairman of ACTIP European Animal Cell Technology Industrial Platform and a member of Scientific Advisory Boards of several European and American companies and also a consultant to many biotech companies. Prior to his forming Rainbow Biotechnologies he was bioprocess Technology Development Director, Serono Biotech Center, Vevey, Switzerland.
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President and Chief Executive Officer,
Biologics Consulting Group
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Chief Executive Officer and President,
Reliant Life Sciences
Gerhard F. Klement currently serves as CEO & President for Reliance Biopharmaceuticals. Reliance Biopharmaceuticals is part of Reliance Industries, the largest company in India. He is with Reliance since July 2006. The main goal of Reliance is to establish a global Biotechnology company. Within his role he is responsible for the production of recombinant Proteins and MAB, Blood Plasma Products, Vaccines and API’S.
Prior to joining Reliance he served as VP Manufacturing & Technical Operations for ALTUS Pharmaceuticals. Within this role he was leading the manufacturing, process development, formulation and analytical operations for ALTUS.
Mr. Klement served as Chief Technology Officer for the worldwide Biologics and Chemicals Group at Lonza, where he was responsible for new technologies and business development. From 2003 to 2005 Mr. Klement was the Head of Operations, USA and Chief Operating Officer Biopharmaceuticals, Worldwide at Lonza Biologics.
Previously, Mr. Klement held various positions in manufacturing and engineering at Serono and Centocor. Mr. Klement also serves on the Scientific Advisory Board of the New Hampshire Chamber of Commerce and the Scientific Advisory Board of Laureate Pharmaceuticals. He served as well on the board of directors for the New Hampshire. Mr. Klement holds a B.SC. from the University of Agriculture in Vienna, Austria. He received executive training in general management and leadership from IMD and Babson College.
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Chief Executive Officer and Managing Partner,
Medical Marketing Economics
Dr. Kolassa is CEO and Managing Partner of Medical marketing Economics, LLC, a firm with offices in Oxford, Mississippi and Montclair, New Jersey, that provides clients with comprehensive strategic guidance in the development of pricing and competitive strategies and the execution of customized marketing research for the global pharmaceutical industry. Mick is recognized internationally as the leading expert on pharmaceutical pricing and value-based strategies. He is Adjunct Professor of Pharmacy Administration in the School of Pharmacy and former Associate Professor of Pharmacy Administration and Marketing in the School of Business at the University of Mississippi
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Chief Executive Officer and Co-Founder,
Roche-Kulmbach
Dr. Roland Kreutzer is Managing Director of Roche Kulmbach GmbH, Roche’s Center of Excellence for RNA Therapeutics. He co-founded the company under the name of Ribopharma AG in 2000 as the first company world-wide focusing on the therapeutic potential of RNAi (later Alnylam Europe AG). Dr. Kreutzer studied biology at the University of Bayreuth, Germany. After completion of his Ph.D. in molecular genetics and research stays at the University of Sussex, UK, and the Institut de Biologie Moléculaire et Cellulaire, Strasbourg, France, he did his postdoctoral lecture qualification (Habilitation) for biochemistry at the University of Bayreuth, where he still holds a teaching position. He is co-inventor at pioneering fundamental patents in the field of RNAi.
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Global Coordinator and Head, Immunosafety of Biotherapeutics,
F Hoffman La Roche
Born in 1962, Harald Kropshofer gained his PhD in 1993 from the University of Tübingen. He subsequently did his post-doc at the German Cancer Research Center, Heidelberg, before becoming senior scientist and group leader there in 1997. In 2000 he gained his lecturing qualification at the University of Heidelberg and in the same year joined the Basel Institute for Immunology as the Group leader in Antigen Presentation. He has been working at F. Hoffmann-La Roche, Basel, since 2002, where he is currently Head of Applied Immunology.
Dr. Kropshofer is a recipient of, among others, the Otto-Westphal Award from the German Society for Immunology, the Robert-Koch Award for Postdoctoral Scientists, and the Georges-Koehler Award from the German Society for Immunology. He has filed three patents, and has around fifty publications to his name.
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Senior Scientist, Analytical Development,
Biogen Idec
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Associate Director International Legal,
Biogen Idec International
Edward is based in Zug, Switzerland where he acts as associate director and international counsel with Biogen Idec responsible for assisting the groups development in Asia Pacific. Edward joined Biogen Idec after having previously acted as director of the award winning Intellectual Property Department within Tilleke & Gibbins International Ltd in Bangkok Thailand. Prior to joining Biogen Idec, Edward also spearheaded a number of groundbreaking patent litigation cases before the Thai courts and also led the defence of compulsory licence attempts by the Thai government against patents held by Merck & Co, Abbott Laboratories and sanofiaventis. He has advised various industry representative and government bodies such PReMA, the European Commission and the United States Trade Representative. Recognised as an AsiaLaw regional expert in the field of IP in 2006 and 2007, Edward has published extensively on IP and pharmaceutical related topics.
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Director of Bioprocess Development,
Biogen Idec
Rohin Mhatre has over 15 years of experience in the biotech industry of which 12 have been with Biogen Idec where is Senior Director Biopharmaceutical Development. His group is involved in product characterization and supports process and formulation development from the pre-clinical stages to commercialization of the product. Rohin is also currently heading the Quality by Design initiative within Biogen Idec.
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Vice President and General Manager,
Genzyme Analytical Services
Dr. Miller is Vice President and General Manager of Genzyme Analytical Services, a division of Genzyme Genetics providing molecular, cytogenetic, FISH, flow cytometric, immunohistochemical, and other pathology-based pre-clinical and clinical trial services to the pharmaceutical and biotechnology community worldwide. Dr. Miller joined Genzyme in 1992 and since that time has been responsible for molecular genetic assay development and technology assessment/development for Genzyme Genetics as well as the pharmacogenetics efforts used in a variety of clinical programs within Genzyme Corporation. He has published and spoken extensively in the areas of molecular genetics and pharmacogenetics. In his prior role as Scientific Director for Genzyme Genetics, Dr. Miller oversaw a broad range of programs directed at the discovery, development and validation of the next generation of laboratory tests bringing clinically relevant information to the medical professional. Dr. Miller received his Ph.D. in Experimental Pathology from Roswell Park Memorial Institute, a graduate division of the State University of New York at Buffalo. His completed his postdoctoral work in molecular hematology and viral leukemogenesis at Memorial Sloan Kettering Cancer Center and molecular genetics at the University of Miami School of Medicine.
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Vice President, BioSciences Division,
SRI
Walter Moos leads SRI's Biosciences Division, a unique organization of approximately 200 people, with all of the resources necessary to take chemical and biological research programs from "idea to IND"™ — from initial discoveries to investigational new drug applications to start human clinical trials. The Biosciences Division performs basic research on disease mechanisms like an academic institution; drug discovery and the development of biologics like a biotechnology or pharmaceutical company; and full-service preclinical contract research and development like a CRO (contract research organization).
During his career, Moos has made significant contributions to all stages of drug development, from basic research, through preclinical and clinical development, to the marketplace. Prior to joining SRI in March 2005, he was Chairman and CEO of MitoKor, Inc. (now Migenix). Previously, for Chiron Corporation (now Novartis) he was a corporate vice president and held positions from Director of Chemical Therapeutics to Vice President of Research and Development in the Technologies Division. He held various positions at the Parke-Davis Pharmaceutical Research Division of the Warner-Lambert Company (now Pfizer), last serving as Vice President, Neuroscience and Biological Chemistry.
Moos has served on the boards of directors of more than a dozen organizations and is a co-founding member of the CEO Council, advisors to Red Abbey Venture Partners. He has served as a member of a number of academic or government advisory boards and committees. He also has edited five books, helped to found multiple scientific journals, published about 100 manuscripts, and is a co-inventor on about 40 issued U.S. patents.
Moos holds a Ph.D. in chemistry from the University of California-Berkeley and received an A.B. in honors chemistry, cum laude, from Harvard University. He has held adjunct faculty positions at the University of Michigan, Ann Arbor, and since 1992 has been an Adjunct Professor at the University of California-San Francisco.
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Chief Executive Officer,
Ablynx
After completing his post-doctoral research in Germany, Edwin Moses began a commercial career with successful periods spent at Amersham International, Enzymatix and Raggio-Italgene. From 1993-2001, first as CEO and later as Chairman, he was responsible for the growth of Oxford Asymmetry (OAI) through a series of venture rounds cumulating in a flotation (LSE) in 1998 at a value of €175m (£120m). This was followed by a sale of the company to Evotec Biosystems in 2000 for €460m (£316m). During this period, OAI grew from 4 people to over 250. Over the past five years Edwin has played an important role at Board level (primarily as Chairman) in over 15 European life science companies. During this time he has been involved in financing rounds totaling €200m, a series of M&A transactions and three IPOs.
Edwin has been Chairman of Ablynx since 2004, and in 2006 Edwin accepted the offer by Ablynx's Board to extend his role as Chairman to include that of Chief Executive Officer. Outside of and in addition to his duties as CEO and Chairman of the Company, Edwin continues to be actively involved at Board level in the following companies: Clinphone Group plc (UK), Biofusion plc (UK), Phoqus Pharmaceuticals Ltd (UK) and Pharmaceutical Profiles Ltd (UK). Furthermore, in the past five years, he has held Board memberships with the following companies: Proimmune Ltd (UK), Paradigm Therapeutics Ltd (UK), Avantium Technologies (the Netherlands), Ionix Pharmaceuticals Ltd (UK), Evotec OAI AG (Germany), Court Gardens Management Company (Goring-on-Thames) Limited (UK), Bioimage A/S (Denmark), Inpharmatica Ltd (UK), Clinphone Holdings Ltd (UK), Castlegate 211 Ltd (UK), Amedis Pharmaceuticals Ltd (UK), Centre for Scientific Enterprise Ltd (UK), Hammersmith Imanet Limited (UK), Inhibox Ltd (UK), London Technology Network Ltd (UK), Prolysis Ltd (UK) and ProPharma Ltd (UK).
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Chief Executive Officer,
Procognia
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President and Chief Executive Officer,
Geron Group
Thomas B. Okarma, Ph.D., M.D. was appointed President and Chief Executive Officer of Geron in July, 1999. Dr. Okarma served as Vice President of Research and Development of the Company since May 1998. From December 1997 until May 1998, Dr. Okarma was Vice President of Cell Therapies. Prior to joining the Company in 1997, Dr. Okarma was a senior Vice President at Rhone-Poulenc Rorer. In 1995, Rhone-Poulenc Rorer acquired Applied Immune Sciences, Inc. (AIS) which was founded by Dr. Okarma in 1985. By the time of its acquisition by Rhone-Poulenc Rorer, AIS was in advanced cell therapy human clinical trials in cancer and bone marrow transplantation and in early gene therapy human trials in breast cancer. Dr. Okarma was Chairman and Chief Executive Officer of AIS. Prior to founding AIS, Dr. Okarma was a member of the faculty of the Stanford University School of Medicine. Dr. Okarma received both his Ph.D. and M.D. from Stanford University. He is the author of over 50 publications on cell and gene therapy and is an inventor on numerous patents in the field.
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Vice President, Global Clinical R&D,
Baxter BioScience
David is currently heading the global clinical development and medical services department at Baxter Bioscience as their VP Global Clinical and Medical Affairs. Before Baxter he established and headed the European clinical research department for the Philadelphia based biopharmaceutical company Cephalon at their European headquarters in the UK. Prior to that David have held a number of clinical research and development management roles with increasing scope and level of responsibilities in a number companies including Ferring (Copenhagen, Denmark), Roche (Palo Alto, California) and Novo Nordisk (Copenhagen, Denmark). David received his M.D. from the Ben-Gurion University in Israel and did his training in hematology-oncology at the Haddasah University Hospital in Jerusalem, Israel.
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Head, Strategic Alliance Management, EU,
Novartis
Esteban Pombo-Villar PhD CChem FRSC is Head of Strategic Alliance Management EU at the Novartis Institutes for BioMedical Reasearch (NIBR) in Europe. Within the Global Strategic Alliances, this group is responsible for identifying, evaluating, negotiating and establishing research collaborations with academic and biopharmaceutical groups world-wide. The NIBR Strategic Alliances group executed over 400 transactions in 22 countries over the last 3 years, and currently manages over 450 existing scientific relationships.
Dr Pombo-Villar obtained his PhD in Organic Chemistry from the University of Warwick in the UK. After postdoctoral studies at the ETH in Zurich, he joined Sandoz Neuroscience Research in Basel in 1988, and worked on drug discovery projects as well as leading collaborative projects for investigation of emerging technologies. He was External Collaborations Manager for Neuroscience, and from 2003, has been Head of Strategic Alliance Management at NIBR.
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Vice President, Science Development,
Genzyme Corp
Dr. Bruce M. Pratt is Vice President, Science Development, for Genzyme Corporation, with responsibilities in the identification and evaluation of early stage opportunities (primarily therapeutic products) and proactive, selective outreach activities to the academic, biotechnology and life science sectors. He has worked for Genzyme for 18 years, initially in positions of increasing responsibility in Cell & Protein Therapeutics Research & Development, culminating as Sr. Director of Cell Biology. From 2002 through 2004, he was based in one of Genzyme's European offices, identifying early stage European research and product opportunities as well as developing relationships with biotechnology companies and academic centers of excellence. Following his return to the United States in July 2004, he has continued his role in early stage opportunity identification and outreach to the biotechnology sector.
Prior to his work at Genzyme, Dr. Pratt worked at Collagen Corporation and Celtrix Pharmaceuticals in Palo Alto California. He earned his Ph.D. from Michigan State University and was a post-doctoral fellow at Yale University School of Medicine, Department of Pathology.
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Vice President, BioProcess/Manufacturing,
MedImmune
As vice president, bioprocess and manufacturing sciences, Dr. Kripa Ram leads a team of more than 80 scientists in cell culture development and manufacture of clinical products. He has direct responsibility for cell line, cell culture medium and cell culture process development for preclinical and clinical products, as well as process scale-up, technology transfer to clinical and commercial manufacturing, manufacture of clinical trial material and ongoing cell culture development support. He was previously senior director of cell culture, fermentation and manufacturing sciences. Prior to joining MedImmune in 2004, Dr. Ram held a series of positions of increasing responsibility at Merck, Glaxo SmithKline and Biogen Idec. In these roles, he focused on process development, technology transfer, scale-up and licensure of biological products including vaccines, fusion proteins and MAbs. Dr. Ram holds a bachelor's degree in chemical engineering and a doctorate in biochemical engineering from Rutgers University.
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Mr Mogens Vang Rasmussen,
Chief Executive Officer,
Zealand Pharma
Interim Chief Executive Officer and Chief Financial Officer additional responsible for IT, Investor Relations and Communications
Mr. Vang Rasmussen obtained an M.Sc. in Economics from the University of Copenhagen and furthered his career with executive seminars from INSEAD and Stanford Business School. Mr. Vang Rasmussen has extensive experience from Novo Nordisk A/S where he served as corporate controller and manager of investor relations at their headquarters in Denmark and later with Novo Nordisk in New York holding responsibility for their North American financial reporting and investor relations activities. Before joining Zealand Pharma, Mr. Vang Rasmussen served as Chief Financial Officer and later as Chief Executive Officer at MediCult a/s. Mr. Vang Rasmussen has been with Zealand Pharma since 2003. Mr. Vang Rasmussen was appointed Chief Financial Officer in May 2005 and Interim Chief Executive Officer in November, 2007.
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Director Immunology, Global Preclinical R&D,
Baxter
Birgit Reipert, PhD, is Director of the Department of Immunology within the division of Global Preclinical R&D at Baxter BioScience. In addition, she has got a lectureship at the Medical University of Vienna (Austria) and leads a research group at the Center for Biomolecular Therapeutics (BMT-Research Center) in Vienna. She received her PhD from the Ernst-Moritz Arndt University, Greifswald (Germany), and postdoctoral training at the Institute for Medical Immunology at the Charitè, Berlin (Germany), at the Department of Immunology of the Institute for Cancer Research, Berlin, and at the Paterson Institute for Cancer Research, Manchester (UK). Birgit Reipert joined Immuno AG in 1994 and Baxter AG in 1997.
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Vice President, Corporate Development,
Sanofi-Pasteur
Jean-Marc Renard is Vice President, Corporate Development at sanofi pasteur. He has worked for more than 20 years in the sanofi-aventis group, where he has held positions in different parts of the organization such as scientist at Roussel-Uclaf SA, Finance Director of Roussel-Uclaf Hong-Kong Ltd, Managing Director of Roussel-Uclaf China Ltd, Managing Director of Hoechst-Marion-Roussel Hong-Kong Ltd, Senior Director Strategic Projects for Aventis, Inc., before joining the vaccine side of the business. Prior to joining the sanofi-aventis group he was a scientist at Biogen, SA in Geneva and visiting scientist at MIT in Boston. Jean-Marc Renard holds an MS degree from Institut National Agronomique with specialty in Applied Biochemistry and an MBA from INSEAD.
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Chief Executive Officer,
Oxford Genome Sciences
Dr. Rohlff received his Ph.D. from the Department of Pharmacology at Georgetown University in 1994. After two appointments at the National Cancer Institute he joined Oxford GlycoSciences and was appointed Director of Proteome Research Collaborations in 2001. As manager of the Proteomics Division's commercial collaborations he gained expertise in the implementation of clinical proteomics programmes to identify novel therapeutic protein targets and protein biomarkers with many pharmaceutical companies and academic partners, including Pfizer, GSK, Bayer, Wyeth, Takeda, the Cystic Fibrosis Foundation, Oxford University and the FDA. These studies have investigated many disease areas including Alzheimer's disease, arteriosclerosis, dermal ulcers, asthma, chronic obstructive pulmonary disease, various metabolic, inflammatory and neuropsychiatric disorders, toxicology, and oncology.
Dr Rohlff co-authored over 20 protein patents originating from these studies and is the founder of Oxford Genome Sciences. Dr. Rohlff is also a founding member on the board of the South East Health Technologies Alliance (SEHTA), whose mission it is to catalyse innovation and international competitiveness in south east England's health technologies sector. Dr. Rohlff is also an honorary visiting fellow at the department of Clinical Pharmacology at Oxford University.
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Associate Director,
Genentech
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Senior Scientist, Head, Exploratory Pilot Plant, Biotechnology Development,
Novartis
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Head, EU Cooperation and Microbiology,
Paul Ehrlich Institute
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Director of Regulatory Affairs Europe,
Genzyme Europe
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Formerly of CBER, FDA and VP for Global Regulatory Affairs, Amgen and Senior Associate,
University of Cambridge
Dr Ken Seamon brings a wealth of experience of USA and European biotech to the MBE programme. Dr Seamon was until recently Vice President, Regulatory Affairs at Amgen Corporation, London, with responsibility for the Regulatory CMC Group and interactions with operations, as well as for developing policy for Follow on Biologics and Biosimilars. Prior to this Dr Seamon was Senior Vice President, Drug Development at Immunex Corporation, Seattle, Washington State. Earlier in his career Dr Seamon spent 13 years with the Food and Drug Administration (FDA), and served latterly as the Director of the Office of Therapeutics Research and Review and Associate Director for Research at the Center for Biologics Research and Review at Bethesda, Maryland.
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Director, Academic Liaison,
GlaxoSmithKline
Malcolm Skingle has BSc in Pharmacology/Biochemistry and a PhD in Neuropharmacology. He has worked in the pharmaceutical industry for more than 30 years and has gained a wide breadth of experience in the management of research activities. Part of his former role as a research leader in a Neuropharmacology department involved co-supervising collaborations with academics in the UK, Europe and USA. He has more than 60 publications including articles on the interface between industry and academia. For more than a decade he has managed Academic Liaison at GSK and has staff in Stevenage, Research Triangle Park and Philadelphia. This role involves close liaison with several groups outside the Company e.g. Government Departments, Research and Funding Councils, Small Biotechnology Companies and other science-driven organisations. He sits on many external bodies including the BBSRC Strategy Board, the East of England RDA Science and Industry Council, the CBI academic liaison group and several UK University Department advisory groups. He chairs several groups including the BBSRC Bioscience for Industry Panel, the Diamond (Synchotron) Industrial Advisory Board, the Inner Core Lambert working group on boilerplate agreements and the ABPI group working on academic liaison.
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EU and US RAC, Principal Regulatory Scientist, Global Regulatory Affairs,
Eli Lilly
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Executive Director, Worldwide Business Development,
Pfizer Global R&D
Jeff Southerton began his career in the pharmaceutical industry in 1988 as a cardiac electrophysiologist at Syntex, in Edinburgh. Prior to this he had studied pharmacology at the University of Manchester, gaining his PhD through the study of smooth muscle potassium channels. He joined Pfizer’s Discovery Biology group (in Sandwich, England) in 1991 and after working on a number of preclinical cardiovascular projects joined Pfizer’s Strategic Alliances group in 1995 – where he was responsible for a number of deals on behalf of Pfizer’s Discovery Research organization. Between May 2002 and February 2006 he was responsible for building and leading Pfizer’s Strategic Alliances group in La Jolla. In2006 he became responsible for Pfizer’s Therapeutic Area Strategic Alliances globally. Since February 2008, he has led a team within Pfizer’s Worldwide Business Development organization with responsibility for Biotherapeutic Technology Alliances. His group works closely with Pfizer R&D colleagues to identify potential collaborative opportunities with academic groups and biotechnology companies worldwide; negotiate the terms of such interactions; manage ongoing business aspects; and ensure that collaboration goals are met.
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Senior Director, Business Support, Process Development,
Genentech
Sue Steven joined Genentech in 2006 as Senior Director, Process Research and Development. She leads a cross functional group responsible for CMC project management, resource management, process economics, operational excellence, CMC documentation, validation, editing, training, capital and space planning, and IT.
Previously Sue was Senior Director, Global Product Lifecycle Management at Invitrogen, Inc. responsible for program management, strategic planning, resource management and integration of acquisitions within R&D. Additionally she led the annual list price team responsible for over 30,000 products in three regions: North America, Europe and Asia.
Prior to that, Sue had 14 years of experience in the Pharmaceutical Industry, most recently at Centocor, Inc. a division of J&J, where she built the Portfolio Management and Resource management groups within R&D. Prior to J&J, Sue held various positions at SmithKline Beecham Clinical Laboratories (Microbiology and Virology Department Manager; Automation Manager); SmithKline Beecham Pharmaceutical R&D (Director of Portfolio Management and Decision Analysis); and GlaxoSmithKline (Business Development Operations Director).
Prior to her business experience, Sue was a commissioned officer in the U.S. Navy for 11 years. She held a variety of positions including electrical repair of submarines and navigator on the USS Hunley (AS-31), Medical Intelligence Analyst at Ft. Detrick, and Research Microbiologist, first in Naples, Italy and then in Bethesda, MD. She was one of the first women assigned to sea duty and earned a Surface Warfare Officer Qualification.
Sue earned her Ph.D. from the University of Maryland and her MBA from Temple University. Sue is on the Board of Directors for the Southern California chapter of the Healthcare Businesswomen’s Association (HBA).
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Head, Biotherapeutics Group,
National Institute for Biological Standards and Control
Robin Thorpe PhD, FRCPath, is Head of the Biotherapeutics Group at the National Institute for Biological Standards and Control (NIBSC). Recent interests include the unwanted immunogenicity of biologicals, development of improved bioassays for cytokines, the immunology of monoclonal antibodies and cytokine contamination of biological products. He attends meetings of the Biologicals Working Party & Biosimilars Working Party of the CHMP at the EMEA. He is a member of the British Pharmacopoeia Commission (MHRA) Expert Advisory Group NOM, the British Pharmacopoeia Panel of Experts on Biological and Biotechnological Products and the Working Group on Monoclonal Antibodies of the European Pharmacopoeia. Dr Thorpe is a member of the Biologicals & Vaccines Expert Advisory Group of the CHM. He is the Chairman of the IUIS nomenclature subcommittee for chemokines and the standardisation and nomenclature committee of the International Cytokine Society. Dr Thorpe is an author on over 200 publications in scientific journals and books. He is an associate editor for the journal Cytokine, Biotherapeutics section editor for Biologicals and editorial board member of the Journal of Immunological Methods & Current Analytical Chemistry.
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Senior Vice President and Global Head of Biologics,
Mylan
Patrick Vink is a citizen of the Netherlands, who, in addition to his doctorate of Medicine holds a post-doctorate Masters of Business Administration. Starting his professional career in the 80’s he held different marketing positions at the dutch affiliate of the French Pharma company Sanofi until he became general manager Nutricia (a dutch babyfood company) in Hungary. When returning at Sanofi he was appointed as Director global Business Unit Cardiovascular & Thrombosis. After joining Biogen he served as Vice-President Sales International, holding responsibility for commercial operations.
In 2002 he became Global Head Business Unit Biopharmaceuticals at Sandoz. After leaving Sandoz in 2006 he became an independent advisor in the Life Sciences Industry, before joining Mylan as Senior Vice President and Global Head of Biologics.
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Senior Director, Therapeutic Area Head,
Wyeth Research
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Managing Director, Biopharamceuticals,
Boehringer Ingelheim
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Chief Executive Officer,
GANYMED Pharmaceuticals
Before joining GANYMED in March 2004, Dr. Rainer Wessel served at Axxima Pharmaceuticals AG as President & CEO. Prior to that, he was Head of Intellectual Property and Licensing at Qiagen GmbH. Dr. Wessel began his industry career at Boehringer Ingelheim, where he served in Japan and Germany in positions of increasing responsibility. He is a member of the Board of BIO Deutschland, and of the Supervisory Board of ConoGenetix GmbH. He also serves as a Senior Advisor to the International Council for the Life Sciences (ICLS) in Washington, D.C.
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Chief Executive Officer,
AM Pharma
Drs Bart Wuurman has 20 years of International Pharma and Biotech Industry experience. Before joining AM-Pharma as CEO in The Netherlands, he worked in the UK for 13 years. During this time he gained a broad industry experience, ranging from drug discovery to marketing and sales with Organon, Medeva and Antisoma, where he was responsible for a $500 million oncology alliance with Roche. In 2003 Bart became CEO of De Novo Pharmaceuticals in Cambridge, which he successfully restructured and refinanced. Bart holds pharmaceutical sciences degrees from Dutch Universities in Utrecht and Leiden.
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