The Sixth European Biotechnology Symposium
Competitive Biotechnology: Advanced Biologics Manufacturing and Closing the Deal: Joint Ventures and Partnerships
Radisson SAS Scandinavia Hotel Copenhagen
NOVEMBER 13 ? 15, 2005
Conference Program
Sunday, 13 November, 2005
16:00-18:00
Early Registration
18:00-19:30
Reception and Welcoming Address in Exhibit Area
Monday, 14 November, 2005
8:00-9:00
Continental Breakfast in Exhibit Area
9:00-9:05
GEN, Welcoming Remarks
John Sterling
Cell Culture and Process Development
9:05-9:30
Mammalian Cell Culture Processes for Large Scale Operation ? from DNA to Product
Florian M. Wurm, PhD, Prof. of Biotechnology, Swiss Federal Institute of Technology, Lausanne, Switzerland
9:30-9:55
Application of Parallel Fermentation Equipment for Rapid Bioprocess Development
Simon Curvers, PhD, CEO, AC Biotec GmbH, Jülich, Germany
9:55-10:20
Clinical Material Supply ? More Than Delivery of Product
Liselotte Larsson, Marketing Manager, Novozymes Biopharma AB, Copenhagen, Denmark
10:20-10:30
Questions
10:30-11:00
Coffee Break in Exhibit Area
11:00-11:25
Streamlining Production of Antibody Fragments by Selecting the Most Appropriate Fully Human and Highly Stable Proteins
Dominik Escher, PhD, CEO, ESBATech AG, Zurich-Schlieren, Switzerland
11:25-11:50
Production of Recombinant Human Polyclonal Antibodies Against Rhesus-D
Anne B. Tolstrup, Director, Antibody Expression & Characterization, Symphogen A/S, Lyngby, Denmark
11:50-12:15
Disposables in Bioproduction: Just a Commodity or a Platform for Process Development?
Edwin Schwander, Business Development Manager, Industrial Cell Culture, NUNC A/S, Roskilde, The Netherlands
12:30-14:00
Lunch in Exhibit Area
Manufacturing Infrastructure
14:00-14:25
Systematic Design and Construction of Biotech and Pharmaceutical Plants
Karin Bronnenmeier, PhD, Business Development Pharmaceutical Plants, Linde-KCA-Dresden GMBH, Dresden, Germany
14:25-14:50
Implementation and Validation of a Fully Disposable Commercial Process for Vaccine Manufacture
Mark Wilson, Senior Development Leader, Xenova Biomanufacturing Limited, Cambridge, UK
14:50-15:15
Facility Management to Ensure Maximum Utilization
Friedrich Nachtmann, PhD, Head Cooperations Biopharmaceuticals, Sandoz, Kundl, Switzerland
15:15-15:30
Questions
15:30-16:00
Coffee Break in Exhibit Area
16:00-16:25
Disposable Technologies for Aseptic filling ? a Case Study
Miriam Monge, Marketing Director, Stedim SA, Aubagne, France, and Jan Eric Zandbergen, Manager, Sterile Production, Solvay Pharmaceuticals, Olst, The Netherlands
16:25-16:50
A Perspective on a Validation Approach to Gamma Irradiated Plastic Disposable Assemblies for use in Biopharmaceutical Operations
Jean Marc Cappia, Program Director for High-Performance Filtration and Disposable Technology, Millipore Corp., Bedford, Massachusetts, USA
16:50-17:15
Manufacturing ABR-217620, a Fusion Protein of an Antibody Fragment and a Genetically Engineered Superantigen Variant Produced in E.Coli
Göran Forsberg, PhD, Head of Scientific Affairs, Active Biotech, Lund, Sweden
17:15-17:30
Questions
18:00
Gala Reception in Casino Ballroom
Tuesday, 15 November, 2005
8:00
Continental Breakfast in Exhibit Area
9:00-9:25
Locked Nucleic Acids: Chemistry, Manufacture & Properties
Troels Koch, VP Chemistry & Manufacturing, Santaris Pharma A/S, Hoersholm, Denmark
9:25-9:50
An HTS Platform to Deliver New Tools for Genome Engineering
Frederic Paques, PhD, CSO, Cellectis SA, Romainville, France
9:50-10:00
Questions
10:00-10:30
Coffee Break in Exhibit Area
10:30-10:55
Faster, Cheaper, Purer: Requirements of Modern Bioseparation Processes
Uwe Gottschalk, PhD, Sartorius, VP of Purification Technologies, AG Biotechnology, Goettingen, Germany
10:55-11:20
Quality Reflections over Qualification of a State-of-the-Art Contract Manufacturing Facility
Anders Vinther, PhD, Chief Quality Officer, CMC Biopharmaceuticals A/S, Copenhagen, Denmark
11:20-11:45
From High-speed Miniaturized Process Optimization to High-speed Purification Processes
Ian Sellick, Director of Marketing, Pall Life Sciences, New York City, USA
11:45-12:00
Questions
12:00-13:30
Lunch in Exhibit Area
Doing the Deal
13:30-13:40
Introduction to Doing the Deal Session
Gitte Pedersen, Special Advisor, Invest in Denmark, Copenhagen, Denmark
13:40-14:05
Financing Biotechnologies: An Investor Perspective
Linda F. Powers, Co-founder and Managing Director, Toucan Capital, Bethesda, Maryland
14:05-14:30
Evolution of the Deal Structure Between CMOs, Big Pharma and Biotech Companies
Eric Halioua, Senior Manager, Arthur D Little, Boston, Massachusetts, USA
14:30-14:55
Negotiating a Win-Win Deal
Jesper Zeuthen, DSc, Managing Director, BankInvest Group, Copenhagen, Denmark
14:55-15:20
New European Medicines Legislation: Who Came Out Ahead, Innovators or Generics?
Linda Horton, Regulatory Law Partner, Hogan & Hartson, Washington DC, USA
15:20-15:30
Questions
15:30-16:00
Coffee Break in Exhibit Area
16:00-16:25
Rencarex®: The Challenge of In-Licensing, Clinical Development, and Partnering of a Monoclonal Antibody in Cancer Therapy
Olaf G. Wilhelm, MD, CEO, Wilex AG, Munich, Germany
16:25-16:50
Biopharmaceutical R&D and Manufacturing Expertise on Demand
Thomas Krarup, Business Development Manager, Copenhagen Capacity, Copenhagen, Denmark
16:50-17:15
Creating Added Value in Contract Biomanufacturing Through Partnership: the EBV Vaccine Case Study
Jean-François Pollet, PhD, Head of QA/RA, Henogen, Charleroi, Belgium
17:15-17:30
Questions/Closing