Therapeutic Antibodies Europe 2010
Millenium Mayfair Hotel, London, UK, October 13 & 14, 2010
Conference Day 1 – October 13, 2010
08:15am Registration coffee and refreshments
09:00am Chairman’s opening remarks
CURRENT AND FUTURE MARKET LANDSCAPE
09:10am Keynote address: Innovation to evolving cell culture based manufacturing
processes, technology drivers and future perspectives
- Review of 25 years of cell culture-based development, upstream and downstream technology co-development
- Trends in technology of upstream, downstream, DP formulation, devices and analytical methods
- Future challenges: costs, economics, process robustness and product quality aspects
Dr. Wolfgang Noe, Vice President, Strategic Development and Technical Aliiance, Biogen Idec
09:40am Keynote address: The paradigm shift from antibodies to next generation biologics
based on alternative protein scaffolds
Prof. Dr. Arne Skerra, Chair of Biology Chemistry, Technische Universität München
PROTEIN DEVELOPMENT, PRODUCTION AND PURIFICATION
10:20am A rapid and accurate method for the quantitative analysis of
monoclonal antibodies and therapeutic proteins in biological fluids
- Liquid chromatography tandem mass spectrometry
- Isotope dilution analysis
- Pharmacokinetic and Immunogenicity
Dr. Olivier Heudi, Laboratory Head, Translational Sciences, DMPK/Bioanalytics, Novartis Institute for Biomedical Research
10:50am Networking Coffee & Refreshments
11:20am Presentation: EB66® cell line, a new solution for the production of
monoclonal antibodies with enhanced ADCC activity
- Insight into the development of the EB66 cell line
Regulatory and sanitary status
Understanding the enhancement of ADCC activity
Dr. Frédéric LEGROS, Director,VIVALIS
11:50am Monovalent antagonist antibodies to block CD28-mediated costimulation
- Why monovalent anti-CD28 antibodies are totally antagonist and cannot stimulate T cells
- Why CD28 antagonists block positive costimulation and respects CTLA4-mediated negative costimulation
- Blocking alloreactivity CD28 antagonists in vivo and inducing transplant tolerance
- Pegylated Fab fragments and VH/VL-Fc fusion antibodies for therapeutic
Dr. Bernard Vanhove, Research Director at the CNRS, Project Director, Therapeutics, Tcl Pharma
12:15pm Speed Networking
This session is dedicated to our delegates. With speed networking we make sure that all our delegates meet each other in a 40min session before lunch.
13:00pm Networking luncheon
14:30pm Comparing the throughput of various label-free real-time biosensors in characterizing large panels of antibodies
- Expanding the ProteOn XPR36 into a 36-ligand array facilitates kinetics, epitope binning and epitope mapping
- The flexible configuration of the microfluidic-free Octet QK384 expedites binning and mapping studies
- Results correlate well with those obtained on Biacore 2000, an industry standard, and are generated faster.
Yasmina Abdiche, Associate Research Fellow, Pfizer, Inc.
NEXT GENERATION ANTIBODIES, SCAFFOLDS, PEPTIDES, DRUG CONJUGATES
15:00pm Development of next generation antibodies
- Latest generation of therapeutic antibody fragments
- Antibody fragment cloning, engineering and expression
-
Compartment-based therapies with small antibody fragments
Dr. Titus Kretzschmar, CSO, Delenex Therapeutics AG
15:30pm Networking coffee and refreshments
16:00pm Discovery and development of non-Ig scaffolds for clinical
applications
- Discovery and engineering of scaffolds
- Best use of protein engineering platforms
- Peptides vs antibodies – understanding the differences and benefits
- Antibody derived scaffolds – preclinical results
Prof. Dr. Arne Skerra, Chair of Biological Chemistry, Technische Universität München
16:30pm Fc-Engineering and bispecific Approaches for the Next Generation of
Therapeutic mAbs
- Fc-Engineering to optimize effector function
- Influence of FcR-polymorphisms on clinical outcomes of licensed mAbs
- Benefits of reduced affinity for the inhibitory receptor CD32B (FcgRIIb)
- Fc-Optimized anti-Her2/neu mAb MGAH22
- Bispecific DART proteins that re-direct NK or T cells for potent tumor cell killing
Dr. Syd Johnson, V.P., Antibody Engineeering, MacroGenics, Inc.
17:00pm Fab-Fv: an antibody fragment format with extended serum half-life
- Introducing a novel antibody fragment format called Fab-Fv
- Understanding how vL and vH is fused to each C-terminus of a Fab fragmend
- How the Fv binds with high affinity to serum albumin in order to confer a long serum half-life
Dr David P Humphreys, Senior Group Leader, Antibody Biology, UCB-Celltech
17:30pm Chairman’s closing remarks
17:35pm Networking reception with drinks
Conference Day 2 – October 14, 2010
08:30am Registration coffee and refreshments
08:55am Chairman’s opening remarks
STRATEGIES FOR OPTIMISING CURRENT AND FUTURE THERAPEUTIC ANTIBODIES
09:00am Keynote presentation: Improving next generation biologics: APharma perspective
- R&D trends for protein Biologics in big Pharmas
- Engineered antibodies and antibody-derived biologics
- New protein scaffolds
Dr. Jean-François Mayaux, Head, Biologics Centre- France, Sanofi-Aventis Research & Development
09:30am Protein engineering and consideration of DVD-lg as the next generation of dual-
specific antibodies
- DVD-lg as a promising bispecific biologic generation platform
- Meeting challenges in manufacturability and drug-like properties of bispecific antibodies
- Assessing DVD-lg in pharmacokinetics, preformulation solubility and stability, and CHO cell line development
Dr. Jijie Gu, Principal Research Scientist, Biologics, Abbott Bioresearch Center
09:55am Microbial identification with genotypic methods – faster, cheaper, accurate and
GMP approved
Genotypic method to improve microbial identification in biological manufacturing environments and processes
Innovative transport support and carrying out a comparing study with traditional but improved methods
Performing a robust validation for GMP compliance.
Dr. Sara Gamberini, Molecular Biology Researcher, Merck Serono Non-Clinical Development
10:20am Networking coffee and refreshments
10:50am Bioanalysis of Therapeutics antibodies: where do we stand?
- Immunoassays are the methods of choice for the assessment of pharmacokinetic of antibodies
- New analytical questions emerges
- Mass spectrometry becomes an alternative
Dr. Eric Ezan, CEA France
11:15am Presentation: Immunogenicity assessment and avoidance of therapeutic
antibodies
- Applying the novel EMEA guidance and industry whitepapers to antibody therapeutics
- Clinical and non-clinical strategies to assess immunogenicity
- Prediction and assessment of T-cell epitope driven immunogenicity at early stage of product development using in silico and in vitro tools.
- Antibody deimmunization to mitigate immunogenicity risk
Dr. Qingyu CAO, MBA, Manager, Licencing and Technology, Lonza Development Services
11:45am Engineering of the Fc region of human antibodies to increase their
serum half-life
- Random mutagenesis of the human Fc region of lgG1
- Selection for FcRn improved binders using phage display
- Fc mutation mapping of FcRn/Fc interaction of over 500 variants
- Validating best binders
Dr. Celine Monnet, Head of Project, Antibody Engineering, MILLEGEN SA
12:15pm Antibody Optimisation based on HTP Screening
- A method combining sequence optimisation and affinity maturation
- Comprehensive site directed saturation mutagenesis and HTS
- Insight into a stable and universally applicable process
Dr. Ullrich Haupts, Director Assay Technology and Analytics, Bayer Schering Pharma AG
12:40pm Bioanalytical support for therapeutic antibodies
- Analytical strategies for novel therapeutic antibodies from preclinical to clinical development
- Overcoming challenges facing PK and immunogenicity assay development and validation
- Bioanalytical support within a regulatory framework
Dr. Andrew Roberts, Sector Manager Biologicals, Bioanalytical Sciences, Quotient Bioresearch
13:05pm Networking luncheon
ANTIBODIES FOR INFECTIOUS DISEASES AND ONCOLOGY
14:05pm Translating academic research into effective therapies
- Types of cell receptors for infectious agents with focus on viruses
- Identification of virus–receptor interaction can lead to understanding of unknown immune and cell regulatory mechanisms
- Cell receptors as therapeutic targets
- Use of phage antibody display technology to identify receptors for infectious agents
Prof. Dr. S. Louise Cosby, Chair of Microbiology, Queen's University Belfast
14:30pm Anti-infective antibodies for treatment of ventilator-associated
pneumonia in preclinical and clinical development
Dr. Michael Rudolf, CSO, Kenta Biotech
14:55pm Recombinant bispecific tetravalent antibody derivatives for
inhibition of HIV infection
- Adapting ‘standard’ antibody technologies to generate bispecific IgG derivatives
- Stability and functionality of bispecific antibodies
- Improved activity of bispecific antibody derivatives compared to monospecific antibodies
Dr. Ulrich Brinkmann, Pharma Research and Early Development, Roche Diagnostics
15:20pm Networking coffee & refreshments
15:50pm Oncology drug development
- Role of biomarkets in oncology
- How to optimise pre-clinical models
- Accelerating human clinical trials in oncology
Prof. Jeff Evans, Ph. D., Professor of Translational Cancer Research and Honorary Consultant in Medical Oncology, University of Glascow
16:15pm Trifunctional antibodies: Immunotherapeutics in cancer therapy
- Structure of trifunctional antibodies
- Mode of action: passive and active immunization
- Targeted cancer therapy with trifunctional antibodies
Dr. Jens Herold, Head of Project Management, TRION Pharma
16:40pm Development of a bispecific TandAb for treating Hodgking's Lymphoma
- TandAb technology for recruiting immune effector cells
- Production and formulation of the first TandAb for clinical trials
- Properties, stability and toxicology studies
Prof. Dr. Melvyn Little, CSO, Affimed Therapeutics AG
17:05pm Cloning and manufacturing of antibody mixtures for infection and cancer
- An antibody cloning approach exploring the complete immune repertoire
- Manufacture of antibody mixtures in a consistent and cost-efficient manner
- MS methods for characterization of antibody mixtures
Dr. Anne Bondgaard Tolstrup, PhD, Symphogen
17:40pm Close of conference