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Conference Day 1, Monday 1st December 2008
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| THERAPEUTIC ANTIBODIES: ADVANCES IN UNDERSTANDING THE STRUCTURE-FUNCTION RELATIONSHIP |
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8am | Registration and coffee
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9am | Chairman’s opening remarks
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| | Dr Alain Beck, Head, Physico-Chemistry Department, Centre d'Immunologie Pierre Fabre (CIPF)
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| CHOOSING THE RIGHT ANTIBODY ISOTYPE FOR THE RIGHT FUNCTION |
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9.05am | Keynote presentation: isotype selection in monoclonal antibody engineering: choosing the right format for success
- A critical overview of monoclonal antibody engineering
- Considering IgG isotype properties to streamline therapeutic antibody development
- Case studies of antibody engineering at Abbott
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9.30am | Natural IgG4 half antibodies, in vivo bispecific antibody rearrangement and implications for IgG4 anti-inflammatory activity
- IgG4 structure and functional implications
- Structural rearrangement studies and findings
- Implications for IgG4 anti-inflammatory activity
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| | Dr Rob C Aalberse, Professor of immunology, Department of Immunopathology, University of Amsterdam
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| ANTIBODY/ANTIGEN COMPLEXES: STOECHIOMETRY AND EPITOPE/PARATOPE MAPPING |
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9.55am | Antibody epitope mapping: structural basis for better functional activity understanding
- Structural and functional mapping methods
- Impact for second generation monoclonal antibody research and development, and on Intellectual Property
- Therapeutic and diagnostic monoclonal antibodies for selecting patients and for efficacy assessment
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| | Dr Alain Beck, Head, Physico-Chemistry Department, Centre d'Immunologie Pierre Fabre (CIPF)
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10.20am | Speed networking
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11.20am | Morning coffee
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11.40am | Case studies on structure-function analysis
- Outlining approaches to antibody epitope characterization
- Importance of Fc-mediated effector function for antibodies in treating cancer
- Case studies of structure-function analysis: ofatumumab and zalutumumab
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| | Dr Paul Parren, Senior Vice President, Research and Preclinical Development, Genmab
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12.05pm | Enhancing IP protection via epitope mapping
- Antibody patent level of protection and implications for development
- Trends in successful patent applications
- Distinguishing antibodies in the eyes of patent law: how to obtain meaningful patent protection
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12.30pm | The Bifunctional Hybrid Protein (BHP), a new enabling technology for non-linear epitope mapping
- Identification of epitope regaion and key amino acid determination using BHP technology as a research and development BioTool
- Enabling a unique and original epitope display within an enzyme scaffold
- An epitope mapping approach suited to the determination of conformational epitopes
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12.55pm | Lunch
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| ANTIBODY VH ENGINEERING TO REDUCE IMMUNOGENICITY AND ENHANCE PHARMACOLOGY |
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2pm | V region engineering to reduce immunogenicity and enhance functional and biophysical properties
- Humanization via specificity-determining residues usage resurfacing
- Manipulation of affinity-determining residues to enhance affinity and cross-reactivity
- Assessing and removing chemical stability liabilities
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2.25pm | Stability-engineered IgG-like tetravalent antibody inducing receptor-mediated death in leukaemia cells
- Design and production of IgG-like tetravalent antibodies
- Receptor cross-linking enhances tumor cell apoptosis
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2.50pm | Engineering antibodies in a competitive environment
- Engineering pM affinity antibodies by combination of phage and ribosome display
- The benefits of high throughput functional screening for biologics
- Case studies of V-region engineering
- Structure-function learnings from co-crystal structures
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| ANTIBODY FC AND FAB GLYCOSYLATION: STRUCTURAL AND FUNCTIONAL IMPLICATIONS |
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3.15pm | Engineering differentiating pharmacology in monoclonal antibodies using protein- and glycoengineering
- Leveraging glycoengineering in monoclonal antibodies to develop ‘fit for purpose’ therapeutic antibodies
- Differential pharmacology of well-defined monoclonal antibody glycoforms
- Integration of glycoengineering into novel Fc variants to maximize the pharmacological efficacy of therapeutic antibodies
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3.40pm | Afternoon tea
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4.10pm | Design of therapeutic antibodies with maximum effector functions, based on the natural IgG isotype and its oligosaccharide heterogeneity
- Shortcomings of current generation antibody therapeutic antibodies
- The importance of improving low in vivo efficacy of therapeutic antibodies
- A new design of next-generation therapeutic antibodies based on the natural IgG isotype and it’s oligosaccharide heterogeneity
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| | Dr Mitsuo Satoh, Director, Antibody Research Laboratories, Kyowa Hakko Kogyo
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4.35pm | Glycosylation strategies for enhancing antibody effector functions
- Overview of the functional implication of glycosylation state of the Fc region
- Methods for metabolically modulating glycosylation of human monoclonal antibodies
- Time-efficient production of antibodies with increased antibody-dependent cellular cytotoxicity
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| | Dr Qun Zhou, Senior Scientist, Therapeutic Protein Research, Genzyme
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5pm | GA101, a novel glycoengineered type II CD20 antibody with outstanding anti-tumor efficacy and superior B cell depletion
- The mode of action of type I and type II CD20 antibodies
- Consequences of glycoengineering of the type II antibody GA101
- Differentiating properties of GA101: In vitro and in vivo pharmacological properties
- Demonstrating superior activity in various xenograft models + superior B cell depletion in Cynomolgus monkeys and hCD20 transgenic mice
- An outlook on GA101 and glycoengineering
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5.25pm | The pro- and anti-inflammatory activities of IgG
- The role of complement and Fc- receptors for antibody activity in vivo
- Impact of fucose, galactose and sialic acid
- Implications for the optimisation of therapeutic antibodies and enhancement of the anti-inflammatory activity
- Mechanistic insights in the anti-inflammatory pathway
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5.50pm | Panel session: translation of antibody structure-function knowledge in clinical drug candidates
- Choosing the best antibody isotype for oncology or autoimmune and anti-inflammatory indications
- Epitope mapping
- Modulation of effector functions by Fc-engineering and glycol-engineering
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| | Confirmed: Dr Alain Beck, Head, Physico-Chemistry Department, Centre d'Immunologie Pierre Fabre (CIPF)
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6.20pm | Close of day one followed by networking drinks
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Conference Day 2, Tuesday 2nd December 2008
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| ANTIBODIES: CHALLENGES AND OPPORTUNITIES |
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8am | Registration and coffee
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9am | Chairman’s opening remarks
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| | Dr Clive Wood, CSO and Seniior Vice President, Discovery Research, Dyax Corporation
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9.05am | An evidence-based perspective on emerging trends and developments in the monoclonal antibodies sector
- Monoclonal antibodies approved for marketing: a global perspective
- Marketing approval success rates and some key indicators
- Making predictions for the future: the development of monoclonal antibodies, antibodies in the clinic and antibodies in the market
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| | Dr Janice M Reichert, Senior Research Fellow/Editor-in-Chief, Tufts Center for the Study of Drug Development/mAbs
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9.30am | Antibody lead discovery and development: a case study in successful pipeline development
- Optimising development capability: selecting antibody candidates for development and choosing the best therapeutic products
- Accelerating development into the clinic
- Wider perspectives on the possibilities for antibodies and the sector as a whole
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9.55am | A European regulator's perspective on monoclonal antibody development and regulation
- An overview of current European regulation relating to antibody development
- Planning for the future of antibodies and antibody alternatives
- Current activities of regulators and future regulatory challenges
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| | Dr Kowid Ho, Head of Biological Products, Biological Evaluation Division, AFSSaPS
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10.20am | Morning coffee
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| ANTIBODY FORMULATION AND DELIVERY |
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10.50am | Considerations for formulation, and enhancing the 'drug-like' qualities of monoclonal antibodies
- High throughput formulation of monoclonal antibodies
- Considerations for drug stability and aggregation, and characterization
- Formulation case studies of monoclonal antibodies
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| | Prof Tudor Arvinte, Professor of Biopharmaceutics/Chairman and CEO, University of Geneva/Therapeomic
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11.15am | Delivery of monoclonal antibodies: State of the art delivery and associated challenges
- Economics and market situation
- The need of highly concentrated antibody formulations
- Stability-points to consider and how to improve
- Excipients and technologies
- Delivery devices
- Managing the administration
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| CLINICAL CONSIDERATIONS FOR ANTIBODY DEVELOPMENT |
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11.40am | Investigating and circumventing resistance to therapeutic monoclonal antibodies
- Preclinical models for invesigation
- The impact of glycoengineered antibodies
- Resistance mechanisms, prediction and clinical relevance
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| | Dr Charles Dumontet, Deputy Vice President, Scientific Hematology Laboratory, University Hospital, Lyon
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12.05pm | Immunogenicity assessment of antibody therapeutics – Bioanalytical strategy and risk-based approach
- Understanding immunogenicity of antibody therapeutics
- Strategies and tools for assessing and characterizing immunogenicity
- Perspectives on risk assessment for immunogenicity
- Regulatory guidelines on immunogenicity assessment
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12.30pm | Lunch
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| PATENTING, INTELLECTUAL PROPERTY AND BIOSIMILARS |
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1.30pm | Patenting and Intellectual Property
- Assessing the true impact of patent expiry in the antibody sector
- Structuring your R&D for maximum Intellectual Property capture: issues for small, intermediate and large biotechs
- European and US patent law: changes, impact and what you need to do
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1.55pm | Biosimilar antibodies – an approaching reality or a distant dream?
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Current EU biosimilar guidelines
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Biosimilar successes and failures
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Advantages and disadvantages of biosimilar antibodies
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Scientific considerations when applying for biosimilar antibody market authorisation
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| | Dr Keith Watson, Pharmaceutical Assessor, Medicines and Healthcare products Regulatory Agency
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| ENHANCED PRODUCTION SYSTEMS FOR MONOCLONAL ANTIBODIES |
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2.20pm | Optimizing the production of monoclonal antibodies in mammalian cells
- Overview of mammalian cell culture as the dominant method for production of high-dose therapeutic antibodies: assessing the key achievements and technical challenges
- Developing advanced cell culture processes to optimize yield and ease of antibody production
- Production/optimization methodology and key benefits
- Future optimization: other options, growing trends and industry activity
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2.45pm | Real-time control of antibody development and the productions process to support a Quality by Design approach
- Current status of PAT and QbD approaches in the biopharmaceutical industry
- Requirements of real-time analysis in bioprocessing
- PAT Bioplatform for antibody development and the production process:
o Online analysis
o Real-time process monitoring and data mining
o Data integration concept
o Process modeling and simulation
o Process adjustment
- Unit-to-unit reliability for support of global task sharing and process comparison
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3.10pm | Afternoon tea
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| GENERATION OF ANTIBODIES AGAINST NEW TARGETS |
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3.40pm | Discovery and development of cancer antibodies using functional screens
- Generating and selecting therapeutic antibodies based on their activity
- Focusing on antibody epitope efficacy and using cell signal or cell death as a measurable
- Outline of antibody candidates developed through functional screening
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3.40pm | Afternoon tea
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4.05pm | Discovery of anticancer monoclonal antibodies targeting JAM-A by functional approaches
- Functional approaches and proteomics
- Innovative targets for oncology
- Anti-proliferative antibodies
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| STATE OF THE ART METHODS FOR ANTIBODY METABOLICS AND PHARMACOKINETICS |
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4.30pm | Quantification of recombinant monoclonal antibodies in biological fluids for faster biotherapeutic development
- Current methods for antibody quantification and limitations
- Designing a procedure for antibody quantification
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4.55pm | Close of day two followed by networking drinks
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Conference Day 3, Wednesday 3rd December 2008
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| INNOVATION IN ANTIBODY AND ANTIBODY ALTERNATIVES DEVELOPMENT |
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9am | Chairman’s opening remarks
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| ADVANCES IN CONJUGATE ANTIBODIES – UPDATES AND LEADING TECHNOLOGIES |
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9.05am | Development of advanced antibody-based therapeutics in oncology
- Introduction to antibody-drug conjugate development
- Conjugate design and the impact on activation and performance
- Case study: antibody-maytansinoid conjugate overview and mechanism of action
- Clinical update for antibody-maytansinoid conjugate drugs
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9.35am | Keynote presentation: Trastuzumab DM1 (T-DM1): an advanced antibody-drug conjugate based on Herceptin
- Dual strategy of T-DM1: anti-HER2 activity and targeted intracellular delivery of cytotoxic DM1
- Phase I clinical data
- Overview of ongoing Phase II clinical trials evaluating for HER2-positive metastatic breast cancer
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10.05am | Auristatin Based Antibody-Drug Conjugates: Preclinical and Clinical Update
- Impact of drug- and linker types on therapeutic activity
- The role of target biology in the selection of optimal drug-linker combinations
- Clinical update on antibody-auristatin conjugates
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10.35am | Human antibody-MGBA conjugates for cancer therapy
- Overview of antibody-MGBA conjugates, including mechanism of action and their advantages and disadvantages
- Human antibody selection and conjugate optimisation
- Update on conjugates in development
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| | Dr David King, Senior Director, Biochemistry and Molecular Biology, Medarex
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11.05am | Morning coffee
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| FOCUS ON BI-SPECIFIC ANTIBODIES |
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11.35am | Development of a dual-specific antibody technology: DVD-Ig
- Support development of next generation biologics therapeutics with enhanced efficacy
- Platform technology with strategic benefits for biopharmaceutical R&D
- Address production and manufacturing issues for bispecific antibodies
- A novel approach for life-cycle management of existing antibody drugs
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12.05pm | An update on bispecific T-Cell Engager (BITE ®) technology
- A brief overview of BITE ® platform technology
- BITE® structure and mechanism
- Drug pipeline and clinical update
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| BEYOND ANTIBODIES: NEW BINDING SCAFFOLDS AND EMERGING TECHNOLOGIES |
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12.35pm | Adnectins™: realizing the promise of a novel class of targeted biologics
- Origin and development of Adnectins ™
- Advantages over traditional protein therapeutics – speed, manufacturing and multi-functionality
- Emerging clinical data from CT-322, and Adnectin inhibitor of VEGFR-2
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| | Dr Eric Furfine, Senior Vice President, Research and Preclinical Development, Adnexus
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1.05pm | Lunch
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2.05pm | Engineering repeat proteins for tumour-targeting
- Designed Ankyrin Repeat Proteins: unique strategies for protein engineering
- Obtaining binding proteins against tumor targets with picomolar affinity and high specificity
- Tumor targeting results, using a variety of targets
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2.35pm | Protease inhibitors from phage display
- Proteases: a critical role in disease pathways but an unsuccessful small molecule drug target
- Designing phage display library selections to yield highly selective and potent protease target inhibitors
- Serine and metallo-protease inhibitor proteins: from phage display to the clinic
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| | Dr Clive Wood, CSO and Seniior Vice President, Discovery Research, Dyax Corporation
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3.05pm | Pulmonary delivery delivered domain antibodies as drugs
- Preclinical and clinical data of domain antibody-based drugs
- Preclinical proof-of-concept for pulmonary delivered domain antibodies
- Advantages over conventional monoclonal antibody-based therapies
- Clinical utility of domain antibodies for treatment of pulmonary disease
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3.35pm | Afternoon tea
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4pm | Antibody variable and constant domains as scaffolds: domain antibodies and nanoantibodies
- Construction and characterization of novel large human VH libraries
- Identification and characterization of potent cross-reactive domain antibodies against HIV and cancer-related proteins
- Constant (CH2) domains as scaffolds for generation of antigen binders that can also mediate effector functions (nanoantibodies)
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| | Dr Dimiter S Dimitriov, Head and Senior Investigator, Protein Interaction Group, National Institutes of Health (NIH)
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4.30pm | Small antibody-mimicking structures for therapeutic applications
- The development of small (< 2000 Da) antibody-mimicking structures that are built of an organic molecule core and peptide loops that are anchored to this core
- The isolation of antibody-mimicking structures with high affinity and specificity for biological targets
- Critical qualities: small size, unique structure and high stability
- Potential advantages: efficient tissue penetration, low immunogenicity and low manufacturing costs
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5pm | Panel discussion: assessing the market impact of domain/fragment approaches on classical antibody development
- Anticipating the competition between antibody domain/fragment approaches and IgG-based drugs
- Overcoming regulatory hurdles associated with new approaches, strategic (and financial) commitment and assessing patient benefit
- Building a biologics pipeline and balancing antibodies with antibody fragments and other alternative antibodies
- Strategic opportunities for building an appropriate antibodies pipeline
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| | Moderator: Dr Robert J Lutz, Executive Director, Preclinical Development, ImmunoGen Inc Confirmed: Dr Clive Wood, CSO and Seniior Vice President, Discovery Research, Dyax Corporation Confirmed: Dr Eric Furfine, Senior Vice President, Research and Preclinical Development, Adnexus
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5.30pm | Close of Congress
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