|
Pre congress briefing - Monday 5 November
|
| REGULATION AND CLINICAL TRAIL DESIGN IN ANTIBODY DEVELOPMENT |
|
| 08.00 | Registration and coffee
|
| |
|
| 09.00 | Chairman’s opening remarks
|
| | Alain Beck, Head of Physico-Chemistry Department, Centre d'Immunologie Pierre Fabre
|
| 09.15 | Keynote address: designing first-in-man clinical trials for antibodies
- How are regulatory agencies handling clinical trials applications for antibody products following the TeGenero case?
- Guidelines on clinical trial design
|
| | Jan Müller-Berghaus, Acting Head of Section, Monoclonal and Polyclonal Antibodies, Paul-Ehrlich-Institut
|
| 09.45 | Overcoming adverse immunogenicity against therapeutic proteins
- Demonstrating the association of T cell epitopes with immunogenicity in therapeutic proteins
- New technologies that allow selection of lead biologics with lower risk of clinical immunogenicity
- Technologies to allow accurate T cell epitope identification
- The removal of T cell epitopes from the sequence of protein therapeutics to reduce immunogenicity
|
| |
|
| 10.15 | Immunogenicity risk assessment in therapeutic antibodies
- Immunoprofiling via epitope identification: in silico and in vitro appraoches
- Advancing lead candidate identification
|
| |
|
| 10.45 | Morning coffee
|
| |
|
| 11.30 | Non-clinical safety assessment for antibodies
- Designing an adequate non-clinical programme
- Antibodies studies in animal models to test toxicity
- Non-clinical requirements for a first-in-man study
|
| | Patrizia Nestby, Associate Director of Regulatory Affairs, ERA Consulting Group
|
| 12.00 | Panel session: reducing immunogenicity in therapeutic antibodies
- Best practice for assessing immunogenicity in therapeutic antibodies
|
| | Moderator: Alain Beck, Head of Physico-Chemistry Department, Centre d'Immunologie Pierre Fabre Confirmed: Patrizia Nestby, Associate Director of Regulatory Affairs, ERA Consulting Group
|
| 12.45 | Lunch
|
| |
|
| 14.15 | 14.15 Production and Quality Control of Monoclonal Antibodies
- Update on current guideline revision
- Regulatory pitfalls
- The future: biosimilar antibodies?
|
| | Keith Watson, Pharmaceutical Assessor, Biologicals and Biotechnology Unit, MHRA
|
| TECHNOLOGY TRANSFER AS A STRATEGY FOR SUCCESS |
|
| 14.45 | Antibody production timeframe shortening and technology transfe
- Rapid and efficient cell cultivation process transfer and scale-up
- Production of clinical supplies of therapeutic antibodies
|
| | Michel Chartrain, Distinguished Senior Investigator, Bioprocess Research and Development, Merck Research Laboratories
|
| 15.15 | Afternoon tea
|
| |
|
| ADVANCING CHARACTERISATION OF THERAPEUTIC ANTIBODIES |
|
| 16.00 | New Developments in structural characterisation of antibodies by high-precision mass-spectrometry
- Analytical methods used to characterize MAbs
- The increasingly important role of mass spectrometry for both global and fine structural characterization
- Complementary techniques for primary structure assessment, glycosylation, structural isotyping, hot -spots mapping and immuno-conjugates characterisation
|
| | Alain Beck, Head of Physico-Chemistry Department, Centre d'Immunologie Pierre Fabre
|
| 16.30 | Establishing molecular mechanisms of a therapeutic antibody against EGF receptor
- Zalutumumab is a fully human antibody against EGFr, currently in phase III clinical trials
- Epitope mapping and molecular mechanisms of binding using protein tomography
- Mechanisms of inhibition tumorigenesis in vivo: studies in animal models
|
| | Paul Parren, Vice President of Research & Technology, Genmab
|
| 17.00 | Chairman’s closing remarks
|
| |
|
|
Congress day one - Tuesday 6 November
|
| ADVANCES IN DISPLAY TECHNOLOGIES AND IDENTIFYING LEAD ANTIBODY CANDIDATES |
|
| 08.00 | Registration and coffee
|
| |
|
| 08.45 | Chairman’s opening remarks
|
| | William Strohl, Executive Director, Department of Biologics Research, Merck Research Laboratories
|
| 09.00 | Keynote address: getting what you want from phage display
-
Issues of antigen generation
-
Factors important for success in generating antibodies with required properties
-
Applying phage display in high throughput |
| |
|
| 09.30 | Fast track production of large numbers of different IgG candidates
-
Engineering therapeutic antibodies with pre-defined characteristics
-
Various strategies to provide antibody material in screening scale for initial functional and biophysical characterisation
-
A fully scalable system for the production of gram amounts of IgG |
| |
|
| 10.00 | Panel session: identifying lead candidates through bioinformatics and display technologies
-
The fundamental role of computation biology in antibody engineering
-
Phage display expression technology
-
Optimising lead candidate identification |
| | Moderator: Ping Zhong, Co-Founder of Abmaxis and Senior Investigator, Merck Research Laboratories Confirmed: Armin Weidmann, Director of Research and Development, MorphoSys AG Confirmed: Gerald Beste, Head of Protein Engineering - Oncology, Cambridge Antibody Technology
|
| 10.45 | Morning coffee
|
| |
|
| LATEST DEVELOPMENTS IN PRODUCTION AND ANTIBODY TESTING |
|
| 11.30 | Development of a human cell line based manufacturing platform
-
Development of the PER.C6® based production platform for therapeutic proteins
-
The PER.C6® manufacturing platform: scalability, speed to clinic and product quality
-
Manufacturing vision and innovative concepts; the 10 g/L XDâ„¢ process |
| | Robert Hof, Program Manager Biomanufacturing, DSM Biologics
|
| 12.00 | Engineering Antibody Effector Function
|
| | Gerald Beste, Head of Protein Engineering - Oncology, Cambridge Antibody Technology
|
| 12.30 | IgG2m4 - an engineered IgG isotype lacking effector functionality for use as a long half-life benign blocker
-
Engineering IgG to remove effector functionality for FcgRI, FcgRII, and FcgRIII, as well as C1q binding
-
Resultant antibody IgG isotype behaves as designed in all assays performed
-
Use of IgG2m4 with several constructs |
| | William Strohl, Executive Director, Department of Biologics Research, Merck Research Laboratories
|
| 13.00 | Lunch
|
| |
|
| 14.15 | Stability engineering and production of IgG-like bispecific antibodies
-
Challenges in production and stability of IgG-like bispecific antibodies
-
Structural and statistical analyses for stability engineering of single-chain Fvs
-
Stabilised scFvs as a component of IgG-like bispecific antibodies enables production of highly purified, stable, active product |
| | Scott Glaser, Director, Molecular Engineering, Biogen Idec, Inc.
|
| 14.45 | Achieving higher productivity in antibody production - improved strategies for cell platform and cell culture engineering
|
| |
|
| AVOIDING BOTTLENECKS IN DOWNSTREAM PROCESSING |
|
| 15.15 | Mixed-mode chromatography: a new tool in antibody purification
-
Overview of mixed-mode sorbents for antibody harvest and purification
-
Application examples and process optimisation parameters
-
Novel mixed-mode sorbents and ligand selectivity screening
-
Scale-up and process orthogonal sequences |
| | Sylvio Bengio, Scientific Communications Specialist, Pall Life Sciences
|
| 15.45 | Speed networking
|
| |
|
| MANUFACTURING CONSIDERATIONS FOR NEXT GENERATION ANTIBODY PRODUCTS |
|
| 16.30 | Afternoon tea
|
| |
|
| 17.00 | Next generation antibodies with enhanced effector functions
-
Application of antibody engineering for the development of a new generation of humanised antibodies with enhanced effector functions
-
Antibody-dependent cellular cytotoxicity achieved through Fc glycoengineering
-
Enhanced apoptosis induction |
| | Pablo Umaña, Head of Research, GlycArt Biotechnology AG, Roche Group
|
| 17.30 | Delivering an antibody fragment to the eye: a novel treatment for eye disease
-
Novel uses of antibody fragments
-
Case study: ranibizumab/ LUCENTIS®
-
Pharmacology and pharmacokinetics for eye delivery |
| | Lisa Damico, Senior Scientist and Group Leader, Early Development Pharmacokinetics and Pharmacodynamics, Genentech, Inc.
|
| 18.00 | scFab fragments and human antibody fusion proteins
-
scFab - a novel antibody format and its production in E. coli and Pichia
-
The Bacillus megaterium antibody expression system
-
Novel human RNAse fusion protein for tumor therapy |
| | Stefan Dübel, Institute of Biochemistry and Biotechnology, Technical University of Braunschweig
|
| 18.30 | Chairman’s closing remarks
|
| |
|
| 18.35 | Networking drinks reception
|
| |
|
|
Congress day 2 - Wednesday 7 November
|
| NOVEL CLASSES OF ANTIBODIES IN DEVELOPMENT |
|
| 08.00 | Registration and coffee
|
| |
|
| 08.45 | Chairman’s opening remarks
|
| | Clive Wood, Executive Vice President and Chief Scientific Officer, Dyax Corp
|
| 09.00 | Keynote address: design and development of novel antibody scaffold molecules
-
Domain antibodies as an alternative to traditional antibodies
-
Improving half-life through formatting with AlbudAbâ„¢ or PEG
-
In vivo efficacy in animal models of rheumatoid arthritis |
| |
|
| 09.30 | PEGylated Fab fragments: expression, purification and clinical use
-
Expression of antibody fragments
-
Purification and downstream processing
-
Site-specific PEGylation to optimise pharmacokinetics |
| |
|
| 10.00 | Fast-track development of antibody drug conjugate processes - the race from lab to plant
-
Methodology used to develop robust and fit for purpose processes for rapid scale-up
-
Approaches used for development of both reactive and purification stages
-
Achieving high levels of product consistency through good process understanding, across the various stages of scale-up, from lab to plant |
| | Colin McKee, Protein Science Team Leader, NPIL Pharmaceuticals
|
| 10.30 | Morning coffee
|
| |
|
| 11.15 | Generation and characterisation of monoclonal antibodies for use in GPCR crystallography
-
Antibody fragments shown to facilitate membrane protein crystallography by stabilising proteins and increasing the polar surface area
-
Generating conformationally selective antibodies to facilitate crystallisation of the human beta 2 adrenergic receptor, a prototypical GPCR for adrenaline and noradrenaline |
| | Brian Kobilka, Department of Molecular and Cellular Physiology and Medicine, Stanford University School of Medicine
|
| 11.45 | In vitro selection and characterisation of binding proteins for the co-crystallisation of membrane proteins
-
Co-crystallisation with specific binding proteins helps to obtain high quality crystals
-
In vitro selection and characterisation of binding proteins specific for integral membrane proteins
-
Designed Ankyrin Repeat Proteins (DARPins) as an alternative to antibody fragments |
| | Thomas Huber, Department of Biochemistry, University of Zurich  Â
|
| 12.15 | Lunch
|
| |
|
| NOVEL THERAPEUTIC TARGETS FOR ANTIBODIES |
|
| 13.30 | ABT-874: an antibody to interleukin 12/23 for the treatment of psoriasis
-
ABT-874: A fully human recombinant anti-IL-12p40 antibody isolated using phage display technology
-
Clinical studies with ABT-874 in Crohn’s disease, multiple sclerosis and psoriasis
-
Clinical data from the 12 week Phase II psoriasis study |
| | Susan Lacy, Senior Scientist, Biologics Generation, Abbott Bioresearch Center, Abbott
|
| 14.00 | Development of therapeutic anti-RAGE antibodies for the treatment of sepsis
-
Receptor for advanced glycation end-products (RAGE) - a cell-surface Ig super-family member
-
Use of RAGE antibody designated XT-M4 to protect mice from the lethal effects of cecal ligation and puncture (CLP)
-
Fully humanized XT-M4 to decrease potential immunogenicity and manufacturability issues |
| | Xiang-Yang Tan, Principal Scientist, Department of Biological Technologies, Wyeth Pharmaceuticals
|
| 14.30 | Selective antibody-based targeting of lymphangiogenesis, angiogenesis and tumor growth
-
The role of endothelial VEGFR-3 and Tie receptors in tumor growth and metastasis
-
Antibodies targeting endothelial growth factor receptors vs. ligand traps as tumor inhibitors
-
The molecular and cellular basis of tumor inhibition via targeting of angiogenesis
|
| | Kari Alitalo, Director of the Center of Excellence in Molecular / Cancer Biology, Biomedicum Helsinki
|
| 15.00 | Generation of therapeutic antibodies for oncology using the humanised mouse
-
Advantages / disadvantages of using humanised mouse
-
Generation of lead Abs with the platform vs. oncology targets
-
Combination of humanised mouse / display approaches for optimal antibody generation |
| | David Blakey, Senior Principle Scientist / Project Director, Cancer Discovery, AstraZeneca
|
| 15.30 | Afternoon tea
|
| |
|
| 16.00 | Selective antibody based targeting of MMP-14 inhibits tumor growth and angiogenesis
-
The role of MMP-14 in tumor growth and metastasis
-
Isolating DX-2400, a potent and selective inhibitor of MMP-14
-
In vivo pharmacological validation of the role of MMP-14 in tumor growth and angiogenesis
-
The 1st of a new generation of antibody-based protease inhibitors for oncology |
| |
|
| 16.30 | Human monoclonal antibodies against emerging and biodefense related viruses
-
Identification and characterisation of a potent cross-reactive antibody, m396, against the SARS CoV
-
Crystal structure of m396 in complex with the SARS CoV receptor binding domain
-
Development of a potent cross-reactive antibody, m102.4, against Nipah and Hendra viruses |
| | Dimiter Dimitrov, Senior Investigator, Protein Interactions, CCRNP, CCR, NCI-Frederick, NIH
|
| 17.00 | Panel session: what are the most promising future therapeutic areas for antibody development?
|
| | Confirmed: Richard Pleass, Institute of Genetics, The University of Nottingham Confirmed: Susan Lacy, Senior Scientist, Biologics Generation, Abbott Bioresearch Center, Abbott Confirmed: Xiang-Yang Tan, Principal Scientist, Department of Biological Technologies, Wyeth Pharmaceuticals
|
| 17.45 | Chairman’s closing remarks
|
| |
|
