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Conference Documentation: Global Proteins Summit (2010)

SMI Publishing, Ltd
June 23, 2010
SKU: SMI2772768

Abstract Table of Contents Related Reports

Protein biotherapeutics have gone from a seldom used subset of treatments to a multi-billion dollar global industry. With the ever-expanding protein therapeutic market, SMi's 6th annual Global Proteins Summit is well timed to investigate the latest developments in protein therapeutics, cell culture expression and immunogenicity.

The conference will explore the next generation of protein therapeutics, how they are being developed and reassess the technology, discovery and delivery trends. Also covered will be expression optimisation, case studies looking at successful drugs along with immunogenic considerations and safety assessment.

Reassess the latest therapeutics, developments, technologies, and methods that work in an interactive, networking friendly environment with major players from the biotech industry.

This meeting will feature talks from experts who will address:

Optimisation of pre-formulation approaches, expression and glycosylation
Next generation nanobodies
Generating therapeutic antibodies to multi-transmembrane receptors
Case studies in successful innovative biotherapeutics
In silico methods to reduce development risks
Recognising and combating immunogenicity
Regulatory perspectives

DAY 1
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks: Bernardo Perez-Ramirez, Senior Scientific Director, BioFormulations Development, Genzyme Corporation.
9.10 Optimizing Pre-formulation Approaches for Successful Development of Therapeutic Proteins: Early assessment of "developmentability" potential; Maximizing data collection and output with minimal amount of protein; Global analysis and thermodynamic assessment; Choosing proper stress conditions; Bernardo Perez-Ramirez, Senior Scientific Director, BioFormulations Development, Genzyme Corporation.
9.50 Multi-Specific Adnectins: Realizing the promise of a novel class of targeted biologics; Advantages compared to traditional targeted biologics; Challenges in modulating two distinct targets; Engineering and optimisation; Clinical potential; Ray Camphausen, Associate Vice President of Protein Design, Adnexus, a Bristol-Myers Squibb R&D Company.
10.30 Morning Coffee
11.00 DARPin Therapeutics: Fast lane from the bench to the clinics; Combining the favourable properties of antibodies with those of small molecule drugs; Engineering of novel types of drugs superior to currently known biologics; Updates on MP0112, a best-in-class therapeutic DARPin for the treatment of ocular neovascularization diseases; H. Kaspar Binz, Vice President Technology, Molecular Partners A G.
11.40 Case Study: Arzerra (Ofatumumab): Generating the next generation of therapeutic antibodies; Introduction to CD20 and Arzerra; Mechanism of action of tumour cell killing activity in vitro and in vivo; Update on progress in the clinic; Paul Parren, Senior Vice President, Research & Pre-Clinical Development, Genmab B.V..
12.20 Networking Lunch
1.20 Next Generation Nanobodies: A unique concept among antibody formats; Distinct structural and functional properties; Advantages over other designed target binders; Engineering to broaden utility; Future therapeutics; Serge Muyldermans, Professor, Department of Molecular and Cellular Interactions, Vrije Universiteit Brussel.
2.00 MetMAb: One-Armed 5D5 Anti-c-Met Antibody: Optimising the level of foreign gene expression; Background; Production issues and solutions; Optimisation; Future novel molecules; Dorothea Reilly, Senior Scientist, Genentech.
2.40 Anticalins®: A unique class of binding proteins and their use as therapeutics; Modified human lipocalins as unique scaffold; PRS-050 (VEGF antagonist) entering human studies; Anticalins against hapten targets; Formulation and formatting flexibility; CMC advantages; Alternative delivery; Andreas Hohlbaum, CTO, Pieris Proteolab AG.
3.20 Afternoon Tea
3.50 Alternates Approaches to Preclinical Safety Assessment of Biologics: Case Studies: Selecting the right animal model to test toxicology; Alternatives to in vivo animal testing; Looking ahead; Rakesh Dixit, Global Head, Biologics Safety Assessment & Exp. Pathology, Medimmune.
4.30 Soluble Fc Receptor (SM101) for the treatment of autoimmune diseases: Inclusion body based expression in E. coli & subsequent refolding of SM101 were optimised to a high yield process; The production method allows a tag-free purification; SM101 has finished a Phase I study in healthy volunteers; Clinical development in autoimmune diseases is ongoing; Peter Sondermann, CSO, SuppreMol GmbH.
5.10 Chairman’s Closing Remarks and Close of Day One: Rakesh Dixit, Global Head, Biologics Safety Assessment & Exp. Pathology, Medimmune.
DAY 2
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks: Darren Hart, Team Leader, European Molecular Biology Laboratory.
9.10 Library-Based Construct Screening: Soluble production of difficult-to-express proteins; Directed evolution strategies for protein expression; ESPRIT (Expression of Soluble Proteins by Random Incremental Truncation); Expression analysis using high throughput robotics; Case study: expression, purification and structural studies on drug targets & vaccine candidates; Darren Hart, Team Leader, European Molecular Biology Laboratory.
9.50 High-Throughput Eukaryotic Protein Expression: Optimizing the level of foreign gene expression; The impact of protein engineering; Expression of human integral membrane proteins; Opher Gileadi, Principal Investigator, Oxford University.
10.30 Morning Coffee
11.00 Protein Tools for Drug Discovery; Lessons Learnt: A review of protein production technologies to enable drug discovery; Technologies and innovations; Accelerating the generation of recombinant proteins for small molecule drug discovery; Tricks of the trade - expression of difficult to make protein; Ian Hunt, Group Leader, Protein Production Group, Novartis Institutes for BioMedical Research.
11.40 New ways of Establishing Production Cell Lines for Structural Biology: Stable CHO cell lines for glycoprotein crystallization established by Flp/FRT-recombination and cell sorting; Site-specific recombination allows shuttling of genes of interest to favourable genetic loci; Preparative FACS of GFP positive cells identifies highly productive and genetically stable clones; Glycosylation deficient CHO lines produce homogenous glycoproteins; The resulting glycoproteins can be deglycosylated enzymatically and crystallized efficiently; Konrad Büssow, Head of Mammalian Protein Expression Group, Helmholtz Centre For Infection Research.
12.20 Networking Lunch
1.20 Optimising Glycosylation for Antibody Therapeutics: Co- and post- translational modifications; Antibody therapeutics as autoantibodies; Immune complexes/aggregation; Cell engineering & glycoform profiles; Human IgG subclasses & polymorphisms; Roy Jefferis, Professor of Molecular Immunology, University Of Birmingham.
2.00 In silico Methods to Reduce Development Risks in Biotherapeutics: Selecting and engineering optimal lead compounds; Development challenges in biopharmaceuticals. Aggregation and stability issues; Upstream risk assessment to improve potential outcome of projects; Opportunities for designing quality in the product & expand the DSP design space; In silico aggregation prediction, opportunities for selection of optimal leads; Engineering biopharmaceuticals for improved developability; Jesús Zurdo, Head of Advanced Protein Technologies, Lonza Biologics plc.
2.40 Immunogenicity Aspects & Risk-Based Approaches: Novel proteins as foreign antigens; Allergic risk factors; Clinical consequences of ADA; Arno Kromminga, CEO, IPM BIOTECH GmbH.
3.20 Afternoon Tea
3.50 Generation of Therapeutic Antibodies against Inflammatory Disease and Cancer Targets: Minimizing the risk of clinical immunogenicity; Problem of anti-therapeutic antibody responses; Importance of ex vivo T cell epitope mapping; Engineering proteins to avoid T cell epitopes; Matthew Baker, CEO & CSO, Antitope.
4.30 Regulatory Guidance - an EU Perspective: Existing and Upcoming EMEA guidelines; Comparing immunogenicity; Best practices and common problems with immunogenicity assessment; Meenu Wadhwa, Head, Cytokines & Growth Factors & Biotherapeutics, National Institute For Biological Standards And Control.
5.10 Chairman’s Closing Remarks and Close of Day Two

Conference Documentation: Global Proteins Summit (2010)

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