- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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Immunogenicity
21 - 22 February 2012
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Informa Life Sciences' 15th Annual Immunogenicity for Biologics Conference: 12+ case studies from Merck Serono, Sandoz, UCB & more. Discover how best to optimise your pre-clinical/clinical programmes to best monitor the immunogenicity of your product
2012 HIGHLIGHTS: Gain expert advice on effective immunogenicity & PK/PD testing, clinical implications and regulatory feedback through BRAND NEW real-life case studies
- Gain clarification of FDA guidelines regarding assay development for immunogenicity testing and validation for both ELISA and cell-based assays
read more Methodology to detect the ADA response and development of an ADA assay as an alternative assay, rather than ELISA assays
read moreHear a biosimilar perspective regarding conducting immunogenicity testing of the originator product compared to the biosimilar/biobetter read more
- Increased focus on PK/PD: Gain the latest feedback regarding how bioassays work in conjunction with PK and PD modelling read more
Interactive dsicussion panel including speakers of the day discussing the regulations behind applications of ligand-binding antibodies, cell-based assays and acid dissociation assays
- Discover the importance of monitoring immunogenicity at the pre-clinical/clinical stage of development read more
2012's Leading Speaker Panel: Meet Key Academic, Regulatory & Industry Experts from FDA, Merck Serono, UCB, NIBSC, Sandoz, HPA & more
2012's Leading Speaker Panel: Meet Key Academic, Regulatory & Industry Experts from FDA, Merck Serono, UCB, NIBSC, Sandoz, HPA & more
Dr Jack Ragheb
Senior Supervisory Regulator
FDA
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Dr Robin Thorpe
Head, Biotherapeutics
NIBSC
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Dr Joel Richard
Senior Director, Head of Drug Product Development
Ipsen, France
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Dr Arno Kromminga
CEO, Immunology
IPM BIOTECH
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PLUS:
- Dr Daniel Kramer,Corporate Expert, Immunogenicity, Merck Serono, Germany
- Dr Vera Koppenburg, Head Bioanalytics, Sandoz Biopharmaceuticals, Germany
- Dr Michael Tovey, Director, INSERM, France
- Dr Peter Lloyd, Head of PK/PD, Biologics Safety and Disposition, Novartis, UK
- Dr Nadja S. Prang Richard, Biotech Expert, BioChallenges Consulting, France
- Dr Bernard Maillere, Laboratory Head, Immunochemistry, CEA, France
Conference Sponsor
2012 Spotlight Session Sponsors
Exhibitors
Literature Sponsor
Media Partners
What did the 2011 delegates think?
‘‘Very good audience questions and participation. Good size for total attendees’’ - Ullrich, Human Genome Sciences, 2011 delegate
‘‘Nice and dynamic conferences. High level speakers’’ - Macé, Sanofi Aventis, 2011 delegate
DO NOT MISS: Choice of 2 interactive workshops
Pre-conference workshop: Monday 20 February 2012
Detecting and Characterising Immunogenic Responses
Ensuring the correct measurement of antidoby responses is vital to ensur the correct characterisation of your immune response. This interactive workshop discussed behaviour of antibodies, evaluation of technologies used to characterise the response, validation and standardisation of assays using practical simulation exercises and a Q&A platform.
Led by Dr Arno Kromminga, CEO, IPM Biotech & Dr Daniel Kramer, Corporate Expert, Immungenicity, Merck Serono
Post-conference workshop: Thursday 23 February 2012
Neutralising antibody (Nabs) Assays: Strategic, Technical and Scientific Considerations
Optimisation and validation of cell based neutralising antibody assays present a number of challenges that need to be addressed to obtain suitable assays for detection and quantification of ADAs. This interactive session gives insight in methods to reduce serum matric effect and strategies to ensure reduced assay variability. This workshop allows delegates to familiarise themselves with the latest techniques for optimising neutralising antibody assays aswell as practical approacheds to validation.
Christophe Lallemand, Researcher Scientist, LBPA, CNRS, France
Who Should Attend?
Heads of Department, Directors, Managers, Team Leaders, Associates, Consultants and Coordinators from:
- Regulatory Affairs
- CEE Regulatory Affairs
- CIS Regulatory Affairs
- Global Regulatory Affairs
- Medical Affairs
- Registration
- International Strategy
- Business Development
Other Events That Will Interest You
Inaugural
Biopharmaceutical Raw Materials:
27 Jun 2012 - 28 Jun 2012
Pullman Hotel, Cologne, Germany
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EVENT NEWS!
Announcing Lonza at Immunogenicity 2012
"Pre-Clinical Strategies to Predict and Avoid Immunogenicity of Biotherapeutics"
Philippe Stas, Head, Applied Protein Services, Lonza
As immunogenicity of biotherapeutics can lead to drug inactivation and adverse effect, immunogenicity should be assessed and avoided as early in the drug discovery process as possible. This presentation will give an overview of possible strategies to follow to mitigate the risk, an approaches will be discussed to minimize or reduce immunogenicity during discovery and pre-clinical research. Selected case studies will be presented.
Quotient Bioresearch & Lonza presentation confirmation
Do not miss Philip Driver, Senior Scientist, Bioanalytical Sciences presenting on behalf of Quotient Bioresearch on the ''Development and validation of neutralising anti-drug antibody assays”
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Philippe Stas, Head, Applied Protein Sciences, Lonza, UK
NEW SPEAKER ANNOUNCED
Do not miss Dr Bernard Maillere, Head, Laboratory of Imunochemistry, CEA, France present on......
Relevance of early prediction methods for predicting immunogenicity in human:
Methods of early prediction of immunogenicity in human mainly rely on in silico and in vitro T cell experiments. They aim to predict the interactions of peptide with HLA class II molecules and to detect the presence of specific T cells, respectively. This talk will present recent achievements of prediction approaches and their confrontation with clinical data.
- Understanding the principles of in silico prediction and their value to identify T cell epitopes
- Understanding the rational of T cell assays and their value to document intrinsic immunogenicity
- Confrontation of the T cell amplication assays with clinical data
- Implementing In vitro T cell assays for the pre-clinical selection
2012 Sponsors
Companeis who have attended in last 2 years
