Conference on Immunogenicity Summit


Conference on Immunogenicity Summit
Offering a novel perspective on immunogenicity and providing insights to formulate a winning strategy

To be held at 26th - 28th April 2010, BSG Conference Centre, London, UK

Key Speakers

Dr. Fareed Mirza, Senior Scientist-PDM Biotherapeutics, Pfi zer
Dr. Claire Holland Manager, Biopharm R&D-Clinical Immunology, GlaxoSmithKline
Dr. Robin Thorpe, Head of Biotherapeutics Group, National Institute for Biological Standards and
Control (NIBSC)
Dr. David Goldsmith, Consultant Nephrologist, Guy’s Hospital and St Thomas’ NHS Foundation Hospital
Joel Richard, Senior Director Head of Drug Product Development, Pharmaceutical Development, Ipsen
Dr. Darren Flower, Group Leader, Jenner Fellow, University of Oxford
Dr. Daryl L. Fernandes, Chief Executive, Ludger
Philippe Stas, Chief Executive Offi cer, Algonomics
Dr. Arno Kromminga, Institute for Immunology, Pathology and Molecular Biology, IPM-Biotech
Dr. Matt Baker, Chief Scientifi c Offi cer, Antitope

Dear Colleague,
Immunogenicity is a signifi cant area of discussion in the pharmaceutical and biotech industry, with new strategies and practices being developed. It is a primary safety concern for regulators. This three day event aims to provide a detailed analysis of the recent developments, challenges and regulatory considerations. Attendees will review key aspects of assay development and validation, new technologies, pre clinical and clinical immunogenicity strategies. Immunogenicity Summit will comprise a series of presentations by an excellent faculty of speakers and interactive discussions covering the key areas.

Key Benefits:
• Examine effi cient methods of immunogenicity testing
• Assess immunogenicity risk assessment strategies
• Evaluate the impact of immunogenic responses on effi cacy and safety
• Analyse the strategies for pre-clinical immunogenicity testing
• Discover how to address immunogenicity issues related to formulation
• Gain an insight into the impact of anti-drug IgE antibody testing • Hear case study updates from top biopharmaceuticals on immunogenicity
• Understand immunogenicity from a practical physician’s perspective
Best regards

Who should attend?
VPs, Directors, Heads and Managers of:
• Immunology
• Biologicals / Biotherapeutics
• Follow on Biologics/Follow on Proteins/Biosimilars
• Immunotherapeutics
• Pharmacology and Toxicology
• Immunoassays / Clinical Assays
• Analytical Development
• Pharmacovigilance
• Bioanalytical and Biomarker Development
• Drug Safety
• Non-clinical Research and Development
• Biopharmaceuticals
• Preclinical Development
• Molecular and Cell Biology
• Antibody Engineering
• Pharmaceutical Research and Development
• Regulatory Affairs
• Scientifi c Affairs
• Patient Safety
• Legal
• Intellectual Property
• Business Development

Day 1
Immunogenicity Summit
Tuesday, 27th April 2010

09:30 Registration and refreshments
10:00 Opening address from the chair
10:10 Unwanted immunogenicity of biologicals:
an overview
• Introduction to unwanted immunogenicity
• Implications of unwanted immunogenicity
• Technical guidance on analytical methodologies
• Strategies for immunogenicity assessment
• Update and overview of guidelines on immunogenicity
. Robin Thorpe
Head of Biotherapeutics Group
National Institute for Biological Standards
and Control (NIBSC)
10:50 An integrative systems biology perspective to understanding immunogenicity
• A systems-level response to immune recognition of generic or epitope-mediated “danger” signals
• An emergent bioinformatics discipline centring on immune system problems can help manipulate immunogenicity as part of a holistic approach to vaccine/bio therapeutic discovery. We explore the limitations and potential of this new technology
. Darren Flower
Group Leader, Jenner Fellow
University of Oxford
11:30 Morning refreshments
11:50 Strategies for pre-clinical immunogenicity testing: sense and non-sense
• Strategies for immunogenicity predicting at lead discovery, lead optimization and early preclinical characterisation.
• Interpreting pre-clinical immunogenicity data in a clinically relevant way
• In vivo, in-silico and in vitro assays for T-cell epitope identification
• Specific case studies will be presented showing the link between clinical and non-clinical data
Philippe Stas
Chief Executive Officer
12:30 Presentation to be announced
. Claire Holland
Manager, Biopharm R&D-Clinical Immunology

13:10 Networking lunch
14:30 Preclinical immunogenicity safety assessment
• Data from available technologies employed at various stages of the preclinical development pipeline to aid pre-clinical decision making
• Specific examples where these technologies have been used for the detection of immunogenicity
• Data from clinical studies showing incidence of clinical immunogenicity and correlation of these observations to preclinical immunogenicity testing technologies
. Matthew Baker
Chief Scientific Officer
15:10 Immunogenicity assay validation
 • Current trends and limitations
 • Factors affecting assay performance
 • Regulatory requirements for immunogenicity assays
15:50 Afternoon refreshments
16:10 The impact of anti-drug IgE antibody testing
• Discussing an increasing concern about the possibility and risk of IgE mediated type I hyperreactivities
 • Assessing the analysis of drug-specific IgE antibodies may be misleading to provoke an unsubstantiated concern about the allergenic potential of the drug
 • Examining challenges associated with development of such methods
. Arno Kromminga
Institute for Immunology, Pathology and Molecular Biology
16:50 Structural aspects of immunogenicity
17:30 Closing remarks from the chair

17:35 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2
Immunogenicity Summit
Wednesday, 28th April 2010

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Epitope identification strategies for biotherapeutics

• Understanding desired and unwanted immune responses
• The potential for immune recognition using protein/peptide
based therapies
• Epitope identification methods
• Use of transgenic systems to aid translation

Fareed Mirza
Senior Scientist-Biotherapeutics & Translational Research
PDM Sandwich Laboratories, Pfizer

10:50 Formulation and immunogenicity: Impact of drug product quality
• Immunogenicity and product quality for protein formulations
• How excipients can influence immunogenicity
• How protein structure alteration and aggregation influence immunogenicity
• How to measure and characterize protein structure alteration and aggregation
• Formulation factors influencing immunogenicity: how to avoid or limit protein aggregation
• How formulation impurities related to container/closure system, processing and storage conditions
• Influence immunogenicity - A case study
• How to address immunogenicity issues related to formulation
• Aggregation-related immunogenicity: a process development and manufacturing challenge

Joel Richard, Ph.D.
Senior Director Head of Drug Product Development,
Pharmaceutical Development

11:30 Morning refreshments
11:50 Presentation to be announced
12:30 Regulatory perspective on immunogenicity
• Current regulatory guidelines
• Pre-clinical and clinical regulatory requirements
• Interaction with the regulatory authorities

13:10 Networking lunch
14:30 Immunogenicity – a practical physician’s perspective
• What is immunogenicity immunologically?
• What is immunogenicity when applied to drug therapies?
• Examples of immunological reactions to foreign protein in drugs
and their consequences
• How can we avoid such problems with new therapies
Dr. David Goldsmith
Consultant Nephrologist
Guy’s Hospital and St Thomas’
NHS Foundation Hospital

15:10 Immunogenicity relating to biopharmaceutical glycosylation
• Immunogenic sugars
• Non-human glycosylation in different biopharmaceutical
expression systems
• Gal-alpha-1,3-Gal
• NeuAc vs NeuGc
• Determining Glycosylation Critical Quality Attributes (GCQAs)
relating to product immunogenicity
• Measuring potentially immunogenic GCQAs during product
development and production
• Reducing potentially immunogenic GCQAs
Dr. Daryl L. Fernandes
Chief Executive

15:50 Afternoon refreshments
16:10 Immunogenicity risk assessment
• What is immunogenicity risk?
• Tools for assessing risk
• Developing strategies for controlling immunogenicity-related risks
16:50 Presentation to be announced
17:30 Chair’s closing remarks
17:40 End of Conference

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