1. SMi presents the 2nd annual conference on...
PLUS AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 1st July 2015, Marriott Regents Park Hotel, London, UK
Tools for early immunogenicity risk assessment and reduction
Workshop leaders: Sofie Pattijn, CTO, ImmunXperts SA and
Morten Nielsen, Associate Professor, Center for Biological Sequence Analysis, Technical University of Denmark
8.30am - 12.30pm
29-30
JUNE
2015Marriott Regents Park Hotel, London, UK
IMMUNOGENICITY
Understanding and modulating immunity in therapeutics
www.immuno.co.uk
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
REGISTER BY THE 27TH FEBRUARY AND SAVE £400
REGISTER BY THE 31ST MARCH AND SAVE £200
REGISTER BY THE 30TH APRIL AND SAVE £100
CONFERENCE CHAIRS:
Annie De Groot,
CEO and CSO, EpiVax, Inc.
Sandra Garcês, Rheumatologist Consultant
and Researcher, Garcia de Orta’s Hospital
KEY SPEAKERS INCLUDE:
David Wraith, Chief Scientific Officer and
Founder, Apitope International NV
Margareta Wikén, Bioanalytical Manager,
Swedish Orphan Biovitrum
Morten Nielsen, Associate Professor,
The Technical University of Denmark
Gerhard Niederfellner, Head of Tumour
Cell Biology, Pharma Research & Early
Development, Roche Innovation Center
Penzberg
Chloé Ackaert, Postdoctoral Researcher,
Cellular and Molecular Immunology
Free University of Brussels
BUSINESS BENEFITS FOR 2015:
• Gain an understanding of immunogenicity and
challenges in biologics development
• Explore tolerance induction techniques in detail
• Discover the latest in pre-clinical models
• Learn more about neutralising antibody assay
best practice
• Receive updates on the ABIRISK project
@SMIPHARM
Sponsored by

2. Register online at: www.immuno.co.uk • Alternatively fax you
Immunogenicity
Day One | Monday 29th June 2015
8.30 Registration & Coffee
9.00 Chair's Opening Remarks
Annie De Groot, CEO and CSO, EpiVax, Inc.
CLINICAL DIRECTIONS - PART 1
OPENING KEYNOTE
9.10 How to switch off unwanted immune responses
• Immunogenicity is unavoidable e.g. enzyme replacement
therapy
• Immunological tolerance mechanisms control immune
responses to self and foreign antigens
• The mechanisms of tolerance induction are now being
revealed: here we will discuss novel insights into tolerance
induction with peptide antigens
• Examples will be given from the fields of allergy,
autoimmune disease and blood clotting disorders
David Wraith, Chief Scientific Officer and Founder, Apitope
International NV
9.50 Synthetic Vaccine Particles (SVPs) for the prevention of
anti-drug antibodies
• The development of anti-drug antibodies (ADAs) is a
common cause for treatment failure and adverse events
associated with biologic therapies
• Selecta Biosciences is a clinical stage company that has
developed a novel platform of Synthetic Vaccine Particles
(SVP) to induce durable antigen-specific immune
tolerance for the prevention of ADAs
• Selecta’s tolerogenic SVP technology has the potential to
improve efficacy and safety profile of novel biologics;
reduce catastrophic late stage clinical failure due to
ADAs; provide life cycle management for existing
products; and differentiate products from biosimilars
Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences
10.30 Morning Coffee
11.00 Achieving immunological tolerance - are we there yet?
• Can immunological tolerance be achieved clinically?
• Pros and Cons of in vitro and in vivo assays of modelling
immunological tolerance pre-clinically will be discussed
• How well do these pre-clinical models translate into the
clinic
Farnaz Fallah-Arani, Group Leader, Pharmacology, UCB
11.40 Evaluation of the immunogenicity of orally administered
recombinant human BSSL in a phase III clinical study in
pre-term infants
• Challenges and limitations due to the vulnerable nature of
the pre-term infant population
• Experience gained from preclinical safety studies
• Outcome from the clinical study during a 1 year follow up
period
Margareta Wikén, Bioanalytical Manager, Swedish Orphan
Biovitrum
12.20 Networking Lunch
ASSAYS AND ASSESSMENTS - PART 1
1.20 Early immunogenicity assessment of biotherapeutics:
a decade at a glance
• Prediction versus assessment?
• A time for standardisation and harmonisation
• Managing expectations
• Innovations and developments
Sofie Pattijn, Chief Technology Officer, ImmunXperts
2.00 Predicting T-cell immunogenicity; Moving beyond MHC
binding
• T-cell epitopes must bind one or more of the host's MHC
molecules
• For CTL epitope, this binding event is highly predictive for
T-cell immunogenicity, for T helper responses this is the case
only to a limited extend
• Overview of recent advances in tools for prediction of
peptide binding to MHC class II molecule and limitations in
improving the accuracy of these methods
• Explore features other than MHC binding that might be
critical for identification of T-cell epitopes
Morten Nielsen, Associate Professor, The Technical University
of Denmark
2.40 Afternoon Tea
3.20 Immune tolerant mice as the model for studying
immunogenicity?
• Types of immune tolerant mouse models
• What can we learn from immune tolerant mice about the
immunogenicity mechanism?
• Can immune tolerant mice be used for immunogenicity
prediction?
• Future of immune tolerant mice models
Grzegorz Kijanka, Postdoctoral Researcher, Leiden
Academic Centre for Drug Research, Leiden University
4.00 Validation of cell based antibody neutralisation assays
• Challenges of development of validation of cell based
assays
• Can cell based assays be quantitative?
• Which parameters can be validated?
• System suitability for cell based assays
Bassam Hallis, Head of Pre-Clinical Development, Public
Health England
4.40 Chair’s Closing Remarks and Close of Day One
Annie De Groot, CEO and CSO, EpiVax, Inc.
SQI Diagnostics is a life sciences company that develops and
commercializes proprietary technologies and products for advanced
microarray diagnostics. SQI has automated, miniaturized, and
multiplexed immunogenicity and bioanalytics testing using patented
technology making it the only company in the world capable of ADA,
epitope mapping, multiplexed PK assays, and many other assays all in
one well. The Company’s proprietary microarray tests and fully-
automated systems are designed to simplify workflow, increase
throughput, reduce costs and provide excellent data quality. With
products in both the IVD and pharmaceutical space, SQI is able to
serve both marketplaces with the unparalleled level of quality
researchers and clinical laboratorians have come to expect.
www.sqidiagnostics.com
Sponsored by SPONSORSHIP AND EXHIBITION
OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising
and branding packages, uniquely tailored
to complement your company’s marketing
strategy.
Prime networking opportunities exist to
entertain, enhance and expand your client
base within the context of an independent
discussion specific to your industry.
Should you wish to join the increasing
number of companies benefiting
fromsponsoring our conferences please
call: Alia Malick on +44 (0) 20 7827 6168
or email: amalick@smi-online.co.uk

3. ur registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Immunogenicity
Day Two | Tuesday 30th June 2015
Supported by
8.30 Registration & Coffee
9.00 Chair's Opening Remarks
Sandra Garces, Rheumatologist Consultant and Researcher,
Garcia de Orta’s Hospital
CLINICAL DIRECTIONS - PART 2
OPENING KEYNOTE
9.10 Does a “win-win situation” really exist between basic
research and industry interactions? Should we learn to be
tolerant?
• The path from macro to micro and vice versa. An overview
of the clinical and basic research ultimate goals
• A long-known mechanism of target elimination: antibody-
dependent cell-mediated cytotoxicity, why we should care
about the details?
• Examples in xenotolerance. Tolerogenic dendritic cells in
xenotransplantation and transgenic animals to modulate
human immune response
Gisella Puga Yung, Scientific Collaborator II, University of
Geneva
9.50 Drug Immunogenicity: what have we learn from the use of
biologics in clinical practice?
• Unwanted immunogenicity is a common feature of many
therapeutic proteins and has a significant impact on the
drug’s efficacy and safety profile
• Despite the drug-related factors, patient’s characteristics
may determine why some patients developed significant
immunogenicity while others do not, when exposed to the
same therapy
• The assessment of unwanted immunogenicity can be
improved by using prediction tools, optimizing the
performance of immunogenicity assays and by immune-
monitoring patients receiving biologic therapies
Sandra Garcês, Rheumatologist Consultant and Researcher,
Garcia de Orta’s Hospital
10.30 Morning Coffee
11.00 RG7787 - The coming of age of immunotoxins for solid tumour
therapy. Are we there yet?
• De-immunizing Pseudomonas Exotoxin
• Differentiation from ADCs
• Clinical development path
• Combination with chemotherapeutics
Gerhard Niederfellner, Head of Tumour Cell Biology, Pharma
Research & Early Development, Roche Innovation Center
Penzberg
11.40 Immunogenicity prediction and assessment of nanobodies
• Nanobodies: an emerging, promising class of biotherapeutics
• Interaction between nanobodies and primary dendritic cells
• ADA assessment towards nanobodies in Phase I
Chloé Ackaert, Postdoctoral Researcher, Cellular and
Molecular Immunology, Free University of Brussels
12.20 Networking Lunch
13.20 Peptide immunotherapy for the treatment of autoimmune
disease - closer to a cure?
• Why peptide immunotherapy over conventional
treatments?
• Peptide immunotherapy in preclinical models
• Translating efficacy from preclinical models into the clinic
Emma Smith, Senior Group Leader, UCB
ASSAYS AND ASSESSMENTS - PART 2
2.00 ABIRISK: using immunological signatures to predict
immunogenicity
• Aims of ABIRISK immunology program
• Using a high throughput flow cytometry platform to identify
novel predictive markers
• Progress with MS patients treated with Interferon-beta
Marsilio Adriani, Postdoctoral Research Associate, University
College London
2.40 Afternoon Tea
3.20 The two main outcomes of T-cell amplification assays for
immunogenicity prediction: T-cell repertoire and epitopes
• Why are T-cell assays performed to predict
immunogenicity?
• What kind of data do they produce?
• Do they have been already confronted to clinical
observations?
• Are they really useful as compared to other predictive
approaches?
Bernard Maillere, Research Director and Head, Immunology
Laboratory, Institute of Biology and Technologies
4.00 An integrated approach to managing immunogenicity risk
and drug immune modulation
• Learn how data from cell-based assays, physical MHC-
peptide binding assays, mass spectrometry antigen
presentation assays and whole blood cytokine storm risk
management assays can be integrated to characterize
immune responses against, or caused by, biotherapeutic
drugs
• Improve decision-making in lead selection, lead
characterisation and re-engineering options
Jeremy Fry, Assay Specialist, ProImmune Ltd.
4.40 Chair’s Closing Remarks and Close of Day Two
Sandra Garces, Rheumatologist Consultant and Researcher,
Garcia de Orta’s Hospital
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Margaret Mugema, SMi Marketing on +44 (0) 20 7827 6072, or email: mmugema@smi-online.co.uk

4. HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 1st July 2015
8.30am - 12.30pm
Marriott Regents Park Hotel, London, UK
Tools for early immunogenicity risk
assessment and reduction
Workshop leaders: Sofie Pattijn, CTO,
ImmunXperts SA and
Professor Morten Nielsen, Associate Professor,
Center for Biological Sequence Analysis,
Technical University of Denmark
Overview of workshop:
This workshop will give an overview of in silico and
in vitro tools and technologies to assess and
reduce immunogenicity at an early development
stage. Next to the technical details and case
studies, there will also be an overview of the
benefits and limitations of the different tools and
how to implement these into your drug
development strategy.
Why should delegates attend this workshop:
• Get an overview of the different tools available
for early immunogenicity assessment and risk
reduction
• Learn which tools can be used during the
different development stages
• Gain an in depth understanding of the type of
results and information generated by these tools
• Discover how to implement these tools in the
drug development process
Programme
8.30 Registration and coffee
9.00 Opening Remarks
9.15 Introduction early immunogenicity
assessment tools
10.15 In silico T cell epitope identification to
guide de-immunisation of biotherapeutics
• Technology overview
• Case studies
10.45 Coffee Break
11.15 In vitro T cell assays for early
immunogenicity assessment
• Technology overview
• Strengths and limitations
11.45 Early immunogenicity risk assessment
strategies
• Implementation of early
immunogenicity assessment tools in the
drug development plan
• Managing expectations and outcomes
12.15 Closing remarks
12.30 End of workshop
About ImmunXperts:
ImmunXperts offers
services to support you in
the risk assessment and
mitigation of your drug candidate’s
immunogenicity profile. In collaboration with our
scientific advisors and international partners,
ImmunXperts offers access to a unique team of
seasoned immunogenicity experts. Our
partnership model allows us to tap into a broad
network of subcontractors and academic
collaborators, resulting in a wide range of
technologies and broad service offering.

5. SMI'S PHARMACEUTICAL
PORTFOLIO 2015
MARCH
Superbugs & Superdrugs
– A focus on Antibacterials
25th – 26th March 2015
Holiday Inn Regents Park, London
Paediatric Clinical Trials
25th – 26th March 2015
Holiday Inn Regents Park, London
APRIL
Asthma & COPD
13th – 14th April 2015
Holiday Inn Regents Park, London
Controlled Release
20th – 21st April 2015
Marriott Hotel Regents Park, London
Adaptive Designs
20th – 21st April 2015
Marriott Hotel Regents Park, London
Pre Filled Syringes USA
27th – 28th April 2015
Renaissance Woodbridge, Iselin, USA
Lyophilisation and Freeze Drying USA
29th – 30th April 2015
Renaissance Woodbridge, Iselin, USA
MAY
Pharmacovigilance, Drug Safety
& Risk Management
11th – 12th May 2015
Holiday Inn Regents Park, London
Pain Therapeutics
18th – 19th May 2015
Holiday Inn Bloomsbury, London
ADC Summit 2015
18th – 19th May 2015
Holiday Inn Bloomsbury, London
Clinical Trial Logistics
20th – 21st May 2015
Marriott Hotel Regents Park, London
JUNE
BioBanking
22nd – 23rd June 2015
London
Cold Chain Distribution North America
24th – 25th June 2015
Iselin, New Jersey, USA
ADMET
29th – 30th June 2015
Marriott Hotel Regents Park, London
Immunogenicity
29th – 30th June 2015
Marriott Hotel Regents Park, London
Lyophilisation
29th – 30th June 2015
London
JULY
Peptides
8th – 9th July 2015
London
Allergies
8th – 9th July 2015
London

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IMMUNOGENICITY
Conference: Monday 29th & Tuesday 30th June 2015, Marriott Regents Park Hotel, London, UK Workshop: Wednesday 1st July 2015, London
4 WAYS TO REGISTER
www.immuno.co.uk
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