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

PLUS ONE INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPWednesday 14th June 2017, Holiday Inn Kensington Forum, London, UK

@SMIPHARM#immuno17

Immunogenicity - from non-clinical detection to clinical impact 08.30 – 12.30

Workshop Leader: Melody Sauerborn, Freelance Consultant

REGISTER BY 31ST MARCH FOR A £300 DISCOUNTREGISTER BY 28TH APRIL FOR A £200 DISCOUNTREGISTER BY 31ST MAY FOR A £100 DISCOUNT

SMi proudly present their 4th annual conference…

Immunogenicity Clinical excellence of biotherapeutics through regulation and advanced immunogenicity assessments

HOLIDAY INN KENSINGTON FORUM, LONDON, UK

CONFERENCE: 12TH - 13TH

WORKSHOP: 14TH

JUNE 2017

Highlights in 2017: • Seeking clarity on regulatory guidance for

immunogenicity assays and clinical reporting • Harmonisation of data reporting methods

for closer prediction of clinical immunogenicity • Focus on unwanted immunogenicity of

immune-oncology drugs • Emerging solutions for reducing immunogenicity

including derisking antibodies and nanobodies

CHAIR: Oreda Boussadia, European Head of Business Development, EpiVax Inc.

FEATURED SPEAKERS: • Meenu Wadhwa, Section Leader, Cytokines and Growth

Factors, NIBSC, MHRA • Annie de Groot, CEO & CSO, EpiVax Inc. • Albert Torri, Executive Director, Bioanalytical Sciences,

Regeneron • John Smeraglia, Senior Director, Bioanalytical Sciences, UCB • Kei Kishimoto, Chief Scientifi c Offi cer, Selecta Biosciences • Katharine Bray-French, Toxicology Project Leader, Roche • Sofi e Pattijn, Chief Technology Offi cer, ImmunXperts • Matthias Hofmann, Senior Investigator, Novartis • Ivo Sonderegger, Project Manager, Boehringer Ingelheim • Rob Caldwell, Principal Research Scientist, Regulatory

Toxicology, AbbVie • Louis Boon, Chief Scientifi c Offi cer, Bioceros • Vibha Jawa, Director, Biologics and Vaccines Analytics,

Merck

Immunogenicity Day One | Monday 12th June 2017

08.30 Registration & Coffee

09.00 Chairman’s Opening Remarks Oreda Boussadia, European Head of Business Development,

EpiVax Inc.

STANDARDISING IMMUNOGENICITY METHODS

OPENING ADDRESS 09.10 The ABIRISK project : an integrated approach to assess predictive

markers of immunogenicity • ADA assays standardisation • Predictive tools • Biomarkers identifi cation • Integrative prediction Sophie Tourdot, Scientifi c Project Manager, INSERM

09.50 Reporting of clinically relevant immunogenicity data for low risk molecules

• Immunogenicity assays have become more sensitive and drug tolerant in recent years resulting in the detection of low titer, transient ADA responses which previously were not detected

• Low risk, fully human MAbs often generate mostly low titer, transient ADA responses which have little to no clinical relevance

• Reporting incidence of total ADA in these cases is not that informative since it may not be clinically relevant and does not guide practice

• Identifying and reporting the most clinically relevant ADA responses which are more likely to impact effi cacy or safety would be more informative to both patients and health care providers

Albert Torri, Executive Director, Bioanalytical Sciences, Regeneron

10.30 Morning Coffee

CASE STUDY 11.00 Cut point setting in the presence of pre-existing

anti-drug antibodies • Conventional methods for cut point (CP) setting may fail in

case a considerable number of sera used for method validation contain pre-existing anti-drug antibodies (ADA). This would result in an overestimation of the CP and thus underestimation in the number of ADA positive samples within the examined study population

• Separating ADA positive and negative samples already during method validation by modelling two (or more) overlaying populations and using only the ADA negative population for CP setting proved to be a viable method to tackle this challenge

• Details on and limitations of the method will be discussed, as well as several examples be presented

Matthias Hofmann, Senior Investigator, Novartis

REGULATORY CONSIDERATIONS FOR IMMUNOGENICITY TESTING

11.40 Perspectives on EU immunogenicity guidance and data reporting • Overview of revised EU guidance • Harmonising information on immunogenicity assays and clinical

reporting • Challenges with immunogenicity assessments for biosimilars Meenu Wadhwa, Section Leader, Cytokines and Growth factors,

NIBSC, MHRA

12.20 Networking Lunch

CASE STUDY

13.30 ADA-Dependent hypersensitivity reactions

in preclinical toxicology studies

• Prevalent adverse immunogenic responses observed during

preclinical toxicology studies resulting in regulatory challenges

for clinical trial progression

• Dedicated preclinical studies were conducted to further

characterize mechanism of adverse responses

• Results of these experiments will be presented, with the

outcome of regulatory acceptance and changes to

internal best practices for parenterally administered biologic

compounds will be discussed

Rob Caldwell, Principal Research Scientist, Regulatory Toxicology,

AbbVie

NOVEL APPROACHES TO IMMUNOGENICITY

CASE STUDY

14.10 Personalizing Biologic Therapy: In Silico Methods for Risk

Assessment

• A case study: ADA in Pompe patients

Annie de Groot, CEO & CSO, EpiVax Inc.

14.50 Afternoon Tea

CASE STUDY

15.20 Preclinical and early development of tolerogenic

nanoparticles to mitigate the formation of anti-drug

antibodies

• Novel and universal approach to mitigate immunogenicity of

biologic drugs

• Anti-specifi c immune tolerance

• Case study-clinical data for a combination product consisting

of tolerogenic nanoparticles with a pegylated uricase for the

treatment of chronic refractory gout

Kei Kishimoto, Chief Scientifi c Offi cer, Selecta Biosciences

16.00 Immunogenicity from basic immunology towards pragmatic

solutions

• Humanization and selection of lead humanized version

• Cell line and process development

• Functional ADA bioassays

Louis Boon, Chief Scientifi c Offi cer, Bioceros

16.40 Chairman’s Closing Remarks and Close of Day One

Supported by

Register online at www.immuno.co.uk

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi 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 specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conferences please call:

Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

Offi cial Publications

Immunogenicity Day Two | Tuesday 13th June 2017

08.30 Registration & Coffee

09.00 Chairman’s Opening Remarks Oreda Boussadia, European Head of Business Development,

EpiVax Inc.

DEVELOPMENTS FOR BIOLOGIC DRUGS AND IMMUNOGENICITY PREDICTIONS

KEYNOTE ADDRESS09.10 Immunogenicity prediction tools : how close are we to

predicting outcomes in clinic ? • Overview of available predictive tools for biologics • Layering of tools to increase accuracy of the clinical

outcome • Implementing a strategy in discovery phase to select better

candidates Vibha Jawa, Director, Biologics and Vaccines Analytics, Merck

09.50 Risk profi ling of biologic drugs • Bioanalytical assessment methods for increasing safety and

reliability of bio therapeutic drug products • Immunogenicity testing for multi domain biologic drugs;

adjusting testing strategy and John Smeraglia, Senior Director, Bioanalytical Sciences, UCB

10.30 Morning Coffee 11.00 Immunogenicity assessment of biosimilars • Presenting data from the humira biosimilars currently in

development at BI • To what extent can we control the immunogenic response? • Use and importance for the stability testing of wanted

immunogenicity Ivo Sonderegger, Project Manager, Boehringer Ingelheim

CASE STUDY11.40 Challenges of in vitro immunogenicity risk

assessment: case study of Nanobodies • Are all DCs the same? • Can the same construct give different immunogenicity risk

outcomes? • Is humanisation always wanted? Chloe Ackaert, Postdoctoral Researcher,

Free University of Brussels

12.20 Networking Lunch

EMERGING SOLUTIONS FOR REDUCING IMMUNOGENICITY

CASE STUDY 13.30 De-risking antibodies in early development • Application of in vitro early development • Case studies with clinical antibodies Katharine Bray-French, Toxicology Project Leader, Roche

14.10 Unwanted immunogenicity of Immuno-oncology drugs • Immune checkpoint-based immunotherapy has shown

remarkable clinical benefi ts in a variety of cancer diseases but these new treatment modalities can also induce an array of immune-related adverse effects such as induction of auto-immunity and anti-drug-antibody based anaphylaxis

• Early tools like in silico and in vitro immunogenicity assessment tests should be applied during the development phase in order to avoid any risk of unwanted immunogenicity

Sofi e Pattijn, Chief Technology Offi cer, ImmunXperts

14.50 Afternoon Tea

15.20 An integrated approach to managing immunogenicity risk and drug immune modulation

• Learn how data from cell-based assays, physical MHC-peptide binding assays and mass spectrometry antigen presentation assays can be integrated to characterize immune responses against, or caused by, bio therapeutic drugs

• Mitigate the risk of fi rst infusion reactions using whole-blood cytokine release assays.

• Improve decision-making in lead selection, lead characterisation and re-engineering options

Jeremy Fry, Director of Sales, ProImmune

PANEL DISCUSSION16.00 Human antibodies versus humanized antibodies

versus de-immunized antibodies Various strategies have been employed to reduce

immunogenicity of antibodies. While it is evident that also human antibodies (either derived from human libraries or from mice carrying a human Ig repertoire) are immunogenic, the question remains which other technologies are available such classical humanization or removing T-cell epitopes to minimise the potential immunogenicity. Pros and Cons will be discussed for either methods

• Immunogenicity of post-translational modifi cations - Infl uence of the production process on immunogenicity.

While it is known that glycosylation or chemical modifi cation (oxidation, deamidation, …) can alter immune response, what precautions need to be taken for the production process?

- Choice of host cell line for biosimilars. Some of the originators are being produced using Sp2/0 or NS0 as host cell lines that put non-human glycan on the molecules which may induce immunogenicity. Since productivity is low in these host cell lines some biosimilar companies switch to CHO as host cell line. These non-human glycans are not produced in CHO.

• Immune stimulatory antibodies versus immunosuppressive antibodies

Moderated by: Oreda Boussadia, European Head of Business Development, EpiVax Inc.

Sofi e Pattijn, Chief Technology Offi cer, ImmunXperts Louis Boon, Chief Scientifi c Offi cer, Bioceros Annie de Groot, CEO & CSO, EpiVax Inc.

16.50 Chairman’s Closing Remarks and Close of Day Two

Supported by

Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

MARKETING OPPORTUNITIESWant to know how you can get involved? Interested in promoting your services to this market?

Contact – Kyra Williams, SMi Marketing on +44 (0) 20 7827 6012 or email: kwilliams@smi-online.co.uk

Immunogenicity - from non-clinical detection to clinical impact

Leader: Melody Sauerborn, Freelance Consultant

HALF-DAY POST-CONFERENCE WORKSHOPWednesday 14th June 2017

08.30 – 12.30Holiday Inn Kensington Forum, London, UK

Overview of Workshop:This workshop will aim to give you an understanding of what immunogenicity is (from an immunological point of view) what factors play a role with a focus on formulation, short overview about assays - binding/neutralizing ADAs-, and we will discuss clinical impact of ADAs.

Why you should attend this workhshop:If you are interested in a broad picture of immunogenicity from non-clinical to clinical development of a drug, this is your workshop. It will guide you through many aspects of immunogenicity.

Programme:08.30 Registration & Coffee

09.00 Introduction: Basics of immunology and immunogenicity

09.20 Factors infl uencing immunogenicity - special focus manufacturing & formulation

09.45 Assays - from set up through validation and routine analysis

10.30 Morning Coffee

11.00 Non clinical aspects and the translation value to the clinics (in specifi c ‘prediction’ tools)

11.30 Clinical aspects (examples of failed biologics and the reasons behind them)

12.00 Discussion

12.30 Workshop leader’s comments and close of the workshop

About the Workshop Leader:Dr. Sauerborn spent most of her undergrad years in well-known institutes such as the Centers for Disease Control and Prevention in Atlanta to widen her knowledge in virology and immunology. After obtaining her PhD, where

she investigated the immunological aspects of antibody formation against aggregated protein therapeutics, she spent numerous years as a project leader, trainer and senior expert in immunogenicity and bioanalysis. In recent years, she was the head of non-clinical development at Mymetics, a viral vaccine company based in the Netherlands. Currently Dr. Sauerborn delivers training and consulting to numerous companies around Europe.

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 specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conferences please call:Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

SMi Pharmaceutical Forward Planner

MARCH

Superbugs & Superdrugs - A Focus on Antibacterials

20th - 21st March 2017, London, UK

Paediatric Clinical Trials20th - 21st March 2017, London, UK

Drug Discovery27th - 28th March 2017, London, UK

Asthma & COPD29th - 30th March 2017, London, UK

APRIL

Controlled Release3rd - 4th April 2017, London, UK

Adaptive Designs3rd - 4th April 2017, London, UK

Pre-Filled Syringes East Coast26th - 27th April 2017, Boston, USA

MAY

Pharmaceutical Freeze Drying Technology8th - 9th May 2017, London, UK

Orphan Drugs Europe15th - 16th May 2017, Berlin, Germany

Pharmaceutical Logistics18th - 19th May 2017, London, UK

Pain Therapeutics22nd - 23rd May 2017, London, UK

Highly Potent Active Pharmaceutical Ingredients22nd - 23rd May 2017, London, UK

JUNE

Pre-Filled Syringes West Coast5th - 6th June 2017, San Diego, USA

Microbiology USA8th - 9th June 2017, San Diego, USA

ADMET12th - 13th June 2017, London, UK

Immunogenicity12th - 13th June 2017, London, UK

Invitro Diagnostics14th - 15th June 2017, London, UK

BioBanking14th - 15th June 2017, London, UK

JULY

Allergies6th - 7th July 2017, London, UK

Peptides6th - 7th July 2017, London, UK

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IMMUNOGENICITYConference: Monday 12th & Tuesday 13th June 2017, Holiday Inn Kensington Forum, London, UK

Workshop: Wednesday 14th June 2017, London, UK

4 WAYS TO REGISTERwww.immuno.co.uk

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