biologics & biosimilars congress 2017

www.global-engage.com/event/biologics/ #GEBB17

6-7 March 2017BERLIN, GERMANY

BIOLOGICS & BIOSIMILARS

CONGRESS 2017

Examining Scientific, Technological & Business Trends to Advance Protein & Antibody Therapeutics

GLOBAL ENGAGE’S 3RD

WARM WELCOME

Thank you for your interest in the 3rd Global Engage Biologics and Biosimilars Congress, which will be held on March 6-7, 2017 in Berlin, Germany. Providing an opportunity to network with senior representatives of leading pharmaceutical and biotech companies, this well received event attracted 200 attendees in 2016.

Attracting industry, regulatory & academic experts working in all areas of protein, antibody & biosimilar research this two-day interactive meeting will explore a variety of topics across three streams. The first stream focuses on the latest innovations in antibody based therapeutics, leaders from the industry will be presenting updates on their strategy, pipeline and exciting candidates. The second stream includes presentations on expression, purification and characterisation, discussing issues around stability and half-life, as well as presenting novel cancer therapy approaches. The Biosimilars stream explores themes of similarity, regulation and public perception, alongside presentations on candidate generics in various stages of development. Executive panels and roundtables will foster discussion on the direction of the field, and the approaches required to ensure that the industry continues to flourish.

MARIE KOSCO-VILBOISChief Scientific Officer,

NovImmune SA

RALF SCHUMACHERGlobal Head of Bioprocess and Pharmaceuticals Development,

Boehringer Ingelheim

ANDREA HAWEChief Scientific Officer,

Coriolis Pharma

RICHARD GREGORYChief Scientific Officer,

ImmunoGen Inc

EXPERT SPEAKERS Include:

CONFERENCE SYNOPSIS

ANTIBODY BASED THERAPEUTICS

• Antibody discovery & optimization ▶ Monoclonal antibodies ▶ Recombinant antibodies

• Overcoming safety and risks • Antibody mixtures

PROTEIN BIOTHERAPEUTICS BIOSIMILARS

• Overcoming immunogenicity and aggregation issues

• Alternative scaffolds• Half-life extension• Fusion proteins

• Development Strategy, Market Access and Commercialization

▶ Developing a successful global biosimilars development strategy▶ Physician & patient attitudes▶ Strategies to successfully commercialize biosimilars products in Europe, USA and Emerging markets▶ Overcoming market access and commercialization barriers▶ Pricing & Reimbursement value▶ IP▶ Case Study examples

• Antibody-drug conjugates – development, potential & challenges

▶ Optimising ADC stability & potency▶ Optimizing payloads & linkers▶ Site specific ADCs▶ ADC design

• Protein Expression, Purification & Characterisation

▶ Examining different expression systems/technologies▶ Strategies to improve expression, purification, increase yields and enhance protein development▶ Difficult proteins▶ Characterization processes▶ HCP analysis▶ Cell line development

• Cancer Immunotherapy▶ T cell therapy ▶ Chimeric antigen receptors (CARS)▶ Immune Checkpoint Blockades▶ Bispecific antibodies

• Development Strategy, Market Access and Commercialization

▶ Current worldwide regulatory issues, updates & guidelines to obtain approval▶ Quality and CMC considerations for biosimilar development▶ Dealing with immunogenicity▶ Demonstrating biosimilarity ▶ Optimising biosimilar clinical trial design▶ Successful Biosimilar drug case study examples

EVENT SPONSORS

Gold Sponsors 2017

Silver Sponsors 2017

Exhibitors 2017

Examples of Attending Institutions 2017

BIOLOGICS & BIOSIMILARS CONGRESS 2017

Sponsors 2017

CONFIRMED SPEAKERS


RONALD HERBSTVice President of Oncology Research, MedImmune

RALF SCHUMACHERGlobal Head of Bioprocess and Pharmaceuticals Development, Boehringer Ingelheim

MARTIN STEEGMAIERHead of Discovery, Large Molecule Research, Roche

MARIE KOSCO-VILBOISChief Scientific Officer, NovImmune SA

NICOLAS POIRIERR&D Director, OSE Immunotherapeutics

SVETLANA SADEKOVAGroup Leader, Experimental Pathology, Merck Sharp & Dohme

HANS HENNING VON HORSTENProfessor, Industrial Biomanufacturing, HTW- Berlin University of Applied Sciences

JENS LOHRMANNSenior Global Programme Manager, Novartis

ANDREA HAWEChief Scientific Officer, Coriolis Pharma

LAURA LINSenior Director, Global BioTherepeutic Technologies, Pfizer

ARNE SKERRAProfessor, Technische Universitat, Munchen & Chief Scientific Officer XL Protein GmbH

ANDREAS PAHLChief Scientific Officer, Heidelberg Pharma Gmbh

SALVADOR VENTURAChair Professor of Biochemistry and Molecular Biology, Universitat Autonoma de Barcelona

JULIA NEUGEBAUERAssociate Director, Morphosys

MARINE RAMANPrincipal Scientist, Protein Science, Immunocore

PIETER FOKKO VAN LOODirector Translational Research, Merus N.V., The Netherlands

ANGELA NEUBAUERHead of Product Development, BIOMAY AG

MARTIN SIEGEMUNDUniversity of Stuttgart

JENS WUERTHNERAssistant Vice President, ADC Therapeutics

MARINA PAVLIDOUGroup Leader Selection Technologies, Pieris

LUKE MASTERSONChemistry Group Leader, Spirogen

GUNDO DIEDRICHAssociate Director, Macrogenics

PETR OBRDLIKFellow, Novartis

RICHARD GREGORYChief Scientific Officer, ImmunoGen Inc

ALEXANDER GOLOVANOVSenior Lecturer, Manchester Institute of Biotechnology and School of Chemistry, University of Manchester

LUIS BORLIDOLab Head, Physico-Chemical Characterisation, Sandoz

BART VAN DEN BEMTHead, Department of Pharmacy, Radboud University

BALAZS VEZERInternational Marketing Manager, EGIS Biologicals

ALEX KUDRINBiopharmaceutical Consultant

UWE GUDATHead of Safety, Biosimilars, Merck Serono

YELENA BISHARYANDirector of External Alliances, Tetragenetics

MIHRIBAN TUNAVice President Discovery, F-star

YUJI KASUYASenior Scientist, Kitasato Daiichi Sankyo Vaccine Co., Ltd, Japan

GRAHAM FOXONManaging Director, ReMAP Consulting

VOLKER SCHELLENBERGERPresident and CEO, Amunix

STEFFEN NOCKSenior Vice President (Global Biologics Head), Teva Pharmaceutical Industries

CONFIRMED SPEAKERS

MOURAD FAROUK REZKGlobal Head Medical Affairs, (Biosimilars) Biogen

JANKO BRAND Senior Scientist, Biotez

DAVID MEININGERPhD, MBA; Chief Business Officer, TRIANNI, Inc.

OLIVER HILLVP Molecular Biology, Apogenix

AUBIN MICHALONSenior Research Scientist, Project Leader Rare Diseases, Neurimmune

NATALIA MARKOVAPrincipal Scientist – MicroCal, Malvern Instruments

PAUL CALVODirector, Sterne, Kessler, Goldstein & Fox P.L.L.C.

GUIDO SEIDELManaging Director Operations, Wacker

GALAHAD DEPERALTA (Track Chair)Senior Scientist, Protein Analytical Chemistry, Genentech

JOACHIM KOCHProfessor, Goethe-University Frankfurt & Project Leader, Affimed GmbH

MATTHEW TURNERGlobal Medical Director, Merck Group

PEER HEINEField Applications Scientist, Europe, MaxCyte

KARL ANDERSONPhD, CEO, Ridgeview

PHILIPP HESSManaging Director, Philipp Hess Associates

STEFAN ARNOLDManaging Director, BPC Arnold GmbH BioPharma Consulting

ALEXANDER BAUMANNSenior Director, Screening & Profiling Services Region Europe, DiscoverX

DAVID PEARLMANDirector, Biologics Software Platform and Senior Scientist, Schrödinger GmbH

DAVID RABUKA (Track Chair)Global Head of R&D, Chemical Biology, Catalent Pharma Solutions

JOHN GUNNPh.D., Senior Research Scientist, Chemical Computing Group

MICHAEL BURNET(Track Chair)Managing Director, Synovo

ANA BARBAS(Track Chair)Coordinator of Bayer Satelite Laboratory at iBET, iBET and Bayer Portugal

JESSIE NIChief Scientific Officer, Irvine Scientific

ANDREAU SOLDEVILA(Track Chair)Founder and CEO, LeanBioPro

TOM PAYNEHead of Cell Engineering, Oxford Genetics

LEON SONGDirector of Biologics Development, GenScript Inc

RENE HOETHead Antibody Lead discovery, Bayer AG

MARK SPENGLERDirector Project Management; Chimera Biotec

JIN-SAN YOOPresident & CEO, PharmAbcine, Inc

TANVIR TABISHHead of Drug Product Development for Gene Therapy and Coagulation Factors, Shire

ANDREW WILLIAMSPartner, McDonnell Boehnen Hulbert & Berghoff LLP

SAM HEYWOOD(Track Chair)Senior Group Leader, Protein Science, UCB

AHUVA NISSIMReader in Antibody and Therapeutic Engineering, Barts and The London, Queen Mary's School of Medicine and Dentistry

ZHINAN XIA(Track Chair)Head of Biotherapeutics, Moderna Therapeutics

MATTHEW BENTLEYScientific Director, Eurofins Bioanalytical Services

KEYNOTE ADDRESS:RONALD HERBSTVice President of Oncology Research, MedImmuneImmunotherapy for Cancer: Beyond Checkpoint InhibitionImmune-evasion is a hallmarks of cancer and enhancement of the anti-cancer immune response by targeting checkpoint pathways, such as CTLA-4 and PD-1/PD-L1, with

monoclonal antibodies are showing significant promise. Combinations of checkpoint therapies have already increased response rates in certain indications. However, a significant subset of patients still fails to benefit from current immune therapies. Going forward it will be key to better understand the immunologic diversity within and across indications, and to develop new combination therapies, based on science, to broaden and deepen the response of cancer patients to immunotherapy.

CONGRESS SCHEDULE DAY 1 MONDAY 6TH MARCH 2017

Registration & Refreshments09

:00-

09:3

5

KEYNOTE ADDRESS: RALF SCHUMACHERGlobal Head of Bioprocess and Pharmaceuticals Development, Boehringer IngelheimManufacturing/development of innovative biologics – obstacles and opportunities • Biologics are complex in nature – therefore translating discovery knowledge in process design and establishment of platforms are key. • Manufacturing of biologics requires a robust and complex production process, modifications of the process may have significant impact on potency and safety - constant technology upgrading and gated development paradigms are key pillars.• The manufacturing process has to be carefully validated and controlled to ensure consistent quality – however, tailored for the respective phase of development.

08:00-08:55

08:55-09:00 Global Engage Welcome Address & Opening Track Chair’s Remarks: Ana Barbas Coordinator of Bayer Satellite Laboratory at iBET

BIOLOGICS CONGRESS BIOSIMILARS CONGRESS

09:3

5-10

:10

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:10


TRACK CHAIR:GALAHAD DEPERALTASenior Scientist, Protein Analytical Chemistry, Genentech

ANTIBODY BASED THERAPEUTICS PROTEIN EXPRESSION, PURIFICATION & CHARACTERISATION BIOSIMILARS CONGRESS

TRACK CHAIR:ANA BARBASCoordinator of Bayer Satellite Laboratory at iBET, iBET and Bayer Portugal

TRACK CHAIR:ANDREAU SOLDEVILAFounder and CEO, LeanBioPro

LUIS BORLIDOLab Head, Physico-Chemical Characterisation, SandozGP2015 (Erelzi™) – Structure-Function relationship as a cornerstone for biosimilarity assessment In August 2016, the Food and Drug Administration (FDA) approved Sandoz’s Erelzi™ as a biosimilar to the reference product Enbrel® (etanercept) in the United States. This talk

highlights the importance of establishing and in-depth knowledge of the structure-function relationship for a successful biosimilarity assessment. Furthermore, it presents the challenges created from the manufacturing changes of the reference product in the statistical assessment.

Royal 2&3

Royal 1 R4 & R5

Royal 1 R1 & R2 R4 & R5

SOLUTION PROVIDER PRESENTATION:ALEXANDER BAUMANNSenior Director, Screening & Profiling Services Region Europe, DiscoverXHarnessing the Complexity of the

Human Tumor Microenvironment to Guide Decisions in Discovery and Combinations• How do I identify a functionally active lead molecule? • How can I determine the efficacy of my drug in a human tumor

microenvironment? • Is my drug safe for the patient outside the cancer context? • Are my drug combinations active, safe, and different?


ANTIBODY BASED THERAPEUTICS PROTEIN EXPRESSION, PURIFICATION & CHARACTERISATION BIOSIMILARS CONGRESS

11:4

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MARTIN STEEGMAIERHead of Discovery, Large Molecule Research, RocheFrom format to function – Transformative antibody therapeutics at Roche • The CrossMAb technology has proven to

be very versatile, allowing the generation of various bispecific antibody formats ranging from heterodimeric/asymmetric bivalent 1+1 CrossMAbs to more complex tri- (2+1), tetravalent (2+2) bispecific and multispecific antibody formats.

• These diverse formats provide great opportunity to tackle novel biology and to convey novel mode of actions.

• Examples given will include new bispecific molecules for cancer immunotherapy, ophthalmology indications and the use of novel targeting approaches to treat neurological disorders.

11:4

0-12

:05

HANS HENNING VON HORSTENProfessor, Industrial Biomanufacturing, HTW- Berlin University of Applied SciencesDesigning affinity ligands for downstream process intensificationBiomanufacturing processes generate ever higher

product titers in shorter periods of time. In order to fully utilize these dramatic increases in upstream efficiency and productivity, it is essential that downstream production turnover is accelerated and adjusted to this progress. This process intensification is addressed by providing chromatography resins with higher capacity, in-line buffer preparation as well as by continuous automated column operation and directly connected steps without hold time. This increasing need for process intensification requires affinity ligands that allow for higher resin capacities and show a stronger suitability for continuous automated operation. Here we present the development of technologies and strategies for improved affinity capture in an intensified downstream process setting.

11:4

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MOURAD FAROUK REZKGlobal Head Medical Affairs, (Biosimilars) BiogenBiosimilars development….From preclinical to clinical...what matters most for Biosimilars developers (TBC)• How do we design the right clinical

development programme for biosimilars?• How do we maximise uptake of biosimilars? • How do we create trust and build confidence among patients and

physicians?As the market for biosimilar products in Europe continues to grow, many biopharmaceutical companies are competing to enter this space. They, however, can struggle to overcome the unique challenges that developing such products presents. From navigating the complex global regulatory landscapes to ensuring optimal access, the road for biosimilar development is riddled with challenges.


12:0

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OLIVER HILLVP Molecular Biology, ApogenixHexavalent single-chain GITRL-Fc fusion proteins: Engineering concept and initial characterization Based on the Apogenix HERA technology

platform, we have created three variants of a fully human hexavalent GITRL-Fc fusion protein intended for T-cell costimulatory approaches in cancer immunotherapy. Minor modifications led to three drug candidates with unique pharmacokinetic properties as explored in mice. We will present the molecular engineering concept and the current results obtained.

12:0

5-12

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AUBIN MICHALONSenior Research Scientist, Project Leader Rare Diseases, NeurimmuneConformation-specific antibodies for the treatment of amyloid diseases• Amyloid formation and efficacy of

immunotherapies for the removal of amyloid plaques in patients• Transthyretin amyloidosis is causing cardiomyopathy and

polyneuropathy• Conformation specific antibody against transthyretin amyloid is

triggering remediation of cardiac amyloid

ALEX KUDRINBiopharmaceutical ConsultantGlobal perspectives on evolution of the biosimilars market• The presentation will focus on brief overview of the current regulatory status and imminent

developments in regulated territories• Regulatory and development challenges for biosimilars• Future prospects and areas of growth

10:10

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SOLUTION PROVIDER PRESENTATION:TOM PAYNEHead of Cell Engineering, Oxford GeneticsOptimised vector systems and bioinformatic services to support

biologics discovery and development applications Oxford Genetics has utilised its proprietary SnapFast vector technology and DNA design algorithms to develop best-in-class vector systems to support biologics discovery and development. These are now being applied in transient and stable contexts and show significant benefits over current industry standards, especially in the case of difficult-to-express and multimeric proteins. These systems, along with bioinformatic tools for antibody reformatting and humanisation, enable integrated offerings, from gene design through to cGMP-compliant stable cell line development and scale-up.

15 MINUTE SOLUTION PROVIDER PRESENTATION:MATTHEW BENTLEYScientific Director, Eurofins Bioanalytical ServicesOptimised vector systems and bioinformatic servicesCharacterisation of mAb Biosimilars by SPR – An evolution

• Orientation of mAb Characterisation within the regulatory framework • Overview of SPR technology• Early work with Alemtuzumab, proof of principle data and

comparison with functional ADCC assay• A summary of the qualification of assays for the binding to mAbs to

Fcy receptors• How advances in SPR platform technology has facilitated rapid

kinetic rate constant determinations

Morning Refreshments / Poster Presentation Sessions / One to One Partnering Meetings10:40-11:40 Royal 2&3



12:3

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:45

12:3

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:00

SOLUTION PROVIDER PRESENTATION:NATALIA MARKOVAPrincipal Scientist – MicroCal, Malvern InstrumentsTurning up the heat on protein stability characterization – Differential Scanning Calorimetry for the regulated environmentThere is an ever-widening range of biophysical assays which play important roles

in biopharmaceutical development, but using Differential Scanning Calorimetry (DSC) to characterize thermal stability gives reliable and reproducible gold standard data throughout the development pipeline.

Due to its versatile nature, DSC finds multiple uses in stability profiling, formulation development, manufacturing support, and biopharmaceutical comparability and biosimilarity analysis. Protein HOS characterization is also becoming expected in regulatory submissions for new biopharmaceutical drugs and biosimilars.

This presentation will introduce PEAQ-DSC, a new generation of MicroCal DSC systems designed for biopharmaceutical and core labs, and will detail some case study examples of the use of MicroCal DSC in formulation development and biosimilarity and biocomparability analysis applications.

15 MINUTE SOLUTION PROVIDER PRESENTATION:JANKO BRANDSenior Scientist, BiotezImproved dose decision with comprehensive diagnostics data Therapeutic Drug Monitoring (TDM) has become increasingly important to reduce inefficient therapy outcomes in patients treated with biologicals. Since TDM is well

established, increasing numbers of TDM standard test become available. Still the quantification of the disease causing, free Antigen remains underrepresented. To ensure an effective biological therapy, a reliable Therapeutic Antigen Monitoring (TAM) is of great importance.

With the recoveryELISA© technology we combine TDM and TAM, resulting in a holistic view of the drug/antigen interplay in the patient during therapy, allowing a precise drug dose adjustment.

With the results of a recent clinical study on Rheumatoid Arthritis patients treated with adalimumab, we could demonstrate the potential of the recoveryELISA© technology as diagnostic tool, to improve dose decision during TNFa-inhibiting therapy.

The presentation will continue with case studies for Infliximab/TNFa, Omalizumab/IgE, Alirocumab/PCSK9, Evocolcumab/PCSK9, ongoing customized developments and will end with an outlook of future projects.

14:0

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50 MINUTE EXECUTIVE PANEL DISCUSSION:Developing Antibody based therapeuticsFeaturing senior executives from a number of prominent organisations, drawing on the experience and insights of leaders within the field, this panel will discuss the challenges and promise of antibody based therapeutics.

CHAIR:TANVIR TABISHHead of Drug Product Development for Gene Therapy and Coagulation Factors, Shire

PANELLIST:STEFFEN NOCKSenior Vice President (Global Biologics Head), Teva Pharmaceutical Industries

14:0

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ANDREA HAWEChief Scientific Officer, Coriolis PharmaImpact of nanoparticle impurities from sugar excipients on monoclonal antibody stabilityPharmaceutical grade sugars (e.g. sucrose)

compose particulate impurities that pose an analytical challenge and may compromise the stability, safety and efficacy of protein pharmaceuticals. The nature of nanoparticulate impurities in commonly used sucrose was elucidated by FTIR microscopy, SEM-EDX, fluorescence spectroscopy and mass spectrometry. Within the talk recent data proofing a destabilizing effect of these impurities on the stability of four monoclonal antibodies with respect to aggregation, particle formation and fragmentation will be shown.

14:0

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BALAZS VEZERInternational Marketing Manager EGIS BiologicalsBiosimilar mAb awareness – Communication challengesWhile biopharmaceutical medicines have been available for more than 30 years, many type of

biosimilars gained European approvals in the last 10 years.

The Celltrion developed biosimilar infliximab (Remsima) become the first EMA approved mAb biosimilar in 2013. The complex structured monoclonal antibody biosimilar have faced new concerns on the market. The chance of their acceptance and success are depend of an effective communication strategy.

Based on real life experience of Remsima launch in Egis region I will summarize the communication strategy development in main topics as:• Biosimilars development paradigm• Biologicals variability and related regulatory authority experience of

their variability• Indication extrapolation• Interchangeability

TRACK CHAIR:SAM HEYWOODSenior Group Leader, Protein Science, UCB

TRACK CHAIR:ZHINAN XIAHead of Biotherapeutics, Moderna Therapeutics

Lunch / One to One Partnering Meetings13:00-14:00 Royal 2&3

CONGRESS SCHEDULE


14:0

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MOURAD FAROUK REZKGlobal Head Medical Affairs, (Biosimilars) Biogen


RENE HOETHead Antibody Lead discovery, Bayer AG

JIN-SAN YOOPresident & CEO, PharmAbcine, Inc

BART VAN DEN BEMTHead, Department of Pharmacy, Radboud UniversitySwitching from originator to biosimilar drugs in clinical practice; lessons learnedIn the Sint Maartenskliniek (the Netherlands)

we switched more than 1000 patients from originator infliximab/etanercept to their biosimilar equivalents. During this process we learned how to successfully realize these transitions with maximal patient involvement. In this lecture we will discuss five major themes with respect to optimal switching: (1) patient communication, (2) health care provider communication, (3) how to act when patients have less effect/(subjective) adverse events, (4) logistics and (5) project organization. Lessons from clinical practice will be shared with the audience.

14:2

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LAURA LINSenior Director, BioMedicine Design, Pfizer Worldwide Research & DevelopmentEarly Stage Developability Assessment to Guide the Design and Optimization of High Quality Antibody Leads

The presentation will describe an early stage developability platform we established in-house to rank, select, and optimize antibody leads in early discovery at Pfizer. I will be discussing our strategies of early screening for optimal physicochemical properties and platform process assessment for projects, sharing several case studies highlighting the impact of such assessment on antibody optimization strategies, and predictability of early screens on efficacy, PK, and manufacturability. 14

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DAY 1 MONDAY 6TH MARCH 2017

14:5

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:15ARNE SKERRAProfessor, Technische Universitat, Munchen & Chief Scientific Officer XL Protein GmbHPASylation®: the biological alternative to PEGylation for plasma half-life extension and beyond

Fusion of proteins or peptides with conformationally disordered polypeptides comprising the L-amino acids Pro, Ala, and/or Ser (PAS) is a beneficial way to enlarge the hydrodynamic volume and retard kidney clearance, a common drawback in biological drug development. PAS sequences are strongly hydrophilic, yet uncharged biological polymers with biophysical properties surprisingly similar to PEG though, in contrast, they allow traceless metabolization. Besides chemical coupling, PAS polypeptides offer simple attachment to a biological drug at the genetic level and they can serve as convenient spacers for the design of bispecific fusion proteins. PASylation has been successfully applied to a series of biopharmaceuticals, including interferon, leptin, enzymes, lipocalins and Fab fragments, yielding several drug candidates currently on the route towards clinical study.

14:5

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SVETLANA SADEKOVAGroup Leader, Experimental Pathology, Merck Sharp & DohmeCharacterization of MK-4166, an agonistic mAb that targets human GITRGITR, a member of the TNFR superfamily,

provides co-stimulatory signals to T cells leading to enhanced cellular and humoral immunity. To explore the potential utility of GITR agonists in cancer immunotherapy, we developed MK-4166, a humanized agonist monoclonal antibody against human GITR. Since very little is known about the function of human GITR compared to its mouse ortholog, we focused on characterizing the expression of GITR in human tumors and blood and used MK-4166 to investigate the potential role of GITR agonism in human anti-tumor immune responses. GITR expression and ex vivo functional activity of MK-4166 which is currently being evaluated in a Phase 1 clinical trial will be discussed.

UWE GUDATHead of Safety, Biosimilars, Merck SeronoBiosimilars: What’s in it for me (WIIFM)• Patients: Hopes and fears• Providers: Expectations and concerns• Payers: Value and price

The promise of biosimilars is comparable value (in terms of clinical performance) at a lower price. Value and cost are distributed over three different stakeholder communities. Broad acceptance of biosimilars in the different geographic locations and varying health care systems requires that the perspectives of these communities is appreciated and respected. We must learn from one another: Biosimilar manufacturers must educate as to the merits of the opportunity, and listen to understand the barriers to uptake and adoption.


15:15

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SOLUTION PROVIDER PRESENTATION: KARL ANDERSSONPhD, CEO, RidgeviewTime-resolved interaction analysis on living cells: Comprehensive data generates new knowledge and better decisions• Enabling precise interaction analysis of biologicals and bispecifics interacting with cell-surface receptors on living cells with LigandTracer

• Using detailed binding data to decipher underlying biology and support mode of action determinations

• Selecting binders based on clear and highly repeatable binding characteristics obtained relevant, cell-based environment

SOLUTION PROVIDER PRESENTATION:PEER HEINEField Applications Scientist, Europe, MaxCyteAccelerating the Development of Protein Therapeutics with MaxCyte’s Scalable, Electroporation-based Transfection TechnologyProtein-based therapeutics have emerged in recent years as the most promising

class of drugs for treating a range of cancers and other diseases. The need to move a rapidly growing number of biologic moieties through clinical pipelines has, in turn, created a demand for robust screening and manufacturing tools. We will present data on the benefits of MaxCyte’s GMP-compliant, scalable electroporation technology for producing monoclonal antibodies, bispecifics, and vaccines. Specifically, we will show how milligram to gram quantities of protein can be generated in less than two weeks via transient expression in cells relevant to bioproduction, including multiple CHO cell lines, while maintaining protein quality and functionality. We’ll also demonstrate how the high levels of transfection efficiency and viability (both typically >95%) provided by MaxCyte electroporation allow streamlined production of stable pools and clones. Finally, we will present data on the rapid production of more complex products, such as viral vectors, VLPs and cellular therapeutics.


16:3

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SALVADOR VENTURAChair Professor of Biochemistry and Molecular Biology, Universitat Autonoma de BarcelonaDesigning protein soluabilityOne of the major challenges that one should face during the development of protein-based

biopharmaceuticals is their inherent propensity to aggregate. Indeed, protein therapeutic agents are both stored and typically administered at very high concentrations. Under these conditions they can easily aggregate, impacting the product's developability, stability, formulation, and immunogenicity. I will discuss how computationally-assisted design of protein structures solubility is helping us to overcome these limitations.

16:3

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PAUL CALVO Director, Sterne, Kessler, Goldstein & Fox P.L.L.C.An Update on IP Issues for Biosimilars (TBC)

JENS LOHRMANNSenior Global Programme Manager, NovartisDelivering consistent, stable ADCs presents drug developers with unique challenges. Besides technical hurdles, a key decisions is to “buy or make” these highly active compounds.

Leveraging the know-how of CMOs can be very powerful, however to ensure an effective relationship, communication aspects are key and will be discussed. Technical challenges of site-transfers, especially with concomitant scale-up are to be expected. Case studies will be presented to discuss impact of conjugation process on key product quality attributes, as well as lessons learned from analytical transfers.

Afternoon Refreshments / One to One Partnering Meetings / Poster Presentation Sessions15:45-16:35 Royal 2&3

CONGRESS SCHEDULE



SOLUTION PROVIDER PRESENTATION:GUIDO SEIDELManaging Director Operations, WackerNew solutions for production of difficult-to-express proteinsWacker Biotech will present highly competitive solutions for production of difficult-to-express proteins based on its proprietary E. coli expression systems ESETEC® and

FOLDTEC®. Recent case studies will include secretion of functional antibody fragments and enzymes to the fermentation broth with up to 14 g/L. Together with its E. coli refolding platform FOLDTEC®, Wacker Biotech offers a novel and comprehensive approach to rapidly assess manufacturability of therapeutic proteins.

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SOLUTION PROVIDER PRESENTATION:DAVID MEININGERPhD, MBA; Chief Business Officer, TRIANNI, Inc. The Trianni Mouse: Best-In-Class Technology for Human Antibody DiscoveryThe Trianni Mouse is the only human transgenic antibody discovery platform offering a complete heavy, kappa and lambda repertoire in a single organism. Sequences of the variable domain exons are human while all genetic machinery including extensively optimized promoters and enhancers are of mouse origin. Titers and class switching are

extremely robust making for highly efficient lead generation. This next-generation technology is seen as best-in-class by multiple Big Pharma and other licensees subsequent to extensive validation and benchmarking. Additional strains in development include Plasma Ig, Autoimmune/All Epitope and a "true" Bispecific.

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JULIA NEUGEBAUERAssociate Director, MorphoSysAntibodies targeting peptide/HLA complexes for cancer therapyTumor-specific peptide/HLA complexes make intracellular targets accessible to antibodies.

However, the generation of therapeutic antibodies, which recognize a particular peptide/HLA complex specifically, is highly challenging. By identifying and applying appropriate counter-targets we generated fully human, high affinity antibodies against a WT1 peptide/HLA complex. These antibodies bind to target-positive cancer cell lines and outperform similar state-of-the-art antibodies regarding target specificity and binding affinity.

17:3

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50 MINUTE EXECUTIVE PANEL DISCUSSION: Overcoming Barriers to Global Biosimilar Adoption

CHAIR:ALEX KUDRINBiopharmaceutical Consultant

PANELLISTS:GRAHAM FOXONManaging Director, ReMAP Consulting

STEFAN ARNOLDManaging Director, BPC Arnold GmbH BioPharma Consulting

MATTHEW TURNERGlobal Medical Director, Merck Group

UWE GUDATHead of Safety, Biosimilars, Merck Serono

ALEXANDER GOLOVANOVSenior Lecturer (Associate Professor) and Principal Investigator, Manchester Institute of Biotechnology and School of Chemistry, University of Manchester, UKApplication of solution NMR spectroscopy for characterizing mAb formulations

Assessing how excipients affect self-association of monoclonal antibodies (mAbs) requires informative and direct in situ measurements which work for highly concentrated solutions. In our study we assessed a number of parameters which can be derived from solution NMR experiments and show that some of them can be used as a very sensitive measure for transient protein association in different formulations. Excipients, such as arginine glutamate, can have a significant effect on reducing transient interactions evident even for most soluble mAbs present at large concentrations. We discuss the application of NMR spectroscopy as an emerging tool providing useful complementary information for formulation development of mAbs and other therapeutic proteins.

CONGRESS SCHEDULE



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MARTIN SIEGEMUNDUniversity of StuttgartFusion proteins with hexavalent TRAIL assembly for cancer therapyWe developed single-chain formats of TNF-related apoptosis inducing ligand (scTRAIL) as components in tumor-associated antigen-targeted as well as non-targeted fusion proteins with hexavalent TRAIL assembly for cancer therapy, combining enhanced

tumor specific activation of death receptors DR4 and DR5 with a good safety profile. Different protein arrangements were used to combine scTRAIL dimerization with for instance EGFR targeting. Using engineered scTRAIL molecules with improved thermal stability, we generated i.a. a new generation of EGFR-targeted diabody-scTRAIL fusion proteins characterized by an improved protein stability and composition and a high bioactivity in vitro as well as in mouse xenograft experiments.18

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MIHRIBAN TUNAVice President Discovery, F-starThe use of bispecific antibodies to modulate anti-tumour immune responsesCombining immunotherapeutic antibodies for treatment of cancer patients has shown benefits over single agent treatment. An alternative to combining two antibodies is the development of bispecific antibodies that not only bring two biologies together but may result in novel mechanisms of action that are impossible to attain with combinations.

A murine-specific anti-LAG-3 and PD-L1 bispecific antibody was engineered which binds both antigens simultaneously and with nanomolar affinities. The anti-LAG-3/PD-L1 bispecific antibody inhibits LAG-3 binding to MHCII and PD-L1 binding to PD-1 and CD80, resulting in T cell activation in an in vitro assay. This potency translates into in vivo efficacy, where the anti-LAG-3/PD-L1 bispecific antibody decreased tumour burden in the MC38 colon carcinoma tumour model, both in early-established or well-established tumours. At the end of the study tumour-free animals were more numerous in the LAG-3/PD-L1 bispecific group than in the group given a combination of individual anti-LAG-3 and PD-L1 antibodies. The results were recapitulated in the CT26 murine colon cancer model, where the LAG-3/PD-L1 bispecific showed an increase of anti-tumour activity as compared to the combination of anti-LAG-3 and anti-PD-L1 antibodies. Thus, the preclinical data supports developing an anti-human LAG-3/PD-L1 bispecific for the treatment of cancer patients.

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PIETER FOKKO VAN LOODirector Translational Research, Merus N.V., The NetherlandsMCLA-117, a CLEC12AXCD3 bispecific IGG targeting a leukemic stem cell antigen, induces t cell mediated AML blast lysis

Patients with acute myeloid leukemia (AML) have a dismal prognosis despite improvements in chemotherapy and supportive care. We have developed MCLA-117, a CLEC12AxCD3 bispecific human IgG1 antibody for treatment of AML. CLEC12A is expressed on 90-95% of AMLs, both on AML blast and their leukemic progenitors but not on normal early hematopoietic progenitors. MCLA-117 efficiently induced CLEC12A-mediated lysis of AML blasts (31-99%) in primary AML samples by autologous T cells, even at very low E:T ratios (E:T 1:3–1:97). Furthermore, MCLA-117 provoked robust T cell proliferation (7-226-fold). Based on its binding profile within the hematopoietic compartment, MCLA-117 is expected to specifically target blasts and leukemic stem cells while sparing the normal stem cells. A phase I clinical study is ongoing to evaluate the preliminary safety and efficacy of MCLA-117 in adult AML patients.

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PETR OBRDLIKFellow, NovartisAutomated generic direct binding ELISA for potency measurementsSelection of an appropriate potency bioassay depends on the mode of action as well as other

properties of the bio-therapeutic drug. If applicable, direct target-binding ELISA is often a preferred potency assay for pre-clinical and early clinical trials because of its low variability, easy execution and convenient lab infrastructure. Nevertheless, the establishment of such potency ELISA still requires target-specific development and drug-specific method qualification. To simplify the process, we first established a manual, generic direct binding ELISA method for measuring potency of process development samples as well as for quality control. In the meantime, this manual ELISA assay is successfully used for several drugs in pre-clinical and clinical trials. As the next step, the method protocol was adapted to allow for fully automated sample preparation, assay execution and potency measurement. In this presentation, we describe the critical protocol parameters and changes which had to be taken to achieve this goal.

Networking Drinks Reception18:45-19:45 Royal 2&3

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CONTINUED

CONGRESS SCHEDULE


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KEYNOTE ADDRESS: MARIE KOSCO-VILBOISChief Scientific Officer, NovImmune SAFoiling tumor microenvironments by unleashing phagocytes• Phagocytes, of which the prototype is a macrophage but also encompasses dendritic cells and fibroblasts, play an important role in host homeostasis and defense• Cancer cells have evolved mechanisms to suppress the anti-tumor role of phagocytes

• Targeting CD47, the ubiquitous ‘don’t eat me signal’, reinstates healthy phagocyte function, as tumor killers and scavengers as well as in activation of anti-tumor T cells through antigen presentation

• Using bispecific antibodies to localize blocking CD47 to the tumor microenvironment, our therapeutic approach offers significant pharmacological and safety advantages to patients

• Launch of the first clinical program

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KEYNOTE ADDRESS:NICOLAS POIRIERR&D Director, OSE ImmunotherapeuticsEffi-DEM: a new generation checkpoint inhibitor which blocks pro-tumors and suppressor myeloid cells in the tumor microenvironmentThe formation of an immunosuppressive tumor environment is regularly observed in

cancer progression and involves several type of suppressor cells. Regulator T lymphocytes (Treg) exert a suppressor activity and the first generation of checkpoint inhibitors (CTLA-4, PD-1 and PDL-1).act on these regulator T cells. Beyond Tregs, Myeloid-Derived Suppressor Cells (MDSC) inhibits effector T lymphocyte functions. In parallel, Tumor Associated Macrophages (TAM) with suppressor and pro-tumoral functions accumulate locally and allow tumor growth and metastasis. A second generation of checkpoint inhibitors could therefore be developed, acting on these new suppressor myeloid cells. Effi-DEM is an antagonist monoclonal antibody of SIRP alpha, a novel immune checkpoint strongly expressed by myeloid suppressor cells. It restores effector functions of these suppressor cells. It demonstrated also preclinical efficacy in combination with other immunotherapies, in particular with checkpoint inhibitors acting on T lymphocytes.

DAY 2 TUESDAY 7TH MARCH 2017

ROUNDTABLE 1:GRAHAM FOXONManaging Director, ReMAP ConsultingThe balance between optimising the price of your biosimilar and securing patient access• What is the optimum list price for a biosimilar?• How much of a discount is required to secure patient access at a local level?• What are the payer evidence requirements to secure patient access at a national and local level?

ROUNDTABLE 2:ANDREW WILLIAMSPartner, McDonnell Boehnen Hulbert & Berghoff LLPStrategies for Addressing Intellectual Property Barriers to Biosimilar Marketing• Biosimilar intellectual-property concerns vary between Europe, the United States, and elsewhere. What factors should be considered in these different jurisdictions before

deciding to either launch at risk or wait until the expiration of patent protection?• When should the development of a biosimilar drug product be influenced by the patents that protect it,

for example with regard to changing the formulation or altering the manufacturing process?When should a primary or secondary patent be challenged in an opposition proceeding before the European Patent Office (EPO) or an IPR or PGR before the U.S. Patent Trial and Appeal Board (PTAB), and when should the patent challenge be reserved for litigation?

ROUNDTABLE 3:ALEX KUDRINBiopharmaceutical ConsultantOvercoming Barriers to Biosimilar Adoption• Monoclonal antibody biosimilar autoimmune and oncology markets will become fiercely competitive in next two years especially in EU. How sponsors will overcome challenges of the crowded market and sustain their presence?

• Discuss different factors and strategies that can assist biosimilar adoption over and above pricing reductions.• Biosimilar adoption in the world: do we have consistent pattern?

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TRACK CHAIR:MICHAEL BURNETManaging Director, Synovo

Refreshments08:30-09:00 Royal 2&3

BIOLOGICS CONGRESS BIOSIMILARS CONGRESS

Royal 1 R4 & R5

SOLUTION PROVIDER PRESENTATION: PATRICK ROBERTSON Director, Program Design at FUJIFILM Diosynth Biotechnologies Overcome Challenges to Manufacture of Biosimilars through Media/Feed Screening and Cell Culture Process OptimizationIn the biosimilar journey of drug development through regulatory approval, the

product quality attributes of the biosimilar protein must compare within defined limits to those of the innovator product. Unlike small molecule drugs, whose structure can usually be completely defined and entirely reproduced, biologicals are typically more complex and are almost unlikely to be shown to be structurally identical to an innovator product. Therefore, biosimilarity is generally demonstrated as having matched product quality attributes, comparable in-vitro biological activity, and no clinically meaningful differences between the biosimilar drug and innovator product.

The complexity of recombinant protein manufacturing processes, including expression systems (i.e. host cell line, expression vector, cell line development process), cell culture process conditions and related nutrient systems, such as cell culture media and feeds, present significant challenges to achieve the required product quality for biosimilars. To address these challenges, Fujifilm Diosynth Biotechnologies (FDB) has developed a systematic approach of combining media toolbox methodology and bioprocess “know-how” to screen and optimize manufacturing conditions that promote the desired product quality profiles of recombinant proteins. Case studies will be presented to highlight the efficacy of this approach and successful implementation in manufacture of biosimilar recombinant monoclonal antibodies.

CONGRESS SCHEDULE DAY 2 TUESDAY 7TH MARCH 2017

RICHARD GREGORYChief Scientific Officer and Executive Vice President, ImmunoGen IncOptimizing the therapeutic Index of Antibody-Drug Conjugates• Challenges of ADC Development• Optimizing Linker/Payload Design• A Look Towards the Future11

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JOACHIM KOCHProfessor, Goethe-University Frankfurt & Project Leader, Affimed GmbHNext-generation immune cell engagers for tumor-targeting of innate immunity • Affimed develops tetravalent, bispecific immuno-engagers for tumor-targeting of T-cells and NK-cells based on proprietary scaffolds and engager domains.• Potency and efficacy of several immuno-engagers are currently being evaluated in

clinical mono and combination trials.• Recent developments from our NK-cell engager platform demonstrating superior efficacy over conventional

Fc-based approaches will be presented.

CANCER IMMUNOTHERAPY ANTIBODY-DRUG CONJUGATES


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TRACK CHAIR:DAVID RABUKAGlobal Head of R&D, Chemical Biology, Catalent Pharma Solutions

TRACK CHAIR:MICHAEL BURNETManaging Director, Synovo

SOLUTION PROVIDER PRESENTATION:MARK SPENGLERDirector Project Management; Chimera BiotecBioanalytical PK Support for Immunotherapeutics: The Need for Sensitivity combined with broad Assay Range – Case StudiesImmunotherapeutic concepts play an increasingly important role in modern drug

development. However, the therapeutic dosing regime of immunotherapeutics may vary significantly from fairly low to rather high dosing, depending on safety, binding targets, potency, clearance rate, physiological effects and other considerations. Hence, for optimal trial support, not merely sensitivity but likewise expansive assay range of the supporting method is key. Still, most ligand-binding assay (LBA) technologies either lack sufficient sensitivity or have considerable restrains in continuous dynamic range. Here we present state-of-the-art bioanalytical approaches to overcome these limitations in GxP regulated study support, discussing several case studies from the development of immunotherapeutic compounds. Related aspects, e.g. LBA support of studies with limited sample volume availability, as e.g. typical in Ophthalmology are discussed as well.

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SOLUTION PROVIDER PRESENTATION:LEON SONGDirector of Biologics Development, GenScript IncAccelerate Your Antibody Drug Discovery & DevelopmentGenScript is the leading gene, peptide, protein and antibody research partner for fundamental life science research, translational biomedical research, and early stage

pharmaceutical development. Since our establishment in 2002, GenScript has exponentially grown to become a global leading biotech company that provides life sciences services and products to scientists over 100 countries worldwide. During our tenure we have built a comprehensive antibody drug discovery & development platform, which includes antibody lead generation, antibody humanization, transient expression, stable cell line development, process development, bio-analytics and protein analytics to meet all your needs from concept to IND.

Royal 1 R1 & R2

Morning Refreshments / Poster Presentation Sessions / One to One Partnering Meetings10:40-11:30 Royal 2&3



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SOLUTION PROVIDER PRESENTATION:DAVID PEARLMANDirector, Biologics Software Platform and Senior Scientist, Schrödinger GmbHComputational Approaches in Antibody Design: Identifying and Reducing Liabilities early in the Discovery ProcessComputational tools facilitating antibody optimization have improved greatly in

recent years. These tools are finding increasing acceptance for liability assessment and reduction early in the discovery process. Using the BioLuminate software platform, we describe both how these calculations can be utilized for workflowed triage among multiple candidates, and how tools such as FEP can be used to suggest sequence engineering that can ameliorate identified liabilities (e.g. aggregation propensity) while maintaining affinity and stability.

SOLUTION PROVIDER PRESENTATION:JOHN GUNNPh.D., Senior Research Scientist, Chemical Computing GroupModeling Protein-Protein Interactions with First-Principles DockingComputer modeling of protein-protein interactions plays an increasingly important role in studies of biologics. This work presents a novel algorithm for predicting

likely antigen epitopes from protein-protein docking results using the MOE software package. Protein structures are represented by a coarse-grained bead model which accurately reproduces the interaction energies of the corresponding all-atom model. An additional aggregation scoring term is provided by mapping hydrophobic patches derived from surface analysis onto the model structure. Automated sequence annotation is used to identify the antibody complementarity-determining regions to further constrain the docked poses. This approach generates good poses ranked in the top 100 in over 80% of the cases in the ZDOCK benchmark test set, a result superior to comparable published methods. Protein-protein residue contacts are then used to generate interaction fingerprints which serve to identify Boltzmann-weighted clusters of poses from which to extract consensus epitope residues. Using this method, at least one predicted epitope from the top-ranked five clusters has significant overlap with the native structure in over 50% of test cases.

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EXECUTIVE PANEL DISCUSSION:Advancing immunotherapyThis panel will examine themes and challenges in one of the most promising fields in modern medicine; focusing on the future of immunotherapy and the next steps forward.

CHAIR:VOLKER SCHELLENBERGERPresident and CEO, Amunix

PANELLISTS:JESSIE NIChief Scientific Officer, Irvine Scientific

ZHINAN XIAHead of Biotherapeutics, Moderna Therapeutics

AHUVA NISSIMReader in Antibody and Therapeutic Engineering, Barts and The London, Queen Mary’s School of Medicine and Dentistry

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EXECUTIVE PANEL DISCUSSION:ADCs design and optimisationExamining the design of ADC’s and looking to the future of the field, this panel will draw together the knowledge of multiple leaders in ADC development.

PANELLISTS:YUJI KASUYASenior Scientist, Kitasato Daiichi Sankyo Vaccine Co., Ltd, Japan


RICHARD GREGORYChief Scientific Officer and Executive Vice President, ImmunoGen Inc.

ANDREAS PAHLChief Scientific Officer, Heidelberg Pharma Gmbh



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YELENA BISHARYANDirector of External Alliances, TetrageneticsAntibodies Against Difficult to Express Membrane Protein Targets Ion channels such as Kv1.3 have been historically difficult to raise antibodies against due to sequence conservation, paucity of cell surface epitopes, and poor expression levels in heterologous systems. Tetragenetics Inc. is addressing these issues by combining its unique

technology for membrane protein expression in Tetrahymena thermophila, and antibody generation in phylogenetically diverse animals, to develop therapeutic antibodies against a range of ion channel targets including Kv1.3, a voltage-dependent channel produced by effector memory T-cells implicated in certain autoimmune disorders.

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LUKE MASTERSONChemistry Group Leader, SpirogenAntibody Pyrrolobenzodiazepine Conjugates• Background and mode of action of Pyrrolobenzodiazepine anti-tumour agents• Preclinical Development of Antibody Pyrrolobenzodiazepine Conjugates• Update on clinical progress of Antibody Pyrrolobenzodiazepine Conjugates

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GUNDO DIEDRICHAssociate Director, MacrogenicsFrom DART® to TRIDENT™: Therapeutic Applications of Bi- and Tri-specific Formats• Salient properties of bivalent, trivalent and tetravalent DART and TRIDENT formats• Tailoring avidity and valency for different target combinations and applications• Examples in diverse therapeutic indications

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ANDREAS PAHLChief Scientific Officer, Heidelberg Pharma GmbhAmanitin-based antibody-drug-conjugates as new therapeutic modalities for cancer therapyAntibody-drug-conjugates (ADCs) combine the well-established principle of targeted antibodies (safety and tolerability) with the effectiveness of ultrapotent toxins (anti-tumor

efficacy). The function of the antibody of the ADC molecule is ´to guide´ the toxin specifically to the target tumor cells, and to keep healthy cells unaffected. Antigen-Targeted Amanitin-Conjugates (ATACs) represent a new class of ADCs using a toxin with a novel mode of action, inhibition of RNA pol II. The high potency of this toxin leads to highly efficacious ADCs. Here we present the development of this technology and strategies to achieve a therapeutic index making this technology applicable for cancer therapy. Preclinical data of a BCMA-ATAC will be presented which lead to the start of the clinical development of this first ATAC.

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MARINA PAVLIDOUGroup Leader Selection Technologies, Pieris Tumor-localized T cell costimulation with CD137-targeting bispecifics: From Flexible Design to In-Vivo Proof of Concept and Beyond• Strong proof of concept and developability data for CD137/HER2 bispecific PRS-343 • Why immuno-stimulatory receptor targeting requires bispecifics for efficacy and safety • How the versatile Anticalin-based multispecifics platform allows selecting the optimal

bispecific geometry for a desired biological effect

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JENS WUERTHNERAssistant Vice President, ADC TherapeuticsBuilding a diversified product portfolio of PBD-based Antibody Drug Conjugates• Introduction to ADC Therapeutics• Introduction to Pyrollobenzodiazepine Antibody Drug Conjugates• Preclinical data for ADCTs investigational products• Overview of pipeline and clinical studies

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MARINE RAMANPrincipal Scientist, Protein Science, ImmunocoreInvestigating mechanisms of off target toxicity in an enhanced affinity TCR based immunotherapyMonoclonal affinity-enhanced T cell receptors (TCRs) recognising tumour-associated antigens bring significant promise for cancer treatment. A key consideration in selecting appropriate targets is off target reactivity and extensive molecular and cellular testing is performed to safeguard against this. However, unpredicted off target effects still occur. TCR-engineered T cells recognising A1-MAGE-A3 led to cardiac arrest and death due to binding of an unrelated protein, Titin. Here, we investigate the structural basis of the cross-reactivity between A1-MAGE-A3 and A1-Titin. Using molecular structures of a soluble variant of the same MAGE-A3 TCR (termed

MAG-IC3) in complex with either A1-MAGE-A3 or A1-Titin revealed molecular mimicry. Structurally-guided TCR mutations reduced cross-reactivity between MAG-IC3 and A1-Titin whilst maintaining TCR specificity towards A1-MAGE-A3.

Conference Close15:45

Lunch / One to One Partnering Meetings13:30-14:30 Royal 2&3

POSTER PRESENTATIONS

MAKING A POSTER PRESENTATIONPoster presentation sessions will take place in breaks and alongside the other breakout sessions of the conference. Your presentation will be displayed in a dedicated area, with the other accepted posters from industry and academic presenters.

We also issue a poster eBook to all attendees with your full abstract in and can share your poster as a PDF after the meeting if you desire (optional).

Whether looking for funding, employment opportunities or simply wanting to share your work with a like-minded and focused group, these are an excellent way to join the heart of this congress.

In order to present a poster at the forum you need to be registered as a delegate. Please note that there is limited space available and poster space is assigned on a first come first served basis (subject to checks and successful registration).

We charge an admin fee of €100 to industry delegates to present, that goes towards the shared cost of providing the poster presentation area and display boards, guides etc. This fee is waived for those representing academic institutions and not for profit organisations.

1UniRat™ – A Human VH Discovery Platform

for the Generation of Bispecific and Multivalent Antibodies

Ute Schellenberger, Harshad Ugamraj, Payal Pratap, Shelley Force Aldred, Starlynn Clarke,

Kat Harris Kevin Dang, Duy Pham, Nathan Trinklein, Wim van Schooten

POSTER TITLE PRINCIPAL AUTHOR(S) AFFILIATION

TeneoBio Inc.

2LBA Bioanalytical PK Support for Biologics:

The Need for Sensitivity combined with broad Assay Range – Case Studies

Christian Pieper, Beena Punnamoottil, Nina Jürgens, Andreas Jonas,

Michael Adler and Mark Spengler

Chimera Biotec; Emil-Figge Str. 76a; D-44227 Dortmund; Germany

3

Development of an Imperacer® (Immuno-PCR) assay combining broad assay range and excellent sensitivity to support development of

a TNF-receptor antagonist Biologics drug

Beena Punnamoottil1, Michael Adler1, Mark Spengler1, Dong Hun Lee2 and

Shuangping Shi2

1 Chimera Biotec; Emil-Figge Str. 76a; D-44227 Dortmund; Germany

2 Merck Research Labs; 2000 Galloping Hill Rd; Kenilworth, NJ 07033; USA

POSTER PRESENTATION EXAMPLES

4 Enabling real-time measurements of molecular interactions on living immune cells Sina Bondza, Karl Andersson and Jos Buijs Ridgeview Instruments AB

5Novel, Improved Cell-based Assays to Enable

Immunotherapy Drug Development for Checkpoint Receptors

Abhi Saharia, Jennifer Lin-Jones, Hanako Daino-Laizure, Mimi Nguyen, Venkatesh

Chari, and Jane E. LamerdinDiscoverX

6Specifically Measure Target Cell Death in a Co-Culture with Immune Cells Through a

Non-Radioactive, Dye-free Cytotoxicity Assay

Simone Krupka1, Hanako Daino-Laizure1, Ben Harman2, Abhi Saharia1, and Jane E. Lamerdin1 DiscoverX

7Phenotypic Human Primary Cell-based Tumor

Microenvironment Models for Evaluation of Drug Combinations for Immune Oncology

Jason Ptacek, Karen Matta, Jennifer Melrose, Marya Liimatta, Hannah Cho, Dat Nguyen,

Ellen Berg, Alison O’MahonyDiscoverX

8 Identification and Quantification of HCPs by Mass Spectrometry

Laura McIntosh, John Babetas, Laetitia Cortes, Rudolf Guilbaud , Stephane Parent,

Michael Schirm, Lorella Di DonatoCaprion Biosciences Inc., Montreal, Canada

9 Antibody Drug Conjugate Characterization using the Xevo G2-XS Q-ToF

Antonio Martínez Ortega, Quality Control Analyst Yoana Nuevo Ordóñez, Head of the

Physical-Chemistry Laboratory, QC3P Biopharmaceuticals

10

Phage Display as a tool for development of function blocking antibodies against Notch

ligand delta-like-1 with anti-oncogenic activity in breast cancer

Joana Sales Dias1, Márcia Lamy1, Andreia Ferreira1, Gabriela Silva1, Tiago Bandeiras1,

2, Ana Barbas1, 3 1- IBET, 2- ITQB, Oeiras, 3 - Bayer, Lisboa, Portugal

IBET – Instituto de Biologia Experimental e Tecnológica

11 Conjugation Services & Novel Technologies for Biosimilars and Biologics

Michael Sefkow, Matthias Baranowski, Ralf Krähmer, Frank Leenders, Christoph Radcke,

Julia WittmannCelares GmbH

POSTER PRESENTATIONS

12 An avian antibody platform to fight bacterial infections

João Laranjeira1, Diana Machado2, Rafael Francisco1,3, Marguerita Rosa4, Miguel Viveiros2 and Ricardo S. Vieira-Pires1

POSTER TITLE PRINCIPAL AUTHOR(S) AFFILIATION

1Center for Neuroscience and Cell Biology, University of Coimbra, UC-Biotech, Biocant - Parque Tecnológico de Cantanhede, Núcleo 04, Lote 8, 3060-197 Cantanhede,

Portugal 2Unit of Mycobacteriology, Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa (IHMT/UNL), Rua da Junqueira 100, 1349-008 Lisboa, Portugal,

3HBT – Saúde e Biotecnologia Lda, Rua Paulo Quintela 168, Apartado 10066, 3031-601 Coimbra, Portugal 4CICECO-Aveiro Institute of Materials, Department of Chemistry,

University of Aveiro, 3810-193 Aveiro, Portugal

13 Diagnostic tool to improve dose decision during TNFa-inhibiting therapy

Janko Brand1, Michael Zänker2, Astrid Schäfer1, Gunther Becher3, Marcus Maurer4 BioTeZ Berlin-Buch GmbH, Germany1, Immanuel Klinikum Bernau Herzzentrum

Brandenburg, Germany2, BecherConsult GmbH, Berlin, Germany3, Dermatology and Allergy Director of Research

Dpt. of Dermatology and Allergy Allergie-Centrum-Charité/ECARF Charité – Universitätsmedizin Berlin, Germany4

BioTeZ

14Highly versatile tool box for generation of

monoclonal antibodies against different domains and epitopes of soluble and membrane targets

Diana Ramos1; Joana Assunção1; Ildikó Tóth1; Maria Gonzalez-Pajuelo1; Daniela Teixeira1;

António Barroso1

1FairJourney Biologics, Rua do Campo Alegre 823, 4150-180 Porto, Portugal

15

Generation and validation of Naïve libraries as an immunization-free source of diverse panels of specific human antibodies and

llama single domain antibodies

João Santos1; Pedro Canhão1; Joana Queiroz1; Fernando Martins1; Joana Assunção1; Diana Ramos1;

Ildikó Tóth1; António Barroso1; Daniela Teixeira1; Maria Gonzalez-Pajuelo1; Brígida Antunes1

1FairJourney Biologics, Rua do Campo Alegre 823, 4150-180 Porto, Portugal

16A novel approach for objective HOS comparisons: a biosimilar case study

utilizing circular dichroism.

Bernard Costello, Doug Marshall, Dariusz Sliwa

Applied Photophysics Limited, 21 Mole Business Park, Leatherhead, KT22 7BA,

United Kingdom

17 Deeper profiling of antibodies during high throughput antibody discovery at UCB

Rebecca Munro, John Silva, Daniel Lightwood, Niccolo Pengo, Ashley Hudson, Simon Tickle UCB

18 Using CZE analysis to characterize IgG4 charge variants Jakob Engel, Mirko Sobotta, Matthias Kania Boehringer Ingelheim Pharma GmbH & Co. KG

19 Separation of Bispecific mAbs Using Hydrophobic Interaction Chromatography (HIC)

Julia Baek, Shanhua Lin, Alexander Schwahn, Xiaodong Liu

1Thermo Fisher Scientific, Sunnyvale (CA, USA) 2Thermo Fisher Scientific, Reinach (Switzerland)

20 Analysis of bispecific interactions with the switchSENSE biosensor Johannes Reusch Dynamic Biosensors GmbH

21 Comparability study of Rituximab originator and follow-on biopharmaceutical

Othman Montacira,b, Houda Montacira, Murat Eravcic, Andreas Springerd, Stephan

Hinderlichb, Amirhossein Saadatie, Maria Kristina Parr*a

aInstitut für Pharmazie, Department of Biology, Chemistry, Pharmacy, Freie Universität Berlin, Germany. Königin-

Luise-Str. 2+4, 14195 Berlin, Germany. bLabor für Biochemie, Department of Life Sciences & Technology, Beuth Hochschule

für Technik Berlin, Germany. cInstitut für Chemie und Biochemie, Department of Biology, Chemistry, Pharmacy, Freie Universität Berlin, Germany. dGroßgerätezentrum BioSupraMol, Department of Biology, Chemistry, Pharmacy, Freie Universität Berlin, Germany. eAryoGen Pharmed, Cross Tajbakhsh Street,

24th Kilometer Makhsous, Tehran, Iran.

22High Resolution LC/MS Separation and

Characterization of Chemoenzymatic Site-specific Engineered Antibody-Drug Conjugates (ADCs)

Shanhua Lin1, Terry Zhang2, Jonathan Josephs2, Brian Agnew3, Alexander Schwahn4

and Xiaodong Liu1

1Thermo Fisher Scientific, Sunnyvale (CA, USA) 2Thermo Fisher Scientific, San Jose (CA, USA) 3Thermo Fisher Scientific, Eugene (OR, USA)

4Thermo Fisher Scientific, Reinach (Switzerland)

23ProTIA – Bispecific T cell engagers designed for activation by tumor-associated proteases

based on XTEN® protein polymer

Volker Schellenberger, Bee-Cheng Sim, Fan Yan, Ulrich Ernst Amunix

24 Resolving Protein Glycoform Complexities by Native Mass Spectrometry

Weston Struwe1, Idlir Liko2, Hsin-Yung Yen1, Jonathan Hopper2

1Oxford Glycobiology Institute, University of Oxford, 2OMass Technologies

25Investigation of Biosimilars and Innovator

Monoclonal Antibodies using Multi-Detection SEC John Stenson, Amy Ross, Mark Pothecary Malvern Instruments Ltd.

25

High-level Transient Production of IgGs, Bi-specific T-cell Engaging (BITE) Molecules & Fc Fragments with the Quality, Glycosylation & Functionality Required for

Use as Surrogates for Stably Produced Proteins

Peer Heine, Weili Wang, James Brady, Rama Shivakumar, Pachai Natarajan, Krista Steger,

Madhusudan PeshwaMaxCyte

CONGRESS VENUE

Leonardo Royal Hotel Berlin AlexanderplatzOtto-Braun-Strasse 90,D-10249 Berlin, Germany

The Leonardo Royal Hotel Berlin Alexanderplatz welcomes you to its extraordinary atmosphere: the historical structure meets puristic design, harmonious colour concepts and modern design elements.

SPONSORSHIP AND EXHIBITION OPPORTUNITIES AVAILABLEFor more details contact:

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Tel +44 (0) 1865 849841

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reserve your place at Global Engage’s Biologics & Biosimilars Congress 2017 on the 6th-7th March.

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