World ADC Frankfurt 2015 - sample brochure

l Evaluate novel payloadsl Advance CMC strategyl Improve clinical translation

A comprehensive overview of the state of the art

in ADCs. Menarini

23-25 February

Partners:

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2Tel: +44 (0)20 3141 8700 Email: [email protected] www.worldadc-europe.com

@world_adc #WorldADC Antibody Drug Conjugates

23-25 February 2015

beneFits oF attending

WElCoME toWorld adC FrankFurtEmbracing all that is unique and amazing about ADCs, World adC Frankfurt provides the focal point for discussion of new research that will enhance the next generation of anticancer drugs.

As the community congregates from across Europe, the exchange of ideas, strategies and data begins again. With the dual goals of providing cutting edge ADC science and the most extensive networking opportunities around. this is an unrivaled chance to benefit your ADC work.

Indisputably, World ADC is the premier forum to help progress your antibody-drug conjugate programmes. With a plethora of emerging case studies, from discovery to market, there is a wealth of intelligence available. In particular, the 2015 program will:

• Highlight innovative adC payloads utilised by AstraZeneca, Synthon & ImmunoGen

• Demonstrate which analytical tools have proved effective for Sanofi, Novartis & MedImmune

• Unveil how Seattle Genetics, Genmab & Pfizer are ensuring the best clinical performance of their candidates

Join the European ADC community for what will be the most valuable event of your year.

What’s neW

this year sees the introduction of a dedicated CMC stream to focus on the complex manufacturing and analytical challenges associated with ADCs. Benefit from 10 detailed case studies from ADC pioneers.

100 years after the death of Paul Ehrlich we’ll be holding a special evening reception of drinks, keynote talks and networking to celebrate the past, present and future of the field.

With huge patient benefit shown with Adcetris and Kadcyla, this year we’ve designed an entire afternoon to debate the clinical performance of the next wave of ADCs. Hear clinicians and developers describe what’s needed to advance more clinically meaningful drugs.

PosTEr sEssion in acTion

DElEgaTEs inPlEnarY sEssion

CMC StREAM

NEtWoRKING EVENING

ClINICAl INSIGHtS AFtERNooN

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23-25 February 2015

sPeakers

Eucodis

Peter BachConsultantBioPharmalogic

george BadescuDirector, Scientific AffairsPolyTherics

James BakerSenior LecturerUcl

Michael BauerSVP, Clinical Developmentgenmab

alain BeckHead, Physio-ChemistryPierre Fabre

Dennis BenjaminVPseattle genetics

Patrick BeuskerDirectorsynthon

Klaus BossletHead, Discovery Oncologyroche

giulio casiHead, ADCsPhilochem

carmen cuevasDirectorPharmaMar

lan DaiAssociate Scientistgenentech

akin DavulcuPrincipal ScientistBMs

antoine DeslandesScientific Advisorsanofi

rakesh DixitVP, R&DMedimmune

stefan DubelProfessorTechnische Universitat Braunschweig

charles DumontetProfessorHospices civils De lyon

Michel EppinkHead, Downstream Processingsynthon

David FirthSenior Scientistcovance

adam gibbClinical Research FellowThe christie

Ulf grawunderCEOnBE-Therapeutics

Philip HowardCSOspirogen

John lambertCSOimmunogen

Maxime lampilasHead, Process Researchsanofi

James leggSenior ScientistMedimmune

Florence l’HospiceDirectorinnate Pharma

Brian clarkExecutive Director immunogen

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23-25 February 2015

sPeakers

Petter VeibySenior DirectorTakeda

Justin Mason-HomeManaging DirectorsafeBridge

Palani PalaniappanVP & Global Head, CMCTakeda

Franck PavanBusiness ManagerPierre Fabre

Hooman sajedianSenior ManagerPfizer

christopher scottProfessorQueen’s University Belfast

Jyothi swamyProject ManagersaFc

Marek TrnenyProfessorcharles University general Hospital

andrew ZhangSenior ScientistastraZeneca

Wolfgang noeVP, Technical Operationsagensys/astellas

David rabukaGlobal Head, R&Dcatalent

Kurt schoenfeldManagerBiotest

Dave stoverSVP & Site Headagensys/astellas

David ThurstonProfessorKing’s college london

ash Patel Director Era consulting

Markus WallesGroup Leadernovartis

alexey lugovskoyVP, TherapeuticsMerrimack Pharmaceuticals

David MiaoCSO concortis

Jeremy ParkerPrincipal ScientistastraZeneca

andreas PluckthunProfessorUniversity of Zurich

Puja sapraSenior DirectorPfizer

Manuel simonLaboratory Headroche

Mohammad TabriziDirector & Global HeadMerck

Peter lloyd Director KinDyn consulting ltd

immunogen

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23-25 February 2015

Pre-conference neTworking eVeningto celebrate the centenary of Paul Ehrlich’s death, World ADC is hosting a memorable programme of evening talks, drinks and networking on the evening of the 23rd.

Join us to hear visionary speakers chronicle the past, present and future of antibody drug conjugates. the presentations are set to be touching, provocative, illuminating and the perfect start to World ADC.

Alongside the talks and drinks reception, we’ll be holding our famous speed networking session so that you can meet many of the other conference participants. Be part of the buzz and excitement of what is set to be the most spectacular event of 2015.

taking place after the pre-conference workshops this is open to all conference attendees and we’ll be confirming places in January.

Professor Plückthun will be one of three keynote speakers who will deliver unique talks on the past, present and future of antibody drug conjugates. As part of an exciting evening of networking the speakers will highlight the life and achievements of Paul Ehrlich, share experiences of what ADC treatments are really like and propose views on the future of protein engineering.

We look forward to welcoming you and your colleagues at this special event.

Featured keynote sPeaker

The workshop will share some of the more recent learning from pre-IND meetings and experiences in the electronic submission of INDs for clinical studies. A review of the regulatory guidance and some of the strategies adopted by companies to seek maximum scientific advice will also be discussed. For compiling of INDs, particular emphasis will be made on the CMC and non-clinical sections of an IND for Biopharmaceuticals products. Management of the IND for subsequent clinical studies will be touched on as well as seeking opportunities for filing orphan medicinal products in the uS.

attendees will learn about:• Recent learning from pre-IND meetings and experiences in the electronic submission of INDs for clinical studies• Review of the regulatory guidance• Strategies adopted by companies to seek maximum scientific advice• Opportunities for filing orphan medicinal products in the uS• Filing for “Expedited Programs Status for Serious Conditions”

Date: February 23rd Time: 14:30-17:00

WorKsHoP F: rEgUlaTorY consiDEraTion For Filing inD & sUBsEQUEnT clinical sTUDiEs

ash Patel Director Era consulting

WorKsHoP lEaDEr:

YoU can aTTEnD WorKsHoP E or F

This workshop will focus on the preclinical bioanalytical methods that need to be developed and put in place to ensure that meaningful preclinical safety studies can be undertaken. Safety data from these GLP studies can be translated into relevant information for the selection of starting dose, patient exclusions and clinical Risk Evaluation and Management Strategy (REMS).

attendees will learn about:• Evaluating target risks and managing these through preclinical and clinical development• understanding the need to develop robust and sensitive bioanalytical methods • Biomarker selection to support preclinical and clinical development• Ensuring that the maximum amount of safety information will be generated to facilitate a robust IND submission

with valid patient risk assessment and REMS for first in-human doses• Interacting with regulatory agencies to facilitate their early input to development programmes

Date: February 23rd Time: 14:30-17:00

WorKsHoP E: PrEclinical BioanalYTical & saFETY DEVEloPMEnT oF aDcs

WorKsHoP lEaDEr:

Peter BachConsultantBioPharmalogic

Prof. Dr. andreas PlückthunDirector, Dept. of BiochemistryUniversity of Zurich

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23-25 February 2015

7.50 chair’s opening remarks alain Beck, Head, Physio-Chemistry, Pierre Fabre

8.00 Keynote: Progressing aDcs at seattle genetics• Celebrating clinical success with ADCETRIS: An update from the AETHERA trial

• Evaluating clinical progress of SGN-CD33A

Dennis Benjamin, VP, seattle genetics

8.30 Keynote: advancing aDc candidates at Pfizer• Matching linker payload design with target biology

• Translational biology for ADCs: Combination strategies for ADCs

• Highlights from late stage preclinical & clinical ADCs

Puja sapra, Senior Director, Pfizer

9:00 Morning refreshments & Facilitated networking

main ConFerenCeDAy 1 - TuESDAy 24TH FEBRuARy

Discovery stream: Development stream: cmc stream:

INNOVATIVE BIOCONjuGATION TECHNIquESChair: Klaus Bosslet, roche

BROADENING THE TARGET POOL FOR ADCSChair: alexey lugovskoy, Merrimack

DEVELOPING ROBuST & SCALABLE PROCESSESChair: Palani Palaniappan, Takeda

10.30 site specific aDcs Using next generation Maleimides• Easy production approach of highly

homogeneous ADCs• Efficient conjugation to native disulphide

bonds whilst retaining key interchain bridges• Controlled incorporation of up to 4 payloads

per antibody with no prior mutagenesis

James Baker, Senior Lecturer, Ucl

10.30 redirecting immune response Using synthetic constructs • Exploring potential of antibody recruiting

small molecules • Efficacy of this approach demonstrated in vivo

targeting PSMA expressing prostate cancer• Synthetic constructs which have antigen

targeting & immune directing capabilities of antibodies

• Designing small molecule chemical probes which identify novel targets

andrew Zhang, Senior Scientist, astraZeneca

10.30 Exploring The requirement For comparability When Transitioning To clinical scale• Comparability tenets & approaches through

development continuum• Comply with changing regulatory needs to

establish robust supply chain• Meet clinical demand & commercial viability

Palani Palaniappan, VP & Global Head, CMC, Takeda

11.00 Producing Better aDcs Using ThioBridge™ conjugation• Site specific conjugation to disulphide bonds

of antibodies & antibody fragments reduce ADC heterogeneity

• ThioBridge™ linkers provide stable conjugates & are usable with variety of payloads

• ThioBridge™ technology can be used to create novel ADC formats

• In vitro & in vivo data

george Badescu, Director, Scientific Affairs, PolyTherics

11.00 Examining approaches To antigen selection & antibody screening Which Maximise on Target activity of cytotoxic nanoparticles• Functional screening approaches to antigen

selection & antibody screening• Preclinical & clinical case studies of optimally

designed targeted nanoparticles

alexey lugovskoy, VP, Therapeutics, Merrimack

11.00 case study From Pierre Fabre cDMo• More details to follow

Franck Pavan, Business Manager, Pierre Fabre

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23-25 February 2015

8.25 chair’s opening remarks alain Beck, Head, Physio-Chemistry, Pierre Fabre

8.30 Harness The Benefits of Mass spectrometry as an analysis Tool For aDcs at Different levels• Top down: Native & Ion Mobility MS

• Middle up & down: Fast profiling by LC-MS following IdeS proteolytic digestion

• Bottom up: Positional isomers at cysteine residues by peptide mapping LC-MS analysis

alain Beck, Head, Physio-Chemistry, Pierre Fabre

9.00 Exploring alternative aDc Formats: cytolytic Fusion Protein (cFP) rg7787• In vitro & in vivo data

• Overcoming traditional limitations of immunogenicity & off-target toxicity, particularly vascular leak syndrome

• Development of de-immunised format that has reduced off-target toxicity & retains high therapeutic potency

Klaus Bosslet, Head, Discovery Oncology, roche

9:30 Morning refreshments & networking

DAy 2 - WEDNESDAy 25TH FEBRuARy

Discovery stream: Development stream: cmc stream:

THE FuTuRE: ExPLORING NEW MECHANISMS OF ACTIONChair: Klaus Bosslet, roche

ANALySING & MITIGATING TOxICOLOGICAL LIABILITIES

Chair: alexey lugovskoy, Merrimack

MANAGING SuPPLy CHAIN NETWORKS, OuTSOuRCING & COST OF GOODSChair: Palani Palaniappan, Takeda

10.30 Towards Homogenous aDcs: a new site specific conjugation• Innovative & robust approach for site specific

conjugation• Fast track process for ADC screening in

homogenous format• Developing a scalable & cost-effective

process

Florence l’Hospice, Director, innate Pharma

10.30 characterisation of Thiol-linked antibody-Drug conjugates by lc-Ms• Application of a top-down workflow involving

enzymatic digestion & reversed-phase LC-MS• Generation of visual representation of ADC

structure & drug-conjugation• Mutual internal standardisation for precise

calculation of DAR

David Firth, Senior Scientist, covance

10.30 Disposable Technologies To speed Manufacture & reduce cleaning Validation• Overcoming challenges associated with

manufacturing ADCs • Evaluating the benefits of exclusively using

disposable technologies • Examples of disposable technologies used

for ADCs

Wolfgang noe, VP, Technical Operations, agensys/astellas

11.00 Discovering novel chemical Payloads For Use in aDcs• Advantages & disadvantages of the chemical

payloads in current use• Pharmacological & commercial imperatives

for finding new types of chemical payloads• Which mechanisms of action are likely

to provide novel payloads with optimal cytotoxicity, systemic toxicity & stability characteristics, while retaining ease of synthesis & low cost of production?

David Thurston, Professor, King’s college london

11.00 Toxicity risk Mitigation in The Development of safe & Efficacious aDcs• Strategies for management of on/off target

toxicity• Implications of payload specific toxicity &

related adverse events

rakesh Dixit, VP, R&D, Medimmune

11.00 simplifying complex aDc supply chains: Managing Projects in a global Environment• Tech transfer, manufacturing & analysis of

ADC components, BDS & DP often occur in different locations to take advantage of the high quality vendors

• Coordination of these multiple parties across the country & globe is required to deliver ADCs to patients when promised

• Tools that have been successfully used to navigate & streamline the pathway to ease the experience for innovators

Jyothi swamy, Project Manager, saFc

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23-25 February 2015

Yet another ‘grand slam’ of a conference igenica

prices anD DiscoUnts

code: 4713

registration checklist1. Have you checked if anyone else from your business is attending? If 3 or more of you register together, you will all benefit from reduced rates.

2. Could you register your place early to take advantage of early booking rates?

3. Have you carefully evaluated which package will best help you achieve your goals?

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Full payment is due on registration. Cancellation and Substitution Policy: Cancellations must be received in writing. If the cancellation is received more than 14 days before the conference attendees will receive a full credit to a future conference. Cancellations received 14 days or less (including the four-teenth day) prior to the conference will be liable for the full fee. A substitution from the same organisation can be made at any time.

Changes to Conference & Agenda: Hanson Wade reserves the right to postpone or cancel an event, to change the location or alter the advertised speakers. Hanson Wade is not responsible for any loss or damage or costs incurred as a result of substitution, alteration, postponement or cancellation of an event for any reason and including causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade or industrial disputes, terrorism or hostilities.

Data Protection: The personal information shown and/or provided by you will be held in a database. It may be used to keep you up to date with developments in your industry. Sometimes your details may be obtained or made available to third parties for marketing purposes. If you do not wish your details to be used for this purpose, please write to: Database Manager, Hanson Wade, Suite A, 6 Honduras Street, London EC1y 0TH

TERMS & CONDITIONS

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*Please note: Team discounts are only valid when three or more delegates from one company book and pay at the same time. ‘Early Bird’ discounts require payment at the time of registration (or prior to the cut-off date) to secure the applicable discount. All advertised discounts cannot be combined with any other offer.

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contact us: If you require any further information on the event, or would like us to assist you in making your booking, please contact the ADC Team via the contact details below.

maritim hotel bad homburgLudwigstraße 3 61348 Bad Homburg v. d. H.http://www.maritim.com/en/hotels/germany/hotel-bad-homburg/hotel-overview

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World ADC Frankfurt 2015 - sample brochure

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