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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4Tel: +44 (0)20 3141 8700 Email: [email protected] www.worldadc-europe.com
@world_adc #WorldADC Antibody Drug Conjugates
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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5Tel: +44 (0)20 3141 8700 Email: [email protected] www.worldadc-europe.com
@world_adc #WorldADC Antibody Drug Conjugates
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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7Tel: +44 (0)20 3141 8700 Email: [email protected] www.worldadc-europe.com
@world_adc #WorldADC Antibody Drug Conjugates
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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8Tel: +44 (0)20 3141 8700 Email: [email protected] www.worldadc-europe.com
@world_adc #WorldADC Antibody Drug Conjugates
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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11Tel: +44 (0)20 3141 8700 Email: [email protected] www.worldadc-europe.com
@world_adc #WorldADC Antibody Drug Conjugates
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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16Tel: +44 (0)20 3141 8700 Email: [email protected] www.worldadc-europe.com
@world_adc #WorldADC Antibody Drug Conjugates
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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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.
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