5th - 7th October 2011, Thistle City Barbican, London, UK

Organised By

Implementing clinical, legal, regulatory and developmental strategies for biosimilar safety and acceptance

To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilars

Dr. Ulrike Jägle, Senior Manager R&D Policy, Global Public Affairs, NovartisDr Ian Hudson, Director of Licensing, MHRA Dr Angela Thomas, Chair of Biologicals and Vaccines Expert Advisory Group-Comission on Human Medicines, MHRA Dr Meenu Wadhwa, Leader Cytokine & Growth Factors Section, National Institute for Biological Standards and Control Fredrik Sundberg, Global Director, Strategic Market Development, GE Healthcare Dr Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting Annie Hubert, Director European Government and Public Affairs, Amgen Dr Frank Moffart, Business Developments Emerging Markets, Solvias Dr Steinar Madsen, Medical Director, Department of Drug Information, Norweigan Medicines Agency Dr Anita O’Connor, Senior Director Biopharmaceuticals, CelerionDr Lincoln Tsang, Partner, FDA & healthcare-Arnold & Porter LLP Sebastian Moore, Partner, IP-Herbert Smith LLP Dr Carsten Brockmeyer, Biosimilars Expert & Managing Director, Brockmeyer Biopharma Kristie Khul, Senior VP, Health, Markovsky + Company Dr Jean-Yves le Cotonnec, CEO, Triskel Integrated ServicesAnna Valeri, Non-Clinical Assessor, MHRAGeoff Hale, Chief Sciene Officer, Merck Millipore

Key Speakers

BOOK NOW!

9th Biosimilars

Driving the Industry Forward | www.futurepharmaus.com

Media Partners

Pre-conference Workshop, Wednesday 5th October, 2011

Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situationLed by: Dr. Angela Thomas, Chair of Biologicals and Vaccines Expert Advisory Group-Comission on Human Medicines, MHRA &

Dr Anita O’Connor, Managing Partner, Anita O’Connor Consulting

Associate Sponsor

BioPharmInsight

An Infinata BioPharm Solution

Gold Sponsor Silver Sponsor

Conference Introduction9th Biosimilars

5th - 7th October 2011, London, UK

Dear Colleague, Biopharmaceuticalsareanessentialtherapeuticoptionaccountingforasubstantial

partoftheglobaltherapeuticmarket.Withthepatentsofmanyblockbusterdrugscomingtoanend,anopportunityhasarisenforthemanufactureandapprovalofbiosimilars.

Inaclimatewheretheever-increasinghealthcarecostsareaconcern,biosimilarsare promising to increase access to essential drugs, lower treatment costs andprovidesavingstothehealthcaresystems.

Visiongain’s 9th Biosimilars Conference will look at the multiple facets ofbiosimilars, ranging from the evolving regulatory landscape and challengesin clinical development, to the legal and economic aspects. By attending thisconferenceyouwillgainacomprehensiveoutlookon thekey issuessurroundingbiosimilars.Donotmissthisopportunitytofurtheryourknowledgeinaninteractivelearningenvironmentandnetworkwithdiverseleadersintheindustry!

Reasons to register today: •Evaluatetheemergingmarkets:focusonfareast •Examineeconomicandcommercialprospects •Explorethechangingregulatorylandscapeofbiosimilars •Analysecomparabilitystudies:designingthemanufacturingprocessand

preclinicaltesting •Assesschallengesintheclinicaldevelopmentofbiosimilars:demonstrating

efficacyandovercomingimmunogenecity •Reviewkeyissuessuchasnaming,labellingandsubstitution:stepstoensure

patientsafetyinclinicalpractice •Identifystepsforsecuringacceptanceofbiosimilarsontothemarket •Gaininsightintotheclinician’sperspective:utilisingbiosimilarsandchallenges

foracceptance(focusonmonoclonalantibodies) •Developpostmarketingsurveillancestrategies •Investigatelegalaspectssurroundingbiosimilars:intellectualproperty,innovation

andmarketingapprovalissues •Utilisenetworkingopportunitieswithdiverseleaders Ilookforwardtomeetingyouattheconference Bestregards

Carrie Lancaster Conference Producer

Who should attend?Presidents, Vice Presidents, CEOs, Directors, Heads, Team Leaders, CSOs, Senior Managers, Senior Business Developers, Researchers, Parteners & Consultants involved in:

Biosimilars/Follow-on Biologics/Follow-on Proteins Biologics/Biopharmaceuticals/Biogenerics/Biotechnology Clinical Immunology Drug Safety Patient Safety Regulatory Affairs Quality Assurance/Quality Control Scientific Affairs Pharmacovigilance Research and Development Process Science & Manufacturing Analytical Characterization Business Development New Product Development Commercial Affairs Legal Affairs Intellectual Property Patent Law Regulatory Compliance Health Economics Pricing and Reimbursement Marketing and Sales

Branded and Generic Pharmaceutical Companies, Contract Research Organisations/ Contract Manufacturing Organisations, Drug Regulators, Academics & Government

Gold Sponsor:MerckMilliporeistheLifeSciencedivisionofMerckKGaAofGermanyandoffersabroadrangeofinnovative,performanceproducts,servicesandbusinessrelationshipsthatenableourcustomers’successinresearch,developmentandproductionofbiotechandpharmaceuticaldrugtherapies.Throughdedicatedcollaborationonnewscientificandengineeringinsights,andasoneofthetopthreeR&DinvestorsintheLifeScienceToolsindustry,MerckMilliporeservesasastrategicpartnertocustomersandhelpsadvancethepromiseoflifescience.HeadquarteredinBillerica,

Massachusetts,thedivisionhasaround10,000employees,operationsin64countriesandproforma2009revenuesof$2.9billion.MerckMilliporeoperatesasEMDMilliporeintheU.S.andCanada.

For further information please visit: www.merckmillipore.comSilver Sponsor:

AtPfizer,weapplyscienceandourglobalresourcestoimprovehealthandwell-beingateverystageoflife.Westrivetosetthestandardforquality,safetyandvalueinthediscovery,developmentandmanufacturingofmedicinesforpeopleandanimals.Ourdiversifiedglobalhealthcareportfolioincludeshumanandanimalbiologicandsmallmoleculemedicinesandvaccines,aswellas

nutritionalproductsandmanyoftheworld’sbest-knownconsumerproducts.Everyday,Pfizercolleaguesworkacrossdevelopedandemergingmarketstoadvancewellness,prevention,treatmentsandcuresthatchallengethemostfeareddiseasesofourtime.Consistentwithourresponsibilityastheworld’sleadingbiopharmaceuticalcompany,wealsocollaboratewithhealthcareproviders,governmentsandlocalcommunitiestosupportandexpandaccesstoreliable,affordablehealthcarearoundtheworld.Formorethan150years,Pfizerhasworkedtomakeadifferenceforallwhorelyonus.

For further information please visit: www.pfizer.comAssocaite Sponsor:

ORIONClinicalServicesisaEuropean-basedCROwithofficesinUK,Germany,France,Australia,US,RussiaandItaly.WeofferafullrangeofservicesinsupportoftheclinicaldevelopmentprocessincludingStrategicandoperationalregulatorysupport;Monitoring;ProjectManagement;MedicalWriting;QualityAssurance;DataManagementandStatisticsand

Pharmacovigilance–forbothpreandpostauthorisation.WeconductclinicalresearchacrossWestern,CentralandEasternEurope;Scandinavia,USA/Canada,AustraliaandpartsofthePacificRim.

For further information please visit: www.orioncro.com

Media Partners:PharmiWeb.comistheleadingindustry-sponsoredportalforthepharmaceuticalsector.Supportedbymostoftheleadingpharmaceutical

corporations,PharmiWeb.comprovidesdynamicreal-timenews,features,eventslistingsandinternationaljobstoindustryprofessionalsacrossEuropeandtheUS.

For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGYEUROPEisownedbyBIOTECHNOLOGYWORLD.ItisbasedandlocatedinWarsaw,Poland.BiotechnologyWorldwasfoundedin

2007toprovidetheworld’sbiotechandpharmainformationandmarkettomakeituniversallyaccessibleandusefulforscientificandbusinessprocesses.ItsfirststeptofulfillingthatmissionwasbuildingtheBIOTECHNOLOGYEUROPEplatformthatwillallowaquickspreadofinformationindifferentchannels.BIOTECHNOLOGYEUROPEofferscompaniescompletedinternetpublicrelations,publicationandmarketingsolutions.OneofthemainsgoalsofBIOTECHNOLOGYEUROPEistointegratetheBiotechandPharmaSectorinEuropetoglobalbiotechnology,pharmaceuticalandlifescienceactivities.

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FuturePharmaceuticalshasforgedpowerfulrelationshipswithkeyindustryleaderstoprovideaplatformforsuccessfulbrandrecognition,

andforseniordecision-makerstohavethemeanstoprocureandplanimplementationstrategiesbasedonthetopicscovered.Positionedtobeanauthoritativeresourcewithintoppharmacompaniesaswellassmall,specialty,andbiotech,FuturePharmaceuticalsmagazineisgearedtocreateadeeppenetrationintoahighlytargetedandresponsiveaudience,bridgingthegapbetweentheindustries’topissuesandthesolutionstop-tiervendorscanprovide.

For further information please visit: www.futurepharmaus.comInPharmistheonlineplatformforexclusivepharmaceuticalnews,comment,contracts,services,jobsandeventsandishometoInPharmjobs.com,PharmafileandPharmafocus.

For further information please visit: www.inpharm.comTheleadingproviderofintelligencetothebiopharmaindustry.Detailedcompanyprofiles;investigational&approveddrugs;contactinfo;productforecasts;andexclusiveeditorialintelligence.Ourproprietaryjournalistscover

themostimportantsituationstakingplaceinthelifesciencesindustry,providingforwardlookinginsightintodrugpipelines,upcominglitigation,druglicensingdeals,andmergers&acquisitions.

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Driving the Industry Forward | www.futurepharmaus.com

Sponsorship and exhibition opportunitiesThiseventoffersauniqueopportunitytomeetanddobusinesswithsomeofthekeyplayersinthepharmaceuticalandbiotechindustries.Ifyouhaveaserviceorproducttopromote,youcandosoatthiseventby:•Hostinganetworkingdrinksreception•Takinganexhibitionspaceattheconference•Advertisinginthedelegatedocumentationpack•Providingbrandedbags,pens,gifts,etc.Ifyouwouldlikemoreinformationontherangeofsponsorshiporexhibitionpossibilitiesforvisiongain's9thBiosimilarsConference,pleasecontactus:Damian Gorman, +44 (0)20 7549 9934 damian.gorman@visiongainglobal.com

BioPharmInsight

An Infinata BioPharm Solution

Pre-Conference Interactive Workshop9th Biosimilars

Wednesday 5th October 2011

Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situation

Dr. Angela Thomas ChairofBiologicalsandVaccinesExpertAdvisoryGroup-ComissiononHumanMedicinesMHRA

Dr Anita O’Connor ManagingPartnerAnita O’Connor Consulting

Timings: 09:30- 10:00 Coffee&Registration10.00- 11.15 MorningSession

11.15- 11.30 CoffeeBreak 11.30- 12.45 MorningSession 12.45- 13.45 Lunch 13.45- 15.00 AfternoonSession 15.00- 15.15 CoffeeBreak 15.15- 17.00 AfternoonSession

Led by:

About your workshop leaders:Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH

Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH, is Consultant Paediatric Haematologist at the Royal Hospital for Sick Children in Edinburgh.

After qualifying in Medicine from the University of London in 1980, Angela trained in general medicine and then adult haematology, subsequently developing a special interest in paediatrics. She was a fellow in molecular biology at University College London and was awarded a PhD on Genetic Variation of the Fibrinogen Gene.

Angela was appointed in 1992 as a consultant paediatric haematologist at the Royal Hospital for Sick Children in Edinburgh and is co-director of the Haemophilia Centre at the Edinburgh Royal Infirmary with specific responsibility for paediatrics. She cares for children with a wide range of haematological disorders, including those with leukaemia, immune deficiency, haemolytic anaemias and bleeding disorders. She has a special interest in the education of paediatricians in the varied presentation of haematological disease, particularly bleeding disorders presenting as possible non-accidental injury.

In addition to her clinical post, Angela is a member of the Commission for Human Medicines (CHM) and chairs its Biologicals and Vaccines Expert Advisory Group. The CHM advises on the quality, safety and efficacy of human medicinal products and advises the Licensing Authority on the granting

Anita O’Connor

Anita O’Connor, PhD, is the Senior Director for Biopharmaceuticals at Celerion. Anita is responsible for the leadership of biopharmaceutical and biosimilar drug development projects and programs for Celerion. She advises clients on the pivotal elements and regulatory strategy needed for approval of biosimilar and innovator biopharmaceuticals for the EU and US markets.

Prior to joining Celerion in 2008 Anita founded ANITA OCONNOR CONSULTING, LLC, where she advised clients from the pharmaceutical and financial industry on small and large molecule development. From 1989 to 2005, Anita worked for the US FDA in the Center for Biologics (CBER), the Center for Drugs (CDER), the Center for Veterinary Medicine (CVM), the Center for Food Safety (CFSAN) and the Office of the Commissioner (OC). As an FDA pharmacologist she worked on the submissions of several blockbuster biopharmaceuticals to include Orencia®, Avastin®, Kepivance®, Remicade®, Remaira®, and Rituxan®. She also reviewed vaccine and blood product INDs and BLAs. Other FDA experience extends to food safety, animal drugs, women’s health, medical devices, and regulatory science policy. During her tenure at FDA, Dr. O’Connor was detailed to the US House of Representatives to work on food safety and biotechnology issues for House Agriculture committee. In 2008, she wrote a chapter for a reference book on the preclinical development of biopharmaceuticals. She speaks and writes frequently on biopharmaceuticals and biosimilars.

About the workshop:

The purpose of the workshop is to allow you to engage in knowledge sharing with your peers in a smaller, less formal environment than the main conference. As such, the audience size will typically be no more than 20 participants in order to enable maximum interaction between the workshop leaders and the delegates. The format is also more interactive, with less emphasis on ‘lecture-style’ presentations and more emphasis on group discussions, exercises and Q&A sessions.

Agenda:

The EU

• The introduction of biosimilars

• Lessons learned

• The changing Paradigm

• New developments on the Horizon

The US

• The recent introduction of biosimilar legislation in the US

• The basics of the US legislation

• New developments since the law was passed

• Challenges to expect in the future

The regulatory challenges for Biosimilar Medicines in the UK

• European guidance

• How similar does similar have to be

• Experience to date

Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

About visiongain: Visiongain is a specialist business information company focused on providing cutting edge products and services across the Pharmaceutical/Biotech, Telecommunications, Defence and Finance sectors, which include reports, conferences, online daily news and offline news analysis and bespoke consultancy. With a commitment to innovation and excellence, visiongain offers flexible solutions to meet our clients’ business intelligence needs, providing the right information at the right time to facilitate the commercial decision-making process. Our pharmaceutical products include Pharma Business Daily, the leading daily email newsletter for the pharmaceutical, biotech and healthcare industries, and a range of independent, high-quality, in-depth reports covering focused and topical areas of concern. Our pharmaceutical conferences address the hottest commercial, regulatory and technical topics and provide an ideal forum for debate and networking for pharmaceutical professionals from around the world.

For further information, please visit: www.visiongain.com

09:00 Registration and refreshments

09:30 Opening address from the chair

Dr Virginia Acha DirectorofInternationalAffairs,StrategicAnalysisPfizer

09:40 Biosimilars: challenges and choices in developing a biosimilars business

•Rewards&Risks •Thestorysofar–whatisknown? •Definitions •Impactofglobalization •Majorstake-holders •Barriersandpotentialpitfalls •Regulatoryissuesincomparability •CasestudieshighlightinganalyticalCMCchallenges

Dr Frank Moffatt ProductManager,BiopharmaceuticalAnalysisSolvias

10:20 New European legislations and their implications for biologicals including biosimilars

•Aretherespecificissuesforuseofbiologicals,includingbiosimilarsinclinicalpractice?

•INNprescriptionandapplicabilityforbiologicals •Requirementofthenewpharmacovigilancedirective:identification

andtraceability •Naminginthecross-borderhealthcaredirective •R&Dbasedindustrypositiononbiosimilarshealthcarepolicies

Annie Hubert Director,EuropeanGovernmentandPublicAffairsAmgen

11:00 Morning refreshments

11:20 The changing regulatory landscape of biosimilars: a non-clinical assessor’s perspective

•ChangesintheEUregulatoryframework •Qualitymatters •Preclinicalissues •Immunogenicity •Choiceofbiomarkers

Anna Valeri Non-ClinicalAssessor

MHRA

12:00 Tools for in vitro PD comparability studies of biosimilar antibodies

•Comparativeinvitrostudiesprovidecrucialdatatoassessthecomparabilityofthebiologicalactivityofbiosimilarantibodies.Acomprehensivestudymayreduceoreveneliminatetheneedforinvivopre-clinicalstudies.Suchastudywillincludetarget-specificassaysaswellasgenericfunctionalassaystoassessbindingtocomplementandFc

receptors.

Geoff Hale ChiefScienceOfficer,Merck Millipore

12:40 Networking lunch

13:40 The current and ongoing regulatory law development in biosimilars •Thebasicframework •Regulatorystandardsforapproval •Product-classspecificissues

Dr Lincoln Tsang Partner

Arnold & Porter LLP

14:20 Successful development of biosimilars •DemonstratingCMCcomparabilitytotheRegulators

•AssessingImmunogenicity

Dr Jean-Yves le Cotonnec CEO

Triskel Integrated Services

15:00 Afternoon refreshments

15:20 Biosimilars: Building trust through scientific rigour •EMAhasbeensuccessfulinbuildingarigorouspathwayforbiosimilars •However,uptakeandtrustinbiologicsandbiosimilarsremainsanissue

inEurope •Strongsciencewillresolvethekeyquestionsthatwefaceanddrive

confidence

Dr Virginia Acha DirectorofInternationalAffairs,StrategicAnalysis

Pfizer

15:40 Biosimilars - a balanced view based on experience from both sides

•Increasedpatientaccess,supportingsustainablehealthcaresystems,commerciallyviable

•Broadeninggroupofcompaniesinterestedinoriginatorandbiosmilarbiologics

•Science-basedandfairbiosimilarpathways

Dr. Ulrike Jägle SeniorManagerR&DPolicy,GlobalPublicAffairs

Novartis

16:20 Biosimilar IP issues in Europe •Freedomtooperateissuesandconfrontingpatentswithbroad

protection-pitfallsandtips •SupplementaryProtectionCertificatesandbiosimilars–unresolvedissues

Sebastian Moore Partner,IPGroup

Herbert Smith LLP

17:00 Closing remarks from the chair

17:10 Networking drinks

Take your discussions further and build new relationships in a relaxed and informal setting

Day 19th Biosimilars

Thursday 6th October 2011

Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

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09:00 Registration and refreshments

09:30 Opening address from the chair

Geoff Hale ChiefScientist

Millipore BioPharma Services Europe

09:40 Licensing of biosimilars •ExperiencetodateintheEU •Regulatoryrequirementsandguidance •Scientificadvice •Futurebiosimilarproducts

Dr Ian Hudson DirectorofLicensing

MHRA

10:20 Innovative label-free solutions to support product comparability testing and process development operations •Enablinglabel-freetechnologysolutionsoverview •Improvingproductcharacterizationandoverallproductivityforbiologics •Monitoringpatientimmunogenicityinpre-clinicalandclinical development •Optimizingproteinpurificationandformulationconditions •Controllingbatch-to-batchcomparabilityduringmanufacturing •Validationmanagementstrategiesformeetingregulatoryexpectations

Fredrik Sundberg GlobalDirector,StrategicMarketDevelopment

GE Healthcare

11:00 Morning refreshments

11:20 Immunogenicity issues with biosimilars •Theimportanceofimmunogenicityissues •Strategiesandmethodsfordetectionofimmunogenicity •Update

Dr Meenu Wadhwa Leader,cytokine&GrowthFactorsSectionNational Institute for Biological Standards

and Control

12:00 Biosimilar market uptake – taking the question out of acceptance

•Examiningthebusinessrisksandmarketplaceopportunities •Measuringregulatorsandfinancialanalystsmandates •Projectingdataandclinicalconfidence •Trackinghealthprofessionalandpatientexpectations •Buildinganawarenessandthird-partyadvocacyprogram •Understandingneededservicesandcommunications •Settingacourseforpayersandpatientpull-through

Kristie Khul SeniorVP,HealthMarlovsky + Company

12:40 Networking lunch

13:40 Uptake of biosimilars in clinical practice

•Whatdodoctorsknowaboutbiosimilars?

•Whataretheobstaclestoincreaseduse?

•Whatdoweknowaboutpricesonbiosimilars?

•Whoshalldecidewhichdrugtouse?

Dr Steinar Madsen Medicaldirector,DepartmentofDrugInformationNorwegian Medicines Agency

14:20 Safety issues with biosimilars

•Overviewofsafetyissues

•Immunogenicity

•Postmarketingsurveillance

•Futureinnovation

Dr Sandy Eisen ChiefMedicalOfficerFrontline Pharma Consulting

15:00 Afternoon refreshments

15:20 The development of biosimilar monoclonal antibodies and other complex molecules

•Monoclonalantibodies:contextofmarket

•Manufacturingprocess

•Productheterogeneity

•Standardproductcharacterisation

•Biologicalcomparability

•Futureopportunities

Dr Carsten Brockmeyer ManagingDirectorBrockmeyer Biopharma

16:00 Chair’s closing remarks

16:10 End of Conference

Day 29th Biosimilars

Friday 7th October 2011

Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

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How to bookEmail:conferences@visiongainglobal.comWeb:http://www.visiongain.com/biosimilars

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Registration Form9th Biosimilars

5th - 7th October 2011, London, UK

www.visiongain.com/biosimilars

9th Biosimilars 5th - 7th October 2011Location:ThistleCityBarbican

Address:CentralStreet,ClerkenwellLondonEC1V8DSUK