KEY SPEAKERS:WHY ATTEND THIS EVENT:• Discover guidelines issued by regulatory bodiesand how they impact your business model• Understand market access pathways and seecase studies on successful products• Hear development processes from preclinicalfocussed research from big pharma companies• Learn from expert legal opinions on intellectualproperty and patent protection programmes• Evaluate global research co-operationproducing blockbuster Biosimilars• Develop clinical plan for Biosimilar andBiobetters drug design for your clinical trial -When is the right time to proceed?SMi presents their fourth annual...PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSThursday 3rd October 2013, Marriott Regents Park Hotel London, UKLinking Performance to Strategy in the PharmaceuticalMarket: Developing your Marketing PlanWorkshop Leader: Edward Ghabour, Head of Strategic Planning, Novartis8.30am - 12.30pm1ST - 2NDOCTOBER2013Marriott Regents Park Hotel LondonBiosimilars &Biobetters• Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals• Edward Ghabour, Head of Strategic Planning, Novartis• Josh Adelson, Director, Commercial Development, BusinessDevelopment Biosimilars, Pfizer• Haiyan Jing, Senior Director, Biogen Idec• Malcolm Mitchell, Senior Medical Fellow, Eli Lilly & Co• Thomas Klein, IP Specialist, Roche• Jennifer Campbell, Director Worldwide Biosimilars Programme,Merck• Steinar Madsen, Medical Director, Norwegian Medicines Agency• Meenu Wadhwa, Section Leader, Cytokines & Growth factorSection, Health Protection Agency (NIBSC)• Gary Walsh, Professor Industrial Biochemistry, University ofLimerickwww.biosimilars-biobetters.co.ukRegister online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711Biosimilars, thecommercial realityWorkshop Leader: Peter Whittner, Founder, Findacure1.30pm - 5.00pmBOOKBY31STMAYANDSAVE£300BOOKBY28THJUNEANDSAVE£100
SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and brandingpackages, uniquely tailored to complement yourcompany’s marketing strategy. Prime networkingopportunities exist to entertain, enhance and expand yourclient base within the context of an independent discussionspecific to your industry. Should you wish to join theincreasing number of companies benefiting fromsponsoring our conferences please call:Alia Malick on +44 (0) 20 7827 6168 oremail: firstname.lastname@example.orgWant to know how you can get involved? Interestedin promoting your services to this market?Contact Margaret Mugema, SMi Marketingon +44 (0) 207 827 6072,or email: email@example.comRegister online at: www.biosimilars-biobetters.co.uk • Alternatively faBiosimilars & BiobettersDay One | Tuesday 1st October 2013 www.biosimilars-• Analytics• Business Development• Business Strategy• Corporate DevelopmentStrategy• Commercial Affairs• Intellectual Property• Marketing & Sales• Medical Affairs• New Product Development• Legal Affairs• CMC• Preclinical and ClinicalDevelopment• Product Development• Regulatory Affairs• Pricing and Reimbursement• Research and Development• Biologic Production• Quality Assurance• Scientific Affairs• Strategic Planning• Strategic SourcingWHO SHOULD ATTEND THIS CONFERENCE?You should attend this event if you are a Director, Area Head, CSO, or VP from within thePharmaceutical or Healthcare industry with responsibilities in the following areas:8.30 Registration & Coffee9.00 Chairmans Opening RemarksRichard Dicicco, Chairman, Harvest Moon PharmaceuticalsRecent developments and introductions to Biosimilars & Biobetters9.10 A clinical pharmacologists view of Biosimilars•PK and/or PD•Population to Study•Design of Study•3-way comparison-a need too farMalcolm Mitchell, Director, BioPharmaceuticals, Eli Lilly & Co9.50 Biosimilar guidelines in the USA: Why industry has not yetfiled a 351k•Summary of the USA Law•FDA’s non-legal barriers for filing a 351k•Deficiencies of the FDA Published Guidelines•FDA’s Scientific Advice•Best strategies to avoid the pathway and still be reimbursed bypayers with physician and patients’ acceptanceRichard Dicicco, Chairman, Harvest Moon Pharmaceuticals10.30 Morning Coffee11.00 Potential partnering in Biosimilar development•Where has partnering been successful in biosimilardevelopment•Where Pfizer has succeeded and failed•Case studies of future pipelinesJosh Adelson, Director, Commercial Development, BusinessDevelopment Biosimilars, PfizerMarket access and biosimilar use11.40 Market Access issues for Biosimilars•Pricing and Reimbursement•Health Technology Assessment•Guidelines Listing•Prescriber PreferenceBrian Lovatt, Managing Director & Chief Executive, VisionHealthcare Consultancy Ltd12.20 Networking Lunch1.20 Linking performance to strategy in the pharmaceuticalemerging markets•Measuring tangible or intangible assets•Limitations of relying only on financial measures•Characteristics of a good PMS•The emergence of the BSC•Linking multiple scorecard measures to a single strategy•Experience with BSC implementation•Key success factors for the BSC implementationEdward Ghabour, Head of Strategic Planning, BusinessDevelopment and Licensing, Novartis2.00 How to encourage physicians and patients to use biosimilars•Physicians and patients views on biosimilars•Which information is needed?•Who will decide?Steinar Madsen, Medical Director, Norwegian Medicines AgencyBiosimilar litigation2.40 Biotech patenting and litigation•Patenting strategies for biotech molecules•Litigation strategies, in particular in emerging markets•Case studyThomas Klein, European and Swiss Patent Attorney, Roche3.20 Afternoon Tea3.40 Avoiding injunctions in biologics patent litigation•Compulsory licences?•Ethical or public health imperatives?•Competition law?•Strategic litigationChristopher Stothers, Counsel, Arnold and Porter4.20 UK patent litigation on biologics•An overview of recent cases, including MedImmune v Novartisand Lilly v HGS•The litigation pitfalls of broad claim drafting•Issues surrounding SPCs•Predictions for litigation involving biosimilarsDominic Adair, Associate, Bristows5.00 Chairmans Closing Remarks and Close of Day One
ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711Day Two | Wednesday 2nd October 2013-biobetters.co.ukSupported by8.30 Registration & Coffee9.00 Chairmans Opening RemarksRichard Dicicco, Chairman, Harvest Moon PharmaceuticalsClinical updates on biosimilar research: Case studies9.10 Preclinical and clinical development of recombinant FIX Fcand FVIII Fc fusion proteins for severe hemophilia•Processes if biologics licence applications•Ideas moving forwards•Case studies on recombinant factor VIII / IX FcHaiyan Jing, Senior Director, Preclinical and Clinical Research,Biogen Idec9.50 Biosimilars: an analysis of EU product approvals•Sourced primarily from regulatory documentation, this workanalyzes in detail the regulatory data that underpinned theapproval of authorized biosimilars in the EU•The data is contextualized in terms of biosimilar guidelines•The duration of regulatory consideration of biosimilarapplications to those of additional biopharmaceuticalapplications received within the same timeframe is compared.•Likely further developments in EU biosimilar regulatory policy isconsideredGary Walsh, Professor Industrial Biochemistry, University ofLimerick10.30 Morning Coffee11.00 Risk Management of a First-in-Class oncological product•Generation and continuous adaptation of the RMP of acomplex biological product•Lessons learned during pre-submission meeting with EMA,validation phase and phase around d120/d180•Link of RMP to other pivotal documents such as SmPC,EPAR, PSUR•Impact of new legislation, Directive 2010/84/EU on RMP•What biosimilars can learn from this caseAlexander Kainz, Vice President, Head Regulatory Affairs &Quality, Fresenius Biotech GmbH11.40 Speeding map to clinic: A predeterminded map processtemplate for your biosililar•Predefined process parameters in a map template•Minimising process design•Ensuring process robustness•Case study: Down stream process developmentJennifer Campbell, Director World Wide Biosimilars Program,Merck12.20 Networking LunchRegulatory perspectives1.40 Registering biosimilars “globally”: a regulatory perspective•Biosimilar development and registration rules in different zones(EU/US/WHO/INDIA): main features and main differences•Focus on the Reference Medicinal Product: points to consider(considering the new EMA overarching guideline)•Other (nonclinical and clinical) considerationsDavid Uguen, Project Director, Drugs & Biologics, VoisinConsulting2.20 Assessing the needs of biosimilars and biobetters from aregulatory perspective•The differences in regulatory pathways for biosimilars andbiobetters•How similar is similar? Do minor product modifications negatethe biosimilar paradigm?•Can reduced development programs support the approval ofbiobetters?•What options exist for biobetters, and what are the likelyregulatory implications?Alex Bloom, Consultant, PAREXEL3.00 Afternoon Tea3.30 Key factors in the generating of anti-drug antibody responsesincluding the importance of T cell help•Data showing the benefits of assessing drug immunogenicity bymeasuring induction of CD4+ T cell responses•Comparison of innovator and biosimilar products for thecapacity to induce T cell responses in vitro•CMC related factors that can modulate T cell activationMatthew Baker, CEO & CSO, Antitope4.10 EU Legal developments and strategies for Biosimilars•EU legislation framework and case law•Key questions and strategic issues•Looking into the future: upcoming developments, revision ofthe guidelines and next stepsMarc Martens, Senior Associate, Bird & Bird4.50 Chairmans Closing Remarks and Close of Day Two
HALF-DAY POST-CONFERENCE WORKSHOPThursday 3rd October 20138.30am - 12.30pmMarriott Regents Park Hotel London, UKLinking performance to strategy in thepharmaceutical market:Developing your marketing planWorkshop Leader:Edward Ghabour, Head of Strategic Planning,NovartisOverview of workshop:In this workshop, you’ll be provided with a casestudy about company’s products in specificenvironment/market. Within such context, you’llwork in teams (and then to present as a team)on 6 main pillars:• SWOT analysis• Objective setting• Segmentation, targeting and positioningstrategy• Customer value proposition• Promotion mix elements• Annual plan of actionWhy you should attend:Engagement in such workshop represents asignificant opportunity to share your experience,gain insights from other experienced colleagues,and enrich your skills in the area ofstrategic/marketing planning. Once back at yourcompany, we believe a lot of experience wouldbe gained to help enhancing the development ofstrategic/marketing plans for your products.Programme8.30 Registration & Coffee9.00 Welcome & Introductions9.10 Lecture: Linking performance to strategyin emerging markets10.30 Morning Refreshments11.00 Workshop: Case study11.40 Group presentation & Discussion12.30 Close of WorkshopAbout the workshop hostEdward has morethan 25 years’experience in sales,marketing, business development and strategicplanning positions at Novartis.He has both academic background andpractical interventions. He holds DBA degree(Doctorate of Business Administration) from SMCUniversity, Switzerland. His degree is accredited inEurope by ECBE [European Council of BusinessEducation] & in the US by ACBSP [AccreditationCouncil for Business Schools and Programs]. Hisdissertation was on “Linking PerformanceManagement and Measurement to Strategy in aPharmaceutical Company, using the BalancedScorecard framework”Being a head of strategic planning, he used to doportfolio analysis and to prepare strategic plansfor Novartis. He also used to lead and work closelywith cross-functional teams to implement theagreed plans.Being a head of BD&L, he prepares business casesto increase both top line and bottom line forNovartis and follow the implementation of theapproved deals. He is also managing the matureproducts and outsourcing business at Novartis.
HALF-DAY POST-CONFERENCE WORKSHOPThursday 3rd October 20131.30pm - 5.00pmMarriott Regents Park Hotel London, UKBiosimilars, thecommercial realityWorkshop Leader:Peter Whittner, Founder, FindacureOverview of workshop:The higher regulatory barriers in Europe andissues of interchangeability have resulted in alimited number of product launches so far andslow progress for those that are already in themarket. Across the Atlantic, the situation ischanging with the long awaited legislation nowin place to simplify biosimilars registration. Bycontrast, in less regulated markets lowerregulatory barriers have allowed a biosimilarsmarket to take off, but there are questions aboutwhether these “biocopies” are indeed trulybiosimilar.The workshop will examine all these issues andtake a look into what the future may bring.• A good overview of the Biosimilars pictureacross the world• Insight into the varying regulatory approachesprevailing in different regions• An understanding of the commercial situationas it is now and likely to develop in the future• Enough background to determine whetherentering the biosimilars market is anappropriate strategy for their companyProgramme1.30 Welcome & Introductions1.40 Overview - Biosimilars? Biogenerics?Follow-on Biologicals?2.10 Biosimilars - the commercial reality3.10 Afternoon Tea4.45 The Future5.00 Close of WorkshopAbout the workshop hostPeter Wittner, B.Sc., is an independent consultantspecialising in the commercial aspects of generics withmore than 30 years’ pharmaceutical experience. Inone of his industry roles, he joined the Indian genericleader Ranbaxy as Managing Director to help set up itsUK business before returning to consultancy workwww.interpharm-consultancy.co.uk.
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VAT is also charged on DocumentPortal and Literature Distribution for all UK customers and for those EU customers not supplyinga registration number for their own country here: ______________________________________CONFERENCE PRICESI would like to attend: (Please tick as appropriate) Fee Total□ Conference & 2 Workshops £2697.00 + VAT £3236.40□ Conference & 1 Workshop £2098.00 + VAT £2517.60□ Conference only £1499.00 + VAT £1798.80□ 1 Workshop only £599.00 + VAT £718.80□ 2 Workshops £1198.00 + VAT £1437.60Workshop A □ Workshop B □PROMOTIONAL LITERATURE DISTRIBUTION□ Distribution of your company’s promotionalliterature to all conference attendees £999.00 + VAT £1198.80The conference fee includes refreshments, lunch, conference papers and accessto the Document Portal containing all of the presentations.BIOSIMILARS & BIOBETTERSConference: Tuesday 1st and Wednesday 2nd October 2013, Marriott Regents Park Hotel, London, UK Workshop: Thursday 3rd October 2013, London4 WAYS TO REGISTERwww.biosimilars-biobetters.co.uk