KEY SPEAKERS:WHY ATTEND THIS EVENT:• Discover guidelines issued by regulatory bodiesand how they impact your business mode...
SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and brandingpackages, uniquely tail...
ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711Day Two | Wednesday 2nd October
HALF-DAY POST-CONFERENCE WORKSHOPThursday 3rd October 20138.30am - 12.30pmMarriott Regents Park Hotel London, UKLinking pe...
HALF-DAY POST-CONFERENCE WORKSHOPThursday 3rd October 20131.30pm - 5.00pmMarriott Regents Park Hotel London, UKBiosimilars...
FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711POST your booking form to: Events Team, SMi Grou...
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SMi Group's 4th annual Biosimilars & Biobetters conference


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SMi Group's 4th annual Biosimilars & Biobetters conference

  1. 1. 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 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
  2. 2. 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: 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: online at: • 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
  3. 3. ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711Day Two | Wednesday 2nd October 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
  4. 4. 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.
  5. 5. 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
  6. 6. FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711POST your booking form to: Events Team, SMi Group Ltd, 2nd FloorSouth, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UKIf you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at If payment is not made at the time of booking, then an invoice will be issued and mustbe paid immediately and prior to the start of the event. If payment has not been received thencredit card details will be requested and payment taken before entry to the event. Bookings within7 days of event require payment on booking. Access to the Document Portal will not be given untilpayment has been received.Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘share’ a place at an event. Please make separate bookings for each delegate.Cancellation: If you wish to cancel your attendance at an event and you are unable to send asubstitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providingthat cancellation is made in writing and received at least 28 days prior to the start of the event.Regretfully cancellation after this time cannot be accepted. We will however provide theconferences documentation via the Document Portal to any delegate who has paid but is unableto attend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovidedocumentationinthesecircumstances.WecannotacceptcancellationsofordersplacedforDocumentationortheDocumentPortalasthesearereproducedspecificallytoorder.Ifwehaveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther liability.Alterations: It may become necessary for us to make alterations to the content, speakers, timing,venue or date of the event compared to the advertised programme.Data Protection: The SMi Group gathers personal data in accordance with the UK Data ProtectionAct1998andwemayusethistocontactyoubytelephone,fax,postoremailtotellyouaboutotherproductsandservices.Unlessyoutickhere□ wemayalsoshareyourdatawiththirdpartiesofferingcomplementary products or services. If you have any queries or want to update any of the datathat we hold then please contact our Database Manager attached letter.Unique Reference NumberOur Reference LVP-081Terms and Conditions of BookingDELEGATE DETAILSPlease complete fully and clearly in capital letters. Please photocopy for additional delegates.Title: Forename:Surname:Job Title:Department/Division:Company/Organisation:Email:Company VAT Number:Address:Town/City:Post/Zip Code: Country:Direct Tel: Direct Fax:Mobile:Switchboard:Signature: Date:I agree to be bound by SMis Terms and Conditions of Booking.ACCOUNTS DEPTTitle: Forename:Surname:Email:Address (if different from above):Town/City:Post/Zip Code: Country:Direct Tel: Direct Fax:Payment must be made to SMi Group Ltd, and received before the event, by one ofthe following methods quoting reference P-081 and the delegate’s name. Bookingsmade within 7 days of the event require payment on booking, methods of paymentare below. Please indicate method of payment:□ UK BACS Sort Code 300009, Account 00936418□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AUSwift (BIC): LOYDGB21013, Account 00936418IBAN GB48 LOYD 3000 0900 9364 18□ Cheque We can only accept Sterling cheques drawn on a UK bank.□ Credit Card □ Visa □ MasterCard □ American ExpressAll credit card payments will be subject to standard credit card charges.Card No: □□□□ □□□□ □□□□ □□□□Valid From □□/□□ Expiry Date □□/□□CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX cardCardholder’s Name:Signature: Date:I agree to be bound by SMis Terms and Conditions of Booking.Card Billing Address (If different from above):DOCUMENTATIONI cannot attend but would like to purchase access to the following DocumentPortal/paper copy documentation Price Total□ Access to the conference documentationon the Document Portal £499.00 + VAT £598.80□ The Conference Presentations – paper copy £499.00 - £499.00(or only £300 if ordered with the Document Portal)PAYMENTVENUE Marriott Hotel Regents Park, 128 King Henrys Road, London, NW3 3ST□ Please contact me to book my hotelAlternatively call us on +44 (0) 870 9090 711,email: or fax +44 (0) 870 9090 712□ Book by 31st May to receive a £300 discount off the conference price□ Book by 28th June to receive a £100 discount off the conference priceEARLY BIRDDISCOUNTVATVAT at 20% is charged on the attendance fees for all delegates. 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