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Biosimilars Conference


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Following on the success of our 3rd Biosimilars conference VIBpharma is proud to announce the 4th annual Biosimilars conference taking place on Tuesday 16 and Wednesday 17 March 2010 in Brussels, Belgium.

Through a series of presentations and interactive discussions covering key issues such as current market trends, biobetters, the global regulatory environment, pricing and reimbursement strategies and biosimilars in emerging markets, participants will gain new insight and share hands-on experiences with leading companies in the pharma and biotech industry.

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Biosimilars Conference

  1. 1. Join our LinkedIn group Search group name Biosimilars VIBpharma (Practical strategies for ensuring a successful product launch) Biosimilars tuesday 16 and Wednesday 17 March 2010, Brussels, Belgium from ose on of Cho ecti to Identifying current and future trends to maximise a sel e topics t bl es ndta s the lat peers rou us the profitability of the biosimilar industry r disc with you es issu MAIN HIGHLIGHtS INCLuDE: kEyNOtE SPEAkErS: • Exploring current market trends and thomas Buchholz Dr Paulo Junqueira, Partner, SIMON-kuCHEr & Medical Leader for developments to maximise your PArtNErS Biologic Products, biosimilar success rOCHE PrODuCtS BrAzIL Dr Sandro Gsteiger, • 14 leading biotech and pharma Senior Statistical Modeller, Dr Anand Iyer, Vice companies represented on the NOVArtIS President, programme – delivering case study rANBAxy LABOrAtOrIES Dr rashbehari tunga, INDIA driven presentations Director Manufacturing, INtAS Frank Landolt, • Overcoming pricing and BIOPHArMACEutICAL VP Intellectual Property reimbursement challenges to and Legal, ABLyNx N.V. maximise the ROI of your biosimilar Anjan Selz, CEO, FINOx Pierre-Henri Belin, products Eprex Global Dr Islah Ahmed, Commercial & EMEA • Outlining the biosimilars status in Medical Director, Brand Leader, emerging markets and how Europe HOSPIrA Strategic marketing, can learn and benefit JANSSEN-CILAG tOP COMPANIES rEPrESENtED INCLuDE: 1. Ablynx 4. Finox 7. Polytherics 2. Intas Biopharmaceutical 5. Hospira 8. Janssen-Cilag 3. roche Brazil 6. ranbaxy Laboratories India 9. AxiCorp rEGIStEr NOW: ■ Email: ■ tel: +44 (0)20 7753 4268 ■ Fax: +44 (0) 20 7915 9773 register online now at:
  2. 2. Programme Day One Tuesday 16 March 2010 08:30 Registration 12:20 Panel session: maximising the market share of a biosimilar product by utilising efficient marketing and 09:00 Opening remarks from the Chair pricing strategies to secure a market share Critical analysis of the current market trends ● Revealing solutions to maximise public awareness of biosimilars to achieve acceptance and developments to understand the impact of ● Utilising different marketing tactics and channels to ensure a successful biosimilars on the healthcare industry marketing campaign Weighing different pricing strategies and choosing the most applicable 09:10 Measuring threats and opportunities of biosimilars – ● one a market barrier for mid-size companies? ● Enhancing market acceptance by utilising successful substitution processes ● Highlighting the development of your biosimilar intentions from vision to strategy 13:00 Lunch and networking ● Outlining patient developments in a major disease challenge as stimulus to actively enter the biosimilars market Determining the most lucrative area of the ● Exploring the strategic roadmap to success and how to overcome biosimilars market to ensure your market share challenges and hurdles ● Identifying key levers on the way to market and how to maximise 14:00 Case study: identifying monoclonal Antibody (mAb) their impact biosimilars as the lucrative future ● Establishing how to meet payers & customer needs to ensure a ● Outlining the potential of mAb biosimilars given the patents expiring in successful market share the next few years Dirk ullrich, CEO, AxICOrP ● Exploring efficacy across indications with comparative clinical trials to ensure bioequivalence 09:50 Exploring the current legal and IP environment for ● Revealing how to successfully source enough comparator drugs to biosimilars to ensure patent protection for originator and ensure successful and sufficient testing biosimilar products ● Overcoming the difficulties of developing mAb biosimilars and outlining ● Outlining different patent litigation strategies to protect against the possible consequences if bioequivalence is not achieved biosimilars ● Implementing risk management plans to avoid toxicity ● Clarifying IP implications and regulatory rules for launching a biosimilar Dr. Steffan Gross, Laboratory Head and Scientific Assessor (Quality: to encourage biogeneric competition and reduce drug prices Non-clinical), Deputy Head Section Monoclonal and Polyclonal ● Exploring different regulatory issues to consider when seeking patent Antibodies, PEI – PAuL EHrLICH INStItutE protection ● Examining if and which patent strategies apply for biosimilars to clarify 14:40 utilization of non human primates in biologics the current legal environment monoclonal Antibody (mAbs) studies ● Optimising your IP strategies for biosimilar life cycle management by ● The scientific case for utilising non human primates in these types of taking patent law and regulatory protection into account biologics/biosimilars studies Frank Landolt, VP Intellectual Property and Legal, ABLyNx N.V. ● The diminishing returns of one-time use of a non human primate in Marc Martens, Senior Associate, BIrD & BIrD Potential study complications of immune-mediated clinical reactions during and after dosing in these animals 10:30 Analysing a critical approach to biosimilars and their impact ● Suggested best-practices to help prevent or address these reactions and on the originator industry and global health industry save study data and treat the animal ● Outlining the current impact biosimilars have on the originator industry William Porter, DVM, Diplomate-American College of Laboratory Animal and forecasting trends Medicine, former Director Laboratory Animal resources, MErCk ● Identifying legal and IP threats caused by biosimilars to understand the economic business side 15:20 Afternoon refreshments and networking Uncovering strategies to achieve the most effective patent protection to ● not loose market shares Overcoming pricing and reimbursement challenges ● Highlighting the different regulations in countries all over the world and to maximise the rOI of your biosimilar product their impact on the quality and safety of launched biosimilars 15:50 Exploring successful pricing and reimbursement Pierre-Henri Belin, Eprex Global Commercial & EMEA Brand Leader, Strategic Marketing, JANSSEN-CILAG strategies in a biosimilar environment ● Understanding key drivers for a successful pricing and reimbursement strategies 11:10 Morning refreshments and networking ● Evaluating value perception of stakeholders and its impact on pricing and reimbursement strategies Assessing the global legislative environment ● Understanding market access hurdles and how to overcome them for biosimilars to understand the current market ● Forecasting market dynamics and their impact on pricing and developments reimbursement strategies thomas Buchholz, Partner, SIMON-kuCHEr & PArtNErS 11:40 Assessing the current WHO guidelines for biosimilars to predict future developments Identifying challenges of biological manufacturing ● Summarising the WHO ‘biosimilar pathway’ and the controversial to overcome them and ensure bioequivalence ‘alternative pathway’ to clarify the current situation ● Reaching a global consensus on regulatory standards for biosimilars to 16:30 Case study: overcoming manufacturing challenges of illuminate the worldwide regulatory environment biosimilars – the process defines the product ● Outlining the International non-proprietary names (INNs) requirements ● Rapid process development strategy for biosimilar product and how they assist and improve pharmacovigilance processes ● Challenges of biological manufacturing – minor changes in the ● Uncovering efficient strategies to meet the distinct trade name manufacturing process can have major impact on product quality requirements to successfully distinguish from originator products ● Identifying the key issues in ensuring protein drug comparability Speaker to be confirmed, WHO – WOrLD HEALtH OrGANISAtION ● Optimising manufacturing processes to mitigate risks and ensure biosimilarity William Dr. rashbehari tunga, Principal Scientist, INtAS BIOPHArMACEutICAL 17:10 Closing remarks from the Chair and close of day one
  3. 3. Programme Day Two Wednesday 17 March 2010 08:30 registration and refreshments Outlining the biosimilars status in emerging 09:00 Opening remarks from the Chair markets and how Europe can learn and benefit 14:10 Evaluating the market landscape for biosimilars 09:10 roundtable morning in emerging markets to establish threats and Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will opportunities with focus on Latin America ● Assessing the current market share and profitability of biosimilars be chaired by an industry expert who will facilitate an exchange of on emerging markets opinions, essential experiences and learning related to an aspect ● Highlighting the different regulatory systems and expectations of biosimilars. compared to Europe roundtable 1 ● Discussing patient safety aspects in emerging markets and outlining differences to Europe Outlining the differences of global regulations and ● Uncovering business models used by successful biosimilar players discussing the need for a global regulatory harmonisation in emerging markets to learn from their experience to achieve acceptance of biosimilars ● Understanding why emerging market biosimilars are not launched Dr Anand Iyer, Vice President, rANBAxy LABOrAtOrIES INDIA in Europe yet Dr. Paulo Junqueira, Medical Leader for Biologic Products, rOCHE roundtable 2 PrODuCtS BrAzIL understanding the biosimilars market in emerging markets 14:50 Case study: essential lessons learned from the such as China, India and Latin America to discuss what we development and launch of biosimilars in emerging can learn from other market developments Dr. Paulo Junqueira, Medical Leader for Biosimilars, Pharmacology, markets rOCHE PrODuCtS BrAzIL ● Outlining the R&D and testing processes and differences to Europe ● Uncovering strategies to achieve regulatory approval to ensure roundtable 3 market access ● Identifying efficient market entry strategies to ensure acceptance and Determining monoclonal antibodies and their potential ROI as biosimilars as patents are running out for originator ● Considering regulatory, manufacturing and pricing differences to products develop successful strategies to enter the European market Dr .Steffen Gross, Laboratory Head and Scientific Assessor (Quality: Dr Anand Iyer, Vice President, rANBAxy LABOrAtOrIES INDIA Non-clinical), Deputy Head Section Monoclonal and Polyclonal Antibodies, PEI – PAuL EHrLICH INStItutE 15:30 Afternoon refreshments roundtable 4 Implementing risk management plans and Conducting a SWOt analysis for the global biosimilar pharmacovigilance strategies to mitigate risks market to identify threats and opportunities and forecast future trends and ensure patients safety Anjan Selz, CEO, FINOx 16:00 Enhancing effectiveness and mitigating risks for patients by putting efficient pharmacovigilance 12:30 Lunch and networking and risk management strategies in place ● Evaluating the potential risks of biosimilars to implement efficient risk management and pharmacovigilance strategies in place to Examining the emerging market for biobetters to increase drug safety exploit its potential and to ensure market shares ● Outlining the current status of characterisation processes of 13:30 Biosimilars versus biobetters – positioning for a new biosimilars and how they improved over the past decade ● Mitigating the risk of adverse events by utilising effective market with lucrative prospects traceability strategies ● Outlining the benefits of second generation biosimilars (biobetters) ● Building a post-marketing educational system to rise public over the first-generation products to clearly understand the market awareness and acceptance ● Uncovering the current biobetter market and underlining the potential Dr Islah Ahmed, Medical Director, HOSPIrA with facts and figures ● Identifying the potential of biobetters to be accepted more readily by end-users and over-exceed the originator products revenue Exploring established and novel analytical tools ● Overcoming concerns of bioequivalence to make biobetters more to maximise comparability demonstration attractive to the global health industry ● Learning from Germany how to incentivise biosimilar usage to get 16:40 Case study: overcoming manufacturing challenges of access to this lucrative market biosimilars – the process defines the product keith Powell, CEO, POLytHErICS ● Exploring effective comparator sourcing strategies to ensure sufficient supplies of the original drug ● Identifying new and established analytical tools to demonstrate comparability ● Mitigating risks of immunogenicity to avoid adverse events REGISTER ONLINE NOW! ● Assessing ways to cut costs and save time while still ensuring patients safety ● Analysing the current regulations for comparability of biosimilar products Dr. Sandro Gsteiger, Senior Statistical Modeller, NOVArtIS register.asp 17:20 Closing remarks from the Chair Book before the 23rd December 17:25 Champagne prize draw and save €490 17:30 Close of conference
  4. 4. Media partners Who should attend Pharmaceutical technology is The audience will be made up of senior used daily as a means of creating representatives from biotech and pharmaceutical partnerships and as a point of companies working within the following areas: reference by professionals within the pharmaceutical industry. This comprehensive resource supplies the latest news ● Regulatory Affairs releases, detailed information on industry projects, white ● Medical Affairs papers, event information and a thorough breakdown of ● Product Development products and services. ● Business Development Pharmaceutical Business review. The Business Review websites are your number ● Preclinical and Clinical Development one stop for all the latest news, comment ● Strategy and industry information. Each Business ● Analytics Review website offers content that is produced by a dedicated team of journalists and global industry experts.In addition to the free ● Scientific Affairs content made available on the sites an intelligence store will provide ● Strategic Planning you with premium market analysis reports from the leading global ● Business Strategy suppliers of market research and industry analysis.Pharmaceutical Business Review is the world's leading pharma website, being used ● Corporate Development Strategy by over 100,000 visitors every month. For further information contact ● Research and Development Medical etrack is the new, interactive desktop tool About the conference designed for executives & analysts active in or supplying services to the medical equipment industry. www. In an environment where resources are scarce and patents are fast expiring, effective product Generics bulletin is the global generic planning is paramount to ensuring the success of industry’s essential source of news your organisation. Biologic drugs - noted as some and views on product launches, of the most-expensive medicines - are major targets company deals, regulatory changes and patent pricing and for cost savings. The developments facilitating reimbursement issues. Two formats: a weekly electronic newsflash and a twice-monthly paper publication provide both follow-on biologics are gaining momentum, with immediacy and depth from a generics industry perspective. For significant commercial opportunities emerging. further information please visit or Significant barriers to entry exist in the biosimilars contact Val Davis at or call +44 (0)1564 777550. market. Significant initial investment and the need for specific expertise favour big players. This information portal is a joint Understanding of the marketplace is critical project by the federal agencies CTI/ for success, acceptance by key stakeholders is KTI (Commission for Technology and Innovation), seco and BBT. The federal partners were joined crucial for market uptake of biosimilars. Achieving by the members of the Swss Life Science Marketing Alliance preferential reimbursement status through (Cluster Initiatives Basel Area for Life Sciences, Bio Alps, Bio constant review of the pricing strategy is essential. Polo Ticino, Greater Zurich Area, the SWX Swiss Exchange and Swiss Biotech Association, the national industry association. Following on the success of our 3rd Biosimilars conference VIBpharma is proud to announce the 4th annual Biosimilars conference taking place Drug Development technology is a on Tuesday 16 and Wednesday 17 March 2010 in procurement and reference resource providing a one-stop-shop for professionals and decision Brussels, Belgium. makers within the drug development and medicines industry. Through a series of presentations and interactive We provide a comprehensive breakdown of drug development discussions covering key issues such as current contractors and suppliers, up-to-date news and press releases, market trends, biobetters, the global regulatory white papers and detailed information on current industry projects and trends. Our recruitment area provides career environment, pricing and reimbursement strategies information and the latest job vacancies in the field. www. and biosimilars in emerging markets, participants will gain new insight and share hands-on experiences with leading companies in the pharma World Pharmaceutical Frontiers The pharmaceutical industry is World Pharmaceutical Frontiers and biotech industry. changing fast. There are more regulations, technologies, faster product launches and shorter product life cycles than ever before. World Pharmaceuticals frontiers is, and will continue to be, at the forefront of these changes, so visit us at www. If you want to be a part of this successful and stay up to date with all latest developments event, we have a number of sponsorship opportunities available. Contact Paul Adams to discuss your specific requirements or call +4420 7753 4259
  5. 5. BOOkING FOrM Biosimilars, Tuesday 16 and Wednesday 17 March 2010, Brussels, Belgium Prices & Payment Information Four Easy Ways to Book: Yes, I would like to register for the event: Book before Book before Book before Book after 23 Deceember 20 January 17 February 17 February ■ register online at Representatives from Biotech and Pharma companies I would like the VIP Attendee Package to include the two day €2899 €3039 €3179 €3389 conference + pre-conference workshop and to receive the ■ Email us at interactive CD-ROM (savings of €220) I would like to attend the 2-day conference and the €2650 (+ 21% €2790 (+ 21% €2930 (+ 21% €3140 (+ 21% workshop VAT = €3206.50) VAT = €3375.90) VAT = €3545.30) VAT = €3799.40) ■ tel +44 (0)20 7753 4268 I would like to attend the 2-day conference + purchase the interactive CD-ROM €2520 (+ 21% €2660 (+ 21% €2800 (+ 21% €3010 (+ 21% ■ Fax +44 (0)20 7915 9773 VAT = €3049.20) VAT = €3218.60) VAT = €3388) VAT = €3642.10) I would like to attend the two day conference only €1820 (+ 21% €1960 (+ 21% €2100 (+ 21% €2310 (+ 21% Venue Details VAT = €2202.20) VAT = €2371.60) VAT = €2541) VAT = €2795.10) The two day conference will take place on Fees for Academic representatives Tuesday 16 and Wednesday 17 March 2010. The venue for both days will be centrally located in Brussels. For I would like the VIP Attendee Package to include the two day €1540 €1680 €1820 €2030 further information contact our Operations department conference + interactive CD-ROM on +44 (o) 207 753 4201. I would like to attend the 2-day conference and the €1710 (+ 21% €1850 (+ 21% €1990 (+ 21% €2200 (+ 21% workshop (save €150) VAT = €2069.10) VAT = €2238.50) VAT = €2407.90) VAT = €2262) Are you registered? You will always receive an acknowledgement of your I would like to attend the two day conference only €910 (+ 21% €1050 (+ 21% €1190 (+ 21% €1400 (+ 21% booking. If you do not receive anything, please call us on VAT = €1101.10) VAT = €1270.50) VAT = €1439.90) VAT = €1694) +44 (0) 20 7753 4268 to make sure we have received Fees for all other attendees (CRO’s, CMO’s, API’s and other vendor companies) your booking. 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