9th Biosimilars (2011) Pp

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9th Biosimilars (2011) Pp

  1. 1. 9th Biosimilars Implementing clinical, legal, regulatory and developmental strategies for biosimilar safety and acceptance 5th - 7th October 2011, Thistle City Barbican, London, UK BOOK NOW! Key Speakers Dr. Ulrike Jägle, Senior Manager R&D Policy, Global Public Affairs, Novartis Dr 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, Celerion Dr 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 Services Anna Valeri, Non-Clinical Assessor, MHRA Geoff Hale, Chief Sciene Officer, Merck Millipore Pre-conference Workshop, Wednesday 5th October, 2011 Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situation Led 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 ConsultingGold Sponsor Silver Sponsor Associate Sponsor Organised By Driving the Industry Forward | www.futurepharmaus.com BioPharmMedia Partners Insight An Infinata BioPharm Solution To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilars
  2. 2. Conference Introduction 9th Biosimilars 5th - 7th October 2011, London, UKDear Colleague, Gold Sponsor: iopharmaceuticals are an essential therapeutic option accounting for a substantial B Merck Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships part of the global therapeutic market. With the patents of many blockbuster drugs that enable our customers’ success in research, development and production of coming to an end, an opportunity has arisen for the manufacture and approval of biotech and pharmaceutical drug therapies. Through dedicated collaboration on biosimilars. new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to n a climate where the ever-increasing healthcare costs are a concern, biosimilars I customers and helps advance the promise of life science. Headquartered in Billerica, are promising to increase access to essential drugs, lower treatment costs and Massachusetts, the division has around 10,000 employees, operations in 64 countries and pro forma provide savings to the healthcare systems. 2009 revenues of $2.9 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada. isiongain’s 9th Biosimilars Conference will look at the multiple facets of V For further information please visit: www.merckmillipore.com biosimilars, ranging from the evolving regulatory landscape and challenges Silver Sponsor: in clinical development, to the legal and economic aspects. By attending this At Pfizer, we apply science and our global resources to improve health and conference you will gain a comprehensive outlook on the key issues surrounding well-being at every stage of life. We strive to set the standard for quality, safety biosimilars. Do not miss this opportunity to further your knowledge in an interactive and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human learning environment and network with diverse leaders in the industry! and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues Reasons to register today: work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading • valuate the emerging markets: focus on far east E biopharmaceutical company, we also collaborate with health care providers, governments and local • xamine economic and commercial prospects E communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. • xplore the changing regulatory landscape of biosimilars E For further information please visit: www.pfizer.com • nalyse comparability studies: designing the manufacturing process and A Assocaite Sponsor: preclinical testing ORION Clinical Services is a European-based CRO with offices in UK, • ssess challenges in the clinical development of biosimilars: demonstrating A Germany, France, Australia, US, Russia and Italy. We offer a full range of efficacy and overcoming immunogenecity services in support of the clinical development process including Strategic and operational regulatory support; Monitoring; Project Management; • eview key issues such as naming, labelling and substitution: steps to ensure R Medical Writing; Quality Assurance; Data Management and Statistics and patient safety in clinical practice Pharmacovigilance – for both pre and post authorisation.We conduct clinical research across Western, Central and Eastern Europe; Scandinavia, USA/Canada, Australia and parts of the Pacific Rim. • dentify steps for securing acceptance of biosimilars on to the market I For further information please visit: www.orioncro.com • ain insight in to the clinician’s perspective: utilising biosimilars and challenges G for acceptance (focus on monoclonal antibodies) Media Partners: PharmiWeb.com is the leading industry-sponsored portal for the • evelop post marketing surveillance strategies D pharmaceutical sector. Supported by most of the leading pharmaceutical • nvestigate legal aspects surrounding biosimilars: intellectual property, innovation I corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and and marketing approval issues international jobs to industry professionals across Europe and the US. • tilise networking opportunities with diverse leaders U For further information please email: corporate@pharmiweb.com I look forward to meeting you at the conference BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is Best regards based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Carrie Lancaster Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. Conference Producer For further information please visit: www.biotechnology-europe.com Driving the Industry Forward | www.futurepharmaus.com Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma Who should attend? companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap Presidents, Vice Presidents, CEOs, Directors, Heads, Team Leaders, CSOs, Senior between the industries’ top issues and the solutions top-tier vendors can provide. Managers, Senior Business Developers, Researchers, Parteners & Consultants involved in: For further information please visit: www.futurepharmaus.com Biosimilars/Follow-on Biologics/Follow-on Proteins InPharm is the online platform for exclusive pharmaceutical news, Biologics/Biopharmaceuticals/Biogenerics/Biotechnology comment, contracts, services, jobs and events and is home to Clinical Immunology InPharmjobs.com, Pharmafile and Pharmafocus. Drug Safety For further information please visit: www.inpharm.com Patient Safety BioPharm The leading provider of intelligence to the biopharma industry. Detailed Regulatory Affairs Insight company profiles; investigational & approved drugs; contact info; product An Infinata BioPharm Solution Quality Assurance/Quality Control forecasts; and exclusive editorial intelligence. Our proprietary journalists cover Scientific Affairs the most important situations taking place in the life sciences industry, providing forward looking insight Pharmacovigilance into drug pipelines, upcoming litigation, drug licensing deals, and mergers & acquisitions. Research and Development For further information please visit: www.biopharminsight.com Process Science & Manufacturing Analytical Characterization Business Development New Product Development Commercial Affairs Sponsorship and exhibition opportunities Legal Affairs This event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can Intellectual Property do so at this event by: Patent Law • Hosting a networking drinks reception Regulatory Compliance • Taking an exhibition space at the conference Health Economics • Advertising in the delegate documentation pack Pricing and Reimbursement • Providing branded bags, pens, gifts, etc. Marketing and Sales If you would like more information on the range of sponsorship or exhibition possibilities for visiongains 9th Biosimilars Conference, please contact us: Branded and Generic Pharmaceutical Companies, Contract Research Organisations/ Contract Manufacturing Organisations, Drug Regulators, Damian Gorman, +44 (0)20 7549 9934 Academics & Government damian.gorman@visiongainglobal.com
  3. 3. Pre-Conference Interactive Workshop 9th Biosimilars Wednesday 5th October 2011 Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situationLed by: Dr. Angela Thomas Dr Anita O’Connor Timings: 9:30 - 10:00 Coffee & Registration 0 Chair of Biologicals and Vaccines Expert Managing Partner 10:00 - 17:00 Workshop Advisory Group-Comission on Human Anita O’Connor Consulting T iming includes lunch and refreshment breaks Medicines MHRAAbout the workshop: About your workshop leaders:The purpose of the workshop is to allow you to engage in Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCHknowledge sharing with your peers in a smaller, less formal Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH, is Consultantenvironment than the main conference. As such, the audience Paediatric Haematologist at the Royal Hospital for Sick Children in Edinburgh.size will typically be no more than 20 participants in order toenable maximum interaction between the workshop leaders After qualifying in Medicine from the University of London in 1980, Angelaand the delegates. The format is also more interactive, with trained in general medicine and then adult haematology, subsequentlyless emphasis on ‘lecture-style’ presentations and more developing a special interest in paediatrics. She was a fellow in molecularemphasis on group discussions, exercises and Q&A sessions. biology at University College London and was awarded a PhD on Genetic Variation of the Fibrinogen Gene.Agenda: Angela was appointed in 1992 as a consultant paediatric haematologist at the Royal Hospital for Sick Children in Edinburgh and is co-director ofThe EU the Haemophilia Centre at the Edinburgh Royal Infirmary with specific• The introduction of biosimilars responsibility for paediatrics. She cares for children with a wide range of• Lessons learned haematological disorders, including those with leukaemia, immune deficiency,• The changing Paradigm haemolytic anaemias and bleeding disorders. She has a special interest in the education of paediatricians in the varied presentation of haematological• New developments on the Horizon disease, particularly bleeding disorders presenting as possible non-accidentalThe US injury.• The recent introduction of biosimilar legislation in the US In addition to her clinical post, Angela is a member of the Commission for• The basics of the US legislation Human Medicines (CHM) and chairs its Biologicals and Vaccines Expert Advisory Group. The CHM advises on the quality, safety and efficacy of human• New developments since the law was passed medicinal products and advises the Licensing Authority on the granting• Challenges to expect in the futureThe regulatory challenges for Biosimilar Medicines in the UK Anita O’Connor• European guidance Anita O’Connor, PhD, is the Senior Director for Biopharmaceuticals at Celerion.• How similar does similar have to be Anita is responsible for the leadership of biopharmaceutical and biosimilar• Experience to date 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 andAbout visiongain: financial industry on small and large molecule development. From 1989Visiongain is a specialist business information company focused on providing cutting to 2005, Anita worked for the US FDA in the Center for Biologics (CBER),edge products and services across the Pharmaceutical/Biotech, Telecommunications, the Center for Drugs (CDER), the Center for Veterinary Medicine (CVM),Defence and Finance sectors, which include reports, conferences, online dailynews and offline news analysis and bespoke consultancy. With a commitment the Center for Food Safety (CFSAN) and the Office of the Commissionerto innovation and excellence, visiongain offers flexible solutions to meet our (OC). As an FDA pharmacologist she worked on the submissions of severalclients’ business intelligence needs, providing the right information at the right blockbuster biopharmaceuticals to include Orencia®, Avastin®, Kepivance®,time to facilitate the commercial decision-making process. Our pharmaceutical Remicade®, Remaira®, and Rituxan®. She also reviewed vaccine andproducts include Pharma Business Daily, the leading daily email newsletter for the blood product INDs and BLAs. Other FDA experience extends to food safety,pharmaceutical, biotech and healthcare industries, and a range of independent, animal drugs, women’s health, medical devices, and regulatory science policy.high-quality, in-depth reports covering focused and topical areas of concern. During her tenure at FDA, Dr. O’Connor was detailed to the US House ofOur pharmaceutical conferences address the hottest commercial, regulatory Representatives to work on food safety and biotechnology issues for Houseand technical topics and provide an ideal forum for debate and networking for Agriculture committee. In 2008, she wrote a chapter for a reference book onpharmaceutical professionals from around the world. the preclinical development of biopharmaceuticals. She speaks and writesFor further information, please visit: www.visiongain.com frequently on biopharmaceuticals and biosimilars.
  4. 4. Day 1 9th Biosimilars Thursday 6th October 2011 09:00 Registration and refreshments 12:40 Networking lunch 09:30 Opening address from the chair 13:40 Overview of legal issues • Overview of the European regulatory pathway • The legislative and policy developments for biosimilars 09:40 Biosimilars: challenges and choices in developing a biosimilars business • Standards for approval  • Rewards & Risks  • Protection for the innovators rights  • The story so far – what is known? Dr Lincoln Tsang  • Definitions Partner CASE STUDY  • Impact of globalization Arnold & Porter LLP  • Major stake-holders  • Barriers and potential pitfalls 14:20 Biosimilar IP issues in Europe  • Regulatory issues in comparability  • reedom to operate issues and confronting patents with broad F  • Case studies highlighting analytical CMC challenges protection-pitfalls and tips Dr Frank Moffatt • Supplementary Protection Certificates and biosimilars – unresolved issues Product Manager, Biopharmaceutical Analysis Solvias Sebastian Moore Partner, IP Group Herbert Smith LLP 10:20 New European legislations and their implications for biologicals including biosimilars 15:00 Afternoon refreshments • re there specific issues for use of biologicals, including biosimilars in A clinical practice?  • INN prescription and applicability for biologicals 15:20 Biosimilars - a balanced view based on experience • equirement of the new pharmacovigilance directive: identification R from both sides and traceability • ncreased patient access, supporting sustainable healthcare systems, I • Naming in the cross-border healthcare directive commercially viable  • R&D based industry position on biosimilars healthcare policies • roadening group of companies interested in originator and B Annie Hubert biosmilar biologics Director, European Government and Public Affairs Amgen • cience-based and fair biosimilar pathways S Dr. Ulrike Jägle Senior Manager R&D Policy, Global Public Affairs 11:00 Morning refreshments Novartis 11:20 The changing regulatory landscape of biosimilars: a non-clinical assessor’s perspective 16:00 Presentation to be announced • hanges in the EU regulatory framework C Dr Jean-Yves le Cotonnec CEO • uality matters Q Triskel Integrated Services • reclinical issues P • mmunogenicity I • hoice of biomarkers C 16:40 Closing remarks from the chair Anna Valeri Non-Clinical Assessor MHRA 16:50 Networking drinks 12:00 Presentation to be announced Take your discussions further and build new Geoff Hale relationships in a relaxed and informal setting Chief Sciene Officer, Merck Millipore 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
  5. 5. Day 2 9th Biosimilars Friday 7th October 201109:00 Registration and refreshments 12:40 Networking lunch09:30 Opening address from the chair 13:40 Uptake of biosimilars in clinical practice • What do doctors know about biosimilars?09:40 Insights into biosimilar licensing • What are the obstacles to increased use? • verview of current licensing process O • What do we know about prices on biosimilars? • onsidering the challenges C • Who shall decide which drug to use? • evelopment of licensing strategies D Dr Steinar Madsen Dr Ian Hudson Medical director, Department of Drug Information Director of Licensing Norwegian Medicines Agency MHRA 14:20 Safety issues with biosimilars10:20 Manufacturing issues and comparability • verview of safety issues O • The technical aspects • mmunogenicity I • The business aspects • ost marketing surveillance P CASE STUDY • ase study: innovative approach for comparability testing of C • uture innovation F biological products Dr Sandy Eisen Fredrik Sundberg Chief Medical Officer Global Director, Strategic Market Development Frontline Pharma Consulting GE Healthcare 15:00 Afternoon refreshments11:00 Morning refreshments 15:20 Sponsor Spotlight Session T ake this unique opportunity to be a part of the conference theme, 11:20 Immunogenicity issues with biosimilars network, share ideas and provide an overview of your product/services • The importance of immunogenicity issues to the audience. For more information please contact damian.gorman@visiongainglobal.com • Strategies and methods for detection of immunogenicity • Update Dr Meenu Wadhwa 16:00 The development of biosimilar monoclonal Leader, cytokine & Growth Factors Section antibodies and other complex molecules National Institute for Biological Standards • onoclonal antibodies: context of market M and Control • anufacturing process M • roduct heterogeneity P12:00 Biosimilar market uptake – taking the question out of acceptance • tandard product characterisation S • xamining the business risks and marketplace opportunities E • iological comparability B • easuring regulators and financial analysts mandates M • uture opportunities F • rojecting data and clinical confidence P Dr Carsten Brockmeyer Managing Director • racking health professional and patient expectations T Brockmeyer Biopharma • uilding an awareness and third-party advocacy program B • nderstanding needed services and communications U 16:40 Chair’s closing remarks • etting a course for payers and patient pull-through S Kristie Khul 16:50 End of Conference Senior VP, Health Marlovsky + Company
  6. 6. Registration Form 9th Biosimilars 5th - 7th October 2011, London, UK Conf. code PPStandard Prices 9th BiosimilarsConference and workshop Fee: £1699 VAT: £339.80 Total: £2038.80 5th - 7th October 2011Conference only Fee: £1299 VAT: £259.80 Total: £1558.80Workshop only Fee: £599 VAT: £119.80 Total: £718.80 Location: Thistle City BarbicanNumber of bookings: Total cost: Address: Central Street, Clerkenwell London EC1V 8DSPromotional Literature Distribution UKDistribution of your company’s promotional literature to all conference attendees Fee: £999 VAT: £199.80 Total: £1198.80 How to bookDetails Email: Piyush.patel@visiongainglobal.com Forename: Surname: Web: http://www.visiongain.com/biosimilars UK Office:Job Title: Company: Tel: +44 (0) 20 7549 9961 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd 230 City Road LondonAddress: EC1V 2QY UK General information Venue: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 9004 / Country: Postcode: +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343 http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html Phone: Fax: Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may Email: be requested if payment has not been received in full before the event. Visiongain Ltd reserves the right to charge interest on unpaid invoices.Signature: Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or I confirm that I have read and agree to the terms and conditions of booking after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences. However, if you cannot attend the conference, you may make a substitution/name Methods of payment change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or organisation and are not transferable between Payment must be made in sterling countries. Please note that discounted delegates places at a visiongain event are non refundable.By Mail: Complete and return your signed registration form together with your cheque payable Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, excluding substitutions/name changes, requested by the customer. This will be charged to the to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK customer by credit card prior to the changes being made.By Fax: Complete and fax your signed registration form with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive to +44 (0) 20 7549 9932 briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or expenses, which may be incurred by the customer as a consequence of the event being postponed or By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses.By Bank Transfer: Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Visiongain Ltd A/C: visiongain Ltd Protection Act 1988. Your personal information contained in this form may be used to update you on visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We Barclays Bank Sort Code: 20-71-64 may also share your data with external companies offering complementary products or services. If you Piccadilly Branch Account No: 6038 7118 wish for your details to be amended, suppressed or not passed on to any external third party, please 48 Regent Street Swift Code: BARC GB22 send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. London, W1B 5RA IBAN: GB80 BARC 20716460387118 Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from Please debit my credit card: visiongain Ltd during the transitional period, whilst the changes are coming into effect. Access MasterCard Visa American Express Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain).Card number: VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT.Expiry Date: How we will contact you: Visiongain Ltd’s preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you.Security number (last 3 digits on back of credit card): Unable to attend Obviously nothing compares to being there but you need not miss out. Simply tick the box and send Signature: with your payment. You will receive speaker talks in PDFs two weeks after the event. Yes, please send me speaker talks Price£550 VAT:£110 Total:£660Cardholder’s name: Office use onlyNews updatesPlease tick if you do not want to receive email news updates in the future www.visiongain.com/biosimilars

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