7th Annual
     Optimising commercial strategies to develop Biosimilars and Biobetters

     5th - 7th Octob...
Conference Introduction
Pre-Conference Interactive Workshop
Day 1
                                                                                                7th Annual Biosimila...
Day 2
                                                                                                7th Annual Biosimila...
Registration Form
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7th Annual Biosimilars (2010)


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7th Annual Biosimilars (2010)

  1. 1. 7th Annual Biosimilars Optimising commercial strategies to develop Biosimilars and Biobetters 5th - 7th October 2010, BSG Conference Centre, London, UK BOOK NOW! Key Speakers Dr Gillian Cannon, Executive Director - Commercial Operations, Merck Bioventures Dr Anne Cook, Biologicals Quality Assessor, Biologicals and Biotechnology Unit, MHRA Mohamed Oubihi, Senior Manager, International Regulatory Affairs, Biogen Idec Jo Pisani, Partner Strategy, PricewaterhouseCoopers LLP Mateja Urlep, Founder & CEO, Tikhe Pharma, Former Global Head of Marketing and Medical, Sandoz Dr Fernando de Mora, Chairman, Dept of Pharmacology, Universitat Autònoma de Barcelona & Partner, Salupharma Robin Thorpe, Head - Biotherapeutics Group, National Institute for Biological Standards and Control Dr David Goldsmith, Consultant Nephrologist, Guy’s Hospital and St Thomas’ NHS Foundation Hospital, UK Michael Dilger, Senior Director, Simon-Kucher & Partners Pre conference workshop Tuesday 5th October, 2010 Patent issues in the development of biosimilar medicines Led by: Dr Duncan Curley, Director, Innovate Legal Associate Sponsors Driving the Industry Forward | www.futurepharmaus.com Organised By Media Partners To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilars
  2. 2. Conference Introduction 7th Annual Biosimilars 5th - 7th October 2010, London UK Dear Colleague, Associate Sponsors Biosimilars, biobetters and follow-on biologics are the new wave of growth for the PharmaNet Devel PharmaNet Development Group, a global, pharmaceutical industry. According to the GIA report, the market for biosimilars in drug development services company, provides expertise to the the US, Europe, and Japan is projected to exceed US$2 billion by 2015. As numerous pharmaceutical, biotechnology, generic drug, and medical device industries. PharmaNet countries including the United Status and EU collaborate, there exists a huge companies offer clinical development solutions including consulting services, Phase I clinical challenge in developing biosimilars across regulated and unregulated markets. studies, bioequivalency and pharmacodynamic studies, bioanalytical analyses, and Phase II, With the newly introduced US health reform bill, the branded drugs would be given a III, and IV clinical development programs. With more than 2,300 professionals in 40 offices 12-year exclusivity period before generics may be developed. The new legislation also around the world, PharmaNet is a recognized leader in outsourced clinical development. allows FDA to approve generic versions of biological drugs. It is vital to understand For further information please visit: www.pharmanet.com what will the future hold for the global biosimilars sector? PAREXEL Consulting provides integrated product development services, Visiongain’s 7th Annual Biosimilars Conference will discuss strategies to understand helping biopharmaceutical and medical device companies shorten time to the complexity of regulatory framework, overcome barriers and gain market access market and maintain product viability for the long-term. Through our unique fusion of scientific, within the global landscape. Our distinguished panel of speakers and interactive regulatory, and business expertise, we help clients manage risk and maximize product value at sessions will provide key solutions to identify growth areas and achieve commercial every milestone and phase of development worldwide.As leaders in biosimilars development, success for biosimilars across diverse environments. Learn, maximise your knowledge we played an integral role in bringing the first biosimilars to the EU market, and are actively and network with diverse industry leaders at our global forum. working with clients seeking FDA biosimilar approval. Download our latest biosimilars white papers on The Dawn of US Biosimilars and Biosimilar mAbs at www.parexel.com. Key topics of discussion include: For further information please visit: www.parexel.com • Gaining insights of the competitive landscape in biosimilars: US, EU and Media Partners: emerging markets PharmiWeb.com is the leading industry-sponsored portal for the • Evaluating biobetters and differentiated biosimilars as practical alternatives to pharmaceutical sector. Supported by most of the leading pharmaceutical biosimilars for regulated markets corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. • Implementing successful commercial models for biobetters and follow-on biological medicines For further information please email: corporate@pharmiweb.com • Reviewing the global pricing and reimbursement models in the biosimilars and BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. generics market It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to • Learning the impact on biosimilars product patenting make it universally accessible and useful for scientific and business processes. Its first step • Leveraging licensing opportunities for biosimilars to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will • Validation of biomarkers and comparative immunogenicity as surrogate endpoints allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of • Exploring technologies for producing improved biologics: Drug delivery, half-life the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector extension, cell production, and glycoengineering methods in Europe to global biotechnology, pharmaceutical and life science activities. I look forward to meeting you at the conference For further information please visit www.biotechnology-europe.com Best regards Future Pharmaceuticals has forged powerful relationships with key industry Driving the Industry Forward | www.futurepharmaus.com 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 companies Maninder Paul as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a Conference Producer deep penetration into a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. For further information please visit: www.futurepharmaus.com InPharm is the online platform for exclusive pharmaceutical Who should attend? news, comment, contracts, services, jobs and events and is Members of Board, Vice President, Directors, Heads and Senior home to InPharmjobs.com, Pharmafile and Pharmafocus. Managers involved in: For further information please visit: www.In-Pharm.com • Follow-on Biologics/Follow-on Proteins/Biosimilars Pharma Connections Worldwide® is the leading professional business • Biologics/Biotechnology/ Biogenerics networking website focused in the Pharmaceutical, Biotechnology and Life • Biopharmaceuticals/ Biotherapeutics Sciences research industry. Our goal is to provide a conduit for delivery of premiere content • Clinical Immunology coupled with the right clientele in order to facilitate business development opportunities • Process Control and Analytical Technologies among industry professionals responsible for making key decisions in a global marketplace. • Quality Affairs/ Quality Control For further information please visit www.pharmaconnections.com • New Product Development • Process Science • Analytical Characterisation • Research & Development Sponsorship and exhibition opportunities: • Quality Assurance This event offers a unique opportunity to meet and do business with some of the • Scientific Affairs key players in the pharmaceutical and biotech industries. If you have a service or • Commercial Affairs product to promote, you can do so at this event by: • Legal Affairs • Hosting a networking drinks reception • Intellectual Property • Taking an exhibition space at the conference • Health Economics • Pricing and Reimbursement • Advertising in the delegate documentation pack • Regulatory Compliance • Providing branded bags, pens, gifts, etc. • Pharmacovigilance If you would like more information on the range of sponsorship or exhibition possibilities • Business Development for visiongain's 7th Annual Biosimilars Conference, please contact us: • Marketing & Sales Ronald Magali, +44 (0)20 7549 9934 - Branded and Generic Pharmaceuticals & Biotechnology Companies ronald.magali@visiongainglobal.com - CROs/CMOs James Hopkins, +44 (0)20 7549 9974 - Drug Regulators, Academic & Government Bodies james.hopkins@visiongain.com
  3. 3. Pre-Conference Interactive Workshop 7th Annual Biosimilars Tuesday 5th October 2010, London UK Patent issues in the development of biosimilar medicines Led by: Dr Duncan Curley Timings: 09:30 - 10:00 Coffee & Registration Director 10:00 - 15:00 Workshop Innovate Legal Timing includes lunch and refreshment breaks About the workshop: Workshop agenda: Biosimilar medicines are already a commercial reality in the European 09:30 Registration and Refreshments Union. The U.S. Healthcare Reform Bill, with its defined pathway for the regulatory approval of follow-on biologics, should open up the U.S. 10:00 PART 1 – A EUROPEAN PERSPECTIVE market in the coming years. However, the next wave of biosimilars faces other difficulties in reaching the market, both in the EU and in the 10:10 Patent issues in the development of biosimilars – an USA, because many valuable second generation biological products are introduction better protected by originator patent estates. The aim of this workshop is to examine and discuss the patent issues that may be confronted in 10:30 Insulin analogues developing biosimilar products for these markets. The discussion will be • Commercial overview framed by reference to specific products. There will also be an analysis • Rapid and long-acting insulin analogues of the patent dispute procedure in the new U.S. legislation. 11:30 Morning Refreshments About the workshop leader: 11:45 Pegylation Dr Duncan Curley qualified as a • PEG-interferon solicitor in 1995. He became a • PEG-filgrastim partner in the intellectual property (IP) department of an international law firm in 2003 and he founded the boutique 12:30 Monoclonal antibodies – the EU guidelines London-based IP law practice, Innovate Legal, in 2007. Duncan is a life sciences specialist and he acts for a number of multinational 13:00 Lunch pharmaceutical companies on freedom to operate, patent clearance and litigation issues. He has worked on many high profile cases, PART 2 – A U.S. PERSPECTIVE including Lenzing v Courtaulds (fibre technology), Bespak v 3M (metered dose inhalers for asthma), Pliva v Eli Lilly (gemcitabine) 14:00 The U.S. approval pathway for Biosimilars – An update and two of the major UK cases on antitrust ‘Eurodefences’ to IP • Terminology: “highly similar” and “interchangeable” claims (Sandvik v Pfiffner, patents and Sportswear v Stonestyle, • Data exclusivity trade marks). He is the author of numerous published articles on IP • The patent dispute procedure issues, the textbook “Intellectual Property Licences and Technology Transfer” (on the European Technology Transfer Block Exemption) and 14:45 Discussions and questions “Extending Rewards for Innovative Drug Development”, a Report on Supplementary Protection Certificates, published in December 2007 by 15:00 Close the Intellectual Property Institute.
  4. 4. Day 1 7th Annual Biosimilars Wednesday 6th October 2010, London UK 09:00 Registration and refreshments 13:40 Biosimilars: Between innovator biomedicines and classcal generics 09:30 Opening address from the chair • The rationale behind the EMA regulation on biosimilars Dr Fernando de Mora • Answering payers, patients and prescribers concerns about biosimilars Chairman, Dept of Pharmacology, Universitat Autònoma de Barcelona • Biosimilar vs. the generic market Partner, Salupharma  • Need for a specific strategic approach to the biosimilar market Dr Fernando de Mora 09:40 Understanding the competitive landscape Chairman, Dept of Pharmacology, in biosimilars Universitat Autònoma de Barcelona Partner, Salupharma • Exploring the biosimilars opportunity • Exploring obstacles to entry: Strategic, pricing, sales & marketing 14:20 Comparability evaluation of biological products • Assessing the major markets for biosimilars: US, EU and emerging markets • Evaluation: Biochemical characterisation, non-clinical and • Identifying current and potential players and business models clinical characterisation • Elements to successful biosimilar comparability Jo Pisani Partner • Process & product comparability PricewaterhouseCoopers Dr Anne Cook Biologicals Quality Assessor, Biologicals and Biotechnology Unit 10:20 Overview of Japanese regulatory framework on MHRA biosimilars: Trends, opportunities and challenges • Introduction of Japanese regulatory environment and biosimilars market 15:00 Afternoon refreshments • PMDA’s new guidelines on follow-on biologics • Opportunities and challenges 15:20 Comparability, biosimilars, “interchangeable biosimilars,” and current US legislation Mohamed Oubihi Senior Manager, International Regulatory Affairs • Comparability as a physical-chemical exercise: Limitations Biogen Idec and open questions • Biosimilars and the FD&C Act: Biosimilars and the US Public 11:00 Morning refreshments Health Service Act • Biosimilars and interchangeability 11:20 Impact of healthcare reform on biosimilars in global • Biosimilars and “proper names” biosimilars development William Egan, Ph.D • Anti-trust aspects (comparing FTC latest reactions as well as its Vice President June 2009 report) PharmaNet  • Patent aspects and the creation of new “Orange book-like system”  • Regulations promulgated pursuant thereto 15.40 Unwanted immunogenicity of biologicals and biosimilars Liz Fuller Director, Life Sciences Regulatory (US qualified) • The problems of unwanted immunogenicity for biologicals Wragge & Co • Assessing unwanted immunogenicity • Guidance available, including regulatory guidance 12:00 Biosimilar erythropoietin: Uptake in Europe • Specific issues with immunogenicity of biosimilars • Rationale for biosimilar epoetins • Epoetin market factors Robin Thorpe Head - Biotherapeutics Group • EMEA regulatory environment National Institute for Biological Standards and Control • Clinical considerations Dr David Goldsmith 16:20 Closing remarks from the chair Consultant Nephrologist Guy’s Hospital and St Thomas’ NHS Foundation Hospital 16.30 Networking drinks 12:40 Networking lunch Take your discussions further and build new relationships in a relaxed and informal setting Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2010
  5. 5. Day 2 7th Annual Biosimilars Thursday 7th October 2010, London UK 09:00 Registration and refreshments 13:40 Believing in biobetters: Half-life and antigenicity • Global market overview for protein drugs • Future of biosimilars/biobetters 09:30 Opening address from the chair • Extending the half-life/duration of action of biologics • Efficacy and safety of PEGylated products 09:40 Developing a long-term commercial strategy Keith Powell for biosimilars CEO Polytherics • Challenges in commercialisation of biosimilars • Understanding the evolving US and EU market environment • Meeting the standards defined by the EMEA and US 14:20 Presentation TBC Dr Gillian Cannon Representative Executive Director - Commercial Operations Parexel Merck Bioventures 14:40 Afternoon refreshments 10:20 Revolutionising biosimilar development in the EU market • Are current regulations adequate?  • Navigating the complexity: Review of the EU guidelines 15:00 The regulatory approaches to chemicals and • Indentifying the risks and benefits for successful development biologicals - Is it time that the “Process is the Mateja Urlep Product” finally died?’’ Founder & CEO, Tikhe Pharma PANEL DISCUSSION Former Global Head of Marketing and Medical, Sandoz Panel members will be drawn from the speakers who take part on day one or day two. If you would like to submit a question to the panel, please email it to: maninder.paul@visiongainglobal.com 11:00 Morning refreshments Panelists: Jeff Edwards Development Director 11:20 Overcoming CMC challenges for successful Polytherics biosimilars development • CMC: Effective process development & biologics manufacturing • Establish knowledge-based process strategy early using QbD & PAT • Development capabilities and infrastructure requirements 15:40 Emerging markets: A spotlight on Asia • Understanding the dynamics of the Asian markets • Benefits and risks of outsourcing the development of biosimilars 12:00 Global P&R models for the biosimilars and generics market • Explore partnership opportunities • Health economic challenges of R&D, registration, P&R of biopharmaceuticals and biosimilars 16:20 Chair’s closing remarks • Identifying inherent differences in safety, effectiveness and costs • Adopting innovative mechanisms such as risk-sharing arrangements Michael Dilger 16:30 End of Conference Senior Director Simon-Kucher & Partners 12:40 Networking lunch
  6. 6. Registration Form 7th Annual Biosimilars 5th - 7th October 2010, London UK Angel For multiple bookings Pentonville Road Photocopy this form Conf. code VG 7th Annual Biosimilars C Ci ty Ro 5th - 7th October 2010 ad Standard Prices Location: BSG Conference Centre Conference and workshop Fee: £1699 VAT: £297.33 Total: £1996.33 Old Street Address: Conference only Fee: £1299 VAT: £227.33 Total: £1526.33 Old Street 226-236 City Road Workshop only Fee: £599 VAT: £104.83 Total: £703.83 London EC1V 2TT City Road Promotional Literature Distribution UK Distribution of your company’s promotional literature to all conference attendees Fee: £999 VAT: £174.83 Total: £1173.83 Details How to book Forename: Surname: Email: conferences@visiongainglobal.com Web: http://www.visiongain.com/biosimilars Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100 Main Switchboard Number: Fax: +44(0) 20 7549 9932 Visiongain Ltd Address: BSG House 226-236 City Road London EC1V 2QY UK Country: Postcode: General information Venue: Directions: BSG Conference Centre 226 – 236 City Road, London, EC1V 2TT. United Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, Email: http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340 Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices. 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 Methods of payment after one month before the start of the event. 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By Fax: Complete and fax your signed registration form with your credit card details 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 +44 (0) 20 7549 9932 customer by credit card prior to the changes being made. By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or By Bank Transfer: expenses, which may be incurred by the customer as a consequence of the event being postponed or Visiongain Ltd A/C: visiongain Ltd cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses. Barclays Bank Sort Code: 20-71-64 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Piccadilly Branch Account No: 6038 7118 Protection Act 1988. Your personal information contained in this form may be used to update you on 48 Regent Street Swift Code: BARC GB22 visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We may also share your data with external companies offering complementary products or services. If you London W1B 5RA, UK IBAN: GB80 BARC 20716460387118 wish for your details to be amended, suppressed or not passed on to any external third party, please send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, Please debit my credit card: EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. Access MasterCard Visa American Express 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 visiongain Ltd during the transitional period, whilst the changes are coming into effect. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. Card number: This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain). VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT Expiry Date: incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. Security number (last 3 digits on back of credit card): 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. Signature: Unable to attend Cardholder’s name: Obviously nothing compares to being there but you need not miss out. Simply tick the box and send with your payment. You will receive your copy of the event CD Rom two weeks after the event. Yes, please send me a copy of the CD for Price£550 VAT:£96.25 Total:£646.25 News updates Office use only Please tick if you do not want to receive email news updates in the future www.visiongain.com/biosimilars