8th biosimilars congregation 2016

1. “Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars” 08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK Key Speakers Include Uwe Gudat, Kenneth Walsh, Paul Greenland, Edward Ghabour, Atakan Yesil, Laurent Rebier, Cecil Nick, Carsten Brockmeyer, Omar Ali, Alex Kudrin, Steinar Madsen, Alan Sheppard, Bernd Liedert, Malcolm I Mitchell, Merck, Head of Safety, Biosimilars Head Emerging Markets Pricing Vice President – Biologics Head of Marketing & Sales Operations (MSO) and Strategic Planning Market Development & Reimbursement Manager Sr.Clinical Program Leader Biosimilars Senior Medical Fellow, Clinical Pharmacology Director Business Development Vice President, Biotechnology CEO Pharmacy Consultant VP and Head of Global Development Medical Director Principal, Global Generics, Thought Leadership GSK, Hospira, Novartis (Egypt), Abbott (Turkey), Merck Biosimilars, PAREXEL, Formycon AG, QIPP Adviser Payer Network ERG panel Celltrion (Korea), Norwegian Medicines Agency, IMS Health, Boehringer Ingelheim, Eli Lilly, & (Former member NICE cost modeling ) Francis P. Crawley, Karsten Roth, Duncan Emerton, Sandy Eisen, Mikhail Samsonov, Christopher Holloway, Dominic Adair, Maarten Meulenbelt, Anna Harrington - Morozova, Good Clinical Practice Alliance – Europe (GCPA) European Academy of Paediatrics (EAP), & Member, Ethics Working Group, Executive Director Director Clinical Operations Senior Director, Syndicated Insights & Analysis Chief Medical Office Chief Medical Officer Group Director of Regulatory Affairs Partner Partner Scientific & Regulatory Director Cinfa Biotech, FirstWord, Frontline Pharma Consulting, R-PHARM, ERA Consulting, Bristows, Sidley Austin, Regem Consulting, Plus Many More..

2. 8th Biosimilars Congregation 2016 08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK Dear Colleagues, Biosimilars market is going to heat up considerably in the next three years. Biosimilar versions of a number of major biologic drugs used in the treatment of cancers and rheumatic diseases are expected to complete their development and potentially come on to the market. In order to ensure the sustainability of public healthcare systems, in the context of ageing populations and growing incidence of chronic diseases, it will be essential to harness to potential of biosimilars to deliver savings, so that greater numbers of patients can be treated with these medicines. The development of the Biosimilars market is growing exponentially with the industry forecast to be worth $25 billion by 2020. This conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. Hence, this 4th Biosimilars Congregation 2014 will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects. This Biosimilars conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, biosimilar products to the market place. By attending this conference you will gain a comprehensive outlook on the key issues surrounding biosimilars. This event will provide an important platform for Biosimilars stakeholders to discuss and share best practices in expediting Biosimilars development. It gives me great pleasure in welcoming all of you to the Virtue Insight’s 8th Biosimilars Congregation 2016. Regards, Fen Castro Head Productions Virtue Insight ORGANIZED BYORGANIZED BY SUPPORTED BYSUPPORTED BY FOR SPONSORSHIP OPPORTUNITIES:- Sponsorship or exhibition is the best way to speed network with decision makers. The world leader speakers in our conferences attract niche delegates from all over the world. This would be a wonderful opportunity to reach the right audience and save money and time on all your other advertising gimmicks. To give you an advertising edge we constantly update the industry pioneers via emails/news letter about the event and advertise the event via different forms of media. Sponsorship Enquires - sponsor.uk@virtueinsight.com FOR DELEGATE REGISTRATIONS:- Our potent conference agenda delivering the latest information and the world class leaders as speakers attract delegates to attend from around the world. We aim for our attendees to be equipped with knowledge of latest developments & enable them to network with the industry key personnel. Delegate Registration - sponsor.uk@virtueinsight.com SILVER SPONSORSILVER SPONSOR

3. 8th Biosimilars Congregation 2016 08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK SPECIAL REASONS TO ATTEND • Current market trends and future challenges for biosimilar success • Biosimilar development in emerging markets • Payer Perspectives on Biosimilars - Current & future landscape with key drivers for NHS payers • Redesigning the biosimilar business model: What is the optimum business model for biosimilars? • Commercial challenges and opportunities - strategies to develop Biosimilars • Leading Biosimilars companies share their views and strategies on successful market penetration and learn to implement best practices through recent successful strategies and business models – real time case studies • How do payers see biosimilars and where the market is going? • Developing successful business models and dealing with every ambiguity in biosimilar product development • Advances in biosimilar clinical development and resulting regulatory challenges and opportunities • Non-Clinical Studies in biosimilars development • Biosimilars development and impact on clinical practice • Capturing the mAb biosimilar opportunity • Research-based industry biosimilar strategies • Gain in-depth knowledge on role of technology transfer - How does this effect market access? • Considerations for the analytical similarity assessments when designing a biosimilar development program • Determining the right investments & potential returns from Biosimilars • Understanding the current regulatory approval standards for Biosimilars in Europe, US and ROI including for monoclonal antibodies • Be part of a major networking opportunity AN EVENT TO VOW Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins. WHY EXHIBIT? Make Sales Debut new products Profile your brand Meet new business partners Develop key relationships Educate pharma and biotech companies WHO WILL YOU MEET CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles: Biopharmaceuticals/ Biotherapeutics, Follow on Biologics/Follow on Proteins/Biosimilars, Biologics/Biotechnology/ Biogenerics Legal Affairs, Intellectual Property, Health Economics, Pricing and Reimbursement, Clinical Immunology, Principal Scientist Chief Scientific Officer, Process Control and Analytical Technologies, Analytical Characterisation, Regulatory Compliance Pharmacovigilance, Drug Safety & Risk Management, Quality Affairs/ Quality Control, New Product Development, Process Science Portfolio Management, Research & Development, Business Development, Business Operations, Scientific Affairs, Commercial Affairs Marketing

4. 08:30 – Coffee and registration – 09:30 – Chairperson opening remarks FirstWord 09:40 – Market access in the EU market and the way forward IMS Health 10:20 – Just Biosimilar or even interchangeable ? Boehringer Ingelheim 11:00 – Morning Coffee/Tea & Discussion An opportunity to meet and to network with your conference colleagues. Senior Director, Syndicated Insights & Analysis, • Biosimilars – Market strategies and techniques to overcome the hurdles • Considerations for successful market of biosimilars • Market access experiences with initial biosimilars • Payer perception of antibody biosimilars • Surveying the battlefield: how are the key players lining up? • The way forward Principal, Global Generics, Thought Leadership, • Impact of comparability and compatibility issues on anti-drug antibody formation • New formulations and immunogenicity • Clinical design: Eligible population and study duration • Dealing with improved immunogenicity profiles • Methodical challenges for post-authorization studies Sr.Clinical Program Leader Biosimilars, DUNCAN EMERTON, ALAN SHEPPARD, BERND LIEDERT, 12:00 – “Education a key component in securing stakeholder confidence and enabling market success” Merck 12:40 - Networking luncheon 13:50 – Topic TBC Formycon AG Head of Safety, Biosimilars, CEO, UWE GUDAT, CARSTEN BROCKMEYER, CECIL NICK, STEINAR MADSEN, 14:20 – Navigating the mAb biosimilar regulatory maze PAREXEL 15:00 – Afternoon Tea/Coffee 15:20 – Biosimilar infliximab – lessons for future biosimilar monoclonals Norwegian Medicines Agency 16:00 – Solution Provider Presentation • Ensuring quality before embarking on clinical Development • Ranking the importance of critical quality attributes • Analysing the monoclonal antibody • Guidelines: How to get regulatory approval of your mAb • Developing Biosimilar Mabs for EU vs. US vs RoW • The challenge of indication extrapolation for mAb Biosimilars • Drivers and barriers for mAb uptake:aligning the players Vice President, Biotechnology, Medical Director, For sponsorship opportunities please contact info.uk@virtueinsight.com DAY ONE 08th MARCH 2016– 11:20 – Keynote Panel Discussion: Market Challenges and Opportunities • Market opportunities for biosimilars – How about biosimilars coming through the R&D pipeline? • How to overcome some of the common developmental stumbling blocks that are being faced within the biosimilar sector? • What characteristics of biosimilar partnerships are critical in developing commercially successful biosimilars? • What is expected from the pricing strategy for this biosimilar? • How can payers and industry work together to ensure that innovative and valuable treatments make it to the market? • How do payers see biosimilars and where the market is going? 8th Biosimilars Congregation 2016 08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK CHALLENGES & OPPORTUNITIES MARKET OVERVIEW & ANALYSIS Moderator: FirstWord Panellists: GSK Hospira Eli Lilly Celltrion (Korea) Senior Director, Syndicated Insights & Analysis, Head Emerging Markets Pricing, Vice President – Biologics, Senior Medical Fellow, Clinical Pharmacology, VP and Head of Global Development, DUNCAN EMERTON, KENNETH WALSH, PAUL GREENLAND, MALCOLM I MITCHELL, ALEX KUDRIN, BUSINESS MODELS

5. 17:10 Chairperson’s closing remarks and end of conference– 08:30 – Coffee and registration – 09:30 – Chairperson opening remarks FirstWord 09:40 – Understanding and reviewing current data regarding the hurdles in commercialisation of biosimilars 10:20 – Forming strategic partnerships and alliances to access new opportunities in emerging markets Novartis (Egypt) 11:00 – Morning Coffee/Tea & Discussion 11:20 – Payer Perspectives on Biosimilars Current & future landscape with key drivers for NHS payers An opportunity to meet and to network with your conference colleagues. Senior Director, Syndicated Insights & Analysis, • Getting a correct balance between cutting costs and treating more patients? • Payer perceptions of biosimilars, and key areas of focus • How influential are payers in the speed in which biosimilars are taken up in healthcare systems? • Enabling patentability of biosimilars to facilitate commercial profitability • What are the pricing and market access challenges associated with biosimilars within these markets? • Determining the right investments & potential returns from Biosimilars • Pricing of biosimilars in the future • Various partnership models • Partner’s selection criteria, and • Key success factors in general • Specific examples from Egypt’s experience Head of Marketing & Sales Operations (MSO) and Strategic Planning, • NHS Fiscal Landscape & Funding streams for medicines • National Guidance on Biosimilars from NICE and key issues for translational to Regional Uptake • Models for aggressive reimbursement from NHS Commissioners, inter-relationship with NHS providers and Clinical engagement models • Phased Introduction of Biosimilars within RA, Dermatology & GI/IBD within current NHS Commissioning Models, PbR issues & innovation trade-offs • Payer's perspectives on applicability of evidence and licensing, EMEA & regulatory issues • Payer's perspectives on the concept of "biosuperiors" and perceptions on biosimilar marketed by 'Big Pharma' – DUNCAN EMERTON, EDWARD GHABOUR, 8th Biosimilars Congregation 2016 08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK 17:20 - 18:10 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting DAY TWO 09th MARCH 2016–16:30 Panel Discussion: Developing successful business models and dealing with every ambiguity in biosimilar product development Moderator: FirstWord Panellists: Merck Biosimilars Frontline Pharma Consulting R-PHARM – • What is the optimum business model for biosimilars? • Which are the emerging markets that represent the greatest commercial opportunity for biosimilars and why? • What are the funding opportunities for biosimilars within the emerging markets? • Global commercialisation strategies: How to strategically build a global biosimilar portfolio • Project management strategies for long-term biosimilar development projects Senior Director, Syndicated Insights & Analysis, Director Business Development, Chief Medical Officer, Chief Medical Officer, DUNCAN EMERTON, LAURENT REBIER, SANDY EISEN, MIKHAIL SAMSONOV, COMMERCIALISATION & MARKET ACCESS

6. 15:50 – Biosimilar litigation is born Bristows 17:00 Chairperson’s closing remarks and end of conference FirstWord 17:10 – End of the 8th Biosimilars Congregation 2016 • A look at the recent Herceptin cases from the UK • Comparing to the Neupogen litigation in the US • Reasons why the litigation started • Future predictions as to what’s next Partner, Senior Director, Syndicated Insights & Analysis, – DOMINIC ADAIR, DUNCAN EMERTON, OMAR ALI, KARSTEN ROTH, CHRISTOPHER HOLLOWAY, ATAKAN YESIL, QIPP Adviser Payer Network ERG panel – Pharmacy Consultant, & (Former member NICE cost modeling ) 12:00 – Biosimilars development and impact on clinical practice 12:40 Networking luncheon 13:50 – Clinical development strategies; a mid size pharma perspective Cinfa Biotech 14:30 – What constitutes a successful biosimilarity package for a biosimilar monoclonal antibody ERA Consulting 15:00 – Afternoon Tea/Coffee 15:20 – Health policy environment in Turkey and impact on Biosimilar R&D and production Abbott (Turkey) • Will biosimilars increase access to biologic therapies in chronic debilitating conditions? • How are Biosimilars developed? • What are the regulatory challenges and expectations currently in the EU and what can we expect in the US? • What does an ideal legal/regulatory framework looks like for a successful Biosimilar model? • What impacts will we see in prescribers, payers and patients and what does this mean for drug developers? • Analysis on the current situation in terms of biosimilar infliximab • Recent regulatory guideline updates, impact for preclinical and clinical development programs • Clinical trial models to test for bioequivalence • Pk, PD and immunogenicity testing in clinical trials Director Clinical Operations, Group Director of Regulatory Affairs, • Macro Political & Economic Environment • Health Policy Environment • Incentives for Biotech products’ R&D and Production • Pricing & Reimbursement of Biosimilars • Interchangibility / Substitution of Biosimilars in Pharmacy Level Market Development & Reimbursement Manager, 8th Biosimilars Congregation 2016 08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK 16:20 – Panel Discussion: The developing regulatory framework in advanced and developing markets – for Today & Tomorrow Moderator: FirstWord Panellists: Good Clinical Practice Alliance – Europe (GCPA) European Academy of Paediatrics (EAP) Sidley Austin Regem Consulting ERA Consulting • The latest in regulatory thinking - Update and current trends for EU and US biosimilar approvals, new and future guidelines. What has changed? – Get yourself updated. • What is the best way for industry to present data to the regulatory authorities? • Regulatory changes necessary to maximize biosimilars potential • How similar is similar? What is likely not to be accepted by the regulator? • What types of additional risk minimisation measures may be necessary? • IP and regulatory rights Senior Director, Syndicated Insights & Analysis, Executive Director, & Member, Ethics Working Group, Partner, Scientific & Regulatory Director, Group Director of Regulatory Affairs, DUNCAN EMERTON, FRANCIS P. CRAWLEY, MAARTEN MEULENBELT, ANNA HARRINGTON – MOROZOVA, CHRISTOPHER HOLLOWAY, PRECLINICAL & CLINICAL DEVELOPMENT REGULATION OVERVIEW & UPDATE

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8th biosimilars congregation 2016

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8th biosimilars congregation 2016