Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars

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Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars Key Speakers Include Uwe Gudat, Merck, Head of Safety, Biosimilars

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

2 SILVER SPONSOR SUPPORTED BY Channel Partner in India: Bharat Book Bureau W: E: T: /

3 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 WHY EXHIBIT? 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. 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 DAY ONE 08th MARCH :30 Coffee and registration An opportunity to meet and to network with your conference colleagues. 09:30 Chairperson opening remarks MARKET OVERVIEW & ANALYSIS 09:40 Market access in the EU market and the way forward 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 ALAN SHEPPARD, Principal, Global Generics, Thought Leadership, IMS Health 10:20 Just Biosimilar or even interchangeable? 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 BERND LIEDERT, Sr.Clinical Program Leader Biosimilars, Boehringer Ingelheim 11:00 Morning Coffee/Tea & Discussion CHALLENGES & OPPORTUNITIES 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? Moderator: Panellists: KENNETH WALSH, Head Emerging Markets Pricing, GSK PAUL GREENLAND, Vice President Biologics, Hospira MALCOLM I MITCHELL, Senior Medical Fellow, Clinical Pharmacology, Eli Lilly ALEX KUDRIN, VP and Head of Global Development, Celltrion (Korea) 12:00 Education a key component in securing stakeholder confidence and enabling market success UWE GUDAT, Head of Safety, Biosimilars, Merck 12:40 - Networking luncheon 13:50 Topic TBC CARSTEN BROCKMEYER, CEO, Formycon AG 14:20 Navigating the mab biosimilar regulatory maze 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 CECIL NICK, Vice President, Biotechnology, PAREXEL 15:00 Afternoon Tea/Coffee BUSINESS MODELS 15:20 Biosimilar infliximab lessons for future biosimilar monoclonals STEINAR MADSEN, Medical Director, Norwegian Medicines Agency 16:00 Solution Provider Presentation

5 16:30 Panel Discussion: Developing successful business models and dealing with every ambiguity in biosimilar product development 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 Moderator: Panellists: LAURENT REBIER, Director Business Development, Merck Biosimilars SANDY EISEN, Chief Medical Officer, Frontline Pharma Consulting MIKHAIL SAMSONOV, Chief Medical Officer, R-PHARM 17:10 Chairperson s closing remarks and end of conference 17:20-18:10 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting DAY TWO 09th MARCH :30 Coffee and registration An opportunity to meet and to network with your conference colleagues. 09:30 Chairperson opening remarks COMMERCIALISATION & MARKET ACCESS 09:40 Understanding and reviewing current data regarding the hurdles in commercialisation of biosimilars 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 10:20 Forming strategic partnerships and alliances to access new opportunities in emerging markets Various partnership models Partner s selection criteria, and Key success factors in general Specific examples from Egypt s experience EDWARD GHABOUR, Head of Marketing & Sales Operations (MSO) and Strategic Planning, Novartis (Egypt) 11:00 Morning Coffee/Tea & Discussion 11:20 Payer Perspectives on Biosimilars Current & future landscape with key drivers for NHS payers 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'

6 PRECLINICAL & CLINICAL DEVELOPMENT 12:00 Biosimilars development and impact on clinical practice 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 12:40 Networking luncheon 13:50 Clinical development strategies; a mid size pharma perspective 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 KARSTEN ROTH, Director Clinical Operations, Cinfa Biotech 14:30 What constitutes a successful biosimilarity package for a biosimilar monoclonal antibody CHRISTOPHER HOLLOWAY, Group Director of Regulatory Affairs, ERA Consulting 15:00 Afternoon Tea/Coffee 15:20 Health policy environment in Turkey and impact on Biosimilar R&D and production 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 DOMINIC ADAIR, Partner, Bristows 16:20 Panel Discussion: The developing regulatory framework in advanced and developing markets for Today & Tomorrow 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 Moderator: Panellists: REGULATION OVERVIEW & UPDATE FRANCIS P. CRAWLEY, Executive Director, Good Clinical Practice Alliance Europe (GCPA) & Member, Ethics Working Group, European Academy of Paediatrics (EAP) MAARTEN MEULENBELT, Partner, Sidley Austin ANNA HARRINGTON MOROZOVA, Scientific & Regulatory Director, Regem Consulting CHRISTOPHER HOLLOWAY, Group Director of Regulatory Affairs, ERA Consulting 17:00 Chairperson s closing remarks and end of conference 17:10 End of the 8th Biosimilars Congregation 2016 ATAKAN YESIL, Market Development & Reimbursement Manager, Abbott (Turkey) 15:50 Biosimilar litigation is born 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

7 Door 8th Biosimilars Congregation 2016 FLOOR PLAN - Book your stalls now before they run out!!! S7 S1 S6 S5 S4 S2 S3 Door CONFERENCE HALL REGISTRATION DESK

8 08th & 09th March 2016 Registration Form For Multiple Bookings - Photo copy this form and send it to info@bharatbook.com; Tel: Delegate Delegate Details: Details: Title Mr Mrs Ms Dr First Name Surname Company Position Address FOR BANK TRANSFER: Account Name -M/S Bharat Book Bureau Account Number Bank Name -Citibank, India SWIFTCode: CITIINBX Your Preference: Special Offer: 3 for 2 Offer *Only few more seats left Postcode Telephone Fax How to Pay (Choose one of the following payment options) RESERVATION PRICING: Super Early Bird VAT per delegate (Valid Till 18th December 2015) Early Bird VAT per delegate (Valid From 19th December 2015 to 5th February 2016) Standard Rate VAT per delegate (Valid From 06th February 2016) PAYMENT: Please send me a VAT invoice I enclose a cheque for Please charge my card Card Number Security No Expiry Date / TERMS AND CONDITIONS: Payment terms: Bharat Book requires the full amount to be paid before the conference. We may refuse entry to delegates who have not paid their invoice in full. Cancellations: Delegates and vendor are subject to the following charges and refunds upon withdrawal or cancellation.between 2-3 month s prior 75% cancellation fee/ 25% refund.less than 2 months prior to the event Full cancellation fee / No refund. Administration Fee: If you cancel your participation (once confirmed) and haven t paid the attendance fee you will be liable to pay an administration fee of VAT Substitutions/Name Change: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. This can be done at not extra cost. Presentation: If you cannot attend the conference, you can still purchase the presentations for VAT Indemnity: Bharat Book 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 due to unfore seen events beyond the control of Bharat Book.If such a situation arises, we will refund your registration fee and we will try to reschedule the event. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel or hotel accommodation. Cardholder s Name Cardholder s Registered Address Signature Our purchase order no.is Payable to Bharat Book Bureau Card type: Visa Mastercard Maestro (Please note that we do not take Amex card payments)

Biosimilars Congregation 2012

Biosimilars Congregation 2012 24th February 2012, Hilton London Euston Hotel, London, UK Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies