GENERICS AND BIOSIMILARS STRATEGIES EMEA

Transcription

1 ADVANCE ANNOUNCEMENT PROGRAMME GENERICS AND BIOSIMILARS STRATEGIES EMEA September 2011, Hotel Novotel, Istanbul, Turkey Exclusive IEIS Discount - BOOK NOW TO SAVE E200 Strengthening your global position and protecting margins through expansion, innovation and differentiation Key features: 25 sessions led by senior industry executives and expert analysts 3 key themes explored in detail pricing and reimbursement, global markets focus and innovation and differentiation strategies Turkish market masterclass featuring practical information and invaluable networking 4 pre-scheduled 1:1 meetings with potential partners or collaborators 7+ hours of informal networking opportunities PLUS, don t miss Understanding and exploiting the potential of biosimilars half day workshop taking place on Thursday 29th September 2011 Hear up-to-date analysis and strategic insight from: Chrys Kokino Sandoz Biopharmaceuticals Nezih Barut IEIS & Abdi Ibrahim Pharmaceuticals Dr. Richard Peck FINOX Biotech Dr. Deepak Murpani Genepharm Group Dr. Nicola Travierso NTC Pharma Jo Pisani PwC Greg Perry European Generic Medicines Association Official partner: Knowledge partner: Media partners:

2 A unique opportunity for senior executives to focus on essential business issues relating to generics and biosimilars and network with peers primarily operating in Europe, the Middle East and Africa. It s estimated that drugs worth nearly $25 billion in sales will come off patent in Strategic alliances and M&A activity looks set to increase. And attention is turning to booming consumer markets around the world. The dynamics of the industry are changing rapidly and CPhI Generics and Biosimilars Strategies EMEA Conference is a timely opportunity to focus on tackling the key strategic and business development issues that result. Why are we holding this conference in Turkey? Given global interest in its booming generics market and its position at the very heart of EMEA, we re delighted to be launching this conference in Istanbul. In close association with the Turkish Pharmaceutical Manufacturers Association (IEIS) we will bring together key national players, providing delegates with invaluable market insight plus unique business and networking opportunities. Key event highlights: DAY 1 Global market trends and strategic insight from generics and big pharma companies Securing regulatory approval in EU and non-eu markets Pricing and reimbursement for generics and biosimilars Global market snapshots including India, Russia, CEE, USA and Brazil One-to-one networking and drinks reception DAY 2 Innovation and differentiation strategies including super generics, niche generics, biosimilars and biobetters Extended networking lunch Turkish market masterclass examining new business opportunities, pricing, legal and regulatory considerations POST-CONFERENCE WORKSHOP Business opportunities and key market issues relating to biosimilars Regulation and registration pathways for biosimilars Biotech innovation and the potential of biobetters Who should attend? Senior executives from generics manufacturers, pharmaceutical manufacturers, biopharmaceutical manufacturers, distributors and wholesalers, API manufacturers, consultancies, law firms and investment banks, including those with responsibility for: Business development Commercial development Product development Sales and marketing Regulatory affairs Scientific research Technical operations Industry alliances and partnering In-licensing Sponsorship Opportunities: CPhI Conferences deliver the latest market trends, critical case study insights and exceptional networking opportunities through a programme of high-level conferences across Europe. Capitalise on the opportunity to build relationships with senior-level decision-makers by sponsoring CPhI s Generics and Biosimilars Strategies EMEA. Benefit from: to the speaker platform, presenting alongside pharma thought-leaders Access Extensive publicity through multi-channel marketing campaigns, reaching up to 45,000 pharma professionals Prominentpre-event on-site branding and exhibition space 1:1 meetings with decision makers across the globe Complimentary delegate passes forfrom senior executives and clients Pre-conference online networking opportunities For more details on how you can get involved, please contact: Richard Fahy, Sponsorship on +44 (0) or richard.fahy@ubm.com

3 ADVANCE ANNOUNCEMENT PROGRAMME DAY 1 - Tuesday 27 September Registration and refreshments Opening remarks from the Chair Jo Pisani, Partner, PwC Opening address Opening address Nezih Barut, Chairman, IEIS & Abdi Ibrahim Pharmaceuticals Nezih Barut, Chairman, IEIS & Abdi Ibrahim Pharmaceuticals Prof. Recep Akdag, The Minister of Health, Understanding EMEA s place in the global generic and biosimilars markets Exploring global trends and the evolving shape of the market Examining the R&D pipeline What are the future growth prospects? Identifying key geographic markets, product types and business development opportunities Evaluating the opportunities and challenges facing EMEA on the world stage Raymond De Vré, Principal, McKinsey & Company Building a successful generics portfolio in an increasingly competitive market Balancing quality against cost Exploring the commercial realities of dealing with low-price competitors Evaluating strategies for increasing margin and volume in the face of increasing market pressures Expanding into new markets Considering licensing, partnership or strategic alliance opportunities Pursuing differentiation strategies Spotting market opportunities and capitalising on them Understanding the strategies Big Pharma are developing to win in the global generics market Exploring the strategic drivers for developing a generics portfolio How will this new business model evolve? Evaluating market expansion and alliance strategies Leveraging the power of branded generics in receptive markets Considering lessons learned and future development opportunities Morning refreshments and networking Expert insight: Securing regulatory approval for generics and biosimilars Understanding the information that s required for generics versus biosimilars Evaluating the required investment of time, expertise and capital Proceeding as cost-effectively as possible Dealing with the increasingly complex requirements of the submission process in the EU Exploring the practicalities of non-eu states Securing approval in Russia, Jordan & Saudi Arabia PRICING AND REIMBURSEMENT Panel discussion: What do healthcare reforms in EMEA mean for generic and biosimilar pricing strategies? Expert panellists will address questions including: How are governments influencing demand for generics and generic uptake and what changes are on the horizon? What challenges and opportunities does this present for generics companies, SME pharma and Big Pharma? How can margins be safeguarded? How does the situation for biosimilars compare to that of generics? Greg Perry, Director, European Generic Medicines Association Country focus: Examining the German tender and rebate contracting system for generics and biosimilars Evaluating the system, its stated aims and results to date Understanding how companies are dealing with this situation The winners and losers Considering strategies for success in this market Opportunities and threats Exploring how the system is likely to develop - What are the implications for competition law? Lunch and networking GLOBAL MARKETS FOCUS Global snapshot: India Evaluating market developments in India, future trends and opportunities Considering the regulatory pathway for generic and biosimilars drugs Business challenges and opportunities What you need to know to succeed Understanding the growth strategies of Indian companies and their position on the world stage What threat might they pose to EMEA companies? Mapping out the growing potential for alliances and agreements with Indian generics companies Extended session: Focusing on the practicalities of entering European pharmerging markets A panel of expert speakers will deliver short market-specific presentations before taking your questions. Questions to be addressed include: What are the key market trends, regulation requirements and healthcare system considerations? What do customers expect and how important are branded generics? What is the best strategy for entering the market and securing growth? Are there opportunities for strategic alliances and licensing deals? What impact might biosimilars have and how should they be approached? Russia Poland Romania Ukraine Dr. Nicola Travierso, NTC Pharma One-to-one networking Each delegate will have the opportunity to arrange one 20-minute meeting with attendees of their choice, including speakers and sponsors Afternoon refreshments and networking One-to-one networking Each delegate will have the opportunity to arrange three further 20-minute meetings with attendees of their choice, including speakers and sponsors Global snapshot: USA Understanding market trends, dominant companies and opportunities for new players Exploring the developing regulatory situation for generics and biosimilars What you need to know Considering business challenges and opportunities for market penetration Global snapshot: Brazil Understanding market trends and projections for future growth in this semi-regulated market Evaluating the regulatory situation and the opportunities and risks it presents to those seeking to enter the market Considering the challenges and opportunities of operating in this market Close of day one Networking drinks reception To register:

4 Visit for latest speaker updates DAY 2 - Wednesday 28 September Registration and refreshments Chair s opening remarks Jo Pisani, Partner, PwC INNOVATION & DIFFERENTIATION STRATEGIES Examining the business case for developing a super generics portfolio Evaluating the financial, scientific and IP drivers for super generic development Identifying key players in super generics and their strategic approaches Understanding the cost, pricing and reimbursement implications of super generics How can you ensure good returns? Considering who is best placed to give credibility to these drugs Is it Big Pharma or generics companies? Dr. Deepak Murpani, Vice President Product Development Genepharm Group Case study: Carving a niche in the generics market to limit competition and maintain margins Examining the decision to pursue this strategy The pros and cons Understanding the product selection process and the regulatory, patent and legal issues faced Spotting opportunities in the market and capitalising on them Evaluating success to date and future development plans Dr. Nicola Travierso, NTC Pharma Evaluating the commercial opportunities of biosimilars and biobetters Examining the success of biosimilars and biobetters to date Where has there been growth? Considering business development opportunities - What patents are expiring in the next 5 years? Understanding the key challenges to entering this market, the level of investment required and strategies for ensuring success Understanding the global dynamics How can Europe best exploit its status as market leader? Chrys Kokino, Head of Global Marketing Sandoz Biopharmaceuticals Question and answer session Morning refreshments Panel discussion: New innovation and taking your generics strategy to the next level Building on the morning s sessions, our expert panellists will address your essential questions including: Where is innovation likely to come from in the next 5-10 years? How can you reformulate or change the delivery method to set your product apart? Do complex formulations or tricky therapeutic areas provide good ROI? What are the most exciting innovations in the generic and biosimilars pipelines? Which markets will be particularly responsive to innovation? Dr. Richard Peck, Director Regulatory Affairs, FINOX Biotech Dr. Deepak Murpani, Vice President, Product Development Genepharm Group Extended networking lunch TURKISH MARKET MASTERCLASS Keynote address: Evaluating the Turkish generics market and opportunities it presents Understanding growth and demand within the Turkish market Evaluating current production capabilities and the importance of quality and GMP standards Identifying leading industry players, new entrants and particularly the potential for licensing or partnership arrangements Considering market penetration opportunities within Turkey Dr. Selcuk Ozceada, Managing Director, Bosfor Bioscience Exploring the pricing and reimbursement situation in Turkey The practicalities of operating in this market Understanding the controls placed on generic and originator prices How are levels decided? Considering the likelihood of further price reductions and impact on the market Understanding the prescription limitations related to the reimbursement system Evaluating opportunities for OTC products Considering regulation, price and profit margin Turgut Tokgoz, Secretary, IEIS Securing access to the Turkish market The legal and regulatory implications Understanding the Turkish licensing system Examining the processes and standard timelines for importation into Turkey The implications of pre-registration independent GMP audits by Turkish MoH Understanding the regulations related to dossiers What one dossier per API means in practice Minimising the risks of technology transfers and licensing agreements Considering future developments and the potential impact of EU membership Prof. Serdar Alpan, Managing Partner, TNC Afternoon refreshments Case study: Pursuing a strategic alliance to build market-share in Turkey Considering different business models Out-licensing v. joint ventures Understanding the key drivers for creating this alliance Focusing on the practicalities of developing this relationship Who does what? Sharing key lessons and successes to date Celik, Elif Candan Karabagli, ChiefEczacibasi ExecutiveBaxter Officer, Gedikli, Marketing and Sales Cuneyt Abdi Ibrahim Pharmaceuticals Ibrahim Abdi Sedat Birol,Pharmaceuticals Executive Vice President, Healthcare Division, Eczacibasi Holding Panel discussion: What new opportunities are developing in the Turkish market? How is the biosimilars market likely to develop? What new innovations have been particularly exciting? How are manufacturing capabilities developing? Bas, BilimBilim Pharmaceuticals Erhan Erhan Bas, Pharmaceuticals Selamoglu, MN Pharmaceuticals Levent Ali Toker, CEO, Sandoz Pharmaceuticals Actavis Serdar Dr. AliSozeri, Akyildiz, IMS Turkey Partner, Managing Director, Antonio Levent Achille, Selamoglu, CEO, MN Pharmaceuticals Boston Consulting Group The Serdar Sozeri, Actavis Close of conference UBMi BV This programme may change due to unforeseen circumstances. UBMi BV reserves the right to alter the venue and/or speakers. Early Bird Discount ends 3 August 2011 BOOK NOW TO SAVE E100

5 27-29 September, Hotel Novotel, Istanbul, Turkey DAY 3 - Thursday 29 September 2011 Optional Post-Conference Workshop Understanding and exploiting the potential of biosimilars Refreshments and networking Opening remarks from the workshop leader Evaluating the business opportunities and key market issues relating to biosimilars Considering the definition of a biosimilar and market trends, particularly uptake of biosimilars and pricing trends Understanding the industry focus on monoclonal antibodies and the commercial implications Exploring Big Pharma and generics companies response to biosimilars - Understanding the main barriers to entry Understanding the business opportunities and realities, particularly the prevalence of strategic alliances Understanding the regulation and registration of biosimilars Examining the newly developed regulatory pathways in the EU and US What is required by EMA and FDA? Understanding how this compares to non-biological generics Exploring recent product approvals and extracting key learning points Considering future developments and the development of new and updated guidelines Dr. Richard Peck, Director Regulatory Affairs, FINOX Biotech Morning refreshments and networking Exploring the key issue of interchangeabilty and consumer uptake of biosimilars Bringing together science and business to address issues of quality and interchangeability Comparing the current biosimilars situation with similar concerns over generics 10 years ago What lessons can be learnt? Considering the naming of biosimilars and substitution policies in key markets Understanding prescriber reluctance around biosimilars and strategies for overcoming it Considering development and production requirements A strategic approach Understanding the practicalities What you need to be aware of Examining the skills and competencies required and where they can be found Evaluating opportunities for CMOs in this market Taking biotech innovation further Understanding the potential of biobetters How has the global market for biobetters developed and who are the key players? What opportunities are there and how can they be capitalised on? Developing a business case for the development of biobetters Commercial, scientific and IP considerations Group discussion Questions and key learning points from the session Close of workshop Official partner: Generics and Biosimilars Strategies EMEA at a glance This unique learning event features three key elements that you can combine to create an agenda that matches your strategic priorities: Conference sessions Benefit from business-focused insights from industry-leading speakers and one-to-one networking time to inform your own strategies, strengthen your global position and ensure you re making the most of opportunities presented by the patent cliff. Turkish market masterclass Take this opportunity to really focus on the realities of entering and operating in the Turkish market, hear from key players and build relationships that could be vital in supporting your own operations in this area. Biosimilars workshop Attend this half-day workshop to explore the business opportunities of biosimilars and biobetters and ensure you re up-to-date with the practicalities of operating in this area. Delegates can choose to attend any of the following combinations of sessions: SESSION COMBINATIONS Early bird rate Standard rate book up to and including 3 August 2011 book after 3 August 2011 Two Day Conference Only (including Turkish Masterclass) Two Day Conference Turkish Masterclass Turkish Masterclass Only Post Conference Workshop Only If you re interested in being a speaker please contact Emily Bright on emily.bright@ubm.com Tel: + 44 (0) conferences@ubm.com

6 GENERICS AND BIOSIMILARS STRATEGIES EMEA BOOKING RATES Early bird rate book up to and including 3 August 2011 Standard rate book after 3 August Sept 2011, Hotel Novotel, Istanbul, Turkey Conference code: IEIS Two Day Conference Only (including Turkish Masterclass) Two Day Conference + Turkish Masterclass Ways to Online: Telephone enquiries and group bookings, please call: +44 (0) Fax: +44 (0) conferences@ubm.com Post: CPhI Conferences, Ludgate House 245 Blackfriars Rd, London, SE1 9UY, UK Turkish Masterclass Only GROUP BOOKING RATES Why not enjoy the benefits of attending the event with your entire team by taking advantage of the generous group booking discounts? Call us on +44 (0) or conferences@ubm.com Venue: Hotel Novotel, Kazlicesme Mah. 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