Global Pharma Outsourcing & Procurement Summit

Pharma Summit Division Global Pharma Outsourcing & Procurement Summit 11-12 June 2014 Maritim proarte Hotel, Berlin, Germany outsourcingevent.com Enhance your outsourcing strategies by benchmarking with small, medium and large pharma companies Programme

Day 1, 11 June 2014 08:00-08:50 REGISTRATION AND REFRESHMENTS 08:50-09:00 CHAIR'S WELCOME ADDRESS Opening Remarks Ryan Viegas Vice President Supply Chain & Procurement Watson Pharma Pvt Ltd, India (Actavis) 09:00-09:30 KEY CONSIDERATIONS WHEN DECIDING TO OUTSOURCE OR MANUFACTURE IN-HOUSE Controlling risk in the pharmaceutical supply chain through an overall sourcing strategy Creating a robust and resilient supply chain able to recover to an improved state of affairs Building flexibility and agility in order to overcome external changes through multiple sourcing partners Increasing speed to market whilst decreasing cost by harnessing existing specialist manufacturing capabilities Partnering in the right environment to get your product your way by assuring compliance David Traynor SVP Manufacturing and Pharmaceutical Science ProStrakan 09:30-10:00 EVOLVING TRENDS OUTSOURCING FROM EMERGING MARKETS The alternative perspective - Indian manufacturing for a global company Advantages and risks in CMO selection Managing vendor relationships to overcome cultural sensitivities and leverage skills Improving service level by satisfying requirements of product integrity and security Ensuring compliance on a domestic and international scale Ryan Viegas Vice President Supply Chain & Procurement Watson Pharma Pvt Ltd, India (Actavis) 10:00-11:50 PREARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS 11:50-12:20 PROCUREMENT EXCELLENCE IN EMERGING MARKETS OVERCOMING TECHNICAL, CULTURAL AND BUREAUCRATIC CHALLENGES: SUCCESSFUL TECHNOLOGY TRANSFER AND DEVELOPING A REGULATORY STRATEGY WHEN MANUFACTURING EXTERNALLY IN INTERNATIONAL MARKETS

MANUFACTURING IN ALGERIA AND NORTH AFRICA Building strong supplier partnerships in order to benefit from national investment Identifying partners and contractors initially through formal questionnaires and due diligence in order to circumvent the variation in supplier quality, including ethics and environmental aspects Technology transfer and manufacturing ramp up: overcoming technical as well as cultural and language challenges to benefit from the well-educated, but non-experienced local workforce Understanding national procedures, including legislation regarding importation and money transfer, in order to manufacture successfully and open up the North African market Successfully ensuring GMP inspections and continuity in supply chains Meeting GMP inspection requirements for new product registration in Russia/CIS, Turkey and MENA Examining CMO contributions to new product applications in Russia/CIS, Turkey & MENA Case studies: Turkey and Kazakhstan Anna Litsiou Senior Regulatory Affairs Manager Astellas Pharma Europe BV Knud E. Daugaard Senior Project Manager Novo Nordisk A/S Contract & License Manufacture 12:20-12:50 IT CASE STUDY Implementing a hybrid supply chain model to reduce cost and improve delivery performance Combining in-house and outsourced manufacturing to deliver a competitive advantage Reducing time to market through demonstrating advanced segmentation and supply chain analytics Cutting end-to-end costs by over 50% and increasing asset utilisation by 10%, whilst maintaining quality Bref O'Donovan Executive Director EMEA Supply Chain Lenovo 12:50-14:00 NETWORKING LUNCH 14:00-14:30 PROCUREMENT EXCELLENCE IN EMERGING MARKETS OVERCOMING CULTURAL DIFFERENCES: ENSURING COMPLIANCE WHEN MANUFACTURING IN INDIA Building a productive relationship with your CMO and avoiding miscommunication to ensure on-schedule delivery COLLABORATING SUCCESSFULLY WITH YOUR CMO TO CREATE BUSINESS GROWTH Aligning working practices through structured communication processes in order to form a successful partnership Understanding Indian culture and personal relationships importance Increasing on-schedule deliveries through extensive communication and follow-up Would hiring local employees improve service level and reduce misunderstandings? Main mistakes to avoid when manufacturing in India Cristina Encinas Supply Chain Director Farmaprojects S.A.U. Building a governance structure with appropriate parties at all levels in order to harness the expertise of your CMO Integrating vendors into the company management structure to maintain open communication and collaboration to meet long-term objectives Collaborating with smaller suppliers by incorporating banks as a third party to facilitate finance and allow business transactions Hitesh Varambhia Former External Manufacturing Business Manager, Combination Products and Devices & Small Molecules Europe F. Hoffmann-La Roche Ltd 14:30-15:00 PANEL DISCUSSION What is the future of the outsourcing/procurement model?

How will the amalgamation of suppliers affect multinationals? How to maximise benefit from the trend towards collaborative working? Will future regulatory changes mean more changes to the supplier relationship? Anna Litsiou Senior Regulatory Affairs Manager Astellas Pharma Europe BV Esa Nauska Director, Contract Manufacturing Orion Corporation Stefan Jung European Head of 3rd Party Procurement TEVA 15:00-15:30 NETWORKING REFRESHMENTS 15:30-16:00 PROCUREMENT EXCELLENCE IN EMERGING MARKETS MARKET ACCESS THROUGH LOCAL PRESENCE IN RUSSIA :?????????????????? How to comply with the Pharma 2020 program of the Russian authorities how can pharma operations effectively help pharma sales organisations to protect their market share in the Russian reimbursement market OPTIMISING SUPPLIER RELATIONSHIP MANAGEMENT AND COST- REDUCTION THROUGH IMPROVED MANAGEMENT OF PROCUREMENT INFRASTRUCTURE Successfully balancing the need for short-term savings, while simultaneously focussing on long-term supplier relationship development Developing long-term supplier relations in Russia by overcoming cultural differences: insights into the Russian soul for pharmaceutical engineers, EQ-survival kit Deadlines, budgets and Russian quality awareness: beyond good and evil The meaning of local presence: own plants versus partnerships; strategy is defined afterwards as whatever works or be cautious and invest in Russia? Jos Van Den Heuvel Director External Manufacturing ESI EMEA J&J Janssen Pharmaceutica, Johnson & Johnson Re-evaluating the system from supplier evaluation to supplier monitoring - developing a more mature SRM system Achieving savings whilst creating long-term sustainable relationships with suppliers, through cost-avoidance and non-standard savings Developing a fully-encompassing system to ensure no hidden costs surprises when working with your suppliers Michele Alba Head of Procurement, TMA & Chemical Business Grünenthal Farmaceutici Formenti 16:00-16:30 OVERCOMING THE HIDDEN CHALLENGES OF PROTECTIONISM TO REACH LUCRATIVE MARKETS Uncovering the different and hidden forms protectionism can take, including those not explicitly recorded by authorities Gaining market access in protective countries by harnessing local knowledge and skills through selective procurement Changing the mind-set towards total cost of ownership, not just price Minimising risk to reputation when building new local partnerships with a step-by-step risk assessment procedure Pre-empting protectionism in emerging markets including Saudi Arabia, Pakistan, Egypt and Algeria, in order to fully prepare for change Corinne Lagarde Procurement Director Middle East & North Africa GSK 16:30-16:40 CHAIR'S CONCLUDING REMARKS Closing comments Ryan Viegas Vice President Supply Chain & Procurement Watson Pharma Pvt Ltd, India (Actavis)

16:40-17:40 PROCUREMENT EXCELLENCE IN EMERGING MARKETS PROCUREMENT EXCELLENCE IN EMERGING MARKETS PROCUREMENT EXCELLENCE IN EMERGING MARKETS Asian Emerging Markets External Manufacturing in Europe Exploring the South American Market PROCUREMENT EXCELLENCE IN EMERGING MARKETS OPTIMISING VENDOR RELATIONSHIP MANAGEMENT OPTIMISING VENDOR RELATIONSHIP MANAGEMENT Africa the New Outsourcing Destination? How Do You Create a Robust Outsourcing Contract? Using Perfermance Metrics to Measure Strategic Partnerships Cost-Reduction Techniques Outsourcing to Smaller CMO's: Sense or Nonsense? Dr Jef Verplaetse Managing Director Laboratoria Smeets N.V. 17:40-18:40 NETWORKING DRINKS RECEPTION Day 2, 12 June 2014 08:50-09:00 CHAIR'S OPENING REMARKS AND REVIEW OF DAY 1 Review of Day 1 Evren Ozkaya Former Director, Strategic Planning & Director, Global Track & Trace Program Sandoz 09:00-09:30 FULFILLING THE GLOBAL SERIALISATION LEGISLATIONS COST-EFFECTIVELY WHILE ENSURING SECURITY OF SUPPLY Developing a complete and cost-effective serialisation program that delivers value beyond compliance and minimises disruption Understanding why we are doing serialisation, why this matters now and why it is the most complex project you will ever do 6-steps to design a cost-effective serialisation program, which minimises non-compliance risk and disruption How to select the right solution providers and technology vendors and how to build long term partnerships for success Managing the wide global variation and unpredictability by approaching serialisation requirements as a business strategy Focusing on the value beyond compliance and making visibility, collaboration and big data real via cloud networks Evren Ozkaya Former Director, Strategic Planning & Director, Global Track & Trace Program Sandoz 09:30-10:00

THINK TANK REDUCING COSTS WITHOUT COMPROMISING ON QUALITY Sharing ideas on the most efficient techniques on bringing down costs without compromising on manufacturing quality A chair-led discussion where breakout groups have the opportunity to debate various topics and then feed-back to the wider room An opportunity to network and share ideas with your peers Hitesh Varambhia Former External Manufacturing Business Manager, Combination Products and Devices & Small Molecules Europe F. Hoffmann-La Roche Ltd 10:00-11:20 PREARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS 11:20-11:50 PANEL DISCUSSION In which locations do the future of outsourcing and procurement lie? Can India's manufacturing capacity be expanded? Are cultural differences still a limitation when manufacturing in China? Are protectionism laws damaging the global market? Glenn Peace Director, External Manufacturing EMEA/AP Drug Product Bristol-Myers Squibb Company Patricia Galván Supplier Relationship Manager - Contract Manufacturing AstraZeneca Ryan Viegas Vice President Supply Chain & Procurement Watson Pharma Pvt Ltd, India (Actavis) 11:50-12:20 PROCUREMENT EXCELLENCE IN EMERGING MARKETS SUCCESSFULLY DEVELOPING A TECH TRANSFER STRATEGY BY OVERCOMING SUPPLIER CHALLENGES IN LATIN AMERICA From supplier selection to regulatory submission ensuring quality when transferring projects between suppliers Differences in supplier selection between Latin America and Europe Examining the milestones of a long-term 36 month project Overcoming the lack of clarity with regulations in Latin America Patricia Galván Supplier Relationship Manager - Contract Manufacturing AstraZeneca SUCCESSFULLY LEVERAGING SHARED SERVICES AND THIRD PARTY PROVIDERS TO CREATE A GLOBAL BUSINESS SERVICES MODEL Reducing costs by optimising business process outsourcing (BPO) to increase automation Optimising costs within financial shared services through global modelling to identify low-cost locations Achieving cost reduction by identifying the right technology to match business needs Creating business value realisation through the end-to-end process standardisation and automation to increase efficiency Enhancing the governance structure for effective performance management and stake holder engagement Anil Bhavnani Director - BPO Operations, Global Financial Solutions Pfizer Inc. 12:20-14:00 NETWORKING LUNCH 14:00-14:30

PROCUREMENT EXCELLENCE IN EMERGING MARKETS EXAMINING THE MOVE OF OUTSOURCING ACTIVITIES BACK TO EUROPE DISILLUSION WITH THE EASTERN PROMISE A step-by-step insight into the decision making process of outsourcing to Turkey, India or China CREATING A PERFORMANCE PLAN FOR YOUR VENDOR TO ENSURE PRODUCT DELIVERY Setting crucial KPIs to monitor and evaluate CMO performance and set strict targets Benchmarking costs and regulatory differences between outsourcing the manufacturing of APIs and fill/finish in Europe and emerging markets Demonstrating final cost outcomes of labour and energy figures across global manufacturing plants Balancing higher labour costs in Europe with savings from a KATA system philosophy, quality assurance from EU regulations and reduced logistical costs Recai Ozbir Supply Chain and Purchasing Director Abdi Ibrahim Pharmaceuticals Developing a structure of metrics to measure performance in a systematic way Defining requirements of the system in order to catch the complexity of evolving relationships Retaining flexibility by not using software and instead using a gradual evaluation system Andrea Calenne Sr Manager External Manufacturing Biogen Idec International GmbH 14:30-15:00 VESTED FIVE RULES THAT WILL TRANSFORM OUTSOURCING Creating enduring business relationships that provide greater value for all parties Presentation of the Vested business and contract model, based on research at the University of Tennessee How has companies like P&G, Microsoft and Dell achieved decreased costs, quality improvements and innovation in outsourcing What are the five rules that will ensure success when implemented in outsourcing relationships? David Frydlinger Certified Deal Architect University of Tennessee 15:00-15:30 MAXIMISING YOUR STRATEGIC SOURCING PERFORMANCE BY LEVERAGING YOUR PROCUREMENT OUTSOURCING PROVIDERS How strategic is your strategic sourcing organisation is it actually working to drive value? Developing a more strategic focus by shifting your organisational needs away from tactical or transactional solutions Highlighting the key benefits, challenges and lessons learnt within AstraZeneca s procurement outsourcing journey Adapting AstraZeneca s strategy to any organisation by applying these key lessons and making it happen in your company Benny Hall Procurement Outsourcing Leader AstraZeneca 15:30-15:40 CHAIR'S CONCLUDING REMARKS AND CLOSE OF SUMMIT Close of summit Evren Ozkaya Former Director, Strategic Planning & Director, Global Track & Trace Program Sandoz

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