Global Pharma Outsourcing & Procurement Summit

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Phar

ma S

ummit D

ivision

Programme

11 - 12 June 2014

Maritim proArte Hotel, Berlin, Germany

outsourcingevent.com

Global Pharma Outsourcing

& Procurement Summit

Enhance your outsourcing strategies by benchmarking

with small, medium and large pharma companies

(2)

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

KEYNOTE

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

KEYNOTE

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

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

OPTIMISING VENDOR RELATIONSHIP MANAGEMENT

DEVELOPING A REGULATORY STRATEGY WHEN MANUFACTURING EXTERNALLY IN INTERNATIONAL MARKETS

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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

Knud E. Daugaard

Senior Project Manager

Novo Nordisk A/S Contract & License Manufacture

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

12:20-12:50

KEYNOTE

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 mis-communication to ensure on-schedule delivery

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.

OPTIMISING VENDOR RELATIONSHIP MANAGEMENT

COLLABORATING SUCCESSFULLY WITH YOUR CMO TO CREATE BUSINESS GROWTH

Aligning working practices through structured communication processes in order to form a successful partnership

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

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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

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

OPTIMISING VENDOR RELATIONSHIP MANAGEMENT

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

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

KEYNOTE

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

(5)

Day 2, 12 June 2014

16:40-17:40

PROCUREMENT EXCELLENCE IN

EMERGING MARKETS

ROUNDTABLE DISCUSSION

Asian Emerging Markets

PROCUREMENT EXCELLENCE IN

EMERGING MARKETS

ROUNDTABLE DISCUSSION

External Manufacturing in Europe

PROCUREMENT EXCELLENCE IN

EMERGING MARKETS

ROUNDTABLE DISCUSSION

Exploring the South American Market

PROCUREMENT EXCELLENCE IN

EMERGING MARKETS

ROUNDTABLE DISCUSSION

Africa the New Outsourcing Destination?

OPTIMISING VENDOR RELATIONSHIP

MANAGEMENT

ROUNDTABLE DISCUSSION

How Do You Create a Robust Outsourcing Contract?

OPTIMISING VENDOR RELATIONSHIP

MANAGEMENT

ROUNDTABLE DISCUSSION

Using Perfermance Metrics to Measure Strategic Partnerships

OPTIMISING VENDOR RELATIONSHIP MANAGEMENT

ROUNDTABLE DISCUSSION

Cost-Reduction Techniques

OPTIMISING VENDOR RELATIONSHIP MANAGEMENT

ROUNDTABLE DISCUSSION

Outsourcing to Smaller CMO's: Sense or Nonsense?

Dr Jef Verplaetse

Managing Director

Laboratoria Smeets N.V.

17:40-18:40

NETWORKING DRINKS RECEPTION

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

KEYNOTE

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

Sandoz

(6)

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

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

OPTIMISING VENDOR RELATIONSHIP MANAGEMENT

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

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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

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

OPTIMISING VENDOR RELATIONSHIP MANAGEMENT

CREATING A PERFORMANCE PLAN FOR YOUR VENDOR TO ENSURE PRODUCT DELIVERY

Setting crucial KPIs to monitor and evaluate CMO performance and set strict targets

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

KEYNOTE

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

KEYNOTE

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

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11 - 12 June 2014

Maritim proArte Hotel, Berlin, Germany

outsourcingevent.com

Global Pharma Outsourcing

& Procurement Summit

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Global Pharma Outsourcing & Procurement Summit 2014

11 - 12 June 2014

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11 June 2014

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