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Book by 17 February to SAVE €250

Strategies in Pharma Outsourcing 23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany

Building profitable contract partnerships and driving successful collaborations through innovative CMO and CRO alliances

5 KEY REASONS TO ATTEND:

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Learn from 20+ experts from across the industry including Big Pharma, Generics, CMOs, CROs, Biotech and SME Pharma

Benefit from the experience and expertise of an outstanding speaker panel including: Amer Alghabban Director, Head of GCP Quality Assurance Audit Management Merck

Strategies in Pharma Outsourcing

•

Laurie Chipperfield Senior Director, Strategy, Sourcing, & Operations Pfizer

Discuss and debate the future of contract manufacturing and research and the practicalities of Giles Breault strategic vs. transactional Head of Productivity Service Solutions partnerships Novartis 23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany Ulrich Ruemenapp Discover essential strategies for Head Biotech Projects, Contract Manufacturing Biotech creating a cost-effective Bayer outsourcing network that meets your needs Maarten van Geffen Director Product Development Take advantage of exceptional Shire networking opportunities and

• •

dedicated 1:1 meeting sessions

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Choose from two bespoke streams, individually tailored for senior professionals looking for specific content on contract research or manufacturing

Richard Fazackerley Director - Global Technology Strategy, European Knowledge Centre Eisai Philip Pratten Vice President, Business Development, Contract Pharma Services Alkermes

PRE-CONFERENCE WORKSHOP

Lean pharma supply chain management | 23 April 2012, 1.00pm - 4.30pm Michail Heinmann, Visionary Officer, Camelot Management Consultants

Supported by:

Media partners:

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Strategies in Pharma Outsourcing 23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany

CPhI Conferences’ 5th annual Strategies in Pharma Outsourcing conference has established itself as the market-leading forum for the pharmaceutical outsourcing community, allowing you to discover new partnership models and contracting strategies to enhance your pre-clinical, clinical and commercial development.

Strategies in Pharma Outsourcing

Learn how to build new, more effective partnerships by adapting and updating your existing contracting model to capture value in new ways, providing your company with the crucial advantage in this ultra competitive industry. 23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany

This year a market-leading speaker line-up including senior executives from Merck, Teva, AstraZeneca, Wockhardt, Bayer, Pfizer, Novartis, Shire and Eisai will provide you with first-hand insight and expert analysis of their experiences in selecting, establishing and managing a successful contract partnership.

KEY THEMES AND TOPICS The conference programme has been strategically designed to provide you with content-rich plenary sessions together with dedicated streams covering contract research and contract manufacturing, allowing you to tailor the agenda to meet your business needs, including:

• • • • • •

Strategies for effective portfolio management Securing your supply chain - IP and patent protection Creating successful long-lasting partnerships and alliances First-hand insight on using CMOs for Biopharma Successful collaborations with CROs and biotechs A look at the strategic and operational future of contract manufacturing and research

HIGH LEVEL NETWORKING OPPORTUNITIES This year there are even more opportunities to meet your peers through enhanced networking sessions including:

Pre-scheduled 1:1 meetings using the online • meeting system of informal networking time • 6+An hours unmissable opportunity to meet the key • decision-makers from pharma companies involved in contract manufacturing and research Excellent prospects to acquire new leads and • business connections

WHO SHOULD ATTEND THIS EVENT? VP’s, Directors, Heads of: Outsourcing Supply chain Sourcing

Contract alliances Compliance External manufacturing

Procurement R&D sourcing Clinical outsourcing

Showcase your brand at Strategies in Pharma Outsourcing Maximise your company’s profile and meet key decision-makers face-to-face by sponsoring Strategies in Pharma Outsourcing. Take advantage of a highly effective means of promoting your business to a targeted group of senior executives with a specific interest in your products and services, in an intimate, knowledge-based environment. With sponsorship packages including exhibition stands, networking drinks and 1:1 meetings, we can create a tailor-made solution to meet your marketing requirements. Benefits of sponsoring include: • Opportunity to influence the audience at the conference • Access to the speaker platform to demonstrate thought leadership • Extensive pre-event publicity through multi-channel marketing campaigns reaching up to 45,000 pharma professionals • Prominent on-site branding opportunities and exhibition space • One-to-one meetings with decision-makers from across the globe • Complimentary delegate passes for senior executives and clients To find out how you can promote your business at Strategies in Pharma Outsourcing, please contact: Jamie Driver, Sales Manager – Life Sciences on +44 (0)207 955 3930 or email [email protected] Please note there are limited sponsorship opportunities available.

www.cphi-outsourcing.com

Strategies in 17 February Book by Pharma Outsourcing

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23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany

DAY Strategies 1 - Tuesday 24th April 2012 in Pharma Outsourcing

9.00am Chairman’s opening remarks

23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany

9.10am State of the market - industry analysis and the socio-political landscape • The industry impact of the EU crisis and wide-reaching US healthcare reform • Current and future trends and how they will affect the contract manufacturing and research markets • Does the market have LCC alternatives? Can Latin America or Central and Eastern Europe provide the solution? • What are the market opportunities for HPAPI production and is the west still the only real choice? 9.50am The strategic and operational future of contract manufacturing and research • Increasing competition with decreasing profits - how sustainable is the industry model? • Overcoming the conflicting management structures between contractors and pharma • Quality and efficiency - establishing the true value proposition • Achieving full integration - processes, skills, governance, technology, accountability and risk Marcel Velterop, Vice President, Global Head, Exclusive Synthesis, Jubilant Life Sciences 10.30am Morning refreshments and networking

TRACK A - CMO Breakout Session Preparing for a new era of strategic partnerships 11.00am Identifying your ingredients CMO - global decision-making criteria • Domestic or offshore CMO - is transcontinental sourcing worth the trouble? • Is API production moving back to the west? Where are the locations that hold true value? • Strategic or transactional outsourcing - is supplier consolidation the logical choice? Roger Cassidy, (Former) Procurement Director - Outsourcing, GSK 11.30am Manufacturing for pharma: A supply-side perspective • The costs of risk free compliance • The realities of successful cost reduction initiatives coupled with flawless execution • Importance of information to avoid scope change/creep and process development on the run • The importance of full transparency, both commercial and structural • Does price mean value? 12.00pm Managing the CMO relationship – the role of quality assurance • Vendor selection process • Auditing your suppliers – working in partnership for more effective results • Understanding and working successfully with different national and business cultures • How to implement best Corrective Actions & Preventative Actions (CAPAs) for audit findings: a win-win situation (Cost, Trust, and partnership longevity) Amer Alghabban, Director, Head of GCP Quality Assurance Audit Management, Merck

TRACK B - CRO Breakout Session Strategies for profitable CRO collaborations Clinical and pre-clinical outsourcing - securing your supply chain • The legal challenges when using CROs • The risks and benefits of differingCRO outsourcing models and how to select the appropriate levels of supervision and control • Overcoming the key challenges - practical points and process • Ensuring a successful relationship between sponsor and CRO • Global compliance issues Tali Guy, Advocate Associate General Legal Counsel, Global Branded Products, Teva Collaboration models between CRO and sponsor

• Encouraging input from both sponsor and supplier • Establishing effective project management through strong management and effective controls • What are the improvements in CRO’s offerings and capabilities? • Cost control through R&D outsourcing, but what are the risks?

Arnoud Huisman, Vice President, Global Business Development Early Development Services, PRA International CASE STUDY Establishing new market entry through effective CRO partnerships • Cooperation - the key to developing strategic partners and facilitating new market entry • Choosing your CRO of choice and establishing your supply chain • The importance of co-development and partnerships in emerging markets • Overcoming the 2 major hurdles • Regulation • Logistics Dr Siegfried Schmitt, Principal Consultant, PAREXEL

12.30pm Networking lunch

1.30pm

1:1 Dedicated networking session

An essential opportunity to arrange one-to-one meetings with key customers and new prospects and build new business relationships. Please use the online meeting scheduler to organise your meetings.

2.30pm An industry debate - suppliers and sponsors • Understanding the Big Pharma decision making process – what CMOs need to know • What can pharma do to facilitate effective and efficient contract negotiation? • How to create a culture of open and transparent dialogue • CMO and CRO issues – adapting to a changing market Roger Cassidy, (Former) Procurement Director – Outsourcing, GSK Marcel Velterop, Vice President, Global Head, Exclusive Synthesis, Jubilant Life Sciences Dr Deven Parmar MD, Vice President - Global Clinical Research, Wockhardt Stuart Hadley, Outsourcing Project Manager, AstraZeneca 3.15pm Afternoon refreshments and networking 3.45pm The realities of a one-stop-shop Strategic vs. transactional partnerships - identifying the model that works for you • What are the pros and cons of each model • Mitigating the risk of a strategic partnership • What does a strategic partnership actually mean or imply? • How should or could it be interpreted? • The need for the status to be conferred intentionally – both parties need to be willing to invest in developing the relationship Laurie Chipperfield, Senior Director, Strategy, Sourcing, & Operations, Pfizer

www.cphi-outsourcing.com

Strategies in 17 February Book by Pharma Outsourcing

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23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany

4.20pm Considerations and challenges of successful partnerships with the small virtual pharma model and the large pharma company • Strategic partnership between a major pharma and a ‘biotech’ are not the same in – selection criteria will be different and include stability, experience, expertise and track record success drivers • KeyStrategies costs) of dealing with the multiplicity of regulatory bodies Pharma (and Outsourcing • Complexities Increased regulatory agency pressure – quality and (GMP) compliance is a given; what else matters? • The importance of creating the right supplier agreements • Security (and assurance) of supply - setting up your support network: Quality support Regulatory support Supply chain support • Risk mitigation and IP protection Philip Pratten, Vice President, Business Development, Contract Pharma Services, Alkermes 23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany

5.00pm Chairman’s closing remarks and close of day one

DAY 2 - Wednesday 25th April 2012 9.00am Chairman’s opening remarks 9.10am OPENING ADDRESS Enhancing end-to-end productivity – creating a tool for success • Integrating the best elements of Lean and Six Sigma • Creating a combinational strategy for outsourcing, offshoring and procurement • Establishing a singular focused productivity tool that can operate across functions • Deriving value from external sources of spend as well as internal consumption and expenditure streams Giles Breault, Head of Productivity Service Solutions, Novartis 9.50am KEYNOTE ADDRESS Biopharma outsourcing - an industry insight • Identifying the key market growth of biologics and where the opportunities lie • With first-generation biopharmaceutical products now maturing – what are the outsourcing opportunities? • The increased use of CMOs by Biopharma as a strategic financial option • Focusing on next-generation products with higher revenues and margins through effective biopharma outsourcing • Will biologics contract manufacturing be the largest driver for CMO growth over the next decade? Ulrich Ruemenapp, Head Biotech Projects, Contract Manufacturing, Biotech, Bayer 10.30am Morning refreshments and networking

TRACK A - CMO Breakout Session Building a model for bio-strategic partnerships

TRACK B - CRO Breakout Session Creating profitable biopharma partnerships – utilising CRO collaborations

11.10am CASE STUDY Biopharma CMO outsourcing • Manufacturing and regulatory challenges for viable genetically modified organisms as API • ActoBiotics - genetically engineered Lactic acid bacteria to locally secrete therapeutic proteins • Discussion of the clinical product and process that was being outsourced to different CMOs • The manufacturing platform and selection strategy undertaken to choose the right CMO partners • Assessing and selecting sub-contractors for production, packaging, labelling and clinical supply Sam Corveleyn, Director CMC, ActoGeniX

INNOVATIVE PARTNERSHIP MODELS Lowering the financing hurdle - risk strategies for CROs • Risk assessment of (early stage opportunities by CROs and venture capitalists • Setting up workable risk sharing models between CROs and companies • Creating longer term collaboration between venture capitalists and CRO’s – what is the feasibility? Edward van Wezel, Managing Partner, BioGeneration Ventures

11.45am CASE STUDY (Virtual) biotech and CMO’s - ensuring successful product development • Choosing your CMO – considerations and challenges • Strategies for success – creating a successful partnership • Integrating the CMO’s skill set into your existing operation • Protecting your investment: Implementing robust contracts to mitigate potential risks • Ensuring effective and judicious communication Maarten van Geffen, Director Product Development, Shire

CASE STUDY Establishing sustainable CRO partnerships conditions for success • Creating a bond of trust and demonstrable transparency • Working as a team for consensus and consultation • Respecting each partner’s organisational mission and understanding expectations and limits • Sharing power, risks and responsibilities and investing jointly in resources • Encouraging commitment and permanency from stakeholders Dr Deven Parmar MD, Vice President - Global Clinical Research, Wockhardt

12.20pm ASK THE EXPERTS How to create a profitable biopharma manufacturing partnership Maarten van Geffen, Senior Director CM&C, Shire Ulrich Ruemenapp, Head Biotech Projects, Contract Manufacturing Biotech, Bayer Sam Corveleyn, Director CMC, ActoGeniX

ASK THE EXPERTS How to establish a workable relationship for your clinical and pre-clinical outsourcing Edward van Wezel, Managing Partner, BioGeneration Ventures Dr Deven Parmar, Vice President - Global Clinical Research, Wockhardt

12.30pm

Networking lunch

© UBMiBV 2012. This programme may change due to unforeseen circumstances. UBMiBV reserves the right to alter the venue and/or speakers.

www.cphi-outsourcing.com

Strategies in 17 February Book by Pharma Outsourcing

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23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany

2.00pm Creating successful partnerships and alliances • Creating an open dialogue between suppliers and sponsors contractor Strategies in relationships • Managing mutuallyOutsourcing agreed KPIs and sharing goals to ensure successful collaboration • Using Pharma • Creating a dedicated alliance team to establish more effective communication • Understanding the relationship between margin, liability, and execution Richard Fazackerley, Director - Global Technology Strategy, European Knowledge Centre, Eisai 23-25 April 2012, The Mövenpick Hotel Berlin, Berlin, Germany

2.40pm ASK THE EXPERTS: Legal Q&A: Securing your supply chain - IP and patent protection • Identifying and strengthening the weak points in your IP supply chain • Creating a robust contract with outsourcing partners to ensure full compliance • Assessment of time limits of IP rights and how it influences market entry strategies Tali Guy, Advocate Associate General Legal Counsel, Global Branded Products, Teva Qu Maio, Intellectual Property Lawyer, Partner, King & Wood Mark Penner, Intellectual Property Lawyer, Patent and Trade-Mark Agent, Partner, Fasken Martineau DuMoulin 3.20pm Afternoon refreshments and networking 3.50pm Creating an outsourcing strategy that works for you • Consolidation of supply: is a strategic partnership really the most cost effective option? • Moving your operation from a functional/transactional model to a fully strategic model • Managing the negotiations to avoid future complications • How to create an outsourcing network that is profitable as well as sustainable • How to mitigate risk and ensure full security of your supply chain Stuart Hadley, Outsourcing Project Manager, AstraZeneca 4.30pm MASTERCLASS: Effective portfolio management • Technical project management -involving scientists and technicians • Supply chain management - supervision from big pharma • Obtaining continuous tactical direction from big pharma • Active performance management - matrices, timelines and accountability Ulrich D. Korneck, Managing Consultant, Camelot Management Consultants 5.00pm Chairman’s closing remarks and close of conference

Pre-conference workshop Monday 23 April Lean pharma supply chain management CPhI Conferences present a unique opportunity to learn first-hand strategies to implement the most efficient and effective supply chain management models currently available. Delivered by one of the leading practitioners in the field of Lean SCM this is a must-attend event for any professional engaged in supply chain optimisation and value chain efficiency. The management of the pharma value chain of process industries is currently facing the challenges of variability and complexity as well as an enormous complicity of planning and co-ordination methods. This leads to dissatisfying service, excessive inventories and nervousness of the asset utilisation. This interactive, specialist workshop will provide an in-depth focus on the adaptation of this philosophy to the pharma value chain planning and scheduling area and present a new paradigm – Lean SCM. The instruments of this paradigm have been successfully implemented in many projects by numerous pharmaceutical companies.

WORKSHOP AGENDA 1.00pm Registration and networking

2.30pm How to prepare for a Lean SCM journey

1.30pm Leader’s opening remarks

3.00pm Refreshments and networking

1.50pm Why do we need a new planning paradigm in the pharmaceutical industry • What are the major principles of Lean supply chain management? • Lean on the demand side: Do we still need a forecast? • Lean on the supply side: How to take assets and products? • Lean end-to-end: How to synchronize an entire value chain?

3.00pm How to master a Lean SCM journey in a pharmaceutical value chain • Strategic, tactical and operative Lean SCM processes • Organization, culture and people • IT systems and performance management 4.30pm Close of workshop and discussion

The workshop will present a framework for the implementation of Lean SCM from different perspectives, including: strategy alignment, strategic, tactical and operative processes, organizational aspects, performance and IT support. Don’t miss your chance to learn business-critical skills in an informative and interactive environment.

YOUR WORKSHOP LEADER Michail Heinmann, Visionary Officer, Camelot Management Consultants AG Michail has more than 10 years of professional experience with a strong focus on management consulting, organization and business transformation. He also has extensive experience in end-to-end value chain management in the pharmaceutical industry with more than 15 projects in different areas from sourcing to distribution with major pharmaceutical companies. Michail is a recognised innovation leader, publication author and speaker. ICSE (International Contract Services exhibition) is the longest running co-located event of CPhI Worldwide and connects the pharmaceutical community with outsourcing solution providers, offering a global platform for business development, networking and education. Part of the worlds leading Pharmaceutical networking event with over 22 years experience plus more than 2000 exhibitors from 140 countries attend ICSE and the co-located events. ICSE is not just a B2B trade show, there’s rich content too! Over 40 dedicated free to attend seminars plus industry experts discussing the future trends in Pharma Outsourcing in the numerous conferences run by the renowned CPhI Conferences team.

For more information visit www.icsexpo.com

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Strategies in Pharma Outsourcing Strategies in Pharma Outsourcing

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23-25 April 2012, Mövenpick Hotel Berlin, Berlin, Germany

BOOKING RATES Full conference (including workshop) €1,648 + VAT @ 19% = €1,961.12

EARLY BIRD PRICE Book up to and including 17 February 2012

STANDARD PRICE Book after 17 February 2012

Conference Only: + VAT @ 19% = €1,664.81

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GROUP BOOKING RATES AVAILABLE Please call us for bookings of 3 or more on +44 (0)20 7921 8039

Full conference (including workshop) €1,898 + VAT @ 19% = €2,258.62 Conference Only: + VAT @ 19% = €1,902.81

Venue details Mövenpick Hotel Berlin, Schöneberger Strasse 3, 10963 Berlin, Germany

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9. To the maximum extent permitted by law, neither the Organiser nor any of its directors, employees or other representatives will be liable for any of the following losses or damage (howsoever arising and whether such losses were foreseeable or not): loss of profit; loss of revenue; loss of business or opportunity; loss of reputation or goodwill; and/or any indirect, consequential or special loss; whether arising in connection with the Conference or the provision of our services to you. 10. Nothing in these terms and conditions shall exclude the Organiser’s liability for (i) death or personal injury as a result of its negligence; (ii) fraud or fraudulent misrepresentation; or (iii) any liability that cannot be limited or excluded by law. 11. These terms and conditions and any dispute or claim arising out of or in connection with them or their subject matter, shall be subject to English law and the exclusive jurisdiction of the English courts. VAT: Under EU Customs and Excise regulations delegates are required to pay VAT on any conference taking place within the EU. Delegates may be entitled to reclaim this cost. In conjunction with Tax Back International VAT Reclaim, the world’s leading VAT recovery organisation, you can make a significant reduction on your attendance costs. For more information please contact Tax Back International on Tel: +353 1 878 3361.

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