Agenda Day One

08:00 Registration and Coffee

09:00 Opening remarks from the Chair:

Dr Patricia Lobo, Managing Partner, RSA

Pharma Market Trends and CMO Partnership Opportunities 

09:15    Analysing The Paradigm Shift In The Pharmaceutical Industry And The New Opportunities Opening Up For Contract Manufacturing

• Changing R&D and faster innovation routes - from large volume/small molecule products to small volumes of large molecule
• Increasing global demand for medication
• Cost effectiveness and cost reduction leading to capacity utilisation measures
• Assessment and management of patient-related safety issues

Dr Enrico Polastro, Vice President Senior Industry Specialist, Arthur D. Little

10:00    Capitalising On Global CMO Sourcing Trends - Opportunities For The Pharmaceutical Industry

• Analysing the effects of the changing face of the pharma industry on contract manufacturing
• Exploring CMO market growth per region and pharma sectors
• Examining CMO growth potential and forecast
• Understanding market developments and the effects of consolidation, mergers & acquisitions and new facilities

Jim Miller, President, PharmSource Information Services

10:45 Networking Coffee Break

11:15 Moving from transactional to strategic partnerships - Understanding big pharma requirements of contract manufacturers

• Identifying the complexities of the CMO client relationship
• Understanding the importance of quality assurance, regulatory compliance, technical capabilities and timescale
• Creating partnerships and strategic alliances with the CMO
• Re-evaluating value:cost,price and risk management

         Philip Sarbutt, Associate Director Sourcing, Wyeth

12:00    The Global Gravity Shift in Pharma Sourcing: Opportunities and Challenges            within Emerging Hotspots

• Pin-pointing the countries that excel in a variety of categories to meet your manufacturing sourcing needs
• Understanding the pace of development in emerging markets and calculating the optimum time to source
• Managing the potential pitfalls of sourcing in emerging markets

Bernhard Raschke, Partner, PricewaterhouseCoopers LLP

12:45 Networking Lunch

CMO Relationship & Performance Management

14:00    CMO Management: Ensuring Reliable Supply From External CMOs

• Implementing a structured business model
• Best practice approaches to management: performance, investment and resources
• Ensuring continuous improvements are taking place
• Maintaining an operational mechanism that ensures day-to-day control
• Risk limitation and product quality assurance

Dr Isabelle Conrot, Head of Global Contract Manufacturing, F. Hoffmann - La Roche

14:45    Examining That Factors That Make For A Successful Partnership

• Evaluating the importance of aligning the expectations of the two partners
• Good auditing and thorough due diligence before contract negotiation stage
• Gaining mutual agreement on performance parameters to ensure productivity from both parties

Dr Sheila W. Weir, Project Management Head, Newron Pharmaceuticals

15:30    The CMO Perspective: Understanding The Requirements To Ensure A Successful Partnership

• Understanding the CMO strategy and business model
• Exploring priorities for the CMO in terms of flexibility, cost reduction and speed-to-market
• Overview of latest innovations in the CMO capability and service offering
• Lessons learnt from partnering with big pharma, mid-small size pharma and innovative biotech
• Current trends and future outlook

Wouter Huizinga, Senior Director Sales and Business Development, Dr Reddy's Laboratories

16:15    Networking Coffee Break

16:45    Creating Value Through Contract Manufacturing For Biopharmaceutical Products

• Exploring the unique features of biopharmaceutical products and processes
• Assessing opportunities for utilising CMOs
• Pin-pointing the challenges of communication in the CMO-client relationship
• Understanding the importance of communication through the process - improving step-by-step communication

Joanne Nunn, Development Business Programme Director, Avecia Biologics

17:30    Panel Debate: Future Outlook For Contract Manufacturing In The Pharmaceutical Industry

• Evaluating the strategic approaches
• Developing strategies for avoiding potential pitfalls
• The long term viability of sourcing from low cost regions
• Bringing CMOs on similar levels of requirements on GMP and EHS standards
• Assessing the viability of the forecasted growth of CMO usage in the pharma industry

Panelists:

Philip Sarbutt, Associate Director Sourcing, Wyeth

Ranjana Pathak, Vice President Quality Assurance - Endo Pharmaceuticals

Karen MacGregor, Director Project Management - Catalent

18:00    Closing Remarks from the Chair

Day Two

08:00    Registration & Morning Coffee

09:00    Opening Remarks from the Chair: Jim Miller, President, PharmSource Information Services

CMO Opportunities

09:15    Understanding The Regulatory Landscape For Sourcing Third Party Manufacturing To Ensure Compliance, Quality And Product Safety

• Understanding the latest developments in European regulatory compliance
• Analysing the relationship between regulatory compliance and product safety and liability
• Reflecting the legal and regulatory requirements in the contracts
• Preparing for changes in regulation to ensure product safety of the final product
• Developing a robust risk mitigation strategy to the prevent negative consequences of non-compliance by the CMO

Paul Ranson, Partner, Fasken Martineau Stringer Saul

10:00    Identifying And Sourcing The Right CMO Partner For Your Particular Manufacturing Needs To Ensure Value For Money And The Highest Quality Of Service

• Analysing specific sourcing needs and requirements, understanding your most important parameters
• Meeting GMP and EHS standards by optimising your site audits
• Completing risk assessment and due diligence cost effectively
• Examining how to ensure local and European manufacturing regulation, quality and safety standards are met
• Understanding the pitfalls of entering new sourcing markets and how these can be avoided

Dr. Ranjana Pathak, VP, Quality Assurance, Endo Pharmaceuticals Inc.

10:45    Networking Coffee Break

11:15    An Introduction To Competitive Intelligence (CI) And Its Potential Application To CMO Deal Making

• Defining the Competitive Intelligence Cycle within a manufacturing context
• Examining the key criteria to third party manufacture as a basis to help frame key intelligence questions (KITs)
• Clarifying the manufacturing strategiees of immediate rivals
• Using CI from a CMO perspective to clearly differentiate its product offering from rival bidders
• Using CI from a pharma perspective to explore the complexity and limitations of sourcing from different CMOs
• Integrating CI into both business development and outsourcing decision making processes

Anthony J. Nagle, Managing Director, Fuld & Company Ltd

12:00    Reviewing The Decision Making Process - CMO Vs. In-House Manufacturing

• Examining the key criteria to third party manufacture
• Understanding the internal decision making process - is price the determining factor?
• Challenges of getting approval internally to third party manufacture
• Calculating unforeseen extra costs
• Safeguarding knowledge and IP rights
• Overcoming capacity limitations - exploring the complexity and limitations of sourcing from different CMOs

Jan-Gunnar Gustafsson, Senior Vice President Process Development and Manufacturing - Resistentia Pharmaceuticals

12:45    Networking lunch

14:00    Implementing Lean Product Development In A CMO Setting

• Exploring the key drivers, constraints and deliverables essential to achieving fast track development through to full production
• Understanding the need for an integrated multi-functional approach
• Examining lean techniques and processes to improve development speed, quality and cost
• Case studies of how the pharmaceutical companies and CMOs are meeting the new challenges

Karen MacGregor, Director, Product Development at Catalent Pharma Solutions

14:45    Exploiting The CMO Service Offering - Capitalising On A Growing Demand For Speciality Services

• Pin-pointing technology and product specific challenges
• Benefiting from utilising specialty technologies that the CMO can offer
• Driving down costs and ensuring safety standards are met through sourcing technology capability
• Understanding how to avoid pitfalls

Hans-Werner Prokasky, Vice President Business Development, Next Pharma Technologies

15:30    Afternoon Tea

16:00    Exploring The Opportunities And Risk Levels Of Low Cost Country CMO Sourcing - China & India

• Examining the challenges of sourcing in China and India and devising a strategy for overcoming these
• Assessing the risk in low cost countries - actual or perceived?
• Understanding how successful relationships can be developed
• Devising a strategy to ensure product control and regulatory compliance
• Meeting general standards, health and safety in low cost operations

Senior Representative, Dishman Pharmaceuticals & Chemicals

16:45   Chairman's Closing Remarks & End of Conference