Globally health core systems and reimbursement policies place major challenges for any innovative pharmaceutical company. Pressure on prices and with this on production costs will increase while additional demands in the areas of GMP, safety, traceability etc. must be covered. A globally rolled out Business Process Excellence program can be successful for significant improvement of competitiveness, where strategy is put into action by specific site missions translated into a global balanced score card.

Operational excellence in a biological drug substance manufacturing facility requires a concerted synergy between manufacturing, quality, and process development. As regulatory expectations increase, companies are challenged to maximize process understanding and demonstrate product comparability, while continuing to meet market supply through continuous improvement. The evolution of the commercial process for Enbrel® (etanercept) will be discussed, and an approach to continuous improvement as a result of lessons learned will be presented.

Christer Karlsson, Gpard Leader Product and Process Robustness, AstraZeneca addresses the implementation of an effective control strategy for QBD from a European and US perspective. He will highlight successful pilot projects at AstraZeneca and the subsequent strategy to manage the process.

Daniel Scheidegger worked in various functions in the chemical and pharmaceutical industry. For F. Hoffmann-La Roche AG in Basel, Switzerland, in R&D and as manager of chemical production. From 1987 to 1993 he was Head of drug production at CIMEX AG in Switzerland, following 4 years with F. Hoffmann-La Roche AG, Basel, as QA manager responsible for quality assurance of APIs. Since 1997 Managing Director and Vice President, Operations at Genzyme Pharmaceuticals, Liestal, Switzerland. Beside of other expert groups, he is chairman of the ECA, the European Compliance Academy, a leading European association with regard to GMP and regulatory compliance.

As Head Production at the Novartis biopharmaceutical site of Huningue (France), Leopold is responsible for all cell culture, downstream processing and planning & logistics operations for drug substance manufactured on the site. His current responsibilities involve management of production and start-up activities, a Lean project, as well as due diligence on new biotech processes. In 2007, his department is introducing a second MAB process, switching the site from dedicated to multi-product. Leopold coordinated the transfer of the Xolair purification process from Genentech in the Novartis team between 2000-04, and he is leading the Xolair DS supply from Novartis in the joint manufacturing and logistics team with Genentech. Currently he is transferring a new phase III process to the Huningue site. His former experience includes (bio) catalysis, biotech downstream process development, and commercial manufacturing of synthetic active drug substances. During the last 10 years he was involved in several due diligence projects on both synthetic and biotech manufacturing processes. Leopold holds a Master in chemical engineering as well as a Ph.D. from ETH Zürich (Switzerland), and started at Novartis (former company) in 1993. He is member of the Bio Manufacturing working group of EBE (European biopharmaceutical enterprises trade association, a specialised group of EFPIA).

Robert Repetto is Director of Global New Technology and Innovation for Wyeth Biotech, Pearl River, NY. He is responsible for the implementation of new technology, risk management, process technology, and real time process monitoring. Robert has over 20 years of process development, manufacturing and clinical production experience. He holds a B.E. in Chemical Engineering from Manhattan College, M.S. in Bioengineering from Polytechnic University of New York, and a MBA from Iona College. Regulatory Agencies have challenged our industry with a strategic vision of transforming manufacturing from its current state, of high losses and testing focused quality, to the desired state of six sigma level quality with continuous process learning and real time verification. The regulatory framework provided in ICH Q8, Q9 and Q10 has laid the groundwork for industry to achieve this disruptive change. Achieving this vision will require innovative new tools and a systematic approach to process governance to continually build process knowledge throughout the products lifecycle. Defining an actionable roadmap from this regulatory framework is the first step to making the current state of manufacturing obsolete

Dr. Fadel Hamed, Head of Operational Excellence, Genentech Product Operations, has an extensive background in process improvement, lean, and six sigma with more than 12 years of experience in multiple industries. Dr.Hamed holds a doctorate in mechanical engineering from UC Berkeley and is an ASQ certified six sigma black belt and quality engineer. His presentation will discuss how Genentech deployed Operational Excellence in manufacturing. Operational Excellence at Genentech is the routine delivery of exceptional business results using the Lean/DMAIC methodology. In the presentation, we will discuss how the decentralized Operational Excellence deployment led to substantial business results in reducing process cycle time and variation across the business. Finally, sustaining the process improvement initiative requires an alignment of the process improvement work in order to truly address bottlenecks and improve the efficiency and effectiveness of the end of the end processes. Enter the Genentech Production System, a production system that Genentech is launching to integrate and align all production related activities using Lean as the driving platform.

Richard Andrews, Operations Manager, MHRA will discuss the implications of the European API directive. Following the implementation of European Directive 2004/27/EC manufacturing authorisation holders are now required only to use active substances manufactured in accordance GMP as starting materials . Compliance is assessed during routine inspections and on receipt of new marketing authorisation applications or variations to change or add a new active substance manufacturer, as these must now be supported by a declaration of GMP compliance for that active substance. The presentation aims to clarify these requirements with the view to improving industry compliance and understanding of: The regulatory requirements for API and dosage from manufacturers, inspection activities and expectations, triggers for inspecting API manufacturers, the scope and content of GMP declarations for marketing authorisation applications and variations.

Mark Foss has been Head of Engineering for Boehringer Ingelheim in the UK for the last 8 years. He has worked since 1977 in both the Nuclear and Pharmaceutical Industries for BNFL, SmithKline Beecham as well as working for Roche Products and Glaxo. He is a member of the Industry Board and European Steering Committee of the GAMP Forum (Good Automated Manufacturing Practice). He chairs the ISPE Good Engineering Practice and Calibration Special Interest Group, which have produced ISPE good practice guides. These groups have developed the Industry Good Practice Guides for the Management of Calibration and on Good Engineering Practice due to be released by the ISPE in 2007. He has had articles on maintenance management, lean manufacturing, calibration and process control published by ISPE and The Institute of Measurement and Control. He has also been a speaker on the above and other topics at many ISPE and other industry conferences, seminars and symposia.

The Genzyme Waterford (Ireland) facility was the initial manufacturing site to select and pilot a Manufacturing Execution System / MES solution for Genzyme Corporate Operations. The vision for this project was to implement paperless Manufacturing, in the Oral dose and warehouse areas. The MES system is now being reviewed as part of a larger global strategy. Philip Doyle who was the site lead, is now responsible for systems strategy across all of Genzyme’s Operations and he will explain the selection and implementation of the Werum PAS-X MES which is now running successfully at their Waterford facility. The presentation will focus on the project approach and the strategic benefits of implementing a MES Solution as part of the complex Genzyme Supply Chain.

Michael Abad, Abbott will discuss PAT implementation and Engineering solutions to ensure successful deployment and planned uniformity throughout operations. PAT has proved challenging for the industry, with little real success, the session pinpoints successful methodologies to achieve tangible benefits in: Process understanding, optimisation and increased processing efficiencies. The presentation examines a PAT installation in a production environment, discussing process and equipment challenges encountered and the innovative solutions implemented.

Dr. Wim Mens, Production Director at Organon discusses the methodology that enabled Organon to reduce costs and FDE budgets by 5% annually in the last four years through the use of total productive maintenance tools throughout the entire production line and operations. He will describe the successful transition towards a culture of continuous improvement and the implementation challenges and timeline for implementation.

Jean-Francois Richard, Chemical Production Director, UCB s.a. was headhunted from the automotive industry to apply his senior level expertise in lean manufacturing to pharma. He has worked in different areas of operations from supply chain to production and tech transfer In the space of just one year, Jean-Francoise has been instrumental in working towards the 5 steps of lean manufacturing, reducing the 7 wastes, changing the "flow" of things with a goal of reducing the lead time by 50% from chemical raw material to final pallet to consumer. UCB s.a. has defined 17 different projects to reduce inefficiences which they will work towards in order to achieve a 30% reduction in lead time. Knowledge transfer occurred via a dedicated structure of lean expert in the organisation, their role was to coach and support all initiatives that originating from the roots of the organisation, listening shop floor employees. Lean is a logical and common sense, and the best people to improve things come from teh shop floor as they are the experts.

Richard Forsyth is an Associate Director in GMP Quality responsible for facility audits as well as regulatory submission document audits. He will discuss the development of a Visible Residue Limit (VRL) program. The control parameters necessary to establish and maintain the program. And the risk-based applications for a cleaning validation program. Richard Forsyth is an Associate Director with GMP quality at Merck & Co., Inc. He is responsible for internal and external facility audits as well as document audits for regulatory submissions. He has worked in Quality for two years and prior to that worked as an Analytical Chemist in Pharmaceutical R&D for 23 years. He has been involved with Cleaning Validation for over 14 years. Mr. Forsyth has a broad range of GMP/GLP analytical experience including methods development and validation as well as formulation development and project management. Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, Pennsylvania, USA.

For 19 years, the Shingo Prize has played a leadership role in promoting the principles of Lean. That Lean continues to have an ever increasing influence for good and proven not to be a business “fad” is in no small part attributable to the work of the Shingo Prize. Business Week describes it this way; “Considered the Nobel prize of manufacturing, the Shingo Prize for Excellence in Manufacturing…awards…sites that have achieved dramatic performance Improvements…” The Shingo Prize now has application for the entire business Enterprise, not just the plant floor, and the model has been expanded for application into many different industries and countries. Mr. Miller will illustrate how you as a leader, can use the Shingo Prize as a powerful motivation for your management team and employees. You will understand the benefits of a holistic, systematic and time proven approach to Lean as well as the value of receiving an objective assessment and feedback report of your progress, prepared by senior lean practitioners from companies who have demonstrated excellence. A recent study indicated that only about 30% of manufacturing companies really understood the principles and tools of lean and less than 5% have been successful at sustaining excellence. Bob will illustrate how over 150 companies who have used the Shingo Prize Model, have demonstrated and sustained world-class status.

Eric Hurtubise has 20 years of experience, including over 15 directly in the pharmaceutical industry. Prior to joining SOLABS, Mr. Hurtubise held different management position (manufacturing IT, Project Management) at Merck & Co, in US and Europe (EMEA). He was previously Pharma consultant at INVENSYS plc after having spent the early year if his career at Bristol-Myers Squibb Pharmaceutical Group as Manager of the Technical Services (Canada) He earned his Bachelor of Science degree in Industrial Engineering from l’École Polytechnique de Montréal in Canada. He also holds a Master Degree in Business Administration (MBA) from École des Hautes Etudes Commerciales (Montreal).

Ralph Haefeli, Head Global IT Systems, has more than 16 years of experience in Automation and IT within the Pharmaceutical Industry. Starting as automation engineer, he then joined IT to evaluate and implement a global MES solution, in support of a paperless and highly integrated manufacturing concept. This activity was and still is one of the typical activities of IT in order to address the business needs for productivity improvements and ensuring compliance. Through joint strategies between business and IT for global process harmonization and best-practice sharing these objectives were successfully supported and applied to many other globally harmonized IT solutions. Today’s business focus is on improving responsiveness and agility in order to adequately address the current and future challenges in the pharmaceutical industry. Having assumed additionally responsibility for Enterprise Architecture, Ralph Haefeli will outline the current business strategy and the subsequent alignment of the IT-Strategy.

Gerard joined Wyeth in January 2003 from Solectron. Has 25+ years experience in the electronics industry working in a variety of engineering roles, including manufacturing support, new product introduction, technology transfer and equipment maintenance.

Spencer Oliver is Associate Director Bioprocess Research & Development, in charge of managing external biological manufacturing relationships within UCB Celltech for early development pipeline products, he will discuss the steps, timelines and schedules UCB has developed to create flexible rolling agreements with various contract manufacturers in order to ensure manufacturing slots for the pipeline at different stages of drug development. After initially working in medical research moved into the BioTech industry in the mid 80s working on mammalian antibody and other biopharmaceuticals manufacturing processes and media development at Celltech, UK. This was followed by a move into vaccine process development, both viral and microbial ultimately for Schering Plough in the UK. This was followed by a period heading up the UK Governments Veterinary Immunologicals GMP Manufacturing Inspection unit, responsible for GMP compliance in the UK and outside the EU. Then taking up a role again back in Celltech, UK (now part of UCB) in process development, focusing on microbial process development and external manufacturing.

Jim leads the Corporate Environment, Health and Safety group responsible for the full range of EHS programmes, including setting the direction for EHS at GSK and the provision of environment, health and safety governance and support to all operations. Prior to joining GSK in 1983, Jim has worked in the chemical industry and the US Environmental Protection Agency on environmental issues in the areas of research, design, construction, permitting, and enforcement. Jim has an undergraduate degree in chemical engineering, a Masters degree in Environment Health Engineering and another in Management Sciences, and a PhD in Environmental Engineering. He is a registered Professional Engineer in Pennsylvania and Maryland, and is a Certified Quality Manager.

Design of Experiments (DOE) has been used for many years within the chemical industries, and the biopharmaceutical industry is beginning to grasp the concept of how to define the so called ‘Design Space’ for bioprocess development. Methods to define the design space using factorial designs are useful for bioprocess development, allowing critical attributes and process variables to be identified and permitting the ability to predict product quality and prevent process deviations. Methods to evaluate the application of process analytical technologies (PAT) and experimental design as tools to expedite process characterisation strategies for the manufacture of biopharmaceuticals will be discussed.’

Steve Bagshaw is head of the Commercial Manufacturing Business and a board member of Avecia Biologics Ltd in the UK. Avecia Biologics has grown rapidly over the last three years in terms of its volume and value of business, the number of clients it serves, its manufacturing capacity and its personnel. This growth has been supported by a major change programme focused on building an operational excellence platform to enable this growth to be delivered effectively. Steve will share insights from this and will identify the key issues Avecia is tackling as it continues to succeed in meeting the challenges contained within the individual needs of each of its clients particularly through late stage manufacturing.He will cover the key improvement areas required in the future to continue delivering promises that are linked to high profile client timeline expectations whilst maintaining an approach that delivers value to the client and the CMO. These include - standardisation, reduction in paper, increased equipment reliability, an integrated process development strategy, the general use of risk based approaches across manufacturing and smarter approaches to staff training and development and internal communication.

Vincent Fender, Manufacturing Information and Control System Leader Eli Lilly Manufacturing Site at Fegersheim, France, will discuss Eli Lilly's approach to paperless production. Significant productivity and efficiency gains can routinely be delivered through intelligent utilisation of automation and information solutions to optimise process and ensure quality, compliance and performance. One solution with the potential to revolutionise manufacturing flexibility, efficiency and productivity is Electronic Batch Recording (EBR). Real-time batch release, where all relevant process and product quality data are collected and analysed against specifications and then used to automate the batch release processes, is the vision that EBR advances forwards.

Ryan Burnside joined Wyeth in October 2006 from Coca-Cola Bottlers Ireland Limited with a total of 15 years experience in the FMCG environment. Ryan's portfolio includes project management for major initiatives for CCHBC in Ireland including the templating and pilot implementation of SAP. Ryan's current role is the I.S. & BPM Director for Grange Castle with responsibility for Applications, Client Services, Compliance and Infrastructure teams, also heading the Business Process Excellence strategy team at Grange Castle

Attendants will be exposed to a new paradigm in quality/business process management (document/ workflow optimization / cost reduction / compliance risk mitigation). They will learn, through a real life business case, how the burden of regulatory compliance can be transformed into a strategic advantage using available technology and regulations. Are you back-order due because of late documentation? Are you desperately tracking CAPA reports? Are you sure that the latest version of an SOP was indeed used? Can you demonstrate, with a “high degree of confidence” that all your operators are trained? What about this “master list of SOPs?” Do you feel at risk? If you answer yes to one of these questions, this workshop is for you. This workshop will provide you with tips and guidance (Do’s and Don’t) on how to implement a paperless Quality Management System.

Asish Adhikari who heads the MES Practice in Tata Consultancy Services brings in a wealth of knowledge from the Process and IT industries spanning the last 11 Years. Having worked both for the Pharma industry and also the MES solution space extensively in his current role at TCS, he has seen the needs of the industry evolve and what initiatives needs to be put in place as a correct methodology for deployment of Manufacturing IT systems in general. The new Manufacturing IT Strategy would aim to dovetail all of the Pharma Industry challenges to define a framework for manufacturing operational excellence. The four pillars on which this IT strategy is based are: Providing information and analyses to multiple layers of management, correlating & managing information from multiple sources, C contextualising information and redefining processes to support continuously shortening business cycles, and sharing information and actively collaborating across business units and enterprises. The workshop will help pharma manufacturers to define an IT Strategy that delivers: Manufacturing visibility & intelligence, integrated production management, lean process management, compliance oriented architecture. Coupled with the above, global program management techniques for rolling-out such initiatives in a regulated environment are also included in the workshop agenda.

François Prautois is Global Industry Manager for the Lifesciences at Endress+Hauser since the actvity started in 2000. He coatches a network of 50 persons within Endress & Hauser, dedicated to the lifesciences tasks. Targets are to create value for our customers in the lifesciences by building mutual beneficial relationships, delivering reliable process measuring instruments, expertise and compliant services and solutions while having internal understanding and knowledge on market's requirements - mainly regulatory aspects and integration of the future trends - as well as the GxP certification of the Endress+Hauser's staff involved in the lifesciences business. He's also a member of the I.S.P.E. and P.A.T. commitee. The keys are the satisfaction of the Customer and the partnership mentality.

Michel Philippart has led change initiatives in Procurement for the last 15 years, for consulting firms such as McKinsey and for consumer good companies like PepsiCo's Frito-Lay, and more recently in the pharmaceutical world, as Global Procurement head for GSK Biologicals, where he successfully transformed Procurement by developing a highly trained and motivated team. Today, his firm, Sourcing Plus, focuses on supporting selected companies to enhance the value of their supplier relationships beyond the traditional cost reduction initiatives. He teaches strategic procurement at various schools in France, Belgium, and Brazil, and train corporate teams that seek to improve their supplier management. He co-authored “Collaborative Sourcing: Strategic value creation through collaborative supplier relationship management”, published at the Presses Universitaires de Louvain. Michel has a degree in engineering from the University of Liège and an MBA from Kellogg.

Most global pharmaceutical manufacturers are faced with increased demands to protect the drug supply chain against counterfeits and parallel trading by regional regulatory bodies. WHO estimates that 8% of all drug supply is counterfeit and the FDA has shown dramatic increase in counterfeit drugs entering the US market. While the manufacturers can deploy serialization solution to comply with those mandates, with the proper data sharing framework, significant business benefits can be attained by all parties in the supply chain. Learn how to deploy solutions to comply with the various serialization mandates and leverage that investment to generate ROI by improving current processes. Protect the patients, your brand, and generate business value.

Given the requirements of the pharmaceutical markets, the diverse nature of organisational structures and the regulatory/governmental drivers, outsourcing within the pharmaceutical sector occurs at almost every stage of the value chain. With an estimated value of US$5 billion and a growth rate of over 20%, getting outsourcing right first time, and being receptive to current change, is key for both the contractor and the company engaging their services. Catalent Pharma Solutions currently work with customers where over half of the top 200 products utilise their services and are ideally placed to view the changing requirements in outsourcing. Through examples, the objective of this workshop is to bring the audience up to date with what are considered key success factors in pharmaceutical outsourcing.

Paul Fowler is VP, Healthcare and Life Sciences, for Global Strategy and Solutions Marketing at Axway where he works to improve the safety and efficiency of the medical supply chain. Mr. Fowler has over thirty years of healthcare technology experience including, ten years in direct patient care, nine years in medical diagnostic research with Abbott Laboratories and eleven years with the world’s largest healthcare distributor, McKesson Corporation. As an industry leader in product security and supply chain integrity strategies, AstraZeneca is the first to implement a global serialization infrastructure and strategy across multiple packaging lines and production sites to safeguard patients. During the next three years the company will enable 12 facilities and 25 product lines with sterilization track and trace technology. Participants will hear what AstraZeneca considered when developing the Product Safety Data Management (PSDM) initiative that is part of the company’s previously announced programme to protect patients from counterfeit medicines. How a successful programme includes enabling broad connectivity to partner communities and ensuring data quality which drives new value into the enterprise by creating insights into supply chain performance.