The MHRA is the regulatory agency for the pharmaceutical industry in the UK, responsible for ensuring compliance across manufacturing sites. Gerald Heddell is Director of the Inspectiona nd Enforcement team and will discuss how the regulators can help the industry to develop excellence in their operations.

The new paradigm of Quality by Design, as described in the ICH Q8(R1), Q9 and Q10 guidance documents, presents a tremendous opportunity for the pharmaceutical industry to improve manufacturing efficiencies and enhance the assurance of quality. This presentation will describe Quality by Design, show how PAT is complementary, and why this is a win-win-win for industry, regulators and patients. The application of QbD principles to gain product and process understanding will be described, and examples from Wyeth’s successful QbD/PAT regulatory submissions will be used to discuss how to incorporate this knowledge in a filing. Some of the tools and approaches used to implement QbD within Wyeth will also be described.

The merger of Merck and Serono required the integration of two different sales and operations planning approaches. This session will discuss Merck Serono's 'Godfather initative' implemented to reconstruct their supply chain network and integrate a push system with a pull system. This initative has been key in maintaining high customer service levels and has highlighted the importance of sales forecast accuract within the commercial organisation.

Novo Nordisk has set ambitious business targets to be achieved through implementation of a Lean Six Sigma program. A major focus of this initiative has been on the importance of change management and communication to ensure the workforce is fully involved. The workforce has been engaged from top to bottom and across multiple sites and has been encouraged to identify best practices to leverage this across the organization. Tangible results, effectively communicated have reduced skepticism and ensured that the workforce remains engaged and supportive of the process.

The challenges in the global economy are not only affecting the pharmaceutical industry but is also causing problems for its' suppliers. Material shortages as a result of supplier bankruptcy or knock on effects from other indutries can seriously affect plant productivity due to a lack of supplies. This session will discuss how Schering Plough overcame the shortage of a critical solvent to avoid an impact on API supply. It was also look at the risk assessment process in place to analyse new and exisiting suppliers.

This session will present detials of Merck's implementation of a lean programme. The programme focussed on beoming lean throughout the whole business structure by better alignment of processes. A number of lean theories were used including kanban, six sigma and kaizen. The programme resulted in simpler and more effective product flows through the plant, saving time and reducing costs. Since the programme has now bwwn runnign for several years this session will also discuss how the changes have been sustained to ensure continues excellence.

This presentation covers the Green Chemistry program at Pfizer, information will be given regarding (i) The development of tools to influence greener solvent and reagent selection in medicinal chemistry (ii) The results of the solvent switching program in Pfizer’s Research Division (iii) The environmental benefits of the enzymatic synthesis to manufacture pregabalin.

Valerio Trifoni is currently Finance and Controlling Director of Technical Operations in Ferring. This presentation will discuss the impact of product development and the manufacutring network on cost of goods sold. In an economy where pharmaceutical companies are under pressure to save money and to reduce the cost of goods financial decisions in the development phase and manufacturing network can significantly reduce the cost of goods sold structure. THis presnetation will discuss the contribution of the controlling and finacne function to cost of goods reduction and analyse the cintribution made by other functions such as purchasing, supply chain and production.

This session will introduce GSK's Innovative Manufacturing Initiative which includes a continuous processing pilot plant based at Stevenage UK. The pilot plant produces API’s on an equivalent 3-5 tpa scale and was fully commissioned in 2008. GSK see continuous processing as the opportunity to lower the capital cost of a new plant and bring enhanced control of process parameters; it is one of the company’s ongoing QbD initiatives.

This session will discuss Genzyme's continuous processing plant. The plant has a capacity >500 tons per year. It incorporates Nitech tubular baffled reactor technology instead of traditional high pressure batch reactors. This session will discuss the benefits of the continuous plant including lower costs, speed of construction, low footprint and ease of adding further capacity if required. The plant has been through successful pre-approval inspections with both FDA and MHRA and is currently ramping up to nameplate capacity.

Integration of the process development process into Manufacturing is key if the company intends to reduce Cost of Goods through designing products that will better fit into its industrial network and strategy.
The presentation intends to illustrate through various examples a framework that plans to:
- Analyze the Cost of Good from Development down the Supply Chain
-Understand influential product characteristics on the process to be implemented
-Integration of development input into Manufacturing, and vice versa, in order to fine-tune optimal configuration
-Highlight the benefits of Process Design.

Dr. O'Criodain has been working in Quality Management since 1980. He began his career with Abbott Laboratories in the area of medical devices. After working with some smaller device and pharmaceutical companies, he joined Wyeth in 1992 as Director of Quality at their tablet manufacturing site in Ireland. From 1998 to 2005, he worked in their European office, first as Director of Quality for Europe, Middle-Ease and Africa, and later as International Director of Compliance Auditing. In 2005, he joined Centocor where he led the Quality function during the construction and start up of their biological manufacturing faciloity in Ireland. Earlier this year, he moved to the position of Head of QA for Pharma Operations at Novartis Pharma AG based in Basel. This discussion draws on his Centocor experience as well as a broad general experience of quality management in pharmaceutical manufacturing.

This presentation will focus on the impact that the EMEA guideline on genotoxic impurities has had on the Pharmaceutical Industry and in particular on process development, and will outline a strategy to allow the risk posed by such impurities to be effectively managed.

This presentation will cover an overview of Merck's 'Commercialization Model' which helps accelerate new products through late stage clinical phases onto the market whilst minimizing at risk capital spend, using fungible resources, mitigating technical and scale-up risk and maximizing launch process capability. It will also include examples of how through a combination of organizational alignment, technical capability enhancement and the application of lean six sigma before, during and after launch that we have successfully and rapidly commercialized new products.

Dr. Karsten Benzing heads the Supply Chain Processes group in the Corporate Center of Boehringer Ingelheim. His group is responsible for developing and implementing world-wide supply chain concepts, comprising all value chain steps from chemicals synthesis to distribution. This session will focus on how Boehringer Ingelheim have optimised the supply chain to improve throughput times, reduce non-operative stock and material loss and gain more transparency. This has involved the implementation of an Economic Order Quantity (EOQ) approach focussing on the total cost of the supply chain. This session will introduce this approach and how it has reduced inventory coverage by 16 days and manufacturing costs by 2-5 million euros annually.

The complexity of the manufacture of biologicals sets high standards for quality oversight. The various steps in the upstream, downstream and fill & finish process may take place at different locations around the globe and should be properly managed. The various locations, (company) cultures and quality standards present multiple challenges to assure a uniform quality of the product. Already during the phase of the technical transfer of a product, a global quality system should address how process changes and deviations should be managed. Technical (Quality) Agreements are a strong means to outline the responsibilities between the contract giver and the external manufacturer. More and more Health Authorities (HA) focus their inspections on the GMP-flow of information associated with the sequential process steps of the product, when manufactured externally. The person who releases the finished product to the market, the Qualified Person in the EU, is assumed to have the complete overview of the process and should be actively involved in situations where product quality, efficacy or safety might be possibly impacted. In this presentation, practical solutions are given, how to consistently manage global quality systems to assure quality oversight.

This presentation will focus on the experiences and results of implementing a business excellence programme within the Global Pharmaceutical Supply Group at Johnson & Johnson. The group have implemented lean improvement cycles to improve efficiency and reduce costs within the department. Furthermore the presnetation will focus on how the group have collaborated with suppliers to further support the lean journey.Twan Kersten graduated from Twente University in the Netherlands with a Msc. degree in Flexible Production Systems in 1990. He has worked for ASM Japan, Unilever/Nippon Lever and Blom Consultancy before joining Johnson& Johnson’s Global Pharmaceutical Supply Chain Group in 2003 where he is supporting the deployment of Lean in the Fill & Finish sites globally. During his career he has worked in Japan twice for a total period of 7 years, during which he learned about Lean and TPM at the source. Twan is a J&J Lean Master Black Belt, J&J 6 Sigma Black Belt, JIPM Certified TPM instructor and APICS Certified Supply Chain Professional.

Dr. Basu will Chair the World Drug Manufacturing Summit. Dr. Basu is Executive Director of NIPTE, an organization dedicated to fundamental research and education in pharmaceutical product development and manufacturing.

Shorter times to market, fast-track-projects and shorter plant life-cycles are getting a bigger challenge in the Life Science industry. This workshop demonstrates how a qualified industry specialist and instrumentation/automation one-stop-shop can help reduce time to production and increase plant efficiency and quality at the same time. New technologies for instrumentation and process analytics support faster qualification in a regulated environment. Due to the demonstration of real application examples, the workshop participants will get a clear understanding of the optimisation potential.

Shorter times to market, fast-track-projects and shorter plant life-cycles are getting a bigger challenge in the Life Science industry. This workshop demonstrates how a qualified industry specialist and instrumentation/automation one-stop-shop can help reduce time to production and increase plant efficiency and quality at the same time. New technologies for instrumentation and process analytics support faster qualification in a regulated environment. Due to the demonstration of real application examples, the workshop participants will get a clear understanding of the optimisation potential.

Shorter times to market, fast-track-projects and shorter plant life-cycles are getting a bigger challenge in the Life Science industry. This workshop demonstrates how a qualified industry specialist and instrumentation/automation one-stop-shop can help reduce time to production and increase plant efficiency and quality at the same time. New technologies for instrumentation and process analytics support faster qualification in a regulated environment. Due to the demonstration of real application examples, the workshop participants will get a clear understanding of the optimisation potential.

EBR is a favourite theme for the Pharmaceutical industry for years. More and more companies evaluating and implementing EBR systems. What is really under the hood of EBR? How to balance investment versus benefits? Beside the obvious, where are the hidden benefits and the hidden pit falls? The talk shares experience of deploying an EBR and looks holistically on all aspects of challenges and results. Themes like deployment of EBR systems, process design, recipe authoring, recipe validation, recipe approval, execution and eBatch records review strategies are covered.

Pharmaceutical manufacturing is a highly complex process and requires robust and scaleable automation solutions to ensure consistent and compliant product output. Scaleable technology solutions enable easier technical transfer of pharmaceutical products as they move through their lifecycle by allowing the same technology, S88 model and recipe structure to be used at all stages of manufacture. PlantPAx from Rockwell Automation is just such a solution and this case study will describe how Rockwell Automation enabled a large Pharma customer to develop systems at both development & clinical scale.

EBR is a favourite theme for the Pharmaceutical industry for years. More and more companies evaluating and implementing EBR systems. What is really under the hood of EBR? How to balance investment versus benefits? Beside the obvious, where are the hidden benefits and the hidden pit falls? The talk shares experience of deploying an EBR and looks holistically on all aspects of challenges and results. Themes like deployment of EBR systems, process design, recipe authoring, recipe validation, recipe approval, execution and eBatch records review strategies are covered.

Herbert heads the virtual group of site responsible contract manufacturing experts within the Global CMO of Nycomed, currently covering 9 sites out of 19. He is responsible for continuous development and implementation of the global contract manufacturing strategy for the Nycomed Operations network. His department provides a global marketing concept for the Nycomed CM services and input for decisions towards a risk balanced and value driven contract manufacturing portfolio. For clients with a multi-site business relationship towards Nycomed, Herbert himself acts as key account manager, aiming at long term partnerships with other global players. His department is the single point of contact for all RFPs & RFQs of new and existing clients and follows up all activities in terms of implementation of products & processes at the various sites.
Being a chemist in profession Herbert started his career in the pharmaceutical industry in 1994 in R&D of an Austrian subsidiary of Knoll Pharmaceuticals (later Abbott). In 1996 he was hired by Fresenius (later Fresenius Kabi), where he held several managing positions in the pharmaceutical-technical area as well as in R&D project & program management.
In 2005 he joined Nycomed Austria as a local manager for contract manufacturing of pharmaceuticals. In line with the globalisation of Nycomed Contract Manufacturing Services in 2007 he took over responsibility for the CM of sterile dosage forms and became head of the global CM business by 2008. The business is integral part of Nycomed Operations strategy and currently Herbert is reporting to the Vice President of Global Supply Chain.

Brandenburg Economic Development Board (ZAB) and Berlin Partner are the regional development agencies for investors. Germany’s capital region offers outstanding potential for companies active in pharmaceutical production. Berlin Brandenburg boasts a large pool of educated professionals, unique and investor-friendly cooperation with public authorities, and the best subsidy opportunities available in Europe. Global players such as Nycomed, BASF, Bayer Schering Pharma and Menarini produce pharmaceutical products at state-of-the-art facilities. Regional pharmaceutical industry with further global players such as Pfizer and sanofi-aventis profits from the region’s outstanding scientific landscape, its renowned clinical research environment and its close proximity to the federal government.

Brandenburg Economic Development Board (ZAB) and Berlin Partner are the regional development agencies for investors. Germany’s capital region offers outstanding potential for companies active in pharmaceutical production. Berlin Brandenburg boasts a large pool of educated professionals, unique and investor-friendly cooperation with public authorities, and the best subsidy opportunities available in Europe. Global players such as Nycomed, BASF, Bayer Schering Pharma and Menarini produce pharmaceutical products at state-of-the-art facilities. Regional pharmaceutical industry with further global players such as Pfizer and sanofi-aventis profits from the region’s outstanding scientific landscape, its renowned clinical research environment and its close proximity to the federal government.

Marty joined WCI in 1997 and, for the last twelve years, he has managed and led global business improvement assignments in the Life Sciences industry. Marty is an expert manager of change in strictly regulated environments and is WCI’s Lean Compliant Operations proposition owner. Key areas of expertise include:

 Large Programme Management
 Change Management
 Lean Compliance
 Lean Operations
 Business Process Transformation

Marty started his professional career in pharmaceutical operations, responsible for setting up and registering a new sterile filing facility for syringes. He holds a degree in Mechanical Engineering and Manufacturing Automation from the Technical Institute of Arnhem, a degree in Business Administration, and a degree in Environmental Management.

During this session, we will introduce existing customer cases that exhibit how pharmaceutical companies spend significant time in expense planning, designing, customizing, and validating (IQ/OQ/PQ) their LIMS project.
Reduce your total cost of ownership - up to 85% versus traditional systems.
Speed of deployment - up to 75% time reduction
Reduce validation costs - up to 92% reduction by deploying industry best practice workflows.
~90% reduction in project personnel.
Very detailed documentation - CAPA and deviation cases such as Stability, OOT/OOS, and other laboratory anomalies such as calibration failures, SST failures and other exceptions that need a documentation history.

JohnsonDiversey’s Global Results Driven Supplier Development (RDSD) program is designed to identify and pursue improvement initiatives with selected suppliers across major spend categories. This initiative includes Supplier Performance Management (SPM) within the enterprise Quality Management System (eQMS) and Global Strategic Sourcing strategy. The objectives of robust SPM are to continuously track selected key performance indicators (KPIs) for all suppliers, and address supplier incidents in a swift and transparent manner. An effective SPM also enables organizations to initiate appropriate, on-going process improvement initiatives with all key suppliers to reduce the total cost of ownership of the supplier relationship and improve negotiations with incumbent suppliers using actual KPI metrics. This session will provide insight into the driver’s behind JohnsonDiversey’s RDSD program and their implementation of CAPA (Corrective Action Preventive Action) and RSM as part of their eQMS and operational excellence initiatives.

Christoph Ebensperger is head of the company’s Business Segment Life Science. As a consultant, he has helped clients in the pharmaceutical industry. Assignments included many optimization initiatives in operations and supply chain management. He recently completed two benchmarking studies on pharmaceutical technical operations. Prior to working as a consultant, Christoph gained experience in the pharmaceutical and biotechnology industry.

Christian Daxboeck is currently head of the Business Segment Supply Chain Management (SCM) / Operations at Horvath & Partners. His main competencies are Supply Chain Strategy, Sales & Operations-Planning (S&OP), Inventory and Sourcing Optimization as well as Performance Management. Prior to joining Horváth & Partners, Christian held a number of management positions in various industries.

Quality by Design (QbD) starts in process development. This is where the best opportunity exists to design improved processes based on new process measurements and by taking advantage of previous experiences with similar processes. With the introduction of Process Analytical Technology (PAT) as a tool for achieving QbD in pharmaceutical and biotechnology processes, the volume of electronic and paper-based data collected during process development and manufacturing has increased dramatically. A critical success factor for achieving the goals of QbD is thus to provide on-demand access all of this data for end users in a collaborative analytics, trending and reporting environment in which the multidisciplinary team can collaborate productively. The most important requirements for this system are: a simple user-centric interface for direct, on-demand access to all the data from disparate sources; a practical way to capture paper-based data and make it easily available in electronic form; the ability to work with continuous (on-line) and discrete data together; sharing data, analysis results and reports across disciplines, scales of operation, and geographically dispersed sites; simplifying the preparation and distribution of analysis results; and automating the generation of periodic reviews and reports of batches and campaigns. This presentation will illustrate how these requirements can be satisfied with technologies readily available today.

Currently Chairman of Health Research Board, Ireland, board member of companies in Ireland/UK, including Chairman of Excelsyn Ltd., a leading supplier of active intermediates to the pharmaceutical industry. In addition, Dr. Shaw acts as consultant to various world leading companies and serves on various Irish Government agencies. From 1999 to 2007, as Managing Director of Wyeth, Ireland, he had overall responsibity for one of the world’s largest biotech facilities from initial design through sustaining operations in Dublin, Ireland. Prior to 1999, he was Senior VP and director for SmithKline’s worldwide operations, involving 26 facilities in 11 countries.

Drug manufacturers face complex challenges the development and execution of manufacturing operations. In this workshop, we will discuss our end-to-end approach to streamline the management of the manufacture of pharmaceuticals using CambridgeSoft’s industry leading suite of applications. We will cover process development and batch sheet execution, template management, documentation of materials and equipment used using the GxP compliant E-Notebook and Inventory Enterprise applications. In addition, we will discuss how the business and technical challenges of outsourcing chemical reagents can be overcome using ChemSource, CambridgeSoft’s outsource management solution.

Mark is a Principal in Ernst & Young's Business Advisory Services practice and is the Global Life Sciences Advisory and Supply Chain Management Leader. He has more than 24 years of management consulting and business advisory services experience in the areas of strategic planning, business transformation, supply chain and manufacturing operations, customer relationship management, shared services design/implementation and enterprise resource planning systems implementations. Mark has extensive experience advising senior management on the achievement of top and bottom line growth through improvements in operations, compliance and information systems and has served clients in the pharmaceutical, biotechnology, medical device, managed care, consumer products, manufacturing, high technology, oil and gas and government industry sectors. Having conducted engagements for clients in the United States, Europe, Africa, Middle East and Asia he has a unique perspective on the global issues that face multi-national pharmaceutical corporations. Mark is a frequent guest speaker and panel participant throughout the world regarding the life sciences industry. He has also published numerous articles on the current challenges and future of the life sciences industry. Mr. Hassenplug is has been quoted in a variety of publications including: The Wall Street Journal, Morningstar, Reuters, Alto Nivel, Chemical & Engineering News, Genetic Engineering News, Pharmaceutical Marketing, Biological Quarterly, Healthcare Executive (China), Chinese Venture, and several other newspapers and periodicals.

Barb was most recently the CTO of Picarro, a company she founded in 1998. At Picarro, she was responsible for technology and business development, which led to a solid-state Cyan laser product in 2003 and cavity ring-down spectroscopy products in 2004. Barb is currently a partner at Skymoon Ventures. Barb received both her Ph.D. (1998) and M.S.E.E. (1994) degrees in electrical engineering from Stanford University, and her BS (1993) in electrical engineering/applied mathematics from the University of Waterloo.

Giovanni Polvani was born in Genoa and is 49 years old. He Graduated in 1986 as Mechanical Engineer, specialised in Thermodynamics of Nuclear Plant, got 1st employment in Planning and logistics in a Petrochemical Plant ( ERG Petroli ). He joined JMAC in 1989, at very early start up of European operations and is today is COO of Jmac Europe B.V. , coordinating 6 JMAC offices in Europe and managing cross business development. He is a Senior Consultant with 2 decades of experience in TPM (appointed Instructor by JIPM in 1993) and Lean. He was responsible in large projects for Emerson Group, Avio, Fiat Iveco, Ermenegildo Zegna, Sagit Unilever, Colgate Palmolive, Trenitalia; (high speed Italian railways), Ansaldo, Heineken, Leaf, CSM, Datalogic, Sogefi. He dealt also with R&D and Product Development, using japanese tenniques as VRP –Variety Reduction Program and VP - Visible Planning. He guided 10 executive study tours in Japan.

Joined JMA Consultants Tokyo in 1993, Nobuyuki Tamaru has been working for logistics and supply chain consulting projects. He has experience to support not only Japanese companies but also non-Japanese companies in Europe, Russia, US, and Asia. He understands the limitations to apply the Japanese methods and Japanese way of thinking in the cross-culture environment. He joined JMA Consultants Europe Milano in April 2008. *Main consulting areas; distribution and logistics, supply chain and demand chain management, procurement cost reduction and supplier improvement, business process reengineering, sales and after-sales improvement, business portfolio restructuring, corporate profitability improvement