focus day | day one | day two

Focus Day2nd December 2009 12:00 Sponsored Luncheon 13:30 14:05 15:35 Refreshments 15:50 16:25 Close of WDM Focus Day, followed by networking drinks reception

 

focus day | day one | day two

Day One3rd December 2009 08:45 Chairman's Introduction Dr. Prabir Basu, Executive Director , Purdue University USA 09:00 KEYNOTE PRESENTATION: SHAPING THE FUTURE OF DRUG MANUFACTURING Maintaining competitiveness in a rapidly changing environment Responding to the economic downturn, patent expiries, shrinking pipelines and increasing regulatory pressures Improving the interface between development and manufacturing The role of new technologies and out-sourcing in streamling operations Becoming leaner and greener What can pharma learn from benchmarking with other industries? 09:30 IMPACT OF PRODUCT DEVELOPMENT AND MANUFACTURING NETWORK ON COST OF GOODS SOLD How decisions in the development phase and/or in the manufacturing network and strategy can influence the Cost of Goods Sold structure Utilising Controlling & Finance focus to optimize performances in different Cost of Goods Sold structures Analysing contributions made by functions like Purchasing, Supply Chain, or Production depending on the Cost of Goods Sold Structure Valerio Trifoni, Finance and Controlling Director, Technical Operations, Ferring Pharmaceuticals Switzerland 10:00 Pre-arranged one-to-one meetings 11:20 SUCCESSFULLY IMPLEMENTING PAT AND QbD Case study: Implementing QbD in Wyeth What is Quality by Design and where does PAT fit? Applying QbD principles throughout the product lifecycle Sharing product and process understanding in regulatory filings Tools and approaches used to successfully implement QbD at Wyeth Dr. Graham Cook, Senior Director, Process Knowledge / Quality by Design, Wyeth UK   UTILISING THE THEORY OF CONSTRAINTS TO STREAMLINE PRODUCTION Accelerating process improvement in manufacturing and project operations Increasing manufacturing throughput without adding labour or capital Increasing on-time deliveries to near 100% and reducing manufacturing lead times by 20-50% Using TOC to drive process improvement by identifying and attacking the steps in the system that will accelerate results the fastest Further improving Lean and Six Sigma implementation with TOC Bart van Hell, Master Black Belt Process Excellence, Centocor The Netherlands   GLOBAL SOURCING STRATEGIES Overcoming material shortages produced by the economic downturn Dealing with the loss of materials supplied as by-products of other, slowing industries Securing long-term supplies of excipients and solvents Identifying new, reliable sources from global locations Ensuring business continuity through a ready supply of essential materials Dolf Gitjtenbeek, Director, Strategic Sourcing, Schering Plough The Netherlands   12:00 INTERACTIVE WORKSHOP ENDRESS + HAUSER WORKSHOP   INTERACTIVE WORKSHOP ENABLING LEAN DECISIONS FOR THE INTEGRATED BUSINESS Fill the gaps in your laboratory quality management program - details matter Accelerating product release by integrating, harmonizing and applying laboratory business processes in a fraction of the time and costs Silo's? No Silo's! Tight integration between shop floor and laboratory information Peter Boogaard, Director LIMS Product Management and LIMS Global Marketing , Applied Biosystems Netherlands   INTERACTIVE WORKSHOP IMPLEMENTING A STRATEGIC SOURCING SOLUTION Streamlining and automating the sourcing process Empowering collaborations with their suppliers with effective relationship management Realising best value from suppliers through effective decision support   13:00 Networking Luncheon 14:00 PANEL DISCUSSION: HOW CAN PHARMA RESPOND TO SURVIVE THE ECONOMIC DOWNTURN? How will companies manage the end of the 'blockbuster'? Is this the beginning of the next round of 'mega-mergers'? How can different departments respond and work together to ride the economic storm? What role can manufacturing play in securing the future of pharma? Dr. Prabir Basu, Executive Director , Purdue University USA Neil Brittain, Global Head, Strategy & Operations IQP, Novartis Pharma AG Switzerland Gerald Heddell, Director, Inspection and Enforcement, MHRA UK 14:40 Pre-arranged one-to-one meetings 16:25 EFFECTIVELY MANAGING DATA FROM PAT PAT data management in relation to the PAT Guidance, ICH Q8, Q9 and Q10 Designing, analysing and controlling manufacturing systems using PAT data Integrating PAT data into business processes and quality decisions James Cheney, Director Global PAT, Novartis USA   IMPLEMENTING LEAN MANUFACTURING - CREATING TRANSFORMATIONAL CHANGE Planning and delivering the holistic, operational and cultural mindset of lean throughout operations Becoming holistically lean - aligning the whole business structure Focussing on plant scheduling, lean operation design, visual factories and operational efficiency Selecting the appropriate applied lean technologies - kanban, six sigma, kaizen and beyond Designing and delivering realistic critical enabling projects to deliver real results Utilising lean to produce simpler more effective processes and product flows Sustaining the use and implementation of lean processes John Smith, Integrated Product Team Head, Merck Sharp & Dohme Ltd Ireland   GLOBAL CMO MANAGEMENT Out-source to Asia vs lean manufacturing in Europe Out-sourcing in the current economic and regulatory environment Understanding the true cost savings associated with out-sourcing to low cost countries Developing a strategy for make or buy decisions Identifying key suppliers and managing relationships to maximise performance Overcoming the challenges of culture, reliability and consistency associated with out-sourcing to Asia Dr. Katharina Kassühlke, Director, Global Sourcing Contract Manufacturing, Bayer Healthcare Germany   17:05 EVALUATING GENOTOXIC RISK WITHIN A MANUFACTURING PROCESS Understanding EMEA guidelines regarding genotoxic impurities Identification of potential impurities, including the scope of such evaluations Use of SAR evaluation and safety testing to determine actual risk Processing steps that can be taken to mitigate risk Case study examples - Sulphonate esters How to factor in results from degradation studies Impact on existing products - in or out of scope of the EMEA guideline? Andrew Teasdale, Senior QA Executive, AstraZeneca UK   BUILDING OPERATIONAL EXCELLENCE THROUGHOUT THE GLOBAL SUPPLY CHAIN Creating a cohesive system to successfully manage clinical material throughout the global supply chain Implementing SAP technologies to capture clinical materials, identify and document them Establishing visibility across the global supply chain Implementing a lean OpEx programmes throughout supply chain operations Effectively managing drug franchises Edgar Sur, Head, Operational Excellence - Product Supply Biotech, Bayer USA   ASSESSMENT OF PROCESSES IN EXTERNAL MANUFACTURING OPERATIONS Ensuring compliance with a corporate assessment programme Monitoring compliance and efficiency through an internal audit programme Driving change to excellence through assessment, evaluation and continuous improvement Ensuring efficiency in manufacturing operations to reduce costs Assessment of compliance in external manufacturers - ensuring quality and value for money   17:45 PHARMACEUTICAL COUNTERFEITING: THE REALITY AND CHALLENGES Securing the legitimate pharmaceutical supply chain - no cure for counterfeiting Security technology "solutions": a false sense of security? The dangers of reliance on technology Alternative anti-counterfeiting strategies Andrew Jackson, VP, Corporate Security, Novartis USA 18:15 Closing remarks and drinks reception

focus day | day one | day two

Day Two4th December 2009 08:25 Chairman's Introduction Dr. Prabir Basu, Executive Director , Purdue University USA 08:30 MATRIX ORGANISATION FOR BUSINESS EXCELLENCE Improving communication and managing relationships in a matrix organisation Allowing team members to share information more readily across task boundaries Combining project management and functional management to effectively utilise the workforce Communicating efficiently to successfully move projects forward Improving productivity through developing a new method of working Neil Brittain, Global Head, Strategy & Operations IQP, Novartis Pharma AG Switzerland 09:00 KEYNOTE PRESENTATION: INDUSTRY AND REGULATORS - PARTNERS IN EXCELLENCE? Progress towards our shared objective - safeguarding and enhancing public health The importance of GMP in a global supply chain Can we reconcile cost and quality? Gerald Heddell, Director, Inspection and Enforcement, MHRA UK 09:30 CLEARING THE REGULATORY HURDLES FOR CONTINUOUS MANUFACTURING Setting up an API continuous manufacturing facility Experiences of FDA and MHRA inspections - gaining approval for this next generation manufacturing process Benefits and pitfalls of continuous manufacturing - lessons learned during the development process Understanding the business case for continuous manufacturing Peter McDonnell, Senior Technical Director, Genzyme UK   SMALL SCALE PROCESS DEVELOPMENT AND IMPROVEMENTS Continuous improvement through simulating manufacturing processes on a small scale Understanding manufacturing process parameters by studying a scaled down version Achieving higher process yields and increasing process robustness through second generation process improvements Managing the scale-up process when transferring technology from R&D to manufacturing Christophe Carnewal, Head of Technical Services, Baxter BioScience Belgium   DEMAND DRIVEN MANUFACTURING Push vs pull systems for effective manufacturing control within the drug industry Integrating different S&OP approaches from Merck and Serono Combining a 'push' system with a 'pull' system - understanding the relative merits Re-developing the supply chain network - the "godfather" initiative Achieving accuracy in sales forecasts Serving pharma and biotech functions with one supply chain network Jacques Dysli, Head, Biotech Supply Chain, Merck Serono Switzerland   10:10 Morning Refreshments 10:30 INTERACTIVE WORKSHOP ACHIEVING THE GOALS OF QbD AND PAT Bridging the Gap Between Process Development and Manufacturing Utilizing a simple, user-centric interface for direct, on-demand access to all relevant data from disparate sources Capturing paper-based data and making it easily available in electronic form Sharing data, analysis results and reports across disciplines, scales of operation, and geographically dispersed sites Simplifying the preparation and distribution of analysis results Automating the generation of periodic reviews and reports of batches and campaigns Dr. Justin O. Neway, Executive Vice President & Chief Science Officer, Aegis Analytical Corporation USA   INTERACTIVE WORKSHOP IMPROVING PERFORMANCE OF ESSENTIAL NON-CORE ACTIVITIES How innovative approaches can help enhance cost control, based on concrete examples Benefits of out-sourcing non-core activities Maximising efficiency in use of utilities to reduce costs Utilising alternative energy sources and saving energy throughout production Implementing water cycle management solutions   INTERACTIVE WORKSHOP ERNST & YOUNG WORKSHOP   11:30 BUILDING THE NEXT GENERATION CONTINUOUS MANUFACTURING FACILITY Strategic and technical challenges of implementing continuous processing Building a pilot plant for end to end continuous manufacturing Turning a batch process into a continuous process - challenges and pitfalls Identifying opportunities for continuous processing - where can it add value? Evaluating the business case for batch vs. continuous processing Dr. Malcolm Berry, Head, Continuous Processing , GSK UK   INTEGRATING GREEN CHEMISTRY INTO PHARMA MANUFACTURING Green chemistry at Pfizer Strategies to influence medicinal and research chemists to make greener solvent and reagent selections Using biocatalysis to substantially reduce waste and energy use in the manufacturing processes for pregabalin Achieving significant environmental and financial savings Dr. Peter Dunn, Global Green Chemistry Lead, Pfizer UK   SUPPLY CHAIN OPTIMISATION Improving throughput times, reducing non-operative stock and gaining more transparency Building a complete economic model and choosing the most cost optimised solution using an Economic Order Quantity (EOQ) approach Prioritising reliability for process throughput times Developing an holistic understanding of the cost elements, which are influenced by the lot size Reducing the inventory coverage of finished goods from 67 days down to 51, on a global scale Reducing manufacturing cost by two to five million euros annually by moving to larger lot sizes Dr. Karsten Benzing, Corporate Director, Supply Chain Processes, Boehringer Ingelheim Germany   12:10 Themed Luncheon Discussions 13:20 ALIGNING R&D AND MANUFACTURING - PROMOTING COMMERCIALISATION Promoting synergies, optimising communication and cooperating across disciplines Commencing technology transfer during Phase IIb and phase III trials Optimising manufacturing processes before filing Developing a more robust and effective process Reducing the time to get products to market Liam Dunne, Director, Process Development and Commercialisation, Merck Sharp & Dohme Ltd Ireland 13:50 INTERACTIVE WORKSHOP FINESSE WORKSHOP   INTERACTIVE WORKSHOP LEAN MANUFACTURING SOLUTIONS Applying lean compliant operations Understanding customer demand, manufacturing capability and the compliance context Simplifying and integrating key processes and ensuring organisational alignment Transforming performance and compliance through best-fit technology Delivering rapid improvements in cost, capacity, stock and service   INTERACTIVE WORKSHOP IMPROVING SUPPLY CHAIN SECURITY - IDENTIFYING THE WEAKEST LINK Overcoming the criminal threat to supply chains in the difficult economic environment Maintaining the integrity of your supply-chain when attacks are increasing by the day Effectively monitoring shipments from the manufacturing facility to the point of distribution Preparing an effective logistical plan to alleviate stoppages and ensure security at every step of the distribution   14:50