3rd Annual Manufacturing Execution Systems

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6 11:30 Case Study Update — Implementing a Highly Integrated MES and the Results to Date at BMS’ Devens Biopharmaceutical Manufacturing Facility Bristol-Myers Squibb is investing $750 million in the construction of a Large-Scale Cell Culture (LSCC) manufacturing facility in Devens , MA , for the commercial production of biopharmaceuticals. The BMS vision is to implement a fully automated, paperless solution that supports release by exception utilizing S95/S88 integrated recipes. This is to be executed using an MES to orchestrate plant floor automation, lab activity and materials management. This case study provides an update on the project thus far and shares key results and lessons learned to date. • Recap on the architecture and design of BMS' Manufacturing Operational Philosophy, with an emphasis on the MES • Interface Design — The what and how of working with SAP, LIMS and Maximo • Recipe Design, equipment versus process functions Case Study and “reusable recipe patterns” • Project Methodology — Proof through use, rapid programming approach, preliminary build versus final build, teams and skill sets Tony Fenn, Senior Principal Engineer, Bristol-Myers Squibb 12:10 Elevating Manufacturing Sophistication — How Schering-Plough and Organon Leveraged Combined Strengths and MES for Added Business Value This case study illustrates some of the key business drivers for why Schering Plough and Organon turned to MES for process automation. Learn how these two manufacturing organizations joined forces, leveraging shared strengths and talent pool and realized measurable business value through MES and process automation. Also hear about some of the chief challenges and lessons learned along the way. • Assessing the key business drivers and goals • Finding ways to extend the business benefit of MES to get more value and automation out of processes • Repositioning personnel away from manual tasks and into roles of higher sophistication and value Case Study • Understanding the technology — How it is configured and why • Feeding new functionality into established MES applications • Deploying a system and effectively working with the primary contractor — Lessons learned along the way David Gerhart, Manager, Computer System, Validation & Automation Integration, Global Technical Services, Schering Plough Corporation Lou Verhagen, Associate Director, Manufacturing, Organon 12:50 Luncheon Integration and Interoperability with Plant-Level and Mobile Systems 2:00 Implementing a Highly-Integrated MES within a Large-Scale Biotechnology – Genentech’s Four Year Project This case history reviews the implementation of a highlyintegrated MES into a large scale biotech manufacturing facility. This four year project resulted in the implementation of an MES as an integral part of a total Manufacturing Control System. This MES is integrated as well with several other Site and Corporate Level 3 and 4 Systems to deliver ERP, QC results, electronicallypresented Procedures, and automatic batch review and closure to this new paperless manufacturing facility. Learn the challenges and opportunities, from the MES perspective, through each phase of this project. • Project requirements definition • Software development • Testing • Plant commissioning • Integration strategies Jeanette Motzer, Manager, Business Applications, Genentech 2:40 Incorporating Wireless MES in a Biopharmaceutical Facility Traditional Manufacturing Execution Systems (MES) place terminals where the work happens, but what if the work moves? What if your equipment, materials and personnel operate in a dynamic environment that is constantly shifting to meet changing demands? That was exactly the challenge faced by Merck & Company at one of their biopharmaceutical pilot facilities. This case study illustrates how Merck met this challenge by embarking on a program to “cut the cord” and implement critical functions on wireless handheld devices, which included the design, development and implementation of wireless applications while integrating with the existing MES infrastructure. Participants learn: • How Merck evaluated and implemented wireless technologies • Review of specific issues, such as: * technology selection * mapping business needs to the solution Case * integrating with legacy MES applications Study * addressing security concerns • Strategies learned while developing an open platform to promote scalability with future systems Mark Tomcavage, Serac Solutions, LLC Andrew Kennedy, Research Biochemical Engineer, Bioprocess Clinical Manufacturing and Technology, Merck & Co 3:20 Close of Conference
WHO SHOULD ATTEND: You will benefit from attending this event if you are an executive or senior level director from a pharmaceutical, biotech or medical device manufacturer with responsibilities or involvement in the following areas: • MES • ERP • Plant/Manufacturing Systems • Manufacturing • Industrial/Plant Operations • Pharmaceutical Production • Production Planning • IT • Process Design • Engineering • QA/QC • Validation • Automation • Regulatory • Continuous Improvement • Process Excellence This conference will also benefit consultants, technology vendors and companies providing services to the above delegation. ACCLAIM FROM PREVIOUS ATTENDEES: “I benefited enormously. The contents were unique.” — Ed Harmon, Associate Director of Manufacturing and Facilities, Biopure “Very unique conference for all that are thinking about starting/deploying MES systems.” — Nirav Shah, Engineer, Schering-Plough “Good blend of vendor/product information and real customer experiences.” — Jerry Cline, IT Manager, GBSC “Comprehensive overview of the state of MES in the industry.” — Ute Bramann, IT Manager, International Operations, Abbott “Great opportunity for networking with industry MES leaders.” — David Henry, Principle Project Manager, Wyeth Biotech “This is an informative, educational sharing of views and experiences on MES.” — Dwaraka Ravulapati, IM Lead Analyst, GBSC Photo by: Jacobs Stock Photography / Getty Images IN RECOGNITION OF OUR SPONSORS: CBI Research, Inc’s corporate sponsors represent select companies that share a common mission: business advancement through thought leadership, strategic interaction and innovation. The companies represented below are proud contributors on this program and have carefully selected messaging, branding or positioning statements to encourage the evaluation and investigation of quality products and/or services available. We applaud these companies, as well as others that wish to join the conference, as important members of this event’s delegation. P l a t i n u m S p o n s o r : Camstar’s Enterprise Manufacturing Execution,Quality and Intelligence platform enables “Closed-Loop Quality Execution,” the end-to-end business process that surrounds manufacturing and quality operations. Camstar’s unparalleled solution optimizes the innovation and risk equation by monitoring and controlling global manufacturing and quality, and by delivering process interoperability and best practices. The result is shorter time to market and time to volume, the highest quality products and leaner, more efficient operations. Designed for ultimate configurability and built on a services-oriented architecture, Camstar’s comprehensive solution set includes industry-specific, out-of-the box applications and a proven implementation methodology ensure successful deployment and rapid time to benefit. More than 100 leading companies, including Johnson & Johnson, Roche, Covidien, 3M, Gambro, ZOLL, CIBA Vision, Zeiss, Kinetic Concepts, BIOTRONIK, Favrille, Stirling Medical Innovations, IBM, Kodak, Philips and Hitachi rely on Camstar as a trusted software partner. S t r a t e g i c C o r p o r a t e S p o n s o r : Emerson Process Management, a business of Emerson (NYSE: EMR) is the leading process automation technology and services provider in the world. With annual revenues in excess of $4B USD in process automation, Emerson enables API and biotechnology manufacturers to optimize operational performance, reduce compliance and validation efforts, shorten cycle and product release times. TECHNOLOGIES: Integrated through its award winning PlantWeb digital architecture, Emerson provides manufacturers the most comprehensive and flexible suite of technologies in process automation. Ranging from hardware that monitors and senses process variables, to control and asset management software, to advanced process control and batch automation, to compliance and management execution systems… Emerson fully integrates data across the enterprise to ensure better control, better data management and easier validation. No automation provider can touch as much of your plant with predictive intelligence and help you extract the most value from your investments. SERVICES: Emerson provides the domain expertise of it’s Life Sciences Industry Center to support customers with project planning, design, engineering and execution, as well as optimization services for existing facilities to analyze and diagnose operational problems that rob efficiency and profitability and provide corrective guidance to bring the facility back to optimal performance. Accessible around the world, Emerson’s Solutions staff integrates with customer personal to collaboratively plan and execute the programs that bring immediate results while setting a platform for long-term, sustainable performance. Emerson combines it’s technology and services offering into a unique program for Life Sciences manufacturers, called the OpX Advantage Program. This proven methodology offers an unparalleled way to leverage the investments you’ve already made plus integrating state-of-the-art, proven automation tools to deliver world-class operations. To learn how Emerson delivers smarter projects and smarter operations, visit www.emersonprocess.com/lifesciences. A d d i t i o n a l S p o n s o r s : If you are interested in sponsorship or exhibit opportunities, please call Karen Hanover at 781-939-2484, fax 781-939-2536 or email k.hanover@cbinet.com 7
Page 1 and 2: Register by May 30, 2008 and Receiv
Page 3 and 4: CHOOSE FROM TWO PRE-CONFERENCE WORK
Page 5: Day Two — Wednesday, August 6, 20

3rd Annual Manufacturing Execution Systems

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