3rd Annual Manufacturing Execution Systems
3rd Annual Manufacturing Execution Systems
3rd Annual Manufacturing Execution Systems
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Register by May 30, 2008 and Receive $300 Off Your Registration Fee!<br />
3 r d A n n u a l<br />
<strong>Manufacturing</strong><br />
<strong>Execution</strong> <strong>Systems</strong><br />
in the Life Sciences Industry<br />
Maximize MES Capabilities within a Lean Organization and<br />
Achieve Enterprise-Wide Integration for Quality and Performance<br />
A U G U S T 5 - 6 , 2 0 0 8 • T H E W E S T I N H O T E L • P H I L A D E L P H I A , P A<br />
16 Industry Perspectives<br />
Michael Asher, Control Engineer, GlaxoSmithKline<br />
Paul Brandenburg, Team Lead,<br />
Site <strong>Execution</strong> <strong>Systems</strong>, Eli Lilly & Co<br />
Andreas Dankelmann, Project Manager,<br />
Organization and Information, Bayer HealthCare<br />
Keith T. Evans, Biotech OpU MES Focal Point,<br />
TO&PS BSP, Wyeth Pharmaceuticals<br />
Tony Fenn, Principal Engineer,<br />
Bristol-Myers Squibb<br />
David Gerhart, Manager, Computer System,<br />
Validation & Automation Integration,<br />
Global Technical Services,<br />
Schering Plough Corporation<br />
Andrew Kennedy, Research Biochemical<br />
Engineer, Bioprocess Clinical <strong>Manufacturing</strong><br />
and Technology, Merck & Co<br />
Samantha Krebs, Senior Process Improvement<br />
Technical Writer, Shire Pharmaceuticals, Inc.<br />
Tom Litterer, Manager, Boston Scientific<br />
Tracy McMorrow, Manager, Boston Scientific<br />
Rey Medina, Director of <strong>Manufacturing</strong> <strong>Systems</strong>,<br />
Cordis, a Johnson & Johnson Company<br />
Jeanette Motzer, Manager, Business Applications,<br />
Genentech<br />
John Oakley, Chief Architect,<br />
<strong>Manufacturing</strong> <strong>Systems</strong>, Applied Biosystems<br />
Richard P. Poska, R.Ph., Director,<br />
Global Pharmaceutical Regulatory Affairs,<br />
CMC-GPRD Small Molecule Support, Abbott<br />
Cathal Strain, Senior Director and Team Leader,<br />
API Automation, Pfizer Inc<br />
Lou Verhagen, Associate Director, <strong>Manufacturing</strong>,<br />
Organon<br />
Case Studies Illustrate How To:<br />
• Apply the ISA-95 approach to manufacturing<br />
• Make dramatic improvements for ‘Right First Time’ metrics for<br />
batch records<br />
• Employ FDA practices and expectations for PAT and Quality by Design<br />
• Achieve seamless and synchronized system architecture with<br />
<strong>Manufacturing</strong> Control <strong>Systems</strong><br />
• Advance in overall quality and performance with MES<br />
• Leverage ISA-88 process mapping for batch record standardization<br />
• Make the move from a home grown legacy system to a<br />
full-functioning MES<br />
• Integrate and interface between ERM, LIMS, SAP and other systems<br />
• Implement mobile technologies for MES<br />
Featuring Two Pre-Conference Workshops — Tuesday, August 5, 2008<br />
A: Unite <strong>Manufacturing</strong> and Quality <strong>Execution</strong> —<br />
Achieving a Closed Loop Process<br />
B: Building an EBR System on a Budget<br />
Platinum Sponsor:<br />
Strategic<br />
Corporate<br />
Sponsor:<br />
Organized By:<br />
A Subsidiary of<br />
Executive<br />
Sponsor:<br />
Outstanding Support Provided by:<br />
To Register Call Toll Free<br />
800-817-8601 or<br />
Register on our website<br />
at www.cbinet.com<br />
photo by: John Foxx / Getty Images
2<br />
A<br />
CHOOSE FROM TWO PRE-CONFERENCE WORKSHOPS — TUESDAY, AUGUST 5, 2008<br />
Unite <strong>Manufacturing</strong> and Quality <strong>Execution</strong> —<br />
Achieving a Closed Loop Process<br />
Innovators who are first to market are winners, but only if they can also be first to produce high quality products in increasing<br />
volumes. New product introductions are a critical path and require manufacturing to remove obstacles such as variability due to<br />
change and risks of inconsistent quality or even product failure. The new manufacturing and quality model is a platform that<br />
unites <strong>Manufacturing</strong> <strong>Execution</strong> with Quality <strong>Execution</strong>, creating an end-to-end, closed-loop process that is predictive, proactive<br />
and preventive. Combined with actionable intelligence, it provides early warning of process issues that can cause product<br />
problems and root cause analysis that pin points the source of problems and enforcement of changes to prevent recurrence.<br />
Attend this workshop to learn take-home strategies and techniques to implement this essential closed-loop manufacturing and<br />
quality model to speed new product introductions, eliminate root causes of variability and reduce product and compliance risks.<br />
7:30 Workshop Registration<br />
8:30 Workshop Leaders’Welcome and Opening Remarks<br />
I. The Traditional Role of MES<br />
• Understand the investment you are making in MES,<br />
and current industry best practices<br />
• Recognize the disjointed relationship between MES<br />
and Quality <strong>Systems</strong>, and the inherent limitations<br />
• Review the dramatic increases in CAPAs, complaints<br />
and recalls, and see how gaps in processes lead to them<br />
II. The <strong>Manufacturing</strong> and Quality<br />
<strong>Execution</strong> Vision<br />
• Understand the principles of a closed-loop enterprise<br />
manufacturing, quality and intelligence platform,<br />
including the relationship of manufacturing process<br />
and quality information to non-conformances, CAPA<br />
and complaints<br />
• Learn how predictive, proactive, preventive quality is<br />
relevant to enterprise manufacturing<br />
• New and effective ways to:<br />
* enforce and verify manufacturing processes<br />
for more effective change management and<br />
issue prevention<br />
* use pattern recognition for early warning and<br />
visibility into process issues<br />
* improve root-cause analysis to understand actual<br />
cause and scope of non-conformances,<br />
CAPAs and complaints<br />
* ramp up new product introductions by quickly<br />
improving quality<br />
III. The Plan Forward — A Roadmap for<br />
New Product Innovation with High Quality<br />
• Learn the design and architecture of a closed-loop<br />
manufacturing, quality and intelligence platform<br />
• See specific examples of how to better enforce<br />
manufacturing best practices, recognize patterns that<br />
can lead to issues, quickly determine root cause of<br />
problems and proactively prevent recurrences<br />
• See how expanded intelligence can give you<br />
real-time actionable data, pattern recognition,<br />
root cause analysis and quick issue resolution<br />
• Understand the plan and roadmap you can follow<br />
to move from today’s siloed solutions to a<br />
closed-loop manufacturing, quality and intelligence<br />
execution platform<br />
12:00 Close of Workshop A<br />
There will be a 30-minute networking and refreshment break at 10:00 a.m.<br />
— About Your Workshop Leaders —<br />
Julie Fraser is Principal of Industry Directions, an analyst firm that<br />
researches manufacturing and its value network. Ms. Fraser has over<br />
twenty years experience as a manufacturing software advisor and marketer.<br />
Prior to Industry Directions, she was Vice President of Marketing for<br />
Baan Supply Chain Solutions, Senior Analyst at AMR and Editor of CIM<br />
Strategies newsletter.<br />
Karim Lokas is the Vice President of Marketing and Product Strategy at<br />
Camstar where he leads Camstar's Industry Marketing, Marketing<br />
Communications and Product Management teams. His responsibilities<br />
include identifying market and customer needs, driving Camstar's corporate<br />
brand and marketing strategy, managing the Master Product Roadmap for all<br />
of Camstar's target verticals and defining product release requirements.<br />
Mr. Lokas has extensive experience working with global manufacturers in<br />
developing enterprise manufacturing and supply chain strategies and<br />
solutions to drive operational excellence and innovation. A recognized<br />
thought leader and frequent speaker at industry events, Mr. Lokas has been<br />
quoted and published in numerous online and print publications such as MX,<br />
Drug Delivery Technology, Medical Device Link and Managing Automation.<br />
Mr. Lokas holds a Bachelors degree in Electrical Engineering and a Masters<br />
degree focused on Bio-Medical Engineering.<br />
Daniel R. Matlis is the Founder and President of Axendia, a trusted advisor<br />
to Life-Science executives on business, technology and regulatory issues.<br />
Mr. Matlis' eighteen years of experience in the life-sciences industry has<br />
included projects in research and development, manufacturing, regulatory<br />
compliance, business development and information technology. Prior to<br />
founding Axendia, Mr. Matlis was Vice President and General Manager at<br />
Stelex, Inc., a leading consultancy to life-science companies. He started his<br />
professional career at Ethicon, Inc., a Johnson & Johnson Company.<br />
He holds degrees from both Polytechnic University (BS in Electrical<br />
Engineering) and New Jersey Institute of Technology (MS in Management).<br />
Mr. Matlis is the chief contributor and editor of Life-Science Panorama,<br />
a publication covering business, regulatory and technology issues facing<br />
industry executives.
CHOOSE FROM TWO PRE-CONFERENCE WORKSHOPS — TUESDAY, AUGUST 5, 2008<br />
B<br />
Building an EBR System on a Budget<br />
For companies looking to implement an electronic batch record system on a small budget and with limited capabilities, EBR<br />
systems can meet essential company requirements, and be less costly and easier to implement. This workshop walks through the<br />
considerations and capabilities for building an in-house EBR system and also provides a case study of a biologics manufacturer<br />
who built an EBR system from scratch.<br />
7:30 Workshop Registration<br />
8:30 Workshop Leader’s Welcome and Opening Remarks<br />
I. Introduction to Electronic Batch Records<br />
• Limitations with paper batch records<br />
• Considerations for building an EBR system:<br />
* requirements<br />
* construction<br />
* validation<br />
* roll out<br />
II. Comparison of MES and EBR Solutions<br />
• Capabilities:<br />
* interfaces — shop floor automation, MRP system,<br />
LIMS and Operators<br />
• Costs:<br />
* purchase, implementation, maintenance and<br />
business interruption<br />
* total cost of ownership<br />
• Resources needed now/later:<br />
* project management, consulting staff for<br />
customization/validation, technical staff to<br />
maintain<br />
• Time to “Go Live”<br />
III. Considerations for Purchase/Build<br />
• Business requirements<br />
* level of interaction needed with external systems —<br />
schedules, bill of material, recipe management<br />
and LIMS<br />
* web-based considerations<br />
* detail internal/external to batch record<br />
* stability of batch record — do they change often?<br />
* PAT<br />
• Budget, justification and ROI<br />
• Level and type of staffing required:<br />
* internal/external<br />
* short term/long term<br />
• Project duration and business interruption<br />
IV. Case Study of a Biologics Manufacturer<br />
• Design, construction, rollout of an EBR system for a<br />
Biologicals Manufacturer<br />
12:00 Close of Workshop B<br />
There will be a 30-minute networking and refreshment break at 10:00 a.m.<br />
— About Your Workshop Leader —<br />
George Bernstein, Ph.D., has consulted with and held project manager and<br />
director-level positions with major pharmaceutical companies since 1988.<br />
As a consultant, Dr. Bernstein realized how frustrating data collection and<br />
compliance is for pharmaceutical manufacturing companies that use paper<br />
batch records. From these experiences, he developed the concepts and<br />
managed the development of a proprietary EBR system. This system<br />
was successfully validated and has been in use for over seven years.<br />
Dr. Bernstein has lectured on root cause analysis to industry trade groups,<br />
quality organizations, and at Interphex, and has consulted internationally.<br />
Consulting projects include EBR development, computer system validation,<br />
IQ/OQ/PQ development and execution, quality systems design and<br />
development, SCADA system implementation, business process reengineering<br />
and root cause analysis.<br />
DON’T MISS OUR CO-LOCATED EVENT:<br />
Take advantage of the opportunity to<br />
attend the co-located Enterprise<br />
Bio/Pharmaceutical LIMS Conference<br />
on Monday, August 4th. Hear case studies<br />
from Wyeth, Biogen-Idec and others!!<br />
Visit www.cbinet.com/MES<br />
Enterprise-WideLIMS<br />
for the Bio/Pharmaceutical Industry<br />
Strategies for Implementation, Integration<br />
and Validation of Enterprise-Wide Laboratory<br />
Information Management <strong>Systems</strong><br />
AUGUST 4, 2008 • THE WESTIN HOTEL • PHILADELPHIA, PA<br />
3
“This conference provided an excellent forum for networking and for discussing<br />
the key challenges and technologies driving the MES industry today.”<br />
— 2007 Attendee, Michael Asher, MES Lead, GlaxoSmithKline<br />
MAIN CONFERENCE<br />
Day One — Tuesday, August 5, 2008<br />
12:00 Main Conference Registration<br />
1:15 Chairman’s Opening Remarks<br />
Dan Matlis, President, Axendia<br />
Achieve Optimal Production and<br />
<strong>Manufacturing</strong> Quality<br />
1:30 How Life Science Manufacturers Are Attaining<br />
Operational Excellence<br />
Pharmaceutical, biotech and medical device manufacturers<br />
face substantial pressures. To compete and succeed, the<br />
industry must decrease costs, achieve operational<br />
improvements and all the while ensure robust regulatory<br />
compliance. An efficient manufacturer must collaborate<br />
between the enterprise and plant floor across order<br />
management / batch execution; inventory / material, line /<br />
equipment, and personnel planning; while improving<br />
quality control and assurance for review, approval, and<br />
release. This is made even more challenging with the need<br />
to have manufacture automation and processes that can<br />
operate in a multi-product environment rather than the<br />
traditional one process for one product design. The need to<br />
collapse Levels 2 and 3 of the S95 model is profound. This<br />
session illustrates the shifting dynamics driving this need<br />
and provides insight into the implications on work practices<br />
and applied technology required to deliver this efficiency.<br />
• Industry challenges in operations and compliance<br />
• Implications of a ISA-S95-based approach<br />
• Solutions for collaboration in the plant<br />
• Strategies for increased consistency and<br />
“Right First Time” metrics<br />
• Approaches for integrating across systems and facilities<br />
John Blanchard, Principal Analyst, ARC Advisory Group<br />
2:15 Achieving Quality by Design in Pharmaceutical<br />
<strong>Manufacturing</strong> — An Update on PAT/QbD<br />
Regulatory Expectations and Submissions<br />
The FDA has challenged the industry to achieve a level of<br />
process understanding that is commensurate with a high<br />
level of control around process variability and product<br />
quality in “real time”. This emphasis on “Quality by<br />
Design” is making it increasingly important for life science<br />
manufacturers to invest early in the product life cycle<br />
during process development and to build a sound basis for a<br />
“control space”. This session provides an update on FDA<br />
regulations related to PAT and QbD and also discusses<br />
considerations for Design Space development in QbD.<br />
• Update on FDA practices and expectations for PAT<br />
and QbD<br />
• Control strategy and use of in-process and final<br />
product testing<br />
4<br />
Panel<br />
Discussion<br />
photo by: Photolink / Getty Images<br />
• Identifying challenges including:<br />
* defining Design Space<br />
* identifying critical process parameters<br />
* integrating control strategy<br />
* reporting requirements for changes within the<br />
Design Space<br />
• Top reasons for drug quality defects<br />
• FDA guidance on the horizon<br />
Richard P. Poska, R.Ph., Director, Global Pharmaceutical Regulatory Affairs,<br />
CMC-GPRD Small Molecule Support, Abbott<br />
3:00 Networking and Refreshment Break<br />
3:30 Emerging <strong>Manufacturing</strong> Control <strong>Systems</strong> for<br />
Improved Operational Performance<br />
This session illustrates how MCS (<strong>Manufacturing</strong><br />
Control <strong>Systems</strong>) can achieve seamless and<br />
synchronized system architecture to support electronic<br />
batch records and exception reporting for automation<br />
and production management.<br />
• What is an MCS (<strong>Manufacturing</strong> Control System)<br />
• Benefits of an integrated system<br />
• Challenges of MES and batch automation<br />
• Standards and technology — Current practice<br />
• Vision for future systems<br />
Carey Clements, Life Sciences MES Product Manager, Honeywell<br />
4:15 Industry Directions for MES Adoption,<br />
Integration and Standards<br />
This panel discussion convenes industry MES leaders<br />
and trailblazers to discuss the state of MES adoption,<br />
challenges in achieving integration and the future of<br />
standards adoption.<br />
• Views on the level of MES sophistication to date<br />
• New enhancements and advancements in systems<br />
and processes<br />
• Most problematic challenges in achieving MES<br />
interoperability and enterprise-wide integration<br />
• Outlook for standards adoption and the need for<br />
further standardization<br />
Moderator: Tony Fenn, Principal Engineer, Bristol-Myers Squibb<br />
Panelists: Paul Brandenburg, Team Lead, Site <strong>Execution</strong> <strong>Systems</strong>, Eli Lilly & Co<br />
Michael Asher, Control Engineer, GlaxoSmithKline<br />
Keith T. Evans, Biotech OpU MES Focal Point, TO&PS BSP,<br />
Wyeth Pharmaceuticals<br />
Cathal Strain, Senior Director and Team Leader, API Automation,<br />
Pfizer Inc<br />
5:15 Close of Day One<br />
5:15-6:15 Networking,<br />
Wine & Cheese Reception<br />
Join colleagues and friends in a relaxed setting.
Day Two — Wednesday, August 6, 2008<br />
7:30 Continental Breakfast<br />
8:00 Chairman’s Review of Day One<br />
Dan Matlis, President, Axendia<br />
MES Implementation Strategy and<br />
Lean/MES Case Studies<br />
8:15 How Device, Diagnostic and Biotech<br />
Manufacturers Are Improving Performance with<br />
Real-Time, Predictive and Actionable Intelligence<br />
In the face of increasing competition, frequent new product<br />
introductions and high customer expectations, medical<br />
device, diagnostic and biotech manufacturers are turning<br />
to <strong>Manufacturing</strong> <strong>Execution</strong> <strong>Systems</strong> to help with data<br />
acquisition and process enforcement. Leveraging the data,<br />
manufacturers are advancing to the next level of quality<br />
and performance. This panel convenes industry<br />
professionals to discuss how they use real-time, predictive<br />
and actionable manufacturing intelligence to improve<br />
quality, address issues at the source and accelerate new<br />
product introductions.<br />
Moderator: Dan Matlis, President, Axendia<br />
Panelists: John Oakley, Chief Architect, <strong>Manufacturing</strong> <strong>Systems</strong>,<br />
Applied Biosystems<br />
Karim Lokas, Vice President of Product Strategy,<br />
Camstar<br />
Rey Medina, Director of <strong>Manufacturing</strong> <strong>Systems</strong>,<br />
Johnson & Johnson Cordis<br />
Gilad Langer, Senior Product Manager,<br />
Camstar<br />
Marc White, MES Program Director,<br />
Boston Scientific (Invited)<br />
Panel<br />
Discussion<br />
9:00 Laying the MES Groundwork through<br />
ISA 88 Process Mapping and Batch Record<br />
Standardization — Shire's Story<br />
Prior to putting the first foot in the “MES waters”, it is<br />
critical that life science organizations plan and execute the<br />
necessary pre-MES groundwork. Ultimate MES success and<br />
measurable results depend upon the early establishment of a<br />
strong MES foundation. This session discusses the steps<br />
taken at Shire to establish a good foundation for an MES<br />
project, scheduled to kick-off in mid-2008. Learn how Shire<br />
walked through the planning, process mapping and<br />
standardization necessary for MES success.<br />
• ISA 88 Mapping —<br />
How ISA 88 mapping probed through four levels<br />
Case<br />
Study<br />
• Leveraging ISA 88 process mapping to<br />
generalize maps configurable for any future products<br />
• Batch Record Standardization — How batch records<br />
were first standardized on paper before going electronic<br />
Samantha Krebs, Senior Process Improvement Technical Writer,<br />
Shire Pharmaceuticals, Inc.<br />
9:40 Advancing from a Home-Grown Legacy<br />
System for Traceability of Device<br />
History Records — Key Considerations,<br />
Objectives and Next Steps<br />
This case study shares the background, business objectives<br />
and considerations taken in mapping out the plan for<br />
advancing Guidant’s home-grown legacy system to a<br />
full-featured MES. As with any medical device organization,<br />
traceability of device history records is paramount.<br />
Medical device manufacturers also need automated and<br />
cost-effective solutions with capabilities to address<br />
regulatory requirements, complex manufacturing needs<br />
and optimized throughput and quality. In this session,<br />
learn the considerations and decision-making steps taken<br />
within Boston Scientific to adapt and advance their<br />
manufacturing organization.<br />
• Home-grown solution for traceability of<br />
Device History Records<br />
• Operational improvements made and underway<br />
• Assessing the current state of the legacy system and<br />
manufacturing quality systems<br />
Case<br />
Study<br />
• Facing the build or buy decision —<br />
Key considerations<br />
• Steps needed to advance from an antiquated<br />
traceability system to a full-functioning MES<br />
• Conducting the “to-be” analysis and examining<br />
next steps<br />
• Lessons learned<br />
Tom Litterer, Manager, Boston Scientific<br />
Tracy McMorrow, Manager, Boston Scientific<br />
10:20 Networking and Refreshment Break<br />
10:50 Embarking on a Pilot and Phased Roll-Out<br />
MES Approach at Bayer's Berkeley Site —<br />
How MES is Taking Form within<br />
Various Production Suites<br />
Bayer Healthcare's Berkeley site is a biotech<br />
facility embarking on an exciting MES roll-out.<br />
This case study discusses the key steps undertaken in<br />
planning for MES implementation, the approach for<br />
MES implementation and the experience to date within<br />
the various production sites using MES.<br />
• Review of Bayer healthcare’s global approach<br />
and the unique approach taken within the<br />
Berkeley facility<br />
• Considerations in choosing an MES supplier<br />
Case<br />
Study<br />
• The pilot approach —<br />
How this works as a phased roll-out for MES<br />
• Experiences to date and lessons learned<br />
Andreas Dankelmann, Project Manager, Organization and Information,<br />
Bayer HealthCare<br />
Case Study Photos by: Getty Images<br />
To Register Call Toll Free 800-817-8601 (781-939-2438 outside the U.S.)<br />
or Fax 781-939-2490. Register on our website at www.cbinet.com<br />
5
6<br />
11:30 Case Study Update — Implementing a Highly<br />
Integrated MES and the Results to Date at BMS’<br />
Devens Biopharmaceutical <strong>Manufacturing</strong> Facility<br />
Bristol-Myers Squibb is investing $750 million in the<br />
construction of a Large-Scale Cell Culture (LSCC)<br />
manufacturing facility in Devens , MA , for the<br />
commercial production of biopharmaceuticals. The BMS<br />
vision is to implement a fully automated, paperless<br />
solution that supports release by exception utilizing<br />
S95/S88 integrated recipes. This is to be executed using<br />
an MES to orchestrate plant floor automation, lab activity<br />
and materials management. This case study provides an<br />
update on the project thus far and shares key results and<br />
lessons learned to date.<br />
• Recap on the architecture and design of BMS'<br />
<strong>Manufacturing</strong> Operational Philosophy, with an<br />
emphasis on the MES<br />
• Interface Design — The what and how of working<br />
with SAP, LIMS and Maximo<br />
• Recipe Design, equipment versus process functions<br />
Case<br />
Study<br />
and “reusable recipe patterns”<br />
• Project Methodology — Proof through use, rapid<br />
programming approach, preliminary build versus<br />
final build, teams and skill sets<br />
Tony Fenn, Senior Principal Engineer, Bristol-Myers Squibb<br />
12:10 Elevating <strong>Manufacturing</strong> Sophistication —<br />
How Schering-Plough and Organon<br />
Leveraged Combined Strengths and MES<br />
for Added Business Value<br />
This case study illustrates some of the key business<br />
drivers for why Schering Plough and Organon turned to<br />
MES for process automation. Learn how these two<br />
manufacturing organizations joined forces, leveraging<br />
shared strengths and talent pool and realized measurable<br />
business value through MES and process automation.<br />
Also hear about some of the chief challenges and lessons<br />
learned along the way.<br />
• Assessing the key business drivers and goals<br />
• Finding ways to extend the business benefit of MES<br />
to get more value and automation out of processes<br />
• Repositioning personnel away from manual tasks and<br />
into roles of higher sophistication and value<br />
Case<br />
Study<br />
• Understanding the technology —<br />
How it is configured and why<br />
• Feeding new functionality into established<br />
MES applications<br />
• Deploying a system and effectively working with the<br />
primary contractor — Lessons learned along the way<br />
David Gerhart, Manager, Computer System,<br />
Validation & Automation Integration, Global Technical Services,<br />
Schering Plough Corporation<br />
Lou Verhagen, Associate Director, <strong>Manufacturing</strong>,<br />
Organon<br />
12:50 Luncheon<br />
Integration and Interoperability with<br />
Plant-Level and Mobile <strong>Systems</strong><br />
2:00 Implementing a Highly-Integrated MES<br />
within a Large-Scale Biotechnology –<br />
Genentech’s Four Year Project<br />
This case history reviews the implementation of a highlyintegrated<br />
MES into a large scale biotech manufacturing<br />
facility. This four year project resulted in the<br />
implementation of an MES as an integral part of a total<br />
<strong>Manufacturing</strong> Control System. This MES is integrated as<br />
well with several other Site and Corporate Level 3 and 4<br />
<strong>Systems</strong> to deliver ERP, QC results, electronicallypresented<br />
Procedures, and automatic batch review and<br />
closure to this new paperless manufacturing facility.<br />
Learn the challenges and opportunities, from the MES<br />
perspective, through each phase of this project.<br />
• Project requirements definition<br />
• Software development<br />
• Testing<br />
• Plant commissioning<br />
• Integration strategies<br />
Jeanette Motzer, Manager, Business Applications, Genentech<br />
2:40 Incorporating Wireless MES in a<br />
Biopharmaceutical Facility<br />
Traditional <strong>Manufacturing</strong> <strong>Execution</strong> <strong>Systems</strong> (MES) place<br />
terminals where the work happens, but what if the work<br />
moves? What if your equipment, materials and personnel<br />
operate in a dynamic environment that is constantly<br />
shifting to meet changing demands? That was exactly the<br />
challenge faced by Merck & Company at one of their<br />
biopharmaceutical pilot facilities. This case study<br />
illustrates how Merck met this challenge by embarking on<br />
a program to “cut the cord” and implement critical<br />
functions on wireless handheld devices, which included the<br />
design, development and implementation of wireless<br />
applications while integrating with the existing MES<br />
infrastructure. Participants learn:<br />
• How Merck evaluated and implemented<br />
wireless technologies<br />
• Review of specific issues, such as:<br />
* technology selection<br />
* mapping business needs to the solution<br />
Case * integrating with legacy MES applications<br />
Study<br />
* addressing security concerns<br />
• Strategies learned while developing an open platform<br />
to promote scalability with future systems<br />
Mark Tomcavage, Serac Solutions, LLC<br />
Andrew Kennedy, Research Biochemical Engineer,<br />
Bioprocess Clinical <strong>Manufacturing</strong> and Technology, Merck & Co<br />
3:20 Close of Conference
WHO SHOULD ATTEND:<br />
You will benefit from attending this event if you are an<br />
executive or senior level director from a pharmaceutical,<br />
biotech or medical device manufacturer with responsibilities<br />
or involvement in the following areas:<br />
• MES • ERP<br />
• Plant/<strong>Manufacturing</strong> <strong>Systems</strong> • <strong>Manufacturing</strong><br />
• Industrial/Plant Operations • Pharmaceutical Production<br />
• Production Planning • IT<br />
• Process Design • Engineering<br />
• QA/QC • Validation<br />
• Automation • Regulatory<br />
• Continuous Improvement • Process Excellence<br />
This conference will also benefit consultants, technology vendors<br />
and companies providing services to the above delegation.<br />
ACCLAIM FROM PREVIOUS ATTENDEES:<br />
“I benefited enormously. The contents were unique.”<br />
— Ed Harmon, Associate Director of<br />
<strong>Manufacturing</strong> and Facilities, Biopure<br />
“Very unique conference for all that are thinking<br />
about starting/deploying MES systems.”<br />
— Nirav Shah, Engineer, Schering-Plough<br />
“Good blend of vendor/product information<br />
and real customer experiences.”<br />
— Jerry Cline, IT Manager, GBSC<br />
“Comprehensive overview of the state of MES<br />
in the industry.”<br />
— Ute Bramann, IT Manager,<br />
International Operations, Abbott<br />
“Great opportunity for networking with<br />
industry MES leaders.”<br />
— David Henry, Principle Project Manager,<br />
Wyeth Biotech<br />
“This is an informative, educational sharing of views<br />
and experiences on MES.”<br />
— Dwaraka Ravulapati, IM Lead Analyst, GBSC<br />
Photo by: Jacobs Stock Photography / Getty Images<br />
IN RECOGNITION OF OUR SPONSORS:<br />
CBI Research, Inc’s corporate sponsors represent select companies that share a<br />
common mission: business advancement through thought leadership, strategic<br />
interaction and innovation. The companies represented below are proud contributors<br />
on this program and have carefully selected messaging, branding or positioning<br />
statements to encourage the evaluation and investigation of quality products and/or<br />
services available. We applaud these companies, as well as others that wish to join<br />
the conference, as important members of this event’s delegation.<br />
P l a t i n u m S p o n s o r :<br />
Camstar’s Enterprise <strong>Manufacturing</strong><br />
<strong>Execution</strong>,Quality and Intelligence platform<br />
enables “Closed-Loop Quality <strong>Execution</strong>,”<br />
the end-to-end business process that<br />
surrounds manufacturing and quality operations. Camstar’s unparalleled solution<br />
optimizes the innovation and risk equation by monitoring and controlling global<br />
manufacturing and quality, and by delivering process interoperability and best practices.<br />
The result is shorter time to market and time to volume, the highest quality products<br />
and leaner, more efficient operations.<br />
Designed for ultimate configurability and built on a services-oriented architecture,<br />
Camstar’s comprehensive solution set includes industry-specific, out-of-the box<br />
applications and a proven implementation methodology ensure successful deployment and<br />
rapid time to benefit. More than 100 leading companies, including Johnson & Johnson,<br />
Roche, Covidien, 3M, Gambro, ZOLL, CIBA Vision, Zeiss, Kinetic Concepts, BIOTRONIK,<br />
Favrille, Stirling Medical Innovations, IBM, Kodak, Philips and Hitachi rely on<br />
Camstar as a trusted software partner.<br />
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 :<br />
Emerson Process Management, a business of Emerson<br />
(NYSE: EMR) is the leading process automation technology and<br />
services provider in the world. With annual revenues in<br />
excess of $4B USD in process automation, Emerson enables<br />
API and biotechnology manufacturers to optimize operational<br />
performance, reduce compliance and validation efforts,<br />
shorten cycle and product release times.<br />
TECHNOLOGIES: Integrated through its award winning PlantWeb digital architecture, Emerson provides<br />
manufacturers the most comprehensive and flexible suite of technologies in process automation. Ranging<br />
from hardware that monitors and senses process variables, to control and asset management software, to<br />
advanced process control and batch automation, to compliance and management execution systems…<br />
Emerson fully integrates data across the enterprise to ensure better control, better data management and<br />
easier validation. No automation provider can touch as much of your plant with predictive intelligence and<br />
help you extract the most value from your investments.<br />
SERVICES: Emerson provides the domain expertise of it’s Life Sciences Industry Center to support<br />
customers with project planning, design, engineering and execution, as well as optimization services for<br />
existing facilities to analyze and diagnose operational problems that rob efficiency and profitability and<br />
provide corrective guidance to bring the facility back to optimal performance. Accessible around the world,<br />
Emerson’s Solutions staff integrates with customer personal to collaboratively plan and execute the<br />
programs that bring immediate results while setting a platform for long-term, sustainable performance.<br />
Emerson combines it’s technology and services offering into a unique program for Life Sciences<br />
manufacturers, called the OpX Advantage Program. This proven methodology offers an unparalleled way<br />
to leverage the investments you’ve already made plus integrating state-of-the-art, proven automation tools<br />
to deliver world-class operations.<br />
To learn how Emerson delivers smarter projects and smarter operations, visit<br />
www.emersonprocess.com/lifesciences.<br />
A d d i t i o n a l S p o n s o r s :<br />
If you are interested in sponsorship or exhibit opportunities,<br />
please call Karen Hanover at 781-939-2484, fax 781-939-2536<br />
or email k.hanover@cbinet.com<br />
7
Register by May 30, 2008 and Receive $300 Off Your Registration Fee!<br />
<strong>3rd</strong> <strong>Annual</strong><br />
<strong>Manufacturing</strong><br />
<strong>Execution</strong> <strong>Systems</strong><br />
in the Life Sciences Industry<br />
Maximize MES Capabilities within a Lean Organization<br />
and Achieve Enterprise-Wide Integration for<br />
Quality and Performance<br />
AUGUST 5-6, 2008 • THE WESTIN HOTEL • P H I L A D E L P H I A , PA<br />
CD-Rom Compendiums<br />
If you are unable to attend the conference or<br />
you would like extra copies for your colleagues,<br />
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Don't miss out on the valuable information<br />
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and the CD-Rom will be shipped to you<br />
2 weeks after the conference occurs. photo by: Keith Brofsky / Getty Images<br />
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Early Bird Discount — Register by May 30, 2008 and SAVE $300.<br />
Fee includes continental breakfast, lunch, wine and cheese reception, refreshments<br />
and CD-Rom Compendium. Please make checks (in U.S. funds drawn on a U.S. bank)<br />
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• Team Discount:<br />
Your organization may send 1 executive FREE for every 3 delegates registered.<br />
All registrations must be made at the same time to qualify.<br />
• Discount Accommodations & Travel:<br />
Contact CBI’s official travel service Travel Concepts for all of your travel needs.<br />
In order to receive CBI’s special discounted hotel rate, you must call<br />
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email chris@travelconcept.com by July 11, 2008. Travel Concepts<br />
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to qualify for hotel and travel discounts. All travel arrangements subject to availability.<br />
• Venue:<br />
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charge can be credited to another CBI conference if you register within 6 months from<br />
the date of this conference. In case of conference cancellation,<br />
CBI’s liability is limited to refund of the conference registration fee only.<br />
CBI reserves the right to alter this program without prior notice.<br />
Please Note: Speakers and agenda are subject to change without notice.<br />
In the event of a speaker cancellation, every effort to find a suitable replacement will<br />
be made. The opinions of the conference faculty do not necessarily reflect those of the<br />
companies they represent or The Center for Business Intelligence.<br />
• Satisfaction Guaranteed:<br />
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quality of the conference, a credit will be awarded towards a comparable<br />
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DON’T MISS THE CONFERENCE THAT CONVENED<br />
OVER 200 EXECUTIVES IN 2007!!<br />
Featuring Speakers From:<br />
Abbott • Applied Biosystems<br />
Bayer HealthCare • Boston Scientific<br />
Bristol-Myers Squibb<br />
Cordis, a Johnson & Johnson Company<br />
Eli Lilly & Co • Genentech<br />
GlaxoSmithKline • Merck & Co • Organon<br />
Pfizer Inc • Schering Plough Corp<br />
Shire Pharmaceuticals, Inc.<br />
Wyeth Pharmaceuticals<br />
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