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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 />

you can order your conference CD-Rom today.<br />

Don't miss out on the valuable information<br />

presented by industry leaders exclusively at this<br />

event. The CD-Rom is available for only $198 and<br />

includes the conference agenda, presentations and<br />

speaker biographies. Simply fill out the order form<br />

and the CD-Rom will be shipped to you<br />

2 weeks after the conference occurs. photo by: Keith Brofsky / Getty Images<br />

• Registration Fee: Standard Early Bird<br />

MES AND LIMS —<br />

ALL-INCLUSIVE 3-DAY PASS * $2,795 $2,395<br />

Conference & Workshop<br />

Conference only<br />

Workshop only<br />

* See page 3 for details.<br />

$1,995<br />

$1,595<br />

$895<br />

$1,695<br />

$1,295<br />

$895<br />

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 />

payable to CBI Research, Inc. (No personal checks accepted)<br />

• 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 />

Travel Concepts at 800-640-8082 (508-879-8600 outside the U.S.) or<br />

email chris@travelconcept.com by July 11, 2008. Travel Concepts<br />

can also negotiate low group airfares and car rentals. Mention that you are attending<br />

CBI’s <strong>3rd</strong> <strong>Annual</strong> <strong>Manufacturing</strong> <strong>Execution</strong> <strong>Systems</strong> in the Life Sciences Industry<br />

to qualify for hotel and travel discounts. All travel arrangements subject to availability.<br />

• Venue:<br />

The Westin Hotel<br />

99 South 17th Street • Philadelphia, PA 19103<br />

Negotiated rates only available through Travel Concepts<br />

• Substitution & Cancellation:<br />

Your registration may be transferred to a member of your organization up to<br />

5 EASY WAYS<br />

TO REGISTER<br />

WEBSITE<br />

www.cbinet.com<br />

Best<br />

Value<br />

CALL TRAVEL CONCEPTS<br />

TODAY AT 800-640-8082<br />

24 hours in advance of the conference. Cancellations received in writing on or before<br />

July 22, 2008 will be refunded, less a $195 administrative charge. No refunds<br />

will be made after this date; however, the registration fee less the $195 administrative<br />

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 />

CBI stands behind the quality of its conferences. If you are not satisfied with the<br />

quality of the conference, a credit will be awarded towards a comparable<br />

CBI conference of your choice.<br />

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Yes! Please register me for CBI’s <strong>3rd</strong> <strong>Annual</strong> <strong>Manufacturing</strong> <strong>Execution</strong> <strong>Systems</strong> in the Life Sciences Industry.<br />

Conference & Workshop A Conference & Workshop B Conference only Workshop A only Workshop B only<br />

Yes! Please register me for CBI’s <strong>3rd</strong> <strong>Annual</strong> <strong>Manufacturing</strong> <strong>Execution</strong> <strong>Systems</strong> in the Life Sciences<br />

Industry AND Enterprise LIMS for the Bio/Pharma Industry all-inclusive 3 day pass.<br />

I am registering for the EARLY BIRD DISCOUNT We would like to take advantage of the TEAM DISCOUNT (see left for details).<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 />

E-MAIL<br />

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