2012 IMACS IN REVIEW 8TH ANNUAL IMA CS AT

2012 BIOVIA USER GROUP MEETING — BOSTON, MAWHITE PAPER

CHAIRMAN’S MESSAGEOur annual 2012 International Meeting on Automated Compliance Systems (IMACS) was co-located with the 2012 BIOVIA User Group Meeting (UGM) for Life Sciences held May 7-9 at the Boston Marriott Long Wharf Hotel. The dedicated IMACS track at this year’s UGM highlighted the use of BIOVIA applications to reduce cost of compliance and improve operational efficiency in Analytical, Development, Quality and Manufacturing (ADQM) operations. Topics covered paperless lab execution systems, method automation, electronic instrument data capture and integration with external systems including BIOVIA ELN, BIOVIA LIMS, BIOVIA MES and BIOVIA ERP.

With our BIOVIA-VelQuest-Aegis integrations now complete, the following chart provides the new product names within the BIOVIA Process Management and Compliance Suite supporting our customers’ ADQM initiatives.

New Name Old NameBIOVIA Lab Execution System VelQuest SmartLab

BIOVIA Electronic Batch Records VelQuest SmartBatch EBR

BIOVIA Inventory Management VelQuest CIMS

BIOVIA Environmental Monitoring VelQuest SmartLab EM

BIOVIA Electronic Lab Notebook Symyx Notebook by Accelrys

BIOVIA Enterprise Platform N/A

BIOVIA Metrology VelQuest Calibration Manager

BIOVIA Discoverant Aegis Discoverant

An important trend we are seeing this year was highlighted by case studies from Bristol-Meyers Squibb and Johnson & Johnson about connecting the BIOVIA Electronic Lab Notebook and BIOVIA Lab Execution System to integrate the product and process lifecycle from early development through production/manufacturing informatics.

IMACS 2012 clearly outlined the integration of the BIOVIA Lab Execution System and the BIOVIA Process Management and BIOVIA Compliance Suite into the operational fabric of the 21st century cGMP informatics environment yielding critical-path benefits in productivity, cycle times and compliance. These issues are THE differentiation features for life sciences companies that will succeed over the next decade.

Key customer metrics cited at IMACS 2012 resulting from deployment of BIOVIA ADQM software solutions include:

• 90% error reduction (Forest Labs)

• 80% correct first-time submissions (Forest Labs)

• 50% time savings in QA reviews (Forest Labs)

• 7-week time savings from method development to NDA report (BMS)

• 40-60% reduction in document review time (Lilly)

• 50% reduction in report writing hours (PPD)

• 25% reduction in QA hours (PPD)

• 23% reduction in archiving hours (PPD)

I look forward to working with the organizing committee to elicit updated customer case studies and metrics for the IMACS track at the 2013 BIOVIA User Group Meeting.

Best Regards,

John P. Helfrich, Chairman BIOVIA 2012 UGM IMACS Track Organizing Committee and Vice President, Strategic Programs Analytical, Development, Quality & Manufacturing (ADQM Solutions BIOVIA, Inc.Table of Contents

TABLE OF CONTENTS

Productivity and Efficiency for Process OperationsAstraZeneca Data Utilization across Operations: What Opportunities Exist within the Current Platforms?........3

Forest Laboratories ALEXIS Efficiency Gains and Global Lab System Harmonization......................................................4

Bristol-Myers Squibb An Integrated Electronic Workflow — From Method Development to Method Execution...............5

Janssen (J&J) ELN Recipe Execution Engine: A Novel Lightweight Solution for Electronic Batch Execution........6

Reducing Compliance Risks PPD The Role of the BIOVIA Lab Execution System (LES) and Consumable Inventory Management System (CIMS) in a CRO cGMP Environment.......................7

Perrigo Implementation of a Lab Execution System: And Now the Rest of the Story.................................8

Eli Lilly & Company Business Challenges in a Global Deployment of BIOVIA Lab Execution System and the Consumable Information Management System..................................................................9

Selection and Rollout of Process Informatics Systems Bristol-Myers Squibb Lessons Learned: Implementing Methods Requiring a Mobile Lab Workflow...............................10

Johnson & Johnson Two Roads Diverge – Lab Execution System (LES) or LIMS or Both...............................................11 If you are interested in more information on the above papers, please contact me at john.helfrich@BIOVIA.com.

DATA UTILIZATION ACROSS OPERATIONS: WHAT OPPORTUNITIES EXIST WITHIN THE CURRENT PLATFORMS?

Mike Stroz, Global Quality Systems Business Partner, AstraZeneca PharmaceuticalsAbstract: AstraZeneca Operations has deployed a multi-tiered set of IS systems to support the Global Operations Sites. The systems are designed to increase efficiency, maintain high quality, reduce errors and reduce operating expenses. Currently the group relies on standard focused reports and common tools to get information from the systems, but the information is typically focused on a single product or step in the process. Lately, as the footprint of the systems increases, the group has started to consider strategic development opportunities for tools that would enable a much greater utilization of data across the systems. This discussion focused on:

• A description of the current systems strategy

• A discussion of the boundaries between the systems and how they link to the business process

• The issues and drivers pushing us towards a strategy (Regulatory, Lean, Incidents/Issues Management, etc.)

• How solving the issues would benefit the organization

• Looking ahead to further exploitation opportunities enabled by the design

The discussion is at this point conceptual, but the issues and opportunities exist. Solving these problems and driving efficient utilization of data across the organization will drive improvement in quality, performance and cost.

As Pharma companies contend with massive quantities of data, they are developing integrated systems for harmonizing data across discovery, development and operations. These systems must enable companies to do more, faster, with less while maintaining excellent quality and compliance across the organization. Companies are only fully leveraging a fraction of this data now, and it is the key to future success. As an industry, we need to think big in this area and push our vendors to consider opportunities beyond their product portfolio.

AstraZenica Representative Slides

ALEXIS EFFICIENCY GAINS AND GLOBAL LAB SYSTEM HARMONIZATION

John Perlow, Assistant Director, Business Information Management PR&D and Preclinical, Forest Laboratories, Inc.Abstract: A few years ago Forest implemented BIOVIA Lab Execution System and Labware LIMS globally in the QC labs as part of the Automated Laboratory Execution Information System. After implementing ALEXIS into the QC environment we noticed an increase in efficiency of the processing of samples in the labs. The systems were also very well received by the chemists in the lab. It was then determined that it would be a good idea to implement these systems into the Product Research & Development (PR&D) environment.

Both Informatics and the business realize that there are differences between the way a QC lab and a PR&D lab operate, so an evaluation is being done to determine which parts of the system can be the same and where we may need to have some differences.

By limiting the differences we can streamline the tech transfer process. We are targeting 75% of the systems to be utilized the same and 25% differences as needed to ensure the labs can perform the daily tasks required without restrictions.

As part of the Forest global system harmonization, Forest is evaluating the various systems used by PR&D and the QC labs. We are looking to harmonize the systems and how they are used as much as possible.

These systems include but are not limited to:

• Chromatography Data Systems

• Electronic Laboratory Notebooks

• Laboratory Information Systems

Benefits achieved by implementing the BIOVIA Lab Execution System in Forest Laboratories’ QC environment include automated workflows, enforcement of standard operating procedures, improved adherence to test methods and consistent capture of timely date stamping and sign-offs. The BIOVIA solution has reduced the time to conduct QA reviews by at least 50 percent and at least 80 percent of submissions are now correct the first time, compared with 10 percent using the previous system.

Forest Laboratories Representative Slides

AN INTEGRATED ELECTRONIC WORKFLOW — FROM METHOD DEVELOPMENT TO METHOD EXECUTION?

Judy Lin, Analytical and Bioanalytical Development; John Rumney, Pharmaceutical Development Informatics, Bristol-Meyers Squibb CompanyAbstract: The lifecycle of an analytical method spans from method development through method validation to method execution for sample analysis. The process involves numerous experiments, reports and data/document reviews over the complete life cycle.

Traditionally, different systems, including paper and electronic, handle discrete parts of the process. As a result, extensive manual data transcription, verification and final review are required. In collaboration with BIOVIA, BMS Analytical and Bioanalytical Development and Pharmaceutical Development Informatics designed an integrated electronic flow using existing features of the BIOVIA Electronic Lab Notebook such as vault workflow, Empower adapter, integration with BIOVIA Instrument Manager and BIOVIA Lab Execution System and BIOVIA Pipeline Pilot reporting. This presentation provided details of the overall work flow, including the interfacing of multiple applications. A cost/benefit analysis of this integrated workflow was also presented.

The analytical method lifecycle is too often encumbered by too many user interfaces, poor communication, inconsistent documentation, slow execution and tedious review processes. The BIOVIA electronic workflow has markedly improved the documenting, reviewing and reporting of BMS’s analytical method validation process, providing standard notebook recording processes, shorter document review times and easier report formatting while eliminating manual data transcriptions.

BMS Representative Slides

ELN RECIPE EXECUTION ENGINE: A NOVEL LIGHTWEIGHT SOLUTION FOR ELECTRONIC BATCH EXECUTION

Ryan Bass, Strategic Operations, PDMS Janssen Research & DevelopmentAbstract: Building upon the framework of the ELN v6.X, in collaboration with BIOVIA, Johnson & Johnson has created an electronic batch record execution system. This talk described the vision for this system and provided a live demo of the functionality. The system utilizes recipes built on ANSI/ISA-88 and ANSI/ISA-95 international standards typically used in manufacturing to direct a dynamic experiment creation engine that builds on-the-fly a control recipe needed to electronically execute a batch record. In addition to instruction set generation, the engine utilizes connections to material inventory and instrument/machinery data systems to create bill of material, bill of equipment and allow for real-time access to plant floor data. The engine is built to be highly configurable based on recipe operation and offers Johnson & Johnson a true lightweight Manufacturing Execution System.

Johnson & Johnson’s (Janssen’s) ELN recipe execution engine for clinical batch manufacturing features dynamic electronic batch record creation based on an externally hosted instruction set, enabling seamless tech transfer from development experiments to master batch record. The BIOVIA toolset connects to a wide range of material, equipment and instrument systems and is built on industry standards for import and export—It plays well with others!

Janssen Representative Slides

THE ROLE OF THE BIOVIA LAB EXECUTION SYSTEM (LES) AND CONSUMABLE INVENTORY MANAGEMENT SYSTEM (CIMS) IN A CRO CGM P ENVIRONMENT

Kathy Shanks, Laboratory Manager, cGMP Laboratories, Laboratory Support Services & Data Management, PPDAbstract: To improve data quality and security, gain efficiencies, decrease review and turnaround time and eliminate manual data entry into analytical reports, the PPD LLC cGMP Laboratory sought a laboratory execution system that could seamlessly interface with an existing internally developed LIMS. In addition, the laboratory required a system for the control and maintenance of consumables. This presentation provided a synopsis of the implementation of the BIOVIA Lab Execution System in conjunction with CIMS (now BIOVIA Inventory Management) including lessons learned, best practices, benefits derived and the plan going forward.

What did we learn from our successful implementation of BIOVIA LES and CIMS (now BIOVIA Inventory Management) in our cGMP CRO environment? We learned that we needed to be the primary driver of the process for installation, validation and electronic procedure creation with input from BIOVIA. We also found that when you’re open to change and paradigm shifts, you’ll find improved quality, efficiencies and cost savings in unexpected places.

PPD Representative Slide

IMPLEMENTATION OF A BIOVIA LAB EXECUTION SYSTEM: AND NOW THE REST OF THE STORY

Deborah Baker, QC Compliance Support, PerrigoAbstract: The Perrigo Company, with headquarters in Allegan Michigan, is continually striving to fulfill the company’s mission, “To meet the world’s growing need for quality, affordable healthcare.” In order to support this vision, Perrigo has strategic goals that focus on both compliance and cost control. This presentation focused on the results of the phased implementation strategy Perrigo chose for their BIOVIA Lab Execution System deployment and lessons learned.

A key lesson learned from deploying the BIOVIA Lab Execution System at Perrigo is: Never compromise the design of the new system to accommodate restrictions of the old one. Implementing a new Laboratory Informatics System is about more than just installing new software. It’s an opportunity to reassess and improve upon your traditional laboratory practices.

Perrigo Representative Slides

BUSINESS CHALLENGES IN A GLOBAL DEPLOYMENT OF BIOVIA LAB EXECUTION SYSTEM AND THE CONSUMABLE INFORMATION MANAGEMENT SYSTEM

Theresa Lawrence, Associate Consultant, QA Global Lab Informatics; Stephanie Maxey-Boyd, Consultant IT – M&Q Labs, Eli Lilly and CompanyAbstract: Eli Lilly & Co. has been deploying BIOVIA LES and Inventory Management products as an integral part of our LIMS system. The BIOVIA solutions have been deployed to over 24 sites. This discussion covered:

• An overview of Lilly’s process with and without BIOVIA Inventory Management software

• Progress to date on Lilly’s deployment of BIOVIA LES and Inventory Management products

• Lessons learned from deployment of BIOVIA LES and Inventory Management products

The discussion included many “ah-ha” moments and benefits gained by using the BIOVIA LES and BIOVIA Inventory Management solutions.

Lilly’s global deployment of BIOVIA LES and Inventory Management software has been highly successful to date. With improved “proceduralization,” we’ve seen fewer lab deviations as usage of BIOVIA technology increases, along with approximately 40-60 percent reduction in review time. We’ve eliminated both manual data entry into LIMS and paper document control. Our folks prefer BIOVIA technology and are pressing for even more automation.

Lilly Representative Slides

IMPLEMENTING METHODS REQUIRING A MOBILE LAB WO RKFLOW

Anil K. Rattan, Ph.D., Manager, Analytical Systems Management, Bristol-Myers Squibb CompanyAbstract: Electronic Laboratory Notebooks (ELNs) have changed the way work is performed in the lab. BIOVIA Lab Execution System, an BIOVIA ELN for use in GxP activities, has assisted in error reduction while streamlining review and saving time for QA/QC operations. Selecting the right methods for initial implementation and building those methods to user specifications has been a challenge for two particular methods: Biacore and Bioassay. Also, with this transition from paper to BIOVIA ELN some workflow gaps that require mobile devices have been identified that reduced overall user adoption rates.

In order to determine which methods received priority implementation, a team assembled a business case based on three criteria: 1. Number of method runs in a year; 2. Length of review time; and 3. Applicability to GxP space. The higher the number of runs in a year and the longer the review time for applicable methods, the better the return on investment (ROI) and therefore the more logical selection for initial implementation. But these criteria failed to identify possible workflow gaps for end users—particularly those who follow a mobile workflow (i.e., the need for real-time data entry in front of balances, bioreactors, pH meters, etc.).

In order to mitigate the reduced user adoption due to these gaps, a project team was tasked with providing some stopgaps for the process. After extensive study, the project team determined that the implementation of mobile computing devices, barcode scanners and label printers would close these mobile workflow gaps and assist with increasing user adoption of these methods.

An ROI calculation for the BIOVIA Lab Execution System, and its applicability to the GMP space, were both good indicators for implementing BMS’s Biacore and Bioassay methods using BIOVIA technology; however, our use case time-savings assessment failed to identify the best mobile workflow for the methods, which subsequently lowered user adoption. Lesson learned: Ask the right questions about workflow early in the selection process.

BMS Representative Slides

TWO ROADS DIVERGE – LAB EXECUTION SYSTEM (LES) OR LIMS OR BOTH

Judy Hancock, Senior Director; Paresh Patel, Quality Fellow, Medical Devices & Diagnostics Laboratories, Johnson & JohnsonAbstract: “Two Roads Diverge,” or do they? How do you select what is best for your laboratory? Is a laboratory Execution System the answer to your compliance and efficiency concerns? Will a BIOVIA LIMS provide you the connectivity that you need? Or do you need both?

This talk provided a roadmap to help determine what may work best in your laboratory, what application(s) should provide the greatest advantage based on the requirements of your lab. For situations requiring laboratory oversight of many laboratories, the presentation offered a breakdown of how the application(s) could be rolled out across laboratories, and where the greatest need is in an environment where budget dollars are tight.

Laboratory software connectivity–BIOVIA LES, BIOVIA LIMS or both–is very much a function of your business challenges and workflow complexity, but beyond selecting the model that best fits your needs, you must also ensure that you can maintain the software applications you choose over the long haul.

J&J Representative Slides

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ABOUT IMACSIMACS is the definitive track on IT-based compliance and productivity solutions at BIOVIA annual User Group Meeting. The life sciences industry is challenged with reducing costs and improving productivity throughout the drug development and production process. Current QbD, ICH and PAT initiatives are a key component to the IMACS presentations and are outlined by industry implementers of the BIOVIA platform solutions. In addition, key interoperation with existing IT/IS solutions (i.e., BIOVIA ELN, BIOVIA LIMS, BIOVIA ERP, BIOVIA EDMS, BIOVIA SDMS, BIOVIA CDS and BIOVIA MES) is outlined.

IMACS provides a forum and information exchange for enabling technologies designed to meet these challenges. IMACS is open to all individuals interested in advances in automating compliance and will feature implementer experiences and insights.

The organizing committee will not accept commercial presentations.

Interested in attending an BIOVIA event? Please visit accelrys.com/events or contact your Account Manager for details. You can also email us at info@accelrys.com.

We look forward to seeing you!

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