2013 PMC Suite User Conference

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2013 Accelrys PMC Suite User Conference
Presentation Abstracts

Product Road Map Sessions

Accelrys ELN Road Map Session

Abstract: In this session we will present the high level roadmap and strategic direction for the next three releases of Accelrys Electronic Lab Notebook. We will dive into detail on the objectives of the next major Notebook release, that being Recipe development and Execution, and flexible data capture. This is intended to be an interactive session with the goal being to validate our direction and identify concerns from our customer base.

This is a closed session open to customers with a current Accelrys software license.


The Process Management and Compliance Suite – An Integrated Software Suite for Development, Manufacturing and Quality Control

Abstract: The Process Management and Compliance (PMC) Suite of integrated software is made from a group of purpose built applications.  Each application provides the specialized functionality typically required in Development and Quality operations.  In this discussion we will review the functionality provided by each of the applications in the PMC Suite and demonstrate how the applications are integrated within the suite and with external applications.


Discoverant Road Map Session

Abstract: In this session we will discuss the high level roadmap and strategic direction for Accelrys Discoverant, including more detailed roadmaps for InVision, Nexus, and PRIMR.  This is intended to be an interactive session with the goal of verifying our product direction and soliciting feedback on other areas of concern within the Discoverant user community.

This is a closed session open to customers with a current Accelrys software license.


Plenary Session

Going Paperless: From Idea to Realization, How Accelrys Management Consulting Can Help You Optimize Your Processes
Ulf Fuchslueger, Accelrys

Abstract: tba


A Recipe-based S88/S95 Approach to Global Harmonization From a Procedure Execution Standpoint
Paul McKenzie, VP, Manufacturing & Technical Operations, Johnson & Johnson

Abstract: tba


Transforming the Scientific and Business Dynamics of New Drug Development and Commercialization – How to Harness All Your Data for True Operational Excellence
Ed Francis, Partner, Global Services, Life Sciences Industry, IBM

Abstract: With the need to reduce the time for new drug development from scientific discovery to manufacturing, to comply with the FDA 21st century cGMP guidelines, and to drive process robustness pharmaceutical companies need to bring about transformational change. This session will examine ways to achieve operational excellence by improving process robustness, eliminating paper, implementing best practice standards and templates that reduce time to value, plus provide a global view of manufacturing operations and supply chain to ensure adequate and high quality raw material inventory, product supply and compliance.


 

Product Development Track

Symyx Notebook: A Chemical Development Perspective
Jeff Simon, Senior Research Scientist, BMS

Abstract: Documenting experiments within an ELN differs based on company rules and the experiment type being conducted, non-GMP vs. GMP. This presentation will describe how BMS and Accelrys collaborated to develop and deploy Symyx Notebook 6 to the BMS Chemical Development organization. Key topics will include how BMS adapted Symyx Notebook for conducting very early GMP operations in a fully electronic environment, the use of templates and customized sections, and overall electronic workflow design and development.


Not Exactly Process Development: Developing Notebook Templates for Process Chemistry and Reimagining the Role of the Template
Martin Berliner, Pfizer

Abstract: Pfizer recently completed the rollout of a second-generation template to process chemists using Symyx Notebook. Our desire to minimize the impact of future template changes led to us developing an independent implementation of self-healing, self-updating documents. Our implementation features the ability to generate multiple unique experiment types from a single template and runtime event script assignments, giving us a very flexible experiment creation and maintenance platform that is essentially invisible to the daily user. This talk describes the development of these two generations of templates and how design decisions were made on the basis of use patterns from the previous generation of software (IntelliChem/Symyx Process Notebook).


Using Work Request Adaptor to Link Studies with Testing Laboratory
Larry Zyontz, GIT Manager, Colgate Palmolive

Abstract: The Work Request Adaptor allows scientists who manage samples to assign tasks, priorities and due dates in a work request generated directly from their experiment. The tasks are assigned by the testing laboratory and the results recorded in a separate experiment which automatically obtains the sample and testing information. Both the original and testing lab experiments are linked. Learn how Colgate has expanded eLN capabilities using the Work Request Adaptor to submit packaging samples for testing, manage tasks and link with test results.


Bioprocess Development in Accelrys ELN
Deqi Chen, Accelrys

Abstract: Scientists can greatly improve efficiency in their labs by implementing an Electronic Lab Notebook, and replace many manual processes which are mostly done today in Excel and on paper. For example, using simple and configurable templates scientists can easily record the parameters, observations and results for experiment activities such as: design, sampling, analysis, etc.  This session will illustrate how Accelrys ELN has been successfully deployed specifically in support of BioProcess workflows. 

To further leverage the value of the Accelrys ELN solution, this session will discuss how integrations with inventory and metrology systems can be used to import information directly into ELN to increase efficiency and accuracy.  The presentation will also highlight how scientists can use Accelrys ELN to capture procedures, recipes, methods, and in-process sample analysis to improve work flow, data collection and traceability, while leveraging the Accelrys Enterprise Platform to help mine, aggregate and visualize the data across experiments and product batches.


What’s In What’s Out
Anil Rattan, Manager, BMS

Abstract: The flexibility of development work and the ever-increasing need for on-demand data assimilation requires a holistic approach to electronic system implementation. For several years our biologics departments employed a series of patchwork solutions to meet these growing demands. Some of these solutions were paper-based, others were home grown. None of them adapted to our long-term electronic systems architecture needed to support our company’s strong biologics portfolio.

In order to move from paper-based systems and home grown solutions, a team of support specialists, subject matter experts, advisory council, program owner, project management, change management, and information technology experts constructed a dynamic system infrastructure to support the non-GMP data flow in our organization. This resulted in the replacement of a Microsoft Access database with a commercial LIMS, the removal of paper laboratory notebooks in favor of ELN, and the purchase of a business intelligence and analytics tool. In conjunction with these upgrades, existing auxiliary support systems such as Waters NuGenesis and Empower were deeply integrated with these new purchases.

This presentation will focus on the as-is infrastructure, consider the future possibilities, and discuss points of possible return on investment that can be accrued through further implementations and automation.


Analytical Development: Preparing for the Future While Enabling the Present
John Rumney, Business Capability Manager, BMS

Abstract: An example of the evolution of a highly productive analytical organization which enables scientists to become more productive while being more disciplined in documentation practices. Using software systems and consistent work structure, we build a history and repository to deepen our knowledgeable about the products and processes used in the organization.


From Development to Manufacturing: Increasing Velocity of Method Validation
Stan Piper, Accelrys

Abstract: Validation is an integral part of the R&D continuum, and whether validating methods, processes, or recipes, researchers must mange several key tasks in this stage of the product development cycle.  Validation activities can be cumbersome and tend to be very manual, so increasing the efficiency, productivity and quality around these activities would represent significant savings within organizations.

These activities include: 

  • Transition of parameters from the iterative development stage into the validation stage
  • Management of the validation protocol development & workflow
  • Execution of validation experimentation
  • Management of validation results
  • Generation of validation summary reports & final method documents

This session will highlight several examples of how components within the Accelrys Process Management & Compliance Suite, particularly Accelrys ELN, can be used to more efficiently manage the complexities of validation activities.  The presentation will show how the transition of final parameters from upstream development can be more easily managed, how capture & transfer of the validation data could be automated, and how the Accelrys Enterprise Platform could be leveraged to generate summary reports.


Trending Data within a Diversely Used Electronic Notebook
Ryan Bass, Senior Engineer, Janssen R&D

Abstract: Trending data across groups is typically done on highly structured GXP/GMP sources but many processes are developed entirely in non-GXP environments bringing a great degree of documentation variety. Modern ELNs offer a variety of data entry modes from free-text to custom form to structured tables. Depending on the process, use of different modes to document data is preferred leading to a wide range of sources. This talk will describe the approach Janssen has taken to unlocking the data from the ELN and allowing for contextualized data analysis of non-GXP data.


QA/QC Track

Process Management and Compliance Suite; Where We Are and Where We Are Going
Gene Tretrault & Ken Rapp, Accelrys

Abstract: Over the last few years, Accelrys has acquired several informatics-based companies with a single goal in mind – to provide a comprehensive data management platform to fully automate the capture, cataloging, management, and reporting needs of life science companies.  This fundamental industry need is the foundation of the Accelrys Scientific Innovation Life-Cycle Management (SILM) initiatives announced during the spring of 2012.  The technology embodies a Knowledge Platform for true operational excellence from development to commercial operations.

A key technology element of the SILM concept for life science companies is the integration of Accelrys acquired critical path products that will focus on the data management needs post discovery of any new therapeutic entity.  As a new drug product or device passes through the development, clinical, pilot and commercialization stages, the vast array of experimental data and compliance related activities increase at an exponential rate.  Implementing a comprehensive data/informatics “platform” with built-in compliance features will provide the automation and informatics use of data across the entire development to commercialization stages. 

The implications of this SILM concept spans Operational Excellence programs, Quality by Design (QbD) initiatives, Lean, Right-First-Time programs and overall reductions in cycle times, deviations and total cost of operations.

This paper will outline each of the key technology components and the integration status today, as well as a plan/vision for the next few years.

Generic Pharma Quality Benefits of a LES Platform One Year After Implementation
Deborah Baker, QC Compliance Support Supervisor, Perrigo & David Redding, QC Compliance Support Team Leader, Perrigo

Abstract: 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 will focus on the benefits of our SmartLab deployment one year after implementation.


The Role of the LES and Inventory Management in a CRO Environment
Kathy Shanks, Manager, Laboratory Informatics, PPD

Abstract: To improve data quality and security, gain efficiencies, decrease review and turnaround time, and to eliminate manual data entry into analytical reports, the PPD LLC cGMP Laboratory implemented a laboratory execution system.  In addition, the laboratory deployed a system for the control and maintenance of consumables.  A synopsis of the implementation of the Accelrys LES in conjunction with Inventory Manager will discussed including lessons learned, best practices, benefits derived, and the plan going forward.


Review of a Pilot Study and Business Case Development for Accelrys LES Application in a Large Multi-National Pharmaceutical Environment
Colin Taft, Senior Manager Lab Systems, Johnson & Johnson

Abstract: A pilot study has been executed to verify the potential of electronic systems to improve laboratory efficiency and compliance through the introduction of paperless solutions for analytical activities across a complex mix of laboratories and product types. The Accelrys LES Application has been trialed to determine the business benefits around improved efficiency and compliance in a highly regulated analytical environment. This presentation will cover:

  • Overview of the pilot study and results
  • S88 recipe approach for method configuration
  • Developing the business case to move forward from assessment to strategic deliverable
  • Strategy for system deployment

Achieving the Business Benefits of Quality by Design (QbD) using Process Management Informatics
Justin Neway, CSO, Accelrys

Abstract: The process and quality data stored in systems like LIMS, LES, EBR, ELN, Historians, ERP, etc., and on Paper Records is organized differently in each system to serve the needs of specialized users who focus on different portions of the production process.  This creates problems for users who need to perform data analysis on the process as a whole, to understand the sources of variability and build process models to improve process performance and implement Quality by Design (QbD).  These users need an automated way to access and contextualize all types of process-related data for analysis outside of the disparate source systems without resorting to labor intensive, inflexible and error prone spreadsheet methods.  This presentation will describe how pharmaceutical companies have overcome these problems by using a Process Management Informatics system that provides self-service, on-demand access and automated contextualization of data located in disparate source systems.


Global Implementation of the Accelrys LES to Achieve a Harmonized cGMP Quality Operation
Nimesh Patel, Senior Analyst Business Informatics Management, Forest Laboratories & Jon Perlow, Associate Director Research Informatics Mgmt, Forest Laboratories

Abstract: tba


Analytical Development: Preparing for the Future While Enabling the Present
John Rumney, Business Capability Manager, BMS

Abstract: An example of the evolution of a highly productive analytical organization which enables scientists to become more productive while being more disciplined in documentation practices. Using software systems and consistent work structure, we build a history and repository to deepen our knowledgeable about the products and processes used in the organization.


Impact of a Global Roll Out of the Accelrys LES on Quality Operations at Lilly
Lukas Gogis, I.T. Manager, Eli Lilly

Abstract: tba



Manufacturing Track

Process and Product Monitoring for "Real"-World Data
Kate Lusczakoski, Accelrys

Abstract: Driven by numerous federal initiatives, the development and maintenance of statistically sound, automated process and product monitoring systems is the focus of many life science manufacturing companies. To increase productivity and enable accurate statistical process control procedures, quality monitoring systems need to account for the nuances of “real”-world data (e.g., non-normality, autocorrelation, missing data, data cleaning, etc.) and the massive quantity of variables necessary to create a comprehensive system. To overcome these typical challenges, techniques for monitoring “real”-world process parameters and quality attributes using Accelrys’ Discoverant solution will be discussed to highlight the statistical and automation advantages, as well as customer use cases. 


Unlocking Historical Spreadsheet Data
Barrett Brown, Accelrys

Abstract: Many biotech and pharmaceutical companies have valuable historical data that is locked in spreadsheets, unavailable for analysis.  Accelrys PRIMR (Paper Record Input ManageR) a specialized data entry tool, enables the data in these spreadsheets to be easily imported, verified against specified data types, value ranges and precisions, and consolidated into a central, audit controlled database ready for detailed analysis. Spreadsheet data that was once lost to the archives is now very easily accessible for monitoring and ad hoc analysis.


Process Map Design for Maximizing Visibility
David Brick, Accelrys

Abstract: Manufacturing and Process Development data is captured in a wide variety of systems designed to address specific needs.  When data that are isolated in ERP, MES, EBR, LIMS, maintenance systems, historians, and even MS Excel spreadsheets, analysts face a significant hurdle to gather and organize their data before they can begin their analysis or investigation.  Additionally, management-level reports are often configured with numerous point-to-point connections to the data in different sources, making them very resource intensive to maintain or grow.  An alternative approach of building process-based maps of the data supports configuration of a range of reports without maintaining custom connections and provides analysts with quick, easy access to their data.


What's the Realized Value of Discoverant for your Quality Organization?
Amy Mason, Accelrys

Abstract: Faced with increased pressure to have a comprehensive, scientifically based, understanding of their products and processes, life science manufacturing organizations are striving to transition from reactive to proactive.  A collaborative relationship with the quality organization is an essential element to achieving critical proactive business objectives and reducing reactive time consuming activities.  Accelrys’ Discoverant solution is a key tool to facilitate relationship building among quality and diverse departments by sharing critical data visualizations and analyses via automated reports, emails, and dashboards. Therefore, life sciences companies can increase proactive behavior and collaboration with their quality department by utilizing the automation and vast amount of tools in Discoverant (e.g., quality metrics, events, process and product monitoring, reporting, automated alerts, etc.). 

To describe a collaboration use case, a representative from Biogen Idec will discuss their utilization of Discoverant to enable communication across their manufacturing and quality organizations.


Evolution of Product Hierarchy Deployment at Biogen Idec to Support the Increase in Drug Substance Manufacturing for BioSimilars
Michael Farrow, Engineer II, Biogen Idec

Abstract: Over the past several years Biogen has expanded its manufacturing capability to meet the needs of a growing product pipeline.  Further expansion into the realm of BioSimilar development and contract manufacturing have resulted in the need for shorter campaigns and rapid tech transfers of new processes to our facilities.  This presentation will provide an overview of how the Discoverant hierarchies at Biogen have been utilized to support processes from clinical to commercial manufacturing.  Furthermore, it will describe the methods used to deploy hierarchies for new processes in a flexible and cost-effective manner.


Beyond Traditional Analytics
Aaron Spence, Accelrys

Abstract: Analytics used in the pharmaceutical, biotechnology, and medical device industries are typically confined to a basic set of traditional statistical tools.  Discoverant leaps beyond these traditional analytics to fuel a culture of data-driven decision making, with a primary goal to maximize investigational insight while minimizing time and resources.  Benefits of Discoverant include the automation of high-level investigational processes and powerful tools with the ability to explore parameters and relationships in unique ways.  The tools’ utility for investigations is discussed, while illustrating their ease of use in a point-and-click environment.


Improving Data Management and Process Visibility Amongst Your Entire Network; Captive and/or Contract Manufacturing
Amy Mason, Accelrys

Abstract: There is an increased trend for life science companies to utilize contract manufacturing organizations (CMO’s).  With a virtual manufacturing environment there are increased challenges around communication, collaboration, response time, data access and management.  In addition to the challenges faced within the sponsor/CMO relationship, the life science industry is also facing increased regulatory demands.  To meet these challenges sponsor companies must create an environment for effective communication and collaboration.  Accelrys’ Discoverant solution enables collaborative process monitoring, reduced regulatory risk, faster response times and more efficient data management across virtual manufacturing environments. Discoverant tools and customer use cases on how sponsors have worked with their CMO’s to overcome these challenges will be discussed.



Discoverant 4.3 Release Update
Karri Unruh, Larry Fiegland, Accelrys

Abstract: In this session we will discuss and demonstrate the new features in Accelrys Discoverant v4.3, including (but not limited to!) a new Stability OOT Alerting tool, alerting in Stability Pooling and Dating, other enhancements to Stability and Expiration Dating, a new and improved Table View, and improved control over titles in Automatic Result Method output.


Unstable Stability Data: Predicting Product Stability Trends Before They Cause Problems
Larry Fiegland, Accelrys

Abstract: An out-of-trend (OOT) result, when analyzing stability data, is a result that does not follow the expected trend.  Trends can be calculated by analyzing stability parameters within the current batch or trends can be calculated by analyzing historical data.  This talk will demonstrate how the Stability Out-of-Trend Alerting tool in Accelrys Discoverant provides modeling and alerting capabilities that give users the ability to detect out-of-trend study results while stability studies are in progress.  Four separate approaches will be discussed that monitor stability data to alert users on stability measurements that are out-of-trend before these measurements become out-of-specification (OOT).  Regression control charts for within a batch and across batches will be discussed as well as tolerance limits calculated using slope control charts and by time point plots.  Email alerting allowing users to monitor their stability studies by exception will also be demonstrated.

If you have any questions regarding the event please email Byron Konold.