2013 pmc suite user conference: in review · manufacturing for biosimilars 11 chemical development,...

1accelrys.com

CHAIRMAN’S MESSAGEOur first annual 2013 Accelrys Process Management and Compliance (PMC) Suite User Conference was held this June in Princeton, NJ. As the successor to our previous International Meeting on Automated Compliance Systems (IMACS), this year’s meeting highlighted our customers’ use of a growing portfolio of powerful, integrated Accelrys PMC solutions that are driving down Total Cost of Ownership and accelerating Time to Value as never before.

This year’s meeting clearly demonstrated that our customers are making a difference in leveraging the electronic lab environment from development through late-stage quality control and manufacturing—with resulting critical-path benefits in productivity, cycle times and compliance. We are truly bringing new products/medicines to market faster from the Lab to the Plant!

This year’s case studies demonstrate how customers are improving operational efficiency by eliminating paper, harmonizing practices and procedures, accelerating innovation through better management of externalization and collaboration and enhancing quality with advanced process visualization and analytics.

Key metrics and capabilities resulting from deployment of Accelrys PMC software solutions and cited at this year’s conference include:

• Average 30 minute cycle-time reduction for method execution with 50-80% reduction in human errors (Janssen/J&J)

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

• 100% of reviewers agree that Accelrys LES saves time and increases productivity (Forest)

• 96% of employees prefer Accelrys LES to the old testing system

• Transformation from clinical to commercial process, “soup-to-nuts” centralized data management (BioGen Idec)

We’re looking forward to updated metrics at next year’s PMC Conference. We’re also delighted to be helping such a broad range of customers bring products to market faster and at lower cost while meeting critical quality and compliance objectives.

Best Regards,

Ken Rapp SVP & Managing Director Analytical, Development, Quality and Manufacturing, Accelrys

2013 PMC SUITE USER CONFERENCE: IN REVIEW — PRINCETON, NJ

http://accelrys.com

2013 PMC SUITE USER CONFERENCE

2accelrys.com

Table of Contents

KEYNOTE ADDRESSES

Janssen (J&J) Lab-to-Patient Model Implementing a Recipe-Based Framework to Support Product Lifecycle Management 3

IBM Transforming the Scientific and Business Dynamics of New Drug Development and Commercialization – How to Harness All Your Data for True Operational Excellence

4

REGULATED INDUSTRIES

Quality

Eli Lilly Impact of a Global Roll Out of the Accelrys LES on Quality Operations at Lilly 5

Perrigo Generic Pharma Quality Benefits of an LES Platform One Year after Implementation 6

Forest Labs Global Implementation of the Accelrys LES to Achieve a Harmonized cGMP Quality Operation 7

Contract Research Organization (cGMP)

PPD Role of the LES and Inventory Management in a CRO Environment 8

Cross-Functional (Development to Manufacturing)

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

9

Janssen (J&J) Review of a Pilot Study and Business Case Development for Accelrys LES in a Large Multi-National Pharmaceutical Environment

10

Biogen Idec Evolution of Product Hierarchy Deployment at Biogen Idec to Support the Increase in Drug Substance Manufacturing for BioSimilars

11

Chemical Development, Early GMP

BMS Accelrys Notebook: A Chemical Development Perspective 12

Analytical/Bioanalytical Development

BMS Analytical Development: Preparing for the Future while Enabling the Present 13

NON-REGULATED INDUSTRIES

Testing Labs

Colgate Using Work Request Adaptor to Link Studies with Testing Laboratory 14

Development (Non-GMP)

BMS What’s In, What’s Out 15

R&D (Non-GXP)

Janssen (J&J) Trending Data within a Diversely Used Electronic Notebook 16

http://accelrys.com

http://accelrys.com/


3accelrys.com

LAB-TO-PATIENT MODEL IMPLEMENTING A RECIPE-BASED FRAMEWORK TO SUPPORT PRODUCT LIFECYCLE MANAGEMENT

Paul McKenzie, VP, Manufacturing & Technical Operations, et al., Janssen Supply Chain (Johnson & Johnson)

Abstract: Effectively managing and leveraging data generated within the entire product

lifecycle is a critical component of a harmonized pharmaceutical quality system. Recent

regulatory guidelines accentuate an integrated approach to quality risk management

and science with a focus on defining the design space and ensuring that pharmaceutical

products meet intended multivariate specifications. Establishing a sustainable approach

to quality by design requires a long-term strategy for managing data-centric content,

execution and visualization across all process and lab segments. Leveraging the S88

and S95 ISA standards to manage methods and procedures across the entire method

development to sample analysis continuum is one way to achieve this strategy by

accurately and uniformly storing enterprise data in a single centralized database. Uniform

data presented in powerful, digital dashboards accelerates data mining, reporting and

sharing for continuous insight and process improvement.

Janssen Representative Slides

We need to get medicines

to patients as quickly and

efficiently as possible. People are

waiting for them. A centralized

data warehouse utilizing the

S88 and S95 industry standards

to represent analytical methods,

recipes and equipment

streamlines the capture and

exchange of analytical methods

and sample analysis across the

organization and accelerates

quality products to market.

KEYNOTE ADDRESS

http://accelrys.com



4accelrys.com

TRANSFORMING THE SCIENTIFIC AND BUSINESS DYNAMICS OF NEW DRUG DEVELOPMENT AND COMMERCIALIZATION – HOW TO HARNESS ALL YOUR DATA FOR TRUE OPERATIONAL EXCELLENCE

Edward Francis, Global Services, Life Sciences Industry, IBM Corporation

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 examined ways to achieve operational excellence

by improving process robustness, eliminating paper and implementing best practice

standards and templates that shorten time to value. The session also touched on the

importance of providing a global view of manufacturing operations and supply chain to

ensure adequate and high quality raw material inventory, product supply and compliance.

KEYNOTE ADDRESS

http://accelrys.com



5accelrys.com

IMPACT OF A GLOBAL ROLL OUT OF THE ACCELRYS LES ON QUALITY OPERATIONS AT LILLY

Lukas Gogis, Global Manufacturing and Quality IT, Eli Lilly and Company, Inc.Abstract: Beginning with an overview of Lilly’s e-manufacturing vision as revealed

through its global LIMS and lab informatics programs, this presentation took a close look

at Lilly’s worldwide deployment of the Accelrys Lab Execution System including general

implementation approach and methodology as well as key lessons learned. One lab’s key

accomplishments have included real-time data documentation, improved audit trails,

direct connection to instrumentation, significant time savings for data documentation

and second person verification, increased quality output and easier access to best

practices across the company.

We began our Accelrys

LES (previously SmartLab)

deployment in 2006, and the

system is now in use at 24 sites

in the US, Europe, Asia, South

America and the Caribbean with

more than 3,300 automated

procedures currently approved.

The implementations have

been a huge success and we’ve

achieved significant compliance

and productivity benefits

with improved procedures

eliminating many common

laboratory deviations. Better

control means fewer deviations

and more time to execute!

Lilly Representative Slides

REGULATED INDUSTRIES: QUALITY

http://accelrys.com



6accelrys.com

GENERIC PHARMA QUALITY BENEFITS OF AN LES PLATFORM ONE YEAR AFTER IMPLEMENTATION

Deborah Baker, QC Compliance Support Supervisor & 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 focused on the benefits

of their Accelrys Lab Execution System (previously SmartLab) deployment one year after

implementation.

We identified usage of paper

and manual signatures by

data reviewers as significant

time wasters. Eighteen months

after Accelrys LES go-live, we’ve

documented 40-50% reduction

in review time, and the review

time is still decreasing! Ninety-

six percent of employees say

they prefer Accelrys LES to the

old testing system; and 88%

report that LES has positively

impacted data recording

productivity. We’re seeing

improved consistency in testing

and documentation, fewer

errors, improved compliance,

lower costs and increased

productivity.

Perrigo Representative Slides

REGULATED INDUSTRIES: QUALITY

http://accelrys.com



7accelrys.com

GLOBAL IMPLEMENTATION OF THE ACCELRYS LES TO ACHIEVE A HARMONIZED CGMP QUALITY OPERATION

Nimesh Patel, Senior Analyst Business Informatics Management & Jon Perlow, Associate Director Research Informatics Management, Forest Laboratories

Abstract: A few years ago Forest implemented Accelrys Lab Execution System and

Labware LIMS globally in the QC Labs as part of the Automated Laboratory Execution

Information System (ALEXIS). 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 chemists. It was then determined to implement a similar

model into the Product Research and Development (PR&D) environment. Informatics and

the business realize that there are differences between QC lab and PR&D lab operations.

An evaluation has been done which determined which parts of the system can be utilized

as a “shared process” and parts that would be different to respective organizations. Our

goal is limiting the differences and streamlining the tech transfer process. As part of a

new ALEXIS project for PR&D, we targeted about 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. Our goal is to harmonize

systems and processes as much as possible.

A survey of approximately 20

day-to-day users of Accelrys

LES indicated that their favorite

aspects of the system included:

Automatic calculation of

results and limit checking; easy

navigation and location of

records; use of only calibrated

instrument and certified

reference standards; ease of

data transfer from LES to LIMS

with no manual entry; and

elimination of common errors.

Forest Laboratories Representative Slides

REGULATED INDUSTRIES: CONTRACT RESEARCH ORGANIZATION (cGMP)

http://accelrys.com



8accelrys.com

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 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. This presentation

discussed the implementation of the Accelrys LES in conjunction with Accelrys Inventory

Manager (IM) including lessons learned, best practices, benefits derived and the plan

going forward.

Our implementation of Accelrys

LES and Accelrys IM has

resulted in a 30% decrease in

review times, 5-10% decrease in

analysis time and peer review,

improved readability and more

accurate data entry. We also

streamlined many methods

and improved the efficiency of

numerous lab-wide processes

during the conversion to LES —

and we have had no findings

during regulatory audits since

converting!

PPD Representative Slides

REGULATED INDUSTRIES: CONTRACT RESEARCH ORGANIZATION (cGMP)

http://accelrys.com



9accelrys.com

NOT EXACTLY PROCESS DEVELOPMENT: DEVELOPING NOTEBOOK TEMPLATES FOR PROCESS CHEMISTRY AND REIMAGINING THE ROLE OF THE TEMPLATE

Martin A. Berliner, Associate Research Fellow, Pfizer Worldwide Research & Development

Abstract: Pfizer recently completed the rollout of a second-generation template to

process chemists using Symyx Notebook (now Accelrys Electronic Lab 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 described 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).

Our challenge was to move

an existing Symyx Process

Notebook installation

containing more than 90,000

experiments to an evolved

second-generation template

with minimal disruptive change

for approximately 200 end-user

scientists across development,

process safety and the kilo lab.

We now have a single template

with significant section-,

material- and file-related

enhancements and the ability

to “automagically” update

cloned experiments to the

latest version: One less thing for

our scientists to worry about!

Pfizer Representative Slides

REGULATED INDUSTRIES: CROSS-FUNCTIONAL (DEV. TO MFG.)

http://accelrys.com



10accelrys.com

REVIEW OF A PILOT STUDY AND BUSINESS CASE DEVELOPMENT FOR ACCELRYS LES IN A LARGE MULTI-NATIONAL PHARMACEUTICAL ENVIRONMENT

Colin Taft, Senior Manager Lab Systems, Pharma Quality Systems, Janssen (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 covered:

• 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

Janssen Pharma Quality Systems

ran a pilot study at two sites

to confirm applicability of the

Accelrys Lab Execution System

as a middle layer for a variety of

release and stability labs. After

conducting sample test method

data and analyst surveys, we are

projecting significant efficiency

savings for both sites including

an average 38% reduction of

analysis time per method and

50-80% reduction in human

errors achieved by eliminating

paper, standardizing processes

and moving to a review by

exception approach. The pilot

studies support the business case

to move forward with system

deployment.



http://accelrys.com



11accelrys.com

EVOLUTION OF PRODUCT HIERARCHY DEPLOYMENT AT BIOGEN IDEC TO SUPPORT THE INCREASE IN DRUG SUBSTANCE MANUFACTURING FOR BIOSIMILARS

Michael Farrow, Manufacturing Sciences – Process Analytics, 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 has resulted in the need for shorter

campaigns and rapid tech transfers of new processes to our facilities. This presentation

provided an overview of how the Accelrys Discoverant hierarchies at Biogen have been

utilized to support processes from clinical to commercial manufacturing. Furthermore, the

presentation described the methods used to deploy hierarchies for new processes in a

flexible and cost-effective manner.

Drug substance and drug

product hierarchies provided by

the Accelrys Discoverant process

management informatics

solutioncover the entire process

flow for a single process

including all key and critical

IPCs/IPTs. The hierarchies enable

us to organize batches across

all facilities while also sharing

them easily with partners

and contract manufacturing

organizations. Accelrys

Discoverant is our one-stop-

shop for batch information.

Biogen Idec Representative Slides


http://accelrys.com



12accelrys.com

ACCELRYS NOTEBOOK: A CHEMICAL DEVELOPMENT PERSPECTIVE

Jeff Simon, Senior Research Scientist, Bristol-Myers Squibb

Abstract: Documenting experiments within an ELN differs based on company rules

and the experiment type being conducted, non-GMP vs. GMP (Good Manufacturing

Practices) This presentation described how BMS and Accelrys collaborated to develop

and deploy Symyx Notebook 6 (now Accelrys Electronic Lab Notebook) to the BMS

Chemical Development organization. Key topics included 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.

Accelrys Electronic Lab

Notebook is currently used

by approximately 1,000 BMS

scientists working in Chemical

Development, Chemical

Development Operations,

Analytical/Bio-analytical

Development, Drug Product

Science and Technology and

Biological Manufacturing/

Process Development. Top

features of the ELN for our end-

user scientists include flexibility

(e.g., ability to undock and

move windows/sections around

within an experiment), the

notebook’s custom templates

and signature workflows, its

ease of use and overall stability.

Bristol-Myers Squibb Representative Slides

REGULATED INDUSTRIES: CHEMICAL DEVELOPMENT, EARLY GMP

http://accelrys.com



13accelrys.com

ANALYTICAL DEVELOPMENT: PREPARING FOR THE FUTURE WHILE ENABLING THE PRESENT

John Rumney, Business Capability Manager, Bristol-Myers Squibb

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 have

built a history and repository to deepen our knowledge about the products and processes

used in the organization.

Our analytical and bio-

analytical development

groups are heavily engaged in

method development, method

qualification/validation

and routine sample testing

with reporting off results. To

provide a dynamic method

development workspace,

we’ve implemented Accelrys

ELN, Accelrys LES, Empower, a

third-party LIMS, NuGenesis and

various other tools. As we put

these systems in place we saw

ways to bring them together

and build broader analytical

knowledge based on improved

method development history,

qualification/validation history

and execution history.


REGULATED INDUSTRIES: ANALYTICAL/BIOANALYTICAL DEVELOPMENT

http://accelrys.com



14accelrys.com

WORK REQUEST ADAPTOR: LINKING STUDIES WITH TESTING LABS

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. This presentation addressed how Colgate

has expanded ELN capabilities using the Work Request Adaptor to submit packaging

samples for testing, manage tasks and link with test results.

In a business process flow

involving engineers, lab

managers and technicians, the

ELN Work Request Adapter links

studies and packaging samples

with testing labs at Colgate

Tech Centers and outside labs

around the world. The system is

globally available and enables

free access to information—

from sample preparation

through work request creation/

assignment to designing

experiments, performing tests,

updating/witnessing results and

generating final reports.

Colgate Palmolive Representative Slides

NON-REGULATED INDUSTRIES: TESTING LABS

http://accelrys.com



15accelrys.com

WHAT’S IN, WHAT’S OUT

Anil K. Rattan, Business Operations, Bristol-Myers Squibb

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 (Good Manufacturing Practice)

data flow in our organization. This resulted in the replacement of a Microsoft Access

database with a commercial Laboratory Information Management System (LIMS), the

removal of paper laboratory notebooks in favor of ELNs 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 focused on the as-is infrastructure, considered

the future possibilities and discussed points of possible return on investment that can be

accrued through further implementations and automation.

An improved informatics

infrastructure at BMS involving

Accelrys ELN, Accelrys Lab

Execution System, Accelrys

Pipeline Pilot and Accelrys

Inventory Management

is improving the way BMS

works by helping us move

away from paper notebooks

and fragmented sample

management towards selective

integration, continuous

improvement and enhanced

innovation.


NON-REGULATED INDUSTRIES: DEVELOPMENT(NON-GMP)

http://accelrys.com



16accelrys.com

TRENDING DATA WITHIN A DIVERSELY-USED ELECTRONIC NOTEBOOK

Ryan Bass, Strategic Operations, PDMS Janssen R&D (Johnson & Johnson)

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 described the approach Janssen has taken to unlocking the data from the ELN and

allowing for contextualized data analysis of non-GXP data.


ELN deployment statistics within

Janssen R&D Pharmaceutical

Development and

Manufacturing Sciences indicate

steady uptake and movement

towards a harmonized electronic

lab environment with common

execution pathways and

seamless internal data flows.

Working with Accelrys, we

have learned that key points

to consider when searching for

data within experiments are:

(1) Non-GxP work is variable by

nature; (2) scientists will always

move towards the quickest way

to document; (3) always avoid

present-day thinking (“why

would I ever want to trend

that data?”); (4) allow for the

evolution of procedures.

NON-REGULATED INDUSTRIES: R&D (NON-GXP)

http://accelrys.com



17 © Accelrys Software Inc. All brands or product names may be trademarks of their respective holders. WP-4729-1213accelrys.com

ABOUT THE ACCELRYS PMC SUITE USER CONFERENCE

The Accelrys PMC Suite User Conference is the definitive forum on IT-based compliance and productivity in Analytical,

Development, Quality and Manufacturing (ADQM) operations. A broad cross section of industries today is challenged with

improving operational effectiveness, innovation and quality. Current Quality by Design (QbD), International Conference

on Harmonization (ICH) and Process Analytical Technology (PAT) initiatives are key components of the conference

presentations offered by industry implementers of Accelrys PMC solutions. In addition, interoperation with existing IT/

IS solutions such as Electronic Lab Notebooks and LIMS, Enterprise Resource Planning Systems, Chromatography Data

Systems and Manufacturing Execution Systems is discussed.

The organizing committee will not accept commercial presentations.

The PMC Suite User Conference provides a forum and information exchange for individuals interested in automating

compliance and improving productivity. If you are interested in attending the 2014 Accelrys PMC Suite User Conference,

contact the Organizing Committee at [email protected] to receive program details.

We look forward to seeing you in 2014!

http://accelrys.com


mailto:[email protected]

2013 pmc suite user conference: in review · manufacturing for biosimilars 11 chemical development,...

Documents