IQPC’s 5th Forum on Laboratory Informatics will provide strategies for overcoming challenges, including: - In-depth regulatory compliance guidance - Extensive ELN deployment and roll out projects, focusing on ROI maximization and impact on business performance - Informatics systems in the biobanking environment - Proactive approaches to address challenges of integration and interfacing - Integrating and embracing knowledge management and social media tools

1. Register by August 7th
and SAVE up to $1,847
5th Forum on
Lab Informatics
Advancing Laboratory Informatics to Speed
up the Analytical Process and Time to Market
October 26 – 28, 2009 San Francisco, CA
Don’t miss the 5th Forum on Lab Informatics featuring:
• In-depth regulatory compliance guidance and practical • Proactive approaches and discussions on the long-
strategies lasting challenges of integration and interfacing
• Extensive and hard-hitting ELN deployment and rolling • Exploring semantic technology application case
out projects with a focus on ROI maximization and impact on studies
business performance • Integrating and embracing knowledge
• Informatics system in the biobanking environment management systems and social media tools
Learning from Informatics Leaders:
Ed Jaeger, Director, Information Mihai Stancu, Systems Architect, John Trigg, Consultant, PhaseFour
Technology, Johnson & Johnson AIT Laboratories Informatics
Pharmaceutical Research &
Development, LLC Julie Spry, Principal Scientist, Pfizer Andy Zaayenga, Director,
SmarterLab
Mahesh Merchant, PhD, Interim Fang He, Project Leader, Allergan
Director, Laboratory Informatics, Pharmaceuticals Debbie Turner, QA Associate Director,
School of Informatics, Indiana Computer and Automation Validation,
University John Zenk, CSV Manager, Alkermes, Inc.
BioDefense Operations, Emergent
David M. Sedlock, PhD, Senior BioSolutions Samy Hernandez, Manager, Analytical
Director, R&D Systems, Millenium, Operations, Genentech, Inc.
the Takeda Oncology Company Mollie Shieks Uehling, President
and CEO, Safe-Biopharma Michael Elliott, CEO, Atrium
Barry Harnick, Associate Quality
Association Research & Consulting LLC
Consultant, Eli Lilly
Bruce Kozuma, IT Project Manager, Gloria Metrick, LIMS Consultant, John Botta, Director of Corporate
Alkermes, Inc. GeoMetrick Enterprises Compliance, AIT Laboratories
Media partners:
www.labinformaticsforum.com

2. Special Thanks to our
5th Forum on Advisory Board:
Lab Informatics
Advancing Laboratory Informatics to Speed
Michael Elliott
CEO
Atrium Research & Consulting LLC
up the Analytical Process and Time to Market Gloria Metrick
LIMS Consultant
GeoMetrick Enterprises
October 26 – 28, 2009 San Francisco, CA
John Trigg
Consultant
PhaseFour Informatics
Andy Zaayenga
Director
SmarterLab
Dear Colleague,
Pharma and biotech laboratories tod Who Will You Meet:
ay are constantly challenged with
improving business performance, Pharmaceutical, biotech, life science and
reducing cost and increasing ROI of
informatics systems. lab academic laboratory CIOs, Vice Presidents,
Directors, Managers, Head and Analysts of:
• Informatics
This innovative forum will address • Pre-Clinical Development
the fundamental challenges that are
shared by both lab directors and info • R&D
rmatics professionals. These
challenges include: • IT/Information Technology/IS
• Laboratory Operations
• Ever
increasing volumes of data prod
• Arising
uced from lab research • Knowledge Management
legal and regulatory compliance
• Inte
pressures • Bioinformatics
rfacing challenges from various
informatics systems • Quality Assurance/ Quality Control
• The
need to seamlessly integrate lab • Software Development
informatics systems into the
enterprise business management • Medicinal Chemistry
systems
• The • Systems Analyst
requirement to swiftly respond
to the rapidly evolving • Discovery
business environments
• Research
• Evolvin
g technologies that may change
the traditional way of • Computational Systems
getting work done • Information Security
• Laboratory Information Systems
IQPC’s 5th Forum on Lab Informatics • Data Analysis
presents unique opportunities to
address all these challenges with hard • Data Management
-hitting case studies. We are
bringing together a stellar speake
r faculty to provide the best practice
on ELN deployment, LIMS system s
integration and interfacing as Sponsorship and
well as legal & regulatory com
pliance. We will also discuss the Exhibition Opportunities
emerging technology developmen
t and its impact on the lab informa
tics. Sponsorships and exhibits are
excellent opportunities for your
San Francisco welcomes you in Oct company to showcase its products
ober and the industry professiona
looking forward to meeting you! ls are and services to high-level, targeted
decision-makers attending the 5th
Forum on Lab Informatics. IQPC helps
companies like yours achieve
important sales, marketing and
branding objectives by setting aside a
limited number of event sponsorships
and exhibit spaces – all of which are
Cathy Gu custom-tailored to assist your
Conference Director organization in creating a platform to
maximize its exposure at the event.
Pharma IQ, a division of IQPC
Cathy.gu@iqpc.com For more information on sponsoring
or exhibiting at this or upcoming
events, please contact Mario Matulich
at 1 (212) 885-2719 or
sponsorship@iqpc.com.
1-800-882-8684 • www.labinformaticsforum.com 2

3. Main Conference Day One Tuesday, October 27, 2009
8:00 Registration & Coffee
12:45 Networking Luncheon
8:45 Opening Remarks from the Chairperson
1:45 Panel Discussion: Developing a Practical
9:00 Leveraging and Maximizing Data Intelligence to Compliance Strategy
Accelerate the R&D and Drug Development • Understanding what the FDA expects when it comes to records
Process • Having a clear understanding of which records you need to
• An overview of computational intelligence in a lab environment keep
• Understanding key strategies for reducing costs and risks
• Turning data into knowledge to assist decision-making
• Optimizing data control, quality and standardization • Developing a roadmap to put in place a compliant records
Ed Jaeger management program
Director, Information Technology Panelists:
Johnson & Johnson Pharmaceutical Research & David M. Sedlock, PhD
Development, LLC Senior Director, R&D Systems
Millennium, the Takeda Oncology Company
9:45 Case Study: Revamping Data Capture, Analysis
and Storage Processes to Drive Business Debbie Turner
Performance QA Associate Director, Computer and Automation
• Analyzing the major data formats and standards from different Validation
systems Alkermes, Inc.
• Examining different approaches for data retention and archiving
• Streamlining data transfer John Botta
Bruce Kozuma Director of Corporate Compliance
IT Project Leader AIT Laboratories
Alkermes, Inc
2:30 Preparing for and Ensuring a Smooth Audit
10:30 Morning Networking Break • Developing your checklist for passing the audit
• Identifying and mitigating operational risks during the audit
11:15 A Practical Approach for Data Quality Assurance • Obtaining support from vendors
• Examining the data quality management challenges Debbie Turner
• Studying the major tools for data automation and quality QA Associate Director, Computer and Automation
• Developing quality assurance programs quickly and effectively Validation
Barry Harnick Alkermes, Inc.
Associate Quality Consultant
Eli Lilly 3:15 Afternoon Networking Break
12:00 Regulatory Compliance – Serving the Business 4:00 Discussing the Arising Challenges and
Quality record management can be accomplished that meets the Opportunities of Electronic Records Management
FDA expectations and is attainable by an organization with a • Addressing regulatory concerns regarding data quality
desire to meet regulatory compliance. To achieve this, a company • Introducing various types of records and specific risks associated
must recognize that records that are created to support or make to those records
• Developing comprehensive technology control and
regulatory decisions and/or records that are submitted or support
a submission to the FDA should be maintained in order to organizational control systems
recreate the decision-making process or regulatory submission at Mahesh Merchant, PhD
a future date. Multiple strategies exist that make it possible to Interim Director, Laboratory Informatics, School of
create a regulatory environment that meets this objective and that Informatics
is cost effective and manages appropriate risks based on the type Indiana University
of business being performed. Join us to discuss a roadmap that
will effectively develop a business environment that meets 4:45 Overcoming the Challenges from System
regulatory compliance and appropriately maintains regulatory Validation
records. • Examining the validation timeframe and validation scope for
• Clarifying the role of compliance: guiding and partnering with various systems
the business •
Achieving cost-efficiency for large system validation
• Developing the model in which quality and compliance do not • Working with vendors to ensure post-validation system
dictate but support maintenance and optimization
• Fostering interactive relationships between compliance and John Zenk
business to make cost-effective and efficient decisions CSV Manager, BioDefense Operations
• Engaging with the business to achieve continuous improvement Emergent BioSolutions
John Botta
Director of Corporate Compliance 5:30 Chairperson’s Closing Remarks and
AIT Laboratories End of Day One
1-800-882-8684 • www.labinformaticsforum.com 3

4. Main Conference Day Two Wednesday, October 28, 2009
8:00 Registration & Coffee 1:45 Case Study: Safe BioPharma – Applying Digital
Signatures for ELN Records
8:45 Opening Remarks from the Chairperson In the drug discovery and lab environment, signing and witnessing
are important as they provide the state-time stamp for when a new
9:00 Defining Requirements and Implementing Cost- compound was discovered. It can be vital many years later when
Effective Lab Informatics Systems company defends the paten for the drug. Developing a much easier
• Reviewing your lab workflow to identify system requirement and less expensive approach to obtain and archive the signatures has
• Examining if LIMS always have to be expensive? long been experimented. In the session, Safe-Biopharma will present
• Rolling out the project with a planned budget the following key points:
• Ensuring integration • Understanding the operational process of obtaining digital
Samy Hernandez signature
Manager, Analytical Operations • Reviewing the cost benefits
Genentech, Inc. • Examining the pros and pitfalls – data authenticity and integrity
• Examining its long-run impact on drug discovery
9:45 ELN System Selection – Effectively Choosing the Mollie Shieks Uehling
System That Works Best for Your Lab President and CEO
• Overview of the ELN system options and selections Safe-Biopharma Association
• Understanding your lab environment to decide on the system
requirements 2:30 Panel Discussion: Examining and Forecasting the
• Identifying the selection and deployment criteria when choosing Impact of Social Media
an ELN system The social media tools like wikis, blogs and messaging etc. have
Julie Spry penetrated into various aspects of the laboratory working
Principal Scientist environment. This session will explore the function and role which
Pfizer these social media tools have in the laboratory environment.
Panel Moderator:
10:30 Morning Networking Break John Trigg
Consultant
11:15 Case Study - Maximizing Lab Informatics ROI: PhaseFour Informatics
Lessons Learned from the Deployment and Use of
an In Vivo Efficacy LIMS Used to Study Anti-Cancer 3:15 Afternoon Networking Break
Compounds
To assist the scientists in their management of laboratory animal 4:00 Case Study: Leveraging Semantic Technology for
efficacy data we developed a LIMS platform as a primary tool for all Scientific Data Integration and Knowledge
compound testing in our oncopharmacology department. This Management
system, the Tumor Measurement System, was designed and The laboratory is under increasing pressure to perform more work
deployed by internal engineers to a business group consisting, today, without increasing its resources while maintaining a high results
of about 30 users. quality. For scientists, this means doing more laboratory work with
• Reviewing the features of the project that contributed to smaller groups and smaller budgets. Automation and improved
successful uptake by the users instrumentation and workflow efficiency make it possible to run
• Sharing metrics that document a positive ROI more experiments, but the result is more data that must be analyzed
• Describing the pitfalls encountered when using ROI metrics to and managed. AIT Laboratories is looking to considerably reduce the
justify project cost time scientists spend managing, reviewing and verifying data. This
David M. Sedlock, Ph.D. talk will describe the project plan for leveraging semantic
Senior Director, R&D Systems technologies in the lab 3.0 to ultimately improve quality, efficiency
Millennium, The Takeda Oncology Company and automation at AIT Laboratories.
• Analyzing the current challenges: the integration of heterogeneous
12:00 Panel Discussion: Brainstorming with Providers to data distributed in silos across the laboratory poses many
Overcome the Interfacing and Integrating challenges due to the differences in formats, terminology, and
Challenges for Different Systems communication protocols between information sources
One of the key challenges for the lab informatics managers and • Examining the current data storage status: a lot of manual
scientists is the interfacing difficulties caused by software and intervention during the interfacing process with different data
instruments from different vendors, in particular extracting the systems or locating data stored in an ad-hoc fashion on multiple
appropriate information from one application in a format suitable for instruments, file servers and desktop hard drives
use in another application in a closed system. In this session, Michael • Providing the solution: by storing the data in a unified semantic
is brainstorming with key vendors and proposing solutions for this repository and explicitly representing the meaning of terms in
particular challenge. vocabularies and the relationships or indicators between those
Panel Moderator: Michael Elliott terms, sharing and linking information sets, data that link to the
CEO same indicator may be discovered, thus improving the retrieval
Atrium Research & Consulting LLC capabilities of relevant information required for scientific research
• Defining and realizing the business advantages
12:45 Networking Luncheon Mihai Stancu
Systems Architect
AIT Laboratories
4:45 Closing Remarks and End of Conference
1-800-882-8684 • www.labinformaticsforum.com 4

5. Pre-Conference Workshops Monday, October 26, 2009
8:00 am – 11:00 am (registration at 7:45 am)
A Exploring ELN Future Development & Evolution
This workshop will address the ELN technology convergence and point out How will you benefit:
the future development trends that will help the organizations to establish • Obtaining the most up-to-date ELN development
and develop the ELN strategy that works best for their organization. • Understanding and evaluating the technology based on your business environment
What will be covered: • Catching up with the ELN and lab informatics convergence to drive real
• Examining ELN elements & best practices business results
• Transforming & improving workflow with ELN
• Change management to move forward the ELN project Your Workshop Leader: Michael Elliott, CEO, Atrium Research &
• Case study: ELN beyond lab – automating and improving organizational Consulting LLC
workflow Other workshop leaders to be announced
11:30 am – 2:30 pm (registration at 11:15am) lunch included
B Tutorial: Lab Informatics Development and Advancement for Biobanking
Biobanking is an emerging area that more and more companies are in the • Optimizing program and project planning in Biobanking to achieve
process of establishing. Informatics systems and technologies are crucial for maximum results
data information accuracy and therefore playing an important role in the How will you benefit:
genomic research advancement. • Understanding the biobanking environment and specific requirements on
What will be covered: lab informatics systems
• Overview of the biobanking landscape • Learning through hands-on case studies on biobanking informatics system
• Designing and implementing: clinic systems, the long term data repository architecture and deployment
and systems to invite participants and manage appointments • Obtaining practical tips on developing the strategy from scratch
• Retrieving follow up health care information
• Managing data standards Your Workshop Leader: Andy Zaayenga, Director, SmarterLab
• Assuring data security and managing safe havens
3:00 pm – 6:00 pm (registration at 2:45 pm)
C Establishing a Solid In-house ELN Selection and Evaluation Strategy
Establishing a set of requirements that all parties are happy with can be a difficult • Understanding the criteria of system evaluation
task but is critical to get right if you are to select the correct system for you. This • Examining best practices for ELN selection and implementation planning
workshop will discuss best practice in establishing internal requirements and how How will you benefit:
to effectively match these to the best system for your needs. • Taking a closer look at various ELN systems pros and cons
What will be covered: • Assessing which system works best for your organization
• Defining the role of the ELN for your organisation • Achieving great cost-saving and maximizing business result
• Developing a set of requirements for ELN selection
Your Workshop Leader: John Trigg, Director, PhaseFour Informatics
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Register by August 7th
and SAVE up to $1,847
5th Forum on
Lab Informatics
Advancing Laboratory Informatics to Speed
up the Analytical Process and Time to Market
October 26 – 28, 2009 San Francisco, CA
www.labinformaticsforum.com