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Main Conference Day Two                                                                       Wednesday, October 28, 2009
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5th Forum on Laboratory Informatics


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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

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5th Forum on Laboratory Informatics

  1. 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:
  2. 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 For more information on sponsoring or exhibiting at this or upcoming events, please contact Mario Matulich at 1 (212) 885-2719 or 1-800-882-8684 • 2
  3. 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 • 3
  4. 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 • 4
  5. 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 Registration Information Qualified Pharmaceutical Register by Register by Register by Register by Standard Organizations 8/7/09 8/21/09 9/4/09 10/2/09 Price Conference Only (Save $600) (Save $500) (Save $400) (Save $200) $1,199 $1,299 $1,399 $1,599 $1,799 All-Access Pass: Includes Main (Save $1,847) (Save $1,747) (Save $1,647) (Save 1,447) (Save $1,247) Conference and 3 Workshops $1,599 $1,699 $1,799 $1,999 $2,199 Workshop Only $549 each $549 each $549 each $549 each $549 each Academic Standard Others Register by Register by Standard Price 9/4/09 10/2/09 Price Conference Only $999 Conference Only (Save $800) (Save $400) $1,999 $2,399 $2,799 All-Access Pass: Includes Main (Save $1,047) All-Access Pass: Includes Main (Save $1,947) (Save $1,547) (Save $1,147) Conference and 3 Workshops $1,599 Conference and 3 Workshops $2,499 $2,899 $3,299 Workshop Only $549 each Workshop Only $549 each $549 each $549 each Visit for an explanation of Special Discounts Available: A limited number of discounts are available For IQPC’s Cancellation, Postponement and Substitution Qualified Pharmaceutical Organizations and All Others. for the non-profit sector, government organizations and academia. For Policy, please visit Please note multiple discounts cannot be combined. more information, please contact customer service at 1-800-882-8684. Venue Information: Venue is to be announced. Please check the A $99 processing charge will be assessed to all Details for making payment via EFT or wire transfer: website at for updates and registrations not accompanied by credit card payment at JPMorgan Chase - Penton Learning Systems LLC dba announcements. the time of registration. IQPC: 957-097239 Special Dietary Needs: If you have a dietary restriction, please ABA/Routing #: 021000021 contact Customer Service at 1-800-882-8684 to discuss your MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC Reference: Please include the name of the attendee(s) and the event specific needs. * CT residents or people employed in the state of CT number: 10367.004 must add 6% sales tax. ©2009 IQPC. All Rights Reserved. The format, design, content and Payment Policy: Payment is due in full at the time of registration and arrangement of this brochure constitute a trademark of IQPC. Team Discounts: For information on team discounts, includes lunches and refreshment. Your registration will not be confirmed Unauthorized reproduction will be actionable under the Lanham please contact IQPC Customer Service at 1-800-882- until payment is received and may be subject to cancellation. Act and common law principles. 8684. Only one discount may be applied per registrant. 1-800-882-8684 • 5
  6. 6. International Quality & Productivity Center REGISTRATION CARD 535 5th Avenue, 8th Floor YES! Please register me for the New York, NY 10017 5th Forum on Lab Informatics ❑ Conference Only ❑ Conference Plus Workshop(s) ❑ Workshop(s) Only Choose Your Workshop(s) See Page 5 for pricing details. ❑A ❑B ❑C Your customer registration code is: When registering, please provide the code above. Name__________________________________ Job Title ________________________ Organization____________________________________________________________ Approving Manager______________________________________________________ Address________________________________________________________________ City__________________________________State______________Zip____________ Phone________________________________Fax_______________________________ E-mail__________________________________________________________________ 5 EASY WAYS TO REGISTER: ❑ Please keep me informed via email about this and other related events. 1 Web: ❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-800-882-8684 ❑ Charge my __Amex __Visa __Mastercard __Diners Club 3 Email: Card #__________________________________Exp. Date___/___ CVM code ______ 4 Fax: 1-646-378-6025 Details for making payment via EFT or wire transfer can be found on 5 Mail: IQPC preceding page. 535 5th Avenue, 8th Floor, ❑ I cannot attend, but please keep me informed of all future events. 10367.004/D/AL New York, NY 10017 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