Customer Case Studies

Strategy Driven Informatics:  Ensuring Value Realization
Jason Bronfeld, Executive Director, Preclinical & Pharmaceutical Development Informatics, Bristol-Myers Squibb

This presentation will illustrate the linkage between business strategy, information management strategy and IM investment in a research setting. It will also discuss value centric planning, implementation and benefits realization with a real-world case study and show how an anchoring IM strategy expressing a multi-year view, creates buy-in, delivers superior value and provides an architecture for expansion. The presentation will discuss how industry solutions, not custom solutions, create the most value for each dollar invested.

LEO Pharma Galilei Project:  Challenges and Successes to an Isentris based Integration of Chemistry and Biological Data
Ulrik Nicolai de Lichtenberg, MSc, Ph.D., Head of Discovery Informatics & Data Management, LEO Pharma A/S

The purpose of this talk is to describe challenges and results of a recent migration project from ISIS to Isentris. The new Isentris installation at LEO Pharma provides scientists with a centralized portal to information across the Discovery research domain by integrating data on chemical compounds, batches, vials, assay test results, and projects. The project also engaged Symyx Consulting in developing functionality beyond what came “out-of-the-box”, including support for Structure-Activity-Relationship (SAR) analysis.  Successes and challenges to customizing the Isentris installation will also be discussed.

How Will We Do Science?
Stephan P. B. Taylor, Ph.D., Director – Project and Process Optimization Systems, Process Research and Development, Bristol-Myers Squibb Pharmaceutical Research Institute

In the last 10 years, the ELN has replaced the paper notebook in many organizations.  It has been integrated with LIMS, and compound registration systems, inventory systems and the like.  By and large these are simple access and messaging applications.  The business of science is much more complicated.  This presentation will review the requirements and possibilities for broader integrations and reporting tools that would facilitate science in a process development organization.

Improved Efficiency and Quality Management for GMP API Manufacture: A Symyx Notebook-Based Electronic Batch Record System
John Leonard, Ph.D., FRSC, Principal Scientist, AstraZeneca Process R & D/Pharmaceutical & Analytical R & D

We have designed and introduced a system for using Symyx ELN software for rapid technology transfer of processes from our process R&D laboratories into our pilot plants, which are used to manufacture API for clinical trials. A risk-assessment based approach was taken in devising workflows that incorporate appropriate electronic approval signatures and provide verifiable audit trails, to provide compliance with the strict governance requirements for pharmaceutical manufacture. An empirical, pilot-driven approach was taken to devise and refine our business processes and an important factor in the success of the project was a strong collaborative cross-functional team with representation from Process Chemistry (R&D), Development Manufacture (pilot plant) and QA. Another important factor in gaining internal approval for immediate implementation of the system was having a system improvement plan in place, which was written in collaboration with Symyx.

The Use of the Symyx ELN System in a GxP Analytical Environment
Graham Clarke, Ph.D., Associate Director
Adele Patterson, Ph.D., Principal Scientist
AR&D, Bristol-Myers Squibb Business Services Limited

The Symyx ELN system at BMS has been successfully rolled out in a GxP analytical environment across multiple sites. Following a pilot program, feedback was obtained from users, Quality Operations, best-practice and compliance monitoring teams to ensure that maximum advantage could be taken of the time saving / efficiency gains inferred when using an ELN system while complying with the rigorous GxP requirements for laboratory note-books. The GxP compliance robustness of the application was evaluated. This presentation will cover the additional procedural controls that were required in addition to the inherent application functionality to meet our compliance needs.

From a Chemistry eNotebook to a Discovery-wide eNotebook
Craig Tulig, Ph.D., Associate Director R&D Systems, Millennium: The Takeda Oncology Company

After deploying a Chemistry eNotebook back in 2004-2005, Millennium has more recently piloted and started the rollout of an eNotebook across the entire Discovery Research organization. This talk will compare and contrast the business drivers and critical success factors for our eNotebook implementations in Chemistry and Biology. Topics will include integration with related lab systems and our Roadmap for how the eNotebook fits into our Drug Discovery systems platform.

Overcoming Development and Implementation Challenges in an Enterprise Deployment of Symyx Notebook at Pfizer
Angela Chabot, Scientist, Pharmaceutical Sciences – Technology Integration Group
Rory Quinn, Analytical R&D
Pfizer Global Research and Development Inc.

Although a large enterprise electronic notebook deployment faces many challenges, this presentation will focus on several specific issues addressed during Pfizer’s implementation of Symyx Notebook v6.4. The development and configuration of several key features will be discussed, including: the Analytical Materials & Preparations Sections, the Empower2 interface, the Analytical Balance interface, and Workflow design to accommodate a diverse user community. All of these features are key to increasing the organization’s documentation efficiency and compliance.

Additional Confirmed Speakers

Elke Hofmann, Group Head, Research IT, Merck KGaA Darmstadt

Guenter Stiegler, Ph.D., Project Coordinator, BASF Societas Europaea

Veit Ulshoefer, Ph.D., Head of Research IT, Merck KGaA Darmstadt

Please continue to check back for program updates