Strategic Research Institute, Hyatt Regency Boston
April 4-5, 2005
Monday, April 4, 2005 (Day 1)
7:00 - 8:00
Pre-Conference Workshop Registration, Networking & Exhibits
8:00 - 10:00
PRE-CONFERENCE WORKSHOP #1
R&D Automation Futures This workshop will captivate anyone needing to know the legal, regulatory, technical, and social aspects of electronic notebooks, recordkeeping, groupware, document management, or other collaborative knowledge management systems used in R&D or technical organizations. It covers new advanced automation technologies and concepts leading to highly collaborative, knowledge-based R&D organizations. It explains and gives examples of the the latest concepts for electronic recordkeeping, archving, electronic books and notebooks, and project data handling systems tied into collaborative infrastructures. It explains the core concepts of knowledge management and how it can be effectively applied in R&D environments. Workshop description subject to change. Who Is It For & What Will You Gain By Attending? Scientists, managers, engineers, MIS and computer support, librarians and notebook administrators, archivists, knowledge managers, patent attorneys, and industry regulators in the chemical, pharmaceutical, environmental, biotech, food and beverage, aerospace, automotive, and related industries, universities or government labs. Stay current with the latest technologies, regulations, and legal imperatives for laboratory recordkeeping. Lead your company into the electronic recordkeeping age by understanding critical requirements. Quickly assess your company's infrastructure and cultural readiness to use electronic lab notebooks; learn how to prepare them if they are not. Learn how to enroll and inform your Legal and Regulatory Affairs Departments as partners rather than adversaries. Learn when to buy versus build systems; how to grow them into bull-blown R&D team computing and knowledge management systems for managing organizational knowledge. Get practical tips for evaluating and selecting vendors and systems. See key products evaluated and demonstrated without vendor hype. Receive top-notch materials and other resources to deepen your understanding of concepts and systems in this course. ABOUT YOUR DISTINGUISHED WORKSHOP LEADER: Rich Lysakowski, Ph.D.
Executive Director/Chief Science & Technology Officer
CENSA Dr. Rich Lysakowski is an Executive Director/CSTO of the Collaborative Electronic Notebook Systems Association (CENSA) and Global Electronic Records Association (GERA. His responsibilities include organising and executing CENSA's efforts to develop robust markets and products for advanced automation for R&D, including electronic notebook systems, intelligent project support environments, and their many component technologies. Lysakowski has a Ph.D. in physical and analytical chemistry, plus 20 years' professional experience with automation systems in various scientific, software engineering, marketing, and project management roles in the public and private sector
10:00 - 10:20
Networking Break & Refreshments
10:20 - 12:20
PRE-CONFERENCE WORKSHOP #2
ELN Implementation Strategies Early adopters have been implementing ELN technology for almost a decade. During this time, a best practice model has begun to emerge that companies new to the market can readily adopt to ease the implementation of ELNs in their own laboratories. In this full interactive session, our facilitator addresses including: The importance of culture in the determination of the success of both large and small scale implementations Strategies to gain, build and maximize internal momentum in fostering widespread ELN acceptance Tips to ease integration Proven strategies to gain management acceptance Creating a detailed plan to implement ELN in your own organization Identify potential stumbling blocks Case studies of both successes and failures The importance of safeguarding laboratory productivity levels during the transition By Attending This Workshop Participants Will Gain: A detailed understanding of the different components that go together to make up an ELN system. An overview of the ELN market, and the various kinds of offerings available. An awareness of the problems and pitfalls which affect ELN projects. The ability to develop a road map for their own ELN projects which delivers real business benefit rapidly, at low risk, and for a realistic cost. An appreciation of the different constituencies involved in an ELN, and how to communicate with them. Who Should Attend: Project managers responsible for ELN implementations and members of ELN project teams Scientists, IT staff, Legal advisors, Regulatory Affairs Officers, Records Management staff Senior Research Management ABOUT YOUR DISTINGUISHED WORKSHOP LEADER: Simon J. Coles, MEng
President & Co-Founder
AMPHORA RESEARCH SYSTEMS Simon became involved with ELNs as a consulting engagement with Eastman Kodak in 1996. This was one of the earliest ELN projects and is still one of the largest ELN deployments in the world. Amphora Research Systems was formed to continue this work, and the company now supplies ELNs to a wide variety of companies worldwide. Amphora’s solutions are the most popular and trusted alternative to the traditional bound laboratory notebook. As one of the world's leading authorities on ELNs, Simon has a wide range of experience in all aspects of the field, from design and implementation to the legal and regulatory considerations which form an essential part of any ELN project. A regular contributor to industry conferences, Simon holds an MEng in Information Systems Engineering as well as various technical qualifications.
12:20 - 1:30
Luncheon for Workshop Attendees
12:30 - 1:30
Main Conference Registration
1:30 - 1:45
Chairs’ Opening Remarks
Colin G. Sandercock
Shareholder
HELLER EHRMAN WHITE & MCAULIFFE LLP David M. Floyd, Ph.D.
Former Vice President of Discovery Chemistry
BRISTOL-MYERS SQUIBB
1:45 - 2:15
Increasing R&D Productivity & Innovation in Drug Discovery through Implementation of an ELN System
Rich Lysakowski, Ph.D.
Executive Director/Chief Science & Technology Officer
CENSA
2:15 - 2:45
Implementation of a Fully Electronic Lab Notebook at Eli Lilly & Co.
In this presentation, Dr. Kopach will describe the pilot phase and implementation of an ELN at Eli Lilly & Company. Michael E. Kopach
Principal Research Chemist
ELI LILLY & CO.
2:45 - 3:15
Establishing Electronic Notebook Standards and Policies
The premise for this session is that good electronic notebook standards and policies begin with a thorough understanding of the business rules for conventional laboratory notebooks. The author draws upon the policies and standards of some 12 distinct pharmaceutical entities to derive a comprehensive set of rules, focusing on the needs of intellectual property and the regulated sciences (GLP, GMP). The presentation will cover the collaborative rule making process, the customized nature of the policy, and primary business drivers. Specific examples of policy statements will be given and translated from paper based for adoption to electronic notebooks. Karl Zoeckler, CRM
Associate Director, Standards & Practices Information Records Management
PFIZER GLOBAL R&D
3:15 - 3:45
Networking, Refreshments & Exhibits
3:45 - 4:15
Chemistry Electronic Notebook Case Study
The transition from the traditional paper notebook to an electronic notebook involves challenges at many different levels, including social, scientific, legal, technical, and business. This case study will examine Millennium's approach to these diverse topics in the context of our experience with an electronic notebook pilot. We will focus upon driving adoption, managing our vendor relationship, and positioning the electronic notebook in our Cheminformatics Product Line. In the final analysis, a highly collaborative interaction between the vendor and Millennium’s Chemistry and Informatics departments was necessary to succeed in producing a custom electronic notebook that met Millennium's needs. Craig Tulig
Chemistry Systems Lead
MILLENNIUM PHARMACEUTICALS, INC.
4:15 - 5:00
Integration of Electronic Laboratory Notebooks and Reaction Databases
The promulgation of electronic laboratory notebooks (ELNs) is underway throughout the chemical and pharmaceutical industries. Many companies are in the process of evaluating and considering the benefits of integrating an ELN. The deployment, integration, and adaptation of enterprise ELNs and reaction databases should be considered carefully. Existing IT, informatics, and chemistry infrastructure must be examined. Management support is also a key factor in implementation. Finally, a proper training regimen is also a vital element in the process. A well planned deployment can make the process go smoothly and promote enthusiasm for a new ELN among scientists and management. The positive impact of ELNs on institutional memory, productivity, communication, and workflow at both small and large companies can be dramatic. Christopher T. Lowden, Ph.D.
Director of Chemistry Training and Support
SYNTHEMATIX, INC. Visualization and Comparison of Synthetic Pathways Third generation ELN’s allow a scientist to easily look at a complicated total synthesis, consisting of many individual reactions. This is now readily performed through data mining, leading to retrosynthetic mapping. Modern software allows ready evaluation of yields, convergence and divergence points, as well as comparison of dissimilar approaches to the same molecule. John S. Bobo, Ph.D.
Director of Sales Support
SYNTHEMATIX, INC.
5:00 - 5:45
PANEL: The Strategic Role of ELN’s in the Evolving Drug Discovery Process
Improving productivity and driving innovation in drug discovery are two imperatives in today’s competitive environment. This panel will explore the ways in which ELN’s can empower individual scientists as well as contribute to the success of the research enterprise. MODERATOR: David M. Floyd, Ph.D.
Former Vice President of Discovery Chemistry
BRISTOL-MYERS SQUIBB PANELISTS: Ashok Tehim, Ph.D.
Vice President of Medicinal Chemistry
MEMORY PHARMACEUTICALS Edward M. Suh, Ph.D.
Director, Lead Identification
EISAI RESEARCH INSTITUTE Third Panelist Member To Be Announced
5:45 - 7:15
Networking Reception Sponsored by: Synthematix®
Synthematix® (www.synthematix.com) provides innovative workflow solutions to research-intensive organizations with an special focus on chemistry solutions. Synthematix’s solutions have been profitably adopted by over one thousand researchers in a variety of organizations and industries. Arthur Suite™, Synthematix’s flagship product, provides chemists across an enterprise with unparalleled tools for researching, planning and recording their work. It facilitates building and mining of reaction and procedure databases containing both internal and external data. For chemists involved in parallel or combinatorial chemistry, Synthematix offers Library Builder™, the most intuitive tool of its kind. Other scientists, managers and executives can mine their Arthur Suite application for chemical reaction and substance data through interactive queries as well as through informative reports. Synthematix’s innovative solutions have also been adopted by world class chemical e-commerce applications including Sigma-Aldrich’s highly regarded chemical searching system.
Networking Reception Sponsored by: Synthematix® Sponsored By...
Tuesday, April 5, 2005 (Day 2)
7:30 - 8:15
Breakfast, Networking & Exhibits
8:15 - 8:30
Chairs’ Recap of Day One
David M. Floyd, Ph.D.
Former Vice President of Discovery Chemistry
BRISTOL-MYERS SQUIBB Colin G. Sandercock
Shareholder
HELLER EHRMAN WHITE & MCAULIFFE LLP
8:30 - 9:00
ELN the Oxford BioMedica Experience
The perception that an ELN solution is reserved for major multi-national companies is a myth, as Oxford BioMedica have proven with their 50 scientist ELN implementation. This case study will show how a biotech organization has increased their scientists’ productivity and capability to collaborate whilst improving records for the defence of our intellectual property. The key issue for Oxford BioMedica surrounded how to introduce new technology to overcome inefficient record keeping whilst not being prohibitively expensive and leveraging existing investments. Oxford BioMedica will show how the ELN helped to unlock the mass of experimental information within the organization. David Brittain
IT Manager
OXFORD BIOMEDICA
9:00 - 9:30
Legal Aspects of ELN Record Keeping
Companies are increasingly using (or considering using) ELNs in their R&D environment. For these companies, creating electronic records that are admissible and reliable in U.S. Patent Office interferences and court proceedings will be critical to protecting their most valuable IP. Colin’s presentation will address the legal requirements for such records in the U.S (whether in written or electronic form), as well as U.S. Patent Office and court standards for admissibility of electronic records. He will also provide practical advice for implementing ELN systems that will stand up if challenged in court. Colin G. Sandercock
Shareholder
HELLER EHRMAN WHITE & MCAULIFFE LLP
9:30 - 10:00
CASE STUDY: The ELN as a Strategic Capability for R&D Through Intelligence and Integration
Many ELN projects have been undertaken solely as tactical productivity improvement projects. And, too many of these projects have failed to deliver the anticipated results. The key to successful deployment of an ELN solution is making it strategic to every level of stakeholder: the end user, information technology (IT), and management. This presentation will demonstrate through case studies how several leading top ten global pharmaceutical company incorporated intelligence and integration into their ELNs to achieve a strategic capability for the corporation. Paul van Eikeren
President and CEO
SYMYX INTELLICHEM
10:00 - 10:30
Networking, Refreshments & Exhibits
ABOUT YOUR GOLD SPONSOR:
Symyx Technologies acquired IntelliChem in November 2004 with the vision of creating a single software product line able to span automated and conventional pharmaceutical and chemical research. IntelliChem specialized in solutions to help scientists and engineers focus on research instead of managing data and writing in paper lab notebooks. Now Symyx IntelliChem provides the broadest and deepest suite of software developed for the pharmaceutical and chemical industries. Symyx IntelliChem is the leading provider of intelligent electronic lab notebooks (iELN) for discovery and development. Symyx IntelliChem has dramatically expanded its iELN offering to include solutions for scientists and engineers in the discovery, chemical development, formulations, analytical, and bioprocess areas. The IntelliChem iELN is the most intelligent ELN platform available in the market today.
Networking, Refreshments & Exhibits Sponsored By...
10:30 - 11:00
Building an Electronic Lab Notebook from a Clear Blueprint
In an ELN tool environment where the capabilities for user support and records management are rapidly evolving, it is critical to use an adoption strategy that allows for early success in meeting core minimum requirements while leaving room for continuing development of capabilities. This session will outline an adoption strategy using a three step process: 1. How to determine the scope of work based on clear and simple expectations. 2. How to create a blueprint for the ELN system which includes these major components – User Specifications; System Development and Deployment; and, Operations and Maintenance. 3. How to build and deploy a simple system to meet core requirements. Jim Engler
Library & Information Systems
ROHM AND HAAS
11:00 - 11:30
Selecting and Implementing the Best ELN Solution in R&D
Roman Sterzycki
Senior Manager R&D
BRISTOL-MYERS SQUIBB
11:30 - 12:00
Deployment of an Electronic Laboratory Notebook - Implementing a Successful Cultural Change
Array Biopharma has been utilizing an electronic notebook for the past six years. This presentation will focus on our experience of changing traditional paper notebooks into a company-wide electronic notebook (ELN). Discussions will include the philosophy of our organization, cultural issues that were addressed, and how we handle the legal concerns. Of most importance was how we obtained “buy-in” from our scientific staff and how this was essential to the overall success of our ELN implementation. Jim Rizzi
Director of Computational Technology
ARRAY BIOPHARMA INC.
12:00 - 1:15
Luncheon
1:15 - 1:45
ELN Architecture
ELN systems need to meet challenging business and technical requirements, building on a diverse base of existing technology and integrating components from numerous different vendors. They will typically survive for a long period of time and be capable of enduring a large amount of change in their environment. Building on years of experience delivering ELN systems to companies of all sizes in multiple industries, the talk will examine the challenges an ELN architecture must meet, the attributes of a good ELN system architecture, and some real-world examples of what has worked - and what hasn't. Simon J. Coles, MEng
President & Co-Founder
AMPHORA RESEARCH SYSTEMS
1:45 - 2:15
Collaboration Between Organizations Using Third Generation ELN’s
Third generation ELN’s enable electronic collaboration between organizations for enhanced knowledge sharing. During this session, two approaches will be reviewed. Boston University’s Center for Chemical Methodology and Library Development shares reaction information from its ELN through its public website. Kalexsyn’s medicinal chemistry organization uses an ELN to retain valuable information and to share reaction data with its many clients. The benefits and challenges of electronic collaboration will be explored during this session. Scott E. Schaus, Ph.D.
Assistant Professor of Chemistry
BOSTON UNIVERSITY David C. Zimmerman
CEO
KALEXSYN
2:15 - 2:45
Using ELN in Drug Discovery - The First Year
During 2004 the bound laboratory notebooks were replaced by Electronic Lab Notebooks in the entire Biovitrum R&D organization. The system is of a hybrid type where security paper printouts are signed and archived in an efficient and controlled fashion, providing full IP protection. Flexibility and ease of use have been crucial success factors. The system is used across all disciplines, with a flexible interface that supports different working habits without a large administrative overhead. A recent survey among the users has revealed a number of interesting aspects on the impact of ELN in the drug discovery process. The ability to search in co-workers experiments is highly appreciated, and the new clarity and ease of experiment documentation has improved record quality considerably. Perhaps surprisingly, the ELN system is providing a better foundation for IP protection than the bound books. The open architecture also serves as a platform for further integration, and e.g. extraction of structures and data from the ELN has reduced the time spent on compound registration for the chemists. Mats Kihlén
Head of Research Informatics
BIOVITRUM AB
2:45 - 3:15
The Current State of the ELN Market
Using information gathered on ELN market for two major market research projects, Atrium Research will present the current state of the ELN market. We will highlight today's current issues, including barriers to adoption and how to overcome them, return on ELN investment, key market leaders, and market trends. Michael H. Elliott
President
ATRIUM RESEARCH & CONSULTING
3:15 - 3:30
Closing Remarks and Final Q&A
3:30 - 3:35
Conference Concludes
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