DAY 2: WEDNESDAY, OCTOBER 29
7:30am Morning Coffee and One-to-One Meetings
8:45 Chairperson’s Opening Remarks & Review of Day One
Mitchell Weisberg, Senior Principal, Information Management Practice, Hewlett-Packard Company
DATA MANAGEMENT SYSTEMS
9:00 CASE STUDY: A Critical Core for Translational Medicine: Development of a Patient-Centric Database
A critical component of the Clinical Breast Care Project, a collaborative effort involving Windber Research Institute and Walter Reed Army Medical Center, has been the development of a unique, temporal patient-centric data repository for the integration of clinical, molecular and imaging data. A specific goal has been to make this resource address the needs of both the clinician and the researcher by establishing a true translational environment for the practice of medicine. Attendees will learn how the data model has evolved to be disease agnostic and supports the fundamental aspects of a true Personalized Health Record as well as supports the rapidly evolving needs of the clinical and biomedical informatics researcher.
Michael N. Liebman, Ph.D., President/Managing Director, Strategic Medicine, Inc.; Senior Institute Fellow, Windber Research Institute
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9:45 CASE STUDY: eClinical - How to Use an eClinical Business Architecture to Optimize R&D
The approach to R&D processes and IT systems is to rethink the entire eClinical landscape (Process, People and Technology) in order to define a larger vision and Business Architecture. This presentation will show how to create an eClinical program to strengthen the R&D department supported by the latest technology and how to integrate the systems used. Actual examples will be demonstrated of how an organization can move away from silo/legacy systems, towards a modular architecture based on process support.
John Aggerholm, eClinical Senior Project Director, NNIT A/S (a wholly owned subsidiary of Novo Nordisk A/S)
Jette Klose, M.Sc., Senior Pharma Consultant, NNIT A/S (a wholly owned subsidiary of Novo Nordisk A/S)
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10:30 Networking Coffee Break
11:00 CASE STUDY: New Electronic SAFety Reporting Notification System: How to Streamline Communication of Safety Information in Clinical Trials
This presentation will illustrate the benefits of creating an automated safety report notification system by comparing the previous manual system used for disseminating adverse event safety reports, and the limitations of that system, to the new automated reporting system and the resulting benefits of this solution. Included will be a breakdown of the flow of information, how the information is integrated from two databases, architecture of the new automated system, implementation of data security requirements, the benefits of providing real-time access to information for stakeholders, and the reduced cost of an electronic safety report system.
 Laurie Valle, M.D., Expedited Reporting Process Owner, Eli Lilly & Company
 Steve Jamrose, Team Leader - Global Patient Safety IT, Eli Lilly and Company
Tom Green, P.M.P., Program Manager, Health and Life Sciences Division IMC, Inc.
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12:00pm Networking Luncheon Hosted by CHI
1:30 CASE STUDY: Biological Test Result Data Platform: Consolidation of Multiple Workflow and Analysis Software Tools into One Service Oriented Platform
This presentation will discuss the consolidation of multiple old-fashioned tools, user friendly interface, and robust data handling within the dynamic research area with changing business rules.
Manja Fieberg, Research IT Service, Bayer Business Services GmbH
DATA INTEGRATION TOOLS
2:15 KEYNOTE: The Role of Ontology in the Pharmaceutical Industry of the Future
The Innovative Medicines Initiative (IMI) is a unique pan-European public and private sector collaboration between large and small biopharmaceutical and healthcare companies, regulators, academia and patients. The aim of IMI is to support the faster discovery and development of better medicines for patients and enhance Europe’s competitiveness by ensuring that its biopharmaceutical sector remains a dynamic, high-technology sector. The IMI initiative may serve as a model for comparable U.S. initiatives. One specific aim is to create a Knowledge Management Platform to arrive at effective data integration and analysis tools. Ontology has been recognized to be an important corner stone. This presentation will discuss the exact place of ontology in such an endeavor and its relationship to terminologies and information models.
Werner Ceusters, M.D., Director, Ontology Research Group, NYS Center of Excellence in Bioinformatics & Life Sciences
3:00 CASE STUDY: Request Fulfillment and ADME Data Upload Tools in ABCD: Automating the PK Component of Drug Discovery
In vitro and in vivo ADME properties are now an essential part of the Drug Discovery process. The current tools developed at Johnson & Johnson allow a seamless interplay and interaction of chemists and biologists within the therapeutic teams, the scientists involved in the evaluation of the ADME properties of candidates, and the information available for decision-making. This presentation gives a concrete example of the combination of scientists and IT professionals in addressing issues of process and information (data) and bridging the cultural issues when dealing with a global organization.
Walter Cedeño, Ph.D., Principal Scientist, Research & Early Development Informatics, Johnson & Johnson Pharmaceutical Research and Development, LLC
Norman Huebert, Ph.D., Principal Scientist and Team Leader of Discovery ADME, Johnson & Johnson Pharmaceutical Research and Development, LLC
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3:45 PANEL: Does Each Side Know What They Need from the Other?
4:45 Close of Day Two
6:30 CHI Organized Social Activity at Napa Valley Grille Restaurant