CPSA Digest 2002

Proceedings -Wednesday, October 9, 2002

WeOC10

NuGenesis SDMS:
A Lab to Enterprise Data Storage, Retrieval and Transfer Solution

Introduction
The pharmaceutical industry challenges are to maintain a 10-15% growth for their shareholders. This effectively means that biopharmaceutical companies must double the number of new lead candidates entering the clinical trial phases of the drug approval process. Over the next decade, the ³data avalanche² with respect to drug discovery and development groups will grow exponentially. This is a direct result of advances in modern high throughput screening and the drive from 96-well plates to 384- and 1536-well plates. Couple this with the large number of new protein targets identified from proteomics initiatives and the number of data points/unit time escalate even further. This wave of data constitutes the knowledge base from which key research-directed decisions are made on the fate of potential new chemical entities. With the diversity of analytical instruments in the laboratory, an application independent and efficient capture and cataloging ³platform² must be in place to manage the explosion in research data.

The SDMS Platform for Drug Discovery and Development
NuGenesis Technologies Corporation was founded on the principle that technology should make data more accessible, so that researchers can focus on using acquired information to full advantage. Electronic information generated in laboratories is currently compartmentalized and highly fragmented. Scores of proprietary instruments (e.g., robotics, gel imagers, HPLC/MS, plate readers etc.) generate volumes of electronic data, which typically can only be read by the machine that created it. Thus far, the only data management method available for scientific information is to "print and file" usually in lab notebooks. Data and graphic images needed for reports, presentation or new drug application submissions are paper-based, and often inaccessible, requiring an inordinate amount of scientific time searching, cutting and pasting. Also, with recent regulatory requirements governing the use of electronic records in support of NDA's, many labs are searching for automated data collection and storage solutions complete with e-signatures and audit trails that meet FDA's 21CFR11 guidelines and internal intellectual property initiatives. NuGenesis SDMS (Scientific Data Management System) was designed to meet these goals. NuGenesis SDMS provides a fast, reliable and secure method for automatically archiving and retrieving raw file data within minutes of its creation or change. A database catalog is created automatically and captured without any intervention by the analyst. The raw binary files are stored on safe, secure media (e.g. optical disks, RAID, CD jukeboxes, SAN etc.) within the existing IT infrastructure and can be retrieved and restored with only a few mouse clicks.

In addition, a patented "Print Content-Capture-to-Database" technology and a sophisticated mining tool allow researchers to browse the database by sorting and filtering human-readable report data using tag data assembled in the database. Both vendor specific instrument generated reports (HPLC's, MS's etc.) and scientist generated reports (spreadsheets, reports and presentations) can be archived and securely communicated to other team members anywhere in the world from anywhere in the world through the web-enabled SDMS software platform (see Figure). Added power is provided through its ability to find text, even embedded within graphics. Creation of "presentation documents" and e-Lab Notebooks containing extracted data sets from disparate instruments can be assembled in minutes, saved and communicated throughout your organization. Each data set contains a hyperlink back to the original data file for fast and efficient restoration if necessary. This is truly a comprehensive data storage and "knowledge transfer" technology platform.

The NuGenesis SDMS Platform is a central repository for all analytical and scientist generated data sources. The repository can be extracted to populate other IT infrastructure needs such as e- Lab Notebooks, analytics programs, LIMS and regulatory submission documentation.

Conclusions
The new high throughput processes are dramatically increasing the raw number of data sets that must be interpreted for decision support across a global research team effort. The NuGenesis SDMS serves as the centralized repository for analytical reports, summary documents, project reports and instrumental raw data. This database can then be ³extracted² to work in conjunction with LIMS, Enterprise Data Management System, e-Lab Notebook and/or local specialized visualization and analytics data software products. If data sources ³saves or prints,² the NuGenesis SDMS platform can get it, automatically save it and allow fast efficient utilization across the entire enterprise. After all, it is the data that becomes information that when effectively communicated turns into critical-path knowledge for decision support in drug discovery.

Company website: www.nugenesis.com

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