Open Competition 1 - Information Technology

A Medical Informatics Data Model, Software Development Toolkit and Applications to Enable the Use of Clinical Information in Genomic-based Pharmaceutical Research

Sponsor: Ardais Corporation

• Project Performance Period: 11/1/2002 - 10/31/2005
• Total project (est.): $3,585,816.00
• Requested ATP funds: $1,957,425.00

Recent advances in genomics -- the high-throughput application of molecular biology and genetics integrated with bioinformatics and new information technologies -- have suggested many new human diagnostic and therapeutic targets. Yet, the development of new drugs remains a very expensive process with a low success rate. Researchers need better tools to help them understand the true molecular basis of disease and select the most clinically relevant targets earlier in the drug development process. One of these new tools is "clinical genomics," an integration of technologies that imbues these new genome-focused discovery projects with a true clinical understanding of disease. The successful application of clinical genomics to target validation will significantly reduce the time and cost associated with drug discovery. Ardais Corp. already is working with several medical institutions to collect clinical data and associated tissue samples, providing a clinical genomic resource for researchers conducting gene activity-based research. The clinical data and sample library provide the capability to statistically design experiments and rapidly, quantitatively analyze experimental results. With the ATP award, Ardais plans a two-year project to develop and test prototype software tools, data structures, and applications for linking quantitative, structured clinical information derived from the medical records of patients to the molecular (biochemical) profiles derived from donated tissue samples. This new technology will directly support the needs for patient privacy when conducting such research. This project, through innovations in both medical informatics and computer science, will greatly enhance the sophistication, content, granularity, and usability of the clinical information in the repository. The data models and ontologies will be specifically defined to support genomics research toward diagnostic and therapeutic development. In addition, the software toolkit will be usable with diverse kinds of information and will be able to rapidly respond to changing research or regulatory needs. Ardais is a three-year-old clinical genomics company, based in Lexington, Mass. Its mission is to provide a clinical genomics platform that can significantly reduce pharmaceutical discovery costs and timelines, thereby providing both cost savings and broader disease treatment benefits to consumers.

For project information:

Marcia Kean, (781) 698-0189
Marcia_Kean@ardais.com

ATP Project Manager

Christopher Currens, (301) 975-8503
christopher.currens@nist.gov