The University of Chicago joins national collaboration to expand human disease-based research capability

December 3, 2001

The University of Chicago is expanding its biomedical research capabilities by joining the National Clinical Genomics Initiative, a strategic collaboration between Ardais Corporation, a privately-held clinical genomics company, and leading medical institutions around the country. The National Clinical Genomics Initiative is enabling researchers to study disease at the molecular level on a large scale through access to an integrated repository of research-quality clinical materials, associated information, and bioinformatics tools.

"This is a strategic move for the University of Chicago that builds on our traditional strengths and will contribute to our continued leadership in life sciences research," said Bryce Weir, MD, interim Dean of the Division of the Biological Sciences and the Pritzker School of Medicine at the University. "For decades, University of Chicago researchers have been pioneers in the process of translating basic scientific discoveries into improved patient care. By combining knowledge of the Human Genome and other biomedical advances with access to more, and more diverse, human clinical materials and information than any one institution could gather, we can now accelerate that process significantly."

"Developing better treatments for cancer requires an understanding of the cancer cell at the molecular level," noted Richard L. Schilsky, MD, Professor of Medicine and Associate Dean for Clinical Research at The University of Chicago Division of the Biological Sciences. "But the only way to know the cancer cell at the molecular level is to study the cancer as it affects real people. As a result, studying human tissue is becoming fundamental to all biomedical research."

A growing number of scientific studies are being published in which researchers examine well-characterized human tissue samples in order to discern the molecular patterns that correlate with how a patient’s disease will progress and how he/she will respond to therapy. In this way, researchers are increasingly able to define which genes are the most important in the origin and progression of disease. For example, the genes involved with breast cancer, with certain forms of B-cell lymphoma, and with prostate cancer have been identified in such experiments. While the use of human tissue is not new, the availability of research-quality clinical materials and associated clinical data on a large, systematized scale is just emerging, and offers promise for enhancing and accelerating research.

Vinay Kumar, MD, Chairman, Department of Pathology at The University of Chicago stated: "The University of Chicago has a long-standing commitment to basic and clinical research that is reflected in our history, our Comprehensive Cancer Center and in the $115 million of research funding from the National Institutes of Health this year. Physicians at The University of Chicago have for many years collected tissue samples in order to find molecular markers of disease."

Thomas Krausz, MD, FRCPath, Professor of Pathology and Director of Anatomic Pathology at the University of Chicago Hospitals, will serve as head of the new program. He stated: "Through the National Clinical Genomics Initiative, all the medical institutions in the Initiative can collect samples according to one standardized set of protocols, thereby ensuring the highest standards. Furthermore, our investigators will gain access through this collection to thousands of clinical materials and derivatives, with associated information, with which to design clinically relevant experiments, and will have new opportunities to conduct collaborative projects with other academic and industrial researchers around the country."

Dr. Schilsky noted: "We are moving towards individualized cancer treatment, in which we will analyze a particular patient’s tumor, define his prognosis, assess whether he needs treatment, and if so what treatment. The most effective way to do that is by linking the characteristics of the cancer at the molecular level with the history of the clinical outcome--the discipline known as clinical genomics--to determine how and why an individual’s cancer behaves as it does. Moreover, by offering patients the opportunity to participate in the discovery stage of research, we are pioneering a new model for therapeutic discovery that could be called ‘from bedside to bench to bedside’."

Eric Gordon, Ardais President and Chief Executive Officer added: "The biomedical research community is increasingly recognizing the value of using actual human disease in all its variation compared with the limitations of model systems. As the National Clinical Genomics Initiative gains momentum with the addition of The University of Chicago, we believe this trend will accelerate, and the drug discovery process will radically change over the next decade."

The National Clinical Genomics Initiative

The Ardais-led National Clinical Genomics Initiative now comprises the Beth Israel Deaconess Medical Center, a Harvard affiliate in Boston, Massachusetts; Duke University Medical Center in Durham, North Carolina; Maine Medical Center, a University of Vermont College of Medicine affiliate in Portland, Maine; and The University of Chicago in Chicago, Illinois. Through the Initiative, Ardais facilitates the collection, processing and archiving of human tissues left over following surgical procedures, and converts the samples and associated medical information into unique formats for research.

Ardais and the participating institutions in the Initiative have set the highest ethical standards to respect patients' wishes and to protect the privacy and confidentiality of patient donors, pioneering a "double-firewall" to ensure that patients are never identified by either the Company or by researchers. Ardais and the collaborating institutions are complying with all existing federal and institutional requirements pertaining to the collection and use of clinical specimens and information, and have developed procedures and safeguards beyond what is required. Tissue donation by patients is completely voluntary, requires their full knowledge and informed consent, and does not affect clinical care in any way.

The University of Chicago

Eleven of the University’s 73 Nobel Prize winners were selected for their work in physiology or medicine, and scientists and physicians at the Medical Center have contributed to all fields of biological research. Researchers at The University of Chicago have made fundamental contributions to the understanding and treatment of cancer--including the development of hormone therapy and the first trials of cancer chemotherapy. They have made major discoveries about the biochemistry and the genetics of diabetes, heart disease, and gastrointestinal disorders. They have also been pioneers with the fields of genetics, infectious diseases, transplantation, sleep research, and public health. Based at the University’s campus in the Hyde Park neighborhood of Chicago, The University of Chicago Hospitals are routinely selected as one of the 15 "best-of-the-best" hospitals in the United States by U.S. News & World Report in their annual survey of America's nearly 7,000 hospitals.

Ardais Corporation

Ardais Corporation, founded in 1999, is a privately-held clinical genomics company headquartered in Lexington, Massachusetts. Clinical genomics is a multi-disciplinary approach to correlate molecular changes, including differences in patterns of gene expression, with the characteristics of actual human disease, to accelerate the discovery and validation of targets for development of new diagnostics and therapeutics. Ardais’ mission is to accelerate drug discovery by enabling a new generation of clinically relevant, statistically-based experimental capabilities on a previously unimaginable scale. Through collaborations with biopharmaceutical companies and medical institutions, Ardais applies its human disease-based technology platform, integrated expertise and tissue collection infrastructure to advance its partners’ clinical discovery programs. The Ardais BIGRTM Library and suite of proprietary bioinformatics tools provide academic and industrial researchers with access to tens of thousands of research-quality clinical materials and associated information in unique formats for research.

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