Gentris® Corporation (www.gentris.com), a global leader in the application of genomic biomarkers to clinical studies, announced today that it has signed a Memorandum of Understanding with the Shanghai Institutes of Preventative Medicine to advance global personalized medicine. The goal of this USA-China collaboration is to create translational research and epidemiological projects, as well as training and education programs, focused on pharmacogenomics and clinical sample banking, which will drive innovation in drug development and improvements in patient care.
Through this collaboration, Gentris and the Shanghai Institutes of Preventative Medicine will work together to launch cutting-edge research projects to discover, develop, and validate new genomic biomarkers. Gentris will take the lead to identify sponsors in the United States, e.g., pharmaceutical companies, for these personalized medicine projects while the Shanghai Institutes of Preventative Medicine will seek support from Chinese organizations.
The tuberculosis drug-induced liver injury pilot (TB DILI Study), conducted between Gentris, the Shanghai Institutes of Preventative Medicine, and a non-profit research institute in Research Triangle Park (RTP) serves as a model for USA-China collaborations. In this study, investigators designed a common protocol and pooled their resources to investigate DILI among tuberculosis patients in three Shanghai hospitals. By utilizing metabolomics and pharmacogenomics, they are evaluating biomarkers for early detection. Dr. Tong Zhou, Senior Director of China Initiatives for Gentris, is Co-Principal Investigator for the TB DILI Study and has significant experience in developing and managing collaborations between the United States and China. Dr. Zhou has also drawn upon his extensive network in China to begin establishing a satellite laboratory for Gentris in Shanghai that complies with U.S. regulatory standards.
Dr. Wu Fan, Director General of the Shanghai Institutes of Preventative Medicine and the Shanghai Municipal Center for Disease Control and Prevention (Shanghai CDC), and Dr. Howard McLeod from the University of North Carolina will provide strategic scientific oversight for personalized medicine collaborations. Director Wu is recognized internationally as a leader in public health initiatives. Dr. McLeod, Chief Scientific Advisor for Gentris, has been involved in numerous global initiatives including the Pharmacogenetics for Every Nation Initiative (PGENI), which he founded. It is anticipated that combining the resources and expertise of a research institute, academic institution, and industry—in both the United States and China—will lead to more rapid improvements in drug development and public health.
For this personalized medicine program, research studies and epidemiological projects will be designed for implementation in Shanghai based on sponsor needs. Key targeted therapeutic areas include oncology, infectious disease, and chronic disease. Training and education initiatives will also be created to bring U.S. quality standards to China including GLP, GCP, CLIA, and CAP. Gentris, the Shanghai Institutes of Preventative Medicine, and their collaborators will work with leading experts to develop workshops, courses, and a fellowship program to educate academic and industry scientists in China regarding best practices in the application of pharmacogenomics for drug development.
The Memorandum of Understanding leverages the relationships that Gentris CEO Rick Williams and Dr. Zhou have built during the past few years between North Carolina and China. While assisting a non-profit research institute in RTP, they helped to create the North Carolina-China Global Bioscience Gateway, a public-private partnership that addresses how to enhance global research innovation. Mr. Williams and Dr. Zhou are also members of the N.C. China Advisory Council, which works with the N.C. Office of the Governor and N.C. Department of Commerce to facilitate economic development between the state and China.
One of the major goals for this new agreement between Gentris and the Shanghai Institutes of Preventative Medicine is to create an expanded network of collaborators among leading universities, pharmaceutical companies, and public health organizations that leads to new pharmacogenomics discoveries, which accelerate drug development and improve patient care globally.