US-China-Japan Research Consortium on Herbal Medicines

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DESCRIPTION (provided by applicant): This planning grant has the long-term goal of developing an International Center for CAM Research focused on the systematic evaluation of East Asian herbal medicines. This project provides the technical, administrative and scientific bases of a future (Phase II) NIH application for an International Center for Research on CAM. Our objective is to develop a formal collaborative partnership involving investigators from the Harvard Medical School, the China Academy of Traditional Chinese Medicine, the Chinese University of Hong Kong, and Keio University (Japan) to jointly identify and prioritize promising herbal medicines, which can be systematically procured, extracted, characterized and tested in preclinical (and clinical) settings. Leading experts from the 4 participating institutions will meet regularly via Internet teleconferencing software (and 2 face-to-face meetings) to review and prioritize herbal medicine candidates worthy of further investigation. Plant materials selected for evaluation will be extracted according to predetermined protocols. Crude extracts, selected fractions as well as pure compounds will be subjected to High Throughput Screening in a wide variety of bioassays at an existing NIH-sponsored facility at Harvard Medical School and in laboratories at the Chinese University of Hong Kong. Those fractions and compounds with biological activity of interest will undergo secondary bioassays and, wherever possible, their molecular structure will be determined. Fractions and compounds with biological activity will be further investigated for the presence of synergy involving multiple compounds/fractions from single plants or from complex mixtures of plants. Only those herbal medicines shown to have significant biological activity will remain candidates for further investigation in human trials. The identification of reproducible, biologically active fractions and compounds and a reprioritized list of candidate herbal medicines will be the principal deliverable of this planning grant. In addition, co-investigators will discuss strategies for the implementation of subsequent multi-site clinical trials which adhere to NIH standards for clinical research. They will negotiate a formal collaboration agreement which satisfactorily addresses issues of intellectual property, royalty sharing, publication procedures and shared access to NIH resources. Legal expertise and recommendations from participating institutions and a consultant in International Law will be obtained. Co-investigators will develop formal plans for training programs and scholarly exchange between participating research sites. Lastly, we will determine, as part of this planning grant, the ideal number of partnering institutions (2, 3 or 4) in anticipation of an application for Phase II of this NIH International Center for Research on CAM.