Liang Qionglin

Prospect on the Composite Drugs Innovation System

Abstract With the analysis of opportunities and challenges for the drug innovation, this research proposed a definition of the composite drug, which means a compatible combination of multiple compounds or multi-group compounds developed under the guidance of multiple therapeutic principles and mechanisms in order to achieve an optimal holistic efficacy. Composite drugs may consist of composite Traditional Chinese Medicine (TCM) and composite synthetic drugs or the combination of the both. The characteristics of composite drug innovation system are the followings: first, its target is the patient, not just a particular disease. Second, it requires the collaboration from physicians and the combination of iatrology and pharmacology. Third, it requires an R&D procedure of clinical experience to animal experiment to clinical trial. Fourth, it requires the development of a comprehensive assessment system for the clinical efficacy. Fifth, it requires developing an integrative system for screening of composite drugs. Sixth, it requires a development of an integrative system with both holistic characterization and specific characterization of the pharmaceutical components group. The current key issues for the innovation of composite TCM drugs are to develop a comprehensive assessment system for the clinical efficacy of TCM, to develop an integrative system for screening of composite drugs according to the characteristics of TCM and to standardize the approaches for the integrative characterizing of composite drugs. As in some demonstrative studies, this research has developed a new approach, Chemomics-integrated Global System Biology based on which a few composite drugs have been developed: one for treatment of ischemic apoplexy using TCM Qingkailing, and another one for treatment of ischemic cardiopathy using TCM Shuanglongfang. The current key issues for the innovation of composite synthetic drugs should focus on how to innovate the notions in order to establish an acknowledged model for the innovation of composite synthetic drugs, to attract physicians to participate in the composite drug innovation in order to establish an R&D procedure of clinical experience to animal experiment to clinical trial, and to strengthen the research of the composite drugs combining TCM and synthetic drugs.

System Medicine and Translational Medicine

Abstract In this perspective study, the authors introduce the background, goals, and roadmap of Translational Medicine, address the differences between oriental and western medicines, as well as their development tendency, and then discuss the developments in and prospects for the System Medicine. The advantages of Traditional Chinese Medicine (TCM) lie in its guidelines based on the holism and systems theory; its methodology based on the theory as “the harmony between humans and nature” to regulate the bodys balance; and its personalized treatment with TCM formulas. However, modernization of TCM still faces some challenges: how to translate the self-explanatory closed system into an receptively open system; how to achieve the combination, integration, and convergence of TCM with other modern sciences and technologies (such as systems biology); how to implement the modern scientific mode, methodologies, and achievements in the study of TCM, and interpret it with data instead words. Although there is a large difference between the oriental and western medicine systems, the trend of complementary development and integration of both is irresistible. We should try to push the progress in the combination, integration, and convergence of oriental and western medicines to welcome the emergence of System Medicines in the 21st century. The development of System Medicine may have following requirements and characteristics: first, the integrated research on medicine and pharmacy requires the “system–system” interaction character between the drug system and biological system; second, the clinical diagnosis system by the combination of disease and syndrome requires an integrative expression, including some quantitative indexes of syndromes in TCM, some pathological and biochemical indexes as well as imaging diagnostic markers in western medicine, and some biomarkers, such as genes, proteins, and metabolites discovered by systems biology studies; third, a clinical-treatment mode based on the correspondence of formula, disease and syndrome requires that the pattern of compound drugs be widely used for the human system by the combination of disease and syndrome, in order to achieve goals known as “correspondence of formula, disease and syndrome, comprehensive management and systematic condition” fourth, the research and development (R&D) mode of new drugs require “participation of physicians and combination of medicine and pharmacy”, which is a route known as “Beside-Bench-Beside” fifth, the representation of compound drugs and human system requires the combination of macroscopic characterization and microcosmic feature, also the combination of qualitative and quantitative analyses.