打造良好生态系统,提高药物创新效率  

Better innovation ecosystem,more output of novel medicines

作　　者：谭初兵[1] 徐为人[1] 邹美香[1] 汤立达[1] 

机构地区：[1]天津药物研究院天津市新药设计与发现重点实验室,天津300193

出　　处：《现代药物与临床》2012年第6期609-613,共5页Drugs & Clinic

基　　金：国家重大新药创制专项(2011ZX09401-009;2012ZX09105102)

摘　　要：过去数十年间,生命科学与疾病基础研究取得了巨大成就,但并未有效转化为临床治疗急需的药物,药物研发的产出反而在不断下降。为了有效填补基础研究与新药研发间的知识鸿沟,更好的提升药物创新效率,急需医药科研人员、生物医药企业、政府管理部门群策群力,构建更为有序的药物创新生态系统。为实现未来10～15年创新药物产出翻番的目标,需要着重做好以下方面的工作:推动药物研发相关科学研究和应用技术的进展,建设临床研究网络、提升临床试验的效率,改善药品监管部门的管理、创新药物审评方式,加强各方沟通、降低药品审评的不确定性。Stunning progress in life sciences and the biological basis of diseases has been achieved in the past several decades,but thescientific discoveries are not being translated rapidly enough into urgently needed medicines for the patients and the output of newmedicines relative to investment has been falling steadily.In order to fill the knowledge gap between basic research and commercialprojects and enhance the efficiency of drug innovation,a thriving ecosystem for innovation medicines and partnership comprised ofacademic researchers,bio-pharmaceutical industry,and regulators is in urgent need.To achieve the overall goal of doubling the outputof innovative new medicines over the next 10—15 years,the following aspects of work should be focused on：to improve the scientificresearches and applied technologies used for the drug development,to establish the clinical trial network and promote the efficacy ofclinical trials,to strengthen the management of drug regulatory authorities and to accelerate the approval pathways used for theinnovative medicines,to expand the more efficacious communication among the stakeholders,and to decrease the uncertainty in drugevaluation as well.

关 键 词：创新生态系统 快速审评 替代终点 特殊治疗应用 适应性审评途径 

分 类 号：R951[医药卫生—药学]