過去數(shù)十年間，生命科學(xué)與疾病基礎(chǔ)研究取得了巨大成就，但并未有效轉(zhuǎn)化為臨床治療急需的藥物，藥物研發(fā)的產(chǎn)出反而在不斷下降。為了有效填補基礎(chǔ)研究與新藥研發(fā)間的知識鴻溝，更好的提升藥物創(chuàng)新效率，急需醫(yī)藥科研人員、生物醫(yī)藥企業(yè)、政府管理部門群策群力，構(gòu)建更為有序的藥物創(chuàng)新生態(tài)系統(tǒng)。為實現(xiàn)未來10～15年創(chuàng)新藥物產(chǎn)出翻番的目標(biāo)，需要著重做好以下方面的工作：推動藥物研發(fā)相關(guān)科學(xué)研究和應(yīng)用技術(shù)的進展，建設(shè)臨床研究網(wǎng)絡(luò)、提升臨床試驗的效率，改善藥品監(jiān)管部門的管理、創(chuàng)新藥物審評方式，加強各方溝通、降低藥品審評的不確定性。

Stunning progress in life sciences and the biological basis of diseases has been achieved in the past several decades, but the scientific discoveries are not being translated rapidly enough into urgently needed medicines for the patients and the output of new medicines relative to investment has been falling steadily. In order to fill the knowledge gap between basic research and commercial projects and enhance the efficiency of drug innovation, a thriving ecosystem for innovation medicines and partnership comprised of academic researchers, bio-pharmaceutical industry, and regulators is in urgent need. To achieve the overall goal of doubling the output of innovative new medicines over the next 10—15 years, the following aspects of work should be focused on: to improve the scientific researches and applied technologies used for the drug development, to establish the clinical trial network and promote the efficacy of clinical trials, to strengthen the management of drug regulatory authorities and to accelerate the approval pathways used for the innovative medicines, to expand the more efficacious communication among the stakeholders, and to decrease the uncertainty in drug evaluation as well.

國家重大新藥創(chuàng)制專項（2011ZX09401-009，2012ZX09105102）