Department of Medicine, Center for Computational & Integrative Biology, Massachusetts General Hospital, Boston, USA.
J Investig Med. 2011 Jun;59(5):746-51. doi: 10.2310/JIM.0b013e3182160d70.
Our understanding of human biology has increased tremendously for the last several decades, yet the pace at which these discoveries have translated into new therapies for patients has been frustratingly stagnant. Universities and academic health centers, as the major recipients of public investment in biomedical science, have an obligation to translate new knowledge into applications that confer human benefit. However, translating fundamental discoveries into practical applications is expensive and involves highly regulated steps with which few academic scientists have experience. Challenges in engaging universities and academic health centers in translational research include building the appropriate infrastructures for human investigation, training and stabilizing the careers of young scientists and physicians interested in the requisite work, educating academic investigators about the regulatory requirements inherent in successful therapeutic discovery and development, and finding more efficient ways to match good ideas with adequate funding resources. The purpose of this article is to examine the early-stage drug development process and evaluate the role that academia could play in it. Because interest in early-stage drug development grows among academic investigators, the need for more integrated partnerships among academia, government, and industry has become increasingly apparent.
在过去的几十年里，我们对人类生物学的理解有了巨大的提高，但这些发现转化为患者新疗法的速度却令人沮丧地停滞不前。大学和学术医疗中心作为生物医学科学公共投资的主要接受者，有义务将新知识转化为为人类谋福利的应用。然而，将基础发现转化为实际应用是昂贵的，并且涉及到高度监管的步骤，很少有学术科学家有经验。在参与转化研究方面，大学和学术医疗中心面临的挑战包括建立适合人体研究的适当基础设施，培训和稳定对必要工作感兴趣的年轻科学家和医生的职业，教育学术研究人员成功治疗发现和开发所固有的监管要求，以及寻找更有效的方法将好的想法与充足的资金资源相匹配。本文的目的是研究早期药物开发过程，并评估学术界在其中可能发挥的作用。由于学术研究人员对早期药物开发的兴趣不断增加，学术界、政府和工业界之间更紧密的伙伴关系的需求变得越来越明显。
