Kennedy Scott P, Bormann B J
Drug Safety Research and Development, Pfizer Global Research and Development, Pfizer Inc, Groton, CT 06340, USA.
Exp Biol Med (Maywood). 2006 Dec;231(11):1690-4. doi: 10.1177/153537020623101105.
This manuscript briefly addresses the drug discovery and development process. It is a long road from the formulation of a good discovery idea to the acceptance of a new drug in the marketplace, and there are many challenges faced along the way to the patient. Collaborations and partnerships are an important part of this process. There are a variety of partnering opportunities, ranging from the discovery of novel technologies and drug targets to lead discovery, compound gifts, and external sourcing. These partnerships help increase confidence and improve decision making on issues of safety and efficacy preclinically, which can reduce attrition and expedite the provision of new quality drugs to patients more quickly and at lower costs. Collaborations involve addressing multiple issues that include infrastructure, safety, regulatory matters, intellectual property, technical and personnel considerations, source document capture and data analysis issues, and legal and strategic alliances. A number of success factors are identified as important for quality collaborations in the drug development process.
本手稿简要介绍了药物发现与开发过程。从形成一个好的发现想法到一种新药在市场上被接受,这是一条漫长的道路,而且在通往患者的道路上面临着许多挑战。合作与伙伴关系是这个过程的重要组成部分。有各种各样的合作机会,从新技术和药物靶点的发现到先导物发现、化合物馈赠以及外部采购。这些伙伴关系有助于增强信心,并在临床前阶段就安全性和有效性问题改进决策,这可以减少损耗,并以更低的成本更快地为患者提供新的优质药物。合作涉及解决多个问题,包括基础设施、安全性、监管事项、知识产权、技术和人员考量、源文件获取和数据分析问题,以及法律和战略联盟。在药物开发过程中,一些成功因素被认为对高质量合作很重要。