Innovative Medicines Initiative, TO 56, Office 6/4, Brussels, 1049, Belgium.
Clin Transl Med. 2013 Jan 15;2(1):2. doi: 10.1186/2001-1326-2-2.
Despite progress in translational research, we are still falling short in developing the innovative medicines required to address major public health needs. Furthermore, the failure rate, time, and cost required for registration of a new drug are pushing the economics of the industry to the breaking point. New models of drug development based on collaborative endeavours are badly needed to improve this dire situation.
In 2004, the US Food and Drug Administration (FDA) introduced the Critical Path Initiative with the intent of modernizing drug development by implementing public-private partnerships (PPP) to share data, expertise, and resources. In response to FDA's initiative, in the following year the non-profit Critical Path Institute (C-Path) was formed. At the same time, the National Institutes of Health (NIH) Public-Private Partnership program was established. In Europe, the Innovative Medicines Initiative (IMI) supported jointly by the European Union and the European Federation of Pharmaceutical Industries and Associations was launched in 2008. These independent efforts have a common long-term objective, namely to facilitate the emergence of innovative medicines by developing new tools for drug discovery, new indicators for drug efficacy or safety, and new approaches for patient stratification. Herein, we present evidence that PPP already exert a positive impact on the drug development process.
Public-private partnerships represent attractive means to leverage resources dispersed across industry, academia, and voluntary health organizations in order to address multiple challenges of drug development in an era of constrained resources and increased regulatory pressure.
尽管转化研究取得了进展，但我们在开发满足重大公共卫生需求的创新药物方面仍不尽如人意。此外，新药注册所需的失败率、时间和成本正在使行业经济达到临界点。急需基于合作努力的新药开发新模式来改善这种严峻局面。
2004 年，美国食品和药物管理局（FDA）推出了关键路径倡议，旨在通过实施公私合作伙伴关系（PPP）来共享数据、专业知识和资源，使药物开发现代化。为响应 FDA 的倡议，非营利性关键路径研究所（C-Path）于次年成立。与此同时，美国国立卫生研究院（NIH）的公私合作伙伴关系计划也成立了。在欧洲，欧盟和欧洲制药工业和协会联合会共同支持的创新药物倡议（IMI）于 2008 年启动。这些独立的努力有一个共同的长期目标，即通过开发药物发现的新工具、药物疗效或安全性的新指标以及患者分层的新方法，促进创新药物的出现。在此，我们提出的证据表明，公私合作伙伴关系已经对药物开发过程产生了积极影响。
公私合作伙伴关系是一种有吸引力的手段，可以利用分散在工业、学术界和志愿卫生组织中的资源，以应对资源有限和监管压力增加时代药物开发的多重挑战。
