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从创新者导向的结果驱动型到多方利益相关者导向的注重影响力的公私合作伙伴关系:整合患者视角。

From Innovator Result-driven to Multi-actor Impact-oriented Public-Private Partnerships: Integrating the Patient Perspective.

机构信息

Foundation Lygature, Utrecht, The Netherlands.

Foundation INVOLV (formerly PGOsupport), Utrecht, The Netherlands.

出版信息

Handb Exp Pharmacol. 2024;286:137-168. doi: 10.1007/164_2024_730.

Abstract

Public-Private Partnerships (PPPs) have been crucial in medicine research and development (R&D) for decades. Initially, PPPs involved private and academic innovators working in bilateral collaborations to advance pharmaceutical innovation. Later, a precompetitive open innovation environment was created, where multiple public and private innovators collaborated on mutual interests. The entry of regulators and patient interest organizations into PPPs has triggered a third shift from an innovator result-driven to a multi-actor impact-oriented partnership model. Using the second Innovative Medicines Initiative program (IMI2) as an example, this chapter focuses on the increasing roles of patient interest organizations in PPPs in roughly the last decade.Most IMI2 partnerships focused on raising awareness and sharing information tailored to patient needs (listener role) and inviting patients to share their experiences and needs (co-thinker role). Many partnerships also integrated the patient perspective by implementing patient advisory bodies (advisor role) or including patients as equal partners in steering the project (partner role). Notably, partnerships like EUPATI and PARADIGM showed that patient interest organizations can lead initiatives, especially those aiming at advancing patient engagement across the medicine R&D lifecycle (decision-maker role). While the overall impact of patient involvement in the IMI2 program is still being assessed, it has exposed many innovators and regulators to the patient perspective and created a community of patient experts with access to tools and guidelines for meaningful involvement.The PPP model continues to evolve, shifting from a treatment-only to a comprehensive diagnosis, treatment, and monitoring approach by incorporating digital and medical technology actors. This development, alongside continued patient and public integration could revolutionize the R&D and accessibility of new treatments and diagnostics.

摘要

公私合作伙伴关系(PPPs)在医学研究与开发(R&D)中已经发挥了几十年的关键作用。最初,PPPs 涉及私营部门和学术创新者在双边合作中合作,以推进药物创新。后来,建立了一个竞争前的开放式创新环境,多个公共和私营创新者在共同利益上进行合作。监管机构和患者利益组织进入 PPPs,引发了从创新者以结果为导向到多方参与者以影响为导向的合作伙伴关系模式的第三个转变。本文以第二个创新药物倡议计划(IMI2)为例,重点关注过去十年左右患者利益组织在 PPPs 中作用的不断增加。大多数 IMI2 合作伙伴关系侧重于提高认识和分享针对患者需求的信息(倾听者角色),并邀请患者分享他们的经验和需求(共同思考者角色)。许多合作伙伴关系还通过实施患者咨询机构(顾问角色)或让患者平等参与项目指导(合作伙伴角色),将患者视角融入其中。值得注意的是,像 EUPATI 和 PARADIGM 这样的合作伙伴关系表明,患者利益组织可以领导倡议,特别是那些旨在推进药物研发周期内患者参与的倡议(决策者角色)。虽然患者参与 IMI2 计划的总体影响仍在评估中,但它让许多创新者和监管机构接触到了患者视角,并为有意义参与的患者专家创建了一个社区,他们可以使用工具和指南。PPP 模式继续发展,通过将数字和医疗技术参与者纳入其中,从仅治疗方法转变为全面的诊断、治疗和监测方法。这种发展,加上持续的患者和公众参与,可能会彻底改变新治疗方法和诊断方法的研发和可及性。

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