以客户为中心的单克隆抗体产品介绍。

AAPS Open Pub Date : 2023-01-01 Epub Date: 2023-01-23 DOI:10.1186/s41120-022-00069-y
Beate Bittner
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引用次数: 0

摘要

为单克隆抗体(mAbs)等生物治疗药物提供以客户为中心的产品演示,是制药科学家长期参与的一个重要领域。其活动包括改善给药过程的体验、减少给药相关支出,以及最终将肠外治疗转移到受控医疗机构环境之外。在成本日益受限的市场和冠状病毒大流行的背景下,医疗保健领域的 "产品优化 "学科已获得了强劲的发展势头,并从 "不错 "变成了 "必须"。本综述总结了医疗保健生态系统的最新趋势,这些趋势为开发以客户为中心的产品提供了关键策略,包括提供更广泛的可持续给药选择和治疗管理计划,以支持在灵活的护理环境中给药。本文介绍了以客户为中心理念实施程度不同的三个疾病领域原型,以突出相关市场的异同。之所以选择类风湿性关节炎和炎症性肠病、多发性硬化症和肿瘤学,是因为这三个疾病的 mAb 药物及其后续生物制剂在皮下给药和即用型自助给药产品的可用性方面存在差异。从制造商的角度描述了不同的上市方案,强调了平台方法的必要性。为了充分发挥以客户为中心的医疗服务的潜力,需要广泛实施以价值为基础的医疗服务提供者报销计划,以激励医疗服务的效率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Customer-centric product presentations for monoclonal antibodies.

Delivering customer-centric product presentations for biotherapeutics, such as monoclonal antibodies (mAbs), represents a long-standing and paramount area of engagement for pharmaceutical scientists. Activities include improving experience with the dosing procedure, reducing drug administration-related expenditures, and ultimately shifting parenteral treatments outside of a controlled healthcare institutional setting. In times of increasingly cost-constrained markets and reinforced with the coronavirus pandemic, this discipline of "Product Optimization" in healthcare has gained momentum and changed from a nice-to-have into a must. This review summarizes latest trends in the healthcare ecosystem that inform key strategies for developing customer-centric products, including the availability of a wider array of sustainable drug delivery options and treatment management plans that support dosing in a flexible care setting. Three disease area archetypes with varying degree of implementation of customer-centric concepts are introduced to highlight relevant market differences and similarities. Namely, rheumatoid arthritis and inflammatory bowel disease, multiple sclerosis, and oncology have been chosen due to differences in the availability of subcutaneously dosed and ready-to-use self-administration products for mAb medicines and their follow-on biologics. Different launch scenarios are described from a manufacturer's perspective highlighting the necessity of platform approaches. To unfold the full potential of customer-centric care, value-based healthcare provider reimbursement schemes that incentivize the efficiency of care need to be broadly implemented.

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