Apogenix AG, VP Global Head Medical Affairs, Im Neuenheimer Feld 584, 69120, Heidelberg, Germany.
Sandoz (Part of Novartis), Global Clinical Development Manager, 83607, Holzkirchen, Germany.
Pharmaceut Med. 2020 Apr;34(2):103-112. doi: 10.1007/s40290-020-00328-x.
Innovative medicinal products are required to achieve progress in oncology; however, these are associated with high financial investments, extensive development times, and significant risk of potential failure in the pivotal clinical trials required for marketing authorization. With increasing budgetary constraints and requirements to demonstrate value, effective strategies to develop and commercialize innovative oncology products are more important than ever. Strategies that have proved successful in other industries require major revision for use in the oncology field, both during preclinical and clinical development as well as in the post approval value chain. This paper will examine how medicinal product strategy development differs from other industries. In particular, it will look at how the global trend toward value-based healthcare requires strategies that are based on an in-depth scientific understanding of the disease area and product-specific characteristics supported by clinical evidence. The findings are complemented by a review of the available literature and a survey of industry representatives.
创新药物是肿瘤学取得进展所必需的；然而，这些药物与高财务投资、广泛的开发时间以及在获得营销授权所需的关键临床试验中潜在失败的巨大风险相关联。随着预算限制的增加和对价值的证明的要求，开发和商业化创新肿瘤产品的有效策略比以往任何时候都更加重要。在肿瘤学领域，在临床前和临床开发以及批准后价值链中，在其他行业中被证明成功的策略需要进行重大修改。本文将探讨药物策略开发如何与其他行业不同。特别是，它将研究全球向基于价值的医疗保健的趋势如何要求基于对疾病领域和产品特定特征的深入科学理解的策略，这些策略得到临床证据的支持。研究结果还辅以对现有文献的回顾和对行业代表的调查。
