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Systematic risk identification and assessment using a new risk map in pharmaceutical R&D
Drug Discovery Today ( IF 7.4 ) Pub Date : 2021-07-03 , DOI: 10.1016/j.drudis.2021.06.015
Alexander Schuhmacher 1 , Clara Brieke 2 , Oliver Gassmann 3 , Markus Hinder 4 , Dominik Hartl 5
Affiliation  

Delivering transformative therapies to patients while maintaining growth in the pharmaceutical industry requires an efficient use of research and development (R&D) resources and technologies to develop high-impact new molecular entities (NMEs). However, increasing global R&D competition in the pharmaceutical industry, growing impact of generics and biosimilars, more stringent regulatory requirements, as well as cost-constrained reimbursement frameworks challenge current business models of leading pharmaceutical companies. Big data-based analytics and artificial intelligence (AI) approaches have disrupted various industries and are having an increasing impact in the biopharmaceutical industry, with the promise to improve and accelerate biopharmaceutical R&D processes. Here, we systematically analyze, identify, assess, and categorize key risks across the drug discovery and development value chain using a new risk map approach, providing a comprehensive risk–reward analysis for pharmaceutical R&D.



中文翻译:

在药物研发中使用新的风险图进行系统的风险识别和评估

在保持制药行业增长的同时为患者提供变革性疗法需要有效利用研发 (R&D) 资源和技术来开发具有高影响力的新分子实体 (NME)。然而,制药行业日益激烈的全球研发竞争、仿制药和生物仿制药的影响越来越大、更严格的监管要求以及成本受限的报销框架对领先制药公司的当前商业模式提出了挑战。基于大数据的分析和人工智能 (AI) 方法已经扰乱了各个行业,并对生物制药行业产生了越来越大的影响,有望改善和加速生物制药研发过程。在这里,我们系统地分析、识别、评估、

更新日期:2021-07-03
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