Risk Management in Project Planning for Life Science R&D: An Integration of the NTCP Framework

YangYang Zhao, Terje Lehn Karlsen, Timothy K. Craig
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Abstract

As with many industries, the early life science R&D drug discovery sector is facing growing pressure and higher demands on products in terms of cost, quality, and time-to-market. Additionally, the complexity of involved targets and systems, requirements for rapid, safe, and developable candidates are increasing. The drug discovery market, often regarded as rather conservative, relies more and more on advanced technologies. It is therefore a significant task for suppliers to create good solutions that meet customer requirements. The life science industry has a long tradition of using projects as the preferred method to manage these complex systems developments, such as the production of target proteins, screening of compounds, and follow-up of hit compounds. When applying the project approach, the level of uncertainty is usually high, and the risk of those uncertainties must be managed starting in the early planning phase. Thus, this paper focuses on the issue of how to manage risks in the early project planning phase. We first review state-of-the-art practices in risk management for complex systems project management and identify an important framework, Novelty-Technology-Cost-Pace (NTCP), and apply it to successful risk management for early life science projects. Through an in-depth case study in the life science industry, we demonstrate a systemic integration of the NTPC framework into project planning.

生命科学研发项目规划中的风险管理:NTCP 框架的整合
与许多行业一样,早期生命科学研发药物发现领域正面临着越来越大的压力,对产品的成本、质量和上市时间提出了更高的要求。此外,涉及的靶点和系统越来越复杂,对快速、安全和可开发候选药物的要求也越来越高。通常被认为相当保守的药物发现市场越来越依赖于先进技术。因此,对于供应商来说,创造满足客户要求的良好解决方案是一项重要任务。生命科学行业有着悠久的传统,将项目作为管理这些复杂系统开发的首选方法,例如目标蛋白质的生产、化合物的筛选以及对命中化合物的跟踪。在采用项目方法时,不确定性通常很高,必须在早期规划阶段就开始管理这些不确定性带来的风险。因此,本文重点讨论了如何在项目规划早期阶段管理风险的问题。我们首先回顾了复杂系统项目管理中风险管理的最新实践,确定了一个重要的框架--新颖性-技术-成本-进度(NTCP),并将其应用于早期生命科学项目的成功风险管理。通过对生命科学行业的深入案例研究,我们展示了 NTPC 框架与项目规划的系统整合。
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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