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

• Published in: INCOSE International Symposium 2024-07, Vol.34 (1), p.1890-1903
• Main Authors: Zhao, YangYang, Karlsen, Terje Lehn, Craig, Timothy K.
• Format: Article
• Language: English
• Subjects: Complex systems development; NTCP framework; Project planning; Risk management
• ISSN: 2334-5837; 2334-5837
• DOI: 10.1002/iis2.13247

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.