Systematic risk identification and assessment using a new risk map in pharmaceutical R&D

Area of Science:

• Pharmaceutical R&D
• Drug Discovery and Development
• Risk Management

Background:

• Pharmaceutical industry growth is challenged by R&D competition, generics, biosimilars, stringent regulations, and cost-constrained reimbursement.
• Current business models are strained by these increasing pressures.
• Big data analytics and AI offer potential to enhance biopharmaceutical R&D processes.

Purpose of the Study:

• To systematically analyze, identify, assess, and categorize key risks across the drug discovery and development value chain.
• To provide a comprehensive risk-reward analysis for pharmaceutical R&D.
• To introduce a novel risk map approach for strategic decision-making.

Main Methods:

• Systematic analysis of the drug discovery and development value chain.
• Development and application of a new risk map approach.
• Categorization and assessment of key risks.
• Risk-reward analysis.

Main Results:

• Identification and categorization of key risks throughout the R&D pipeline.
• A comprehensive risk map illustrating risk-reward trade-offs.
• Insights into optimizing R&D resource allocation and technology adoption.

Conclusions:

• Effective risk management is crucial for delivering transformative therapies and maintaining pharmaceutical industry growth.
• The proposed risk map approach provides a valuable tool for navigating complex R&D challenges.
• Leveraging big data and AI can further mitigate risks and accelerate the development of new molecular entities (NMEs).