P334: Practical Framework for Integrated Risk Management in Pharmaceutical R&D
Poster Presenter
Arun Mathew
Director
AbbVie United States
Objectives
The objective of the abstract is to summarize and communicate the key purpose and value of the Integrated Risk Management (IRM) framework in pharmaceutical R&D, as outlined in the whitepaper, for the DIA annual meeting audience.
Method
The pilot of this framework was done from 2024 to 2025
Results
The pilot was conducted and we realized we need to update the process based on the practical challenges. We have now completed 10 Integrated risk assessments for various assets
Conclusion
Conclusions from the Pilot:
Integrated risk management is practical and achievable in R&D environments using a minimum viable approach (common vocabulary, central risk profile, cross-functional governance, communication triggers, periodic review).
Piloting IRM at AbbVie demonstrated that linking risk information across functions increases visibility, reduces duplicated effort, and accelerates decision-making.
Adopting an shared ownership model, rather than pure control-based, led to faster escalation and resolution of cross-functional risks.
Implementing even a simplified (non-technology-heavy) version of IRM improved portfolio resilience and inspection readiness, with fewer late-stage surprises and better readiness for regulatory scrutiny.
The pilot confirmed that existing organizational processes and tools could be adapted to achieve substantial benefit, without requiring full system overhaul.
Implications:
Other pharmaceutical R&D organizations can achieve significant value from starting small with IRM, focusing on foundational practices before investing in advanced technology or analytics.
Cross-functional collaboration and clear governance are critical to success—organizational alignment on risk language and responsibility is as important as the toolset itself.
Regulatory expectations (like ICH Q9(R1)) can be met more effectively when risk management information is unified and traceable throughout the product lifecycle.
As organizations mature, the foundational IRM elements piloted (like at AbbVie) provide a strong platform to integrate future technologies, advanced analytics, or system architectures described in the framework’s Part 2.
In summary: The AbbVie pilot prove that integrated, cross-functional risk management in R&D is both feasible and valuable, driving better decisions, streamlining compliance, and enabling a proactive risk culture with scalable foundations for the future.
