P311: 3-Step Process for Making High-Quality Drug Development Decisions Quickly
Poster Presenter
Tyler Ludlow
Founder and Chief Decision Scientist
Decision Skills Institute United States
Objectives
Share a process with specific decision science tools and techniques that industry professionals can use 2-3 times a week to make important choices while solving problems and seizing opportunities.
Method
In the 1960s Decision Science emerged, blending math, statistics, and psychology. Honed over 25+ years, pharma companies began adopting it in the 90s for stage-gate and portfolio decisions. In the past 5 years, a faster, practical approach for all industry professionals has been developed.
Results
The Decision Dialogue Process and the Decision Quality framework, developed by Strategic Decisions Group based on research from Stanford and Harvard, are widely recognized standards for complex, strategic organizational decision-making. These tools are used by both external decision consultants and internal decision expertise groups across industries including oil & gas, pharma, agriculture, manufacturing, aviation, and others.
These tools are highly effective for the contexts for which they were designed. However, strengths in one context are often weaknesses in another. They are principle-based, allowing for customization, but require substantial expertise and education to apply properly. The frameworks are excellent at integrating diverse expertise across a company, including executive leadership, project teams, subject matter experts, and professional decision facilitators, ensuring clear thinking and action while reducing biases. However, in a context where a single person assumes all these roles, following the process can be awkward. Furthermore, while they are suited for large projects with ample time to gather varied perspectives, collect information and conduct a thorough analysis, they are less practical for “smaller” decisions, which often need to be made within days, hours, or even minutes.
While decision science has been applied in the industry for decades, it has primarily been by fulltime decision professionals on large projects. The same is true for project management: fulltime professionals on large projects. What’s different about project management, however, is that millions of business professionals who don’t manage projects fulltime, have still learned and apply project management skills in smaller ways on a regular basis. By extension, there is an opportunity for non-decision professionals to learn and apply decision science tools and techniques designed for their specific, smaller-scale needs.
Conclusion
To design a decision process tailored to individual business professionals, three main strategies were employed. First, the most broadly applicable tools from the decision science toolbox were chosen, and then simplified for quick learning and use, ensuring maximum outcome benefits with minimal time investment. Second, a balance was found between structure and flexibility, creating a process with core techniques for most decisions and additional ones for more complex situations, all driving toward clarity. Third, decision archetypes – presolved patterns – were developed, offering users an easy-to-use, mathematically robust way to integrate uncertainty into decisions.
This streamlined yet powerful process enables drug development professionals, who will likely never desire to become decision science experts, to apply decision science techniques in a scientifically sound way without needing full-time decision professionals. Below are examples of decisions where this process has been applied:
• Site selection for an upcoming trial.
• Selecting the best comparator strategy trial design to propose to regulators at an end of Ph2 meeting.
• Vendor selection for target engagement assay work.
• Determining which analyses to perform on investigator initiated data to support NDA filing.
• Optimal cohort sequencing between various subpopulations.
• Figuring out which additional initiatives to add on to an already busy schedule.
• Which is the best strategy for addressing sites that are not performing?
• To what degree to follow a target product profile template for an upcoming and unique candidate selection decision?
• Selecting which activities to outsource to contractors.
