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An All-Human Hepatic Culture System for Drug Development Applications
Published on: October 20, 2023
Fostering culture and optimizing organizational structure for implementing model-based drug development
Liping Zhang1, Sandra R Allerheiligen, Richard L Lalonde
1Discovery Medicine and Clinical Pharmacology, Bristol-Myers Squibb, Princeton, New Jersey, USA. liping.zhang3@bms.com
Journal of Clinical Pharmacology
|October 1, 2010
Summary
Model-based drug development (MBDD) enhances pharmaceutical decision-making. Successful MBDD implementation requires a supportive culture and organizational structure, integrating pharmacometrics (modeling and simulation) for better drug development outcomes.
Area of Science:
- Pharmacometrics and Drug Development
- Pharmaceutical Industry Innovation
- Quantitative Decision-Making in R&D
Background:
- The pharmaceutical industry is transitioning from empirical methods to quantitative approaches.
- Pharmacometrics, including modeling and simulation (M&S), is increasingly vital for decision-making.
- This commentary focuses on the cultural and organizational aspects of implementing MBDD.
Purpose of the Study:
- To summarize industry M&S leaders' experiences and visions for implementing MBDD.
- To outline essential cultural elements for successful MBDD adoption.
- To describe optimal organizational structures for MBDD integration.
Main Methods:
- Qualitative summary of industry leader perspectives.
- Focus on cultural and organizational factors.
- Synthesis of experiences and future vision for MBDD.
Main Results:
- A successful MBDD culture requires broad acceptance, probability-based evidence, transparent rationale, and quantitative metrics.
- An effective MBDD organizational structure includes a dedicated pharmacometrics function and balanced R&D goals.
- Cross-disciplinary collaboration among pharmacologists, statisticians, pharmacometricians, and clinicians is crucial.
Conclusions:
- Companies embracing MBDD need a culture valuing quantitative evidence and collaboration.
- An integrated organizational structure with a dedicated pharmacometrics team is essential.
- These elements prepare pharmaceutical companies to fully implement model-based drug development.
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