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Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap

Arzu Selen1, Anette Müllertz2, Filippos Kesisoglou3

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The Biopharmaceutics Risk Assessment Roadmap (BioRAM) offers a systems approach for drug development decision-making. It uses risk assessment and knowledge leveraging to optimize clinical performance and patient benefit.

Keywords:
biopharmaceuticsblueprint meetingsdecision-making for the systemintegrated risk assessmentsystems thinking

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Area of Science:

  • Pharmaceutical Sciences
  • Systems Biology
  • Drug Development

Background:

  • Effective drug development requires integrated systems approaches for timely, patient-focused decisions.
  • The Biopharmaceutics Risk Assessment Roadmap (BioRAM) provides a framework for applying systems thinking throughout drug discovery and development.
  • Previous work established the BioRAM therapy-driven drug delivery framework, strategic roadmap, and scoring instrument.

Purpose of the Study:

  • To illustrate risk-based decision-making using the BioRAM strategy in diverse drug development scenarios.
  • To demonstrate how BioRAM integrates systems thinking across pharmaceutical development, manufacturing, clinical sciences, and healthcare.
  • To showcase the application of BioRAM in high-risk (rare disease) and moderate-risk development settings.

Main Methods:

  • Utilized semi-hypothetical examples to showcase BioRAM implementation.
  • Applied BioRAM's Blueprint (BP) meeting concept for shared understanding and strategy development.
  • Illustrated risk characterization and balancing within the BioRAM framework.

Main Results:

  • Demonstrated BioRAM's utility in a high-risk rare disease setting, comparing gene therapy and small molecule approaches.
  • Showcased BioRAM's application in moderate-risk scenarios by leveraging manufacturing and clinical data from similar drugs.
  • Illustrated how BioRAM utilizes knowledge of mechanistic pathways to inform drug release profiles and dosing flexibility.

Conclusions:

  • The BioRAM strategy effectively supports risk-based decision-making in drug development.
  • BioRAM enables optimization of clinical performance and patient benefit through integrated knowledge leveraging.
  • The framework is adaptable for various risk levels and developmental stages, promoting informed strategic planning.