Biopharmaceutics data management system for anonymised data sharing and curation: First application with orbito IMI...

Area of Science:

• Pharmacokinetics and Drug Metabolism
• Computational Chemistry and Cheminformatics
• Pharmaceutical Sciences

Background:

• Understanding drug absorption is crucial for effective drug development.
• Existing data sharing models often lack sufficient privacy controls for pre-competitive research.
• The OrBiTo IMI project aimed to address these limitations.

Purpose of the Study:

• To develop and evaluate a novel data management system for pharmaceutical biopharmaceutics and performance data.
• To assess the performance of in silico Physiological Based Pharmacokinetic (PBPK) tools using shared datasets.
• To establish a framework for secure, pre-competitive data sharing in the pharmaceutical industry.

Main Methods:

• A unique database system was designed with dynamic data visibility and blinding strategies.
• Thirteen pharmaceutical companies contributed anonymized biopharmaceutics drug properties and performance data.
• Three in silico PBPK tools were tested using the curated and blinded datasets.
• An anonymous communication tool was developed for data curation and evolution.

Main Results:

• The implemented database system successfully managed data visibility and blinding.
• The PBPK tools were evaluated using the unique dataset, providing insights into their performance.
• The data sharing strategy facilitated pre-competitive research while protecting proprietary information.
• A novel numbering system and blinding strategies were effective in anonymizing data.

Conclusions:

• The OrBiTo project successfully demonstrated a model for secure, pre-competitive data sharing in pharmaceutical research.
• The developed database system and anonymization techniques are valuable for future collaborative drug development initiatives.
• This approach can enhance the understanding and modeling of drug absorption through improved data accessibility and utilization.