Data Intelligence Requires An Intelligent, Data-Driven Approach To Digital Transformation

By Unjulie Bhanot, Product Marketing Manager (Process Development & Manufacturing), IDBS

Digital tools like artificial intelligence (AI) and machine learning (ML) are being adopted into more areas of the BioPharma industry to speed up drug discovery and reduce development costs. However, this digitalization adds complexity to regulatory decision-making. To overcome these challenges, companies are working to ensure their data is complete, accessible, high-quality, and systematically managed. Regulatory authorities like the European Medicines Agency and the EU Heads of Medicines Agencies have published guidelines for using AI-generated data for quality decision-making. Despite the challenges, the potential benefits of AI and ML in the BioPharma industry are significant, with estimates suggesting the technology could generate $60 billion to $110 billion a year in economic value for the pharma and medical-product industries.