JULY 2024LIFE SCIENCES REVIEW8IN MY OPINIONBy Diane Paskiet, Director of Scientific Affairs, West Pharmaceutical Serviceshe pharmaceutical industry has continued to focus on the development of innovative medicines, novel drug delivery systems, and advanced manufacturing technologies to enable timely access to lifesaving medicines. In parallel, digital transformation (e.g., Pharma 4.0), informatics and analytics are providing insights from predictive modeling and artificial intelligence to advance product development, efficient manufacturing technologies, and supply chain management. In this new era, it is essential to acquire substantial, reliable, and fit-for-purpose data across discovery, clinical development, commercialization, and lifecycle management. Timely approval for drug and biological products will be guided by the strength of scientific evidence. As new technologies are progressing, regulators are developing new standards with greater expectations for data quality and knowledge management.In the context of drug product efficacy and chemical safety, a plethora of empirical data can be gathered to derive insights for knowledge management. Meaningful insights can be THE NEW PHARMACEUTICAL ERA BUILT UPON DATA QUALITYTDiane Paskiet
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