TECH OUTLOOK 8NOVEMBER 2024IN MY OPINIONTHE NEW PHARMACEUTICAL ERA BUILT UPON DATA QUALITYBy Diane Paskiet, Director of Scientific Affairs, West Pharmaceutical ServicesThe 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 gathered from various types of data, but in this new era, there are challenges to address, such as the lack of comprehensive digital data, accessibility of siloed data, and quantifiable uncertainty of data. Evidence for informed decisions is based on credible knowledge and depends on data integrity and quality. Data integrity is a compliance aspect of current good manufacturing practices (cGMP) to ensure records are original, complete, consistent, accurate, attributable, legible, contemporaneous, enduring, and unadulterated. Data quality follows the same criteria with an emphasis on a methodology that is fit for purpose, precise, Diane Paskiet
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