Mayer Mark, Canedo Angelica, Dinh Tam, Low Madelyn, Ortiz Ariel, Garay Chloé
Eli Lilly and Company, Indianapolis, IN, USA.
Keck Graduate Institute, Claremont, CA, USA.
Ther Innov Regul Sci. 2019 Nov;53(6):759-766. doi: 10.1177/2168479018812778. Epub 2018 Dec 6.
Pharmaceutical companies rely on regulatory intelligence (RI) to analyze information from internal and external sources. To facilitate RI activities, companies are seeking ways to harness technology to optimize their capabilities. Specifically, there is a growing interest for artificial intelligence (AI) to enhance RI activities. However, exploration of the potential utility of AI and related technologies will be key to begin unlocking these tools for the regulatory community.
To identify potential development paths for these technologies, we interviewed over 30 global regulatory leaders at 22 pharmaceutical companies and 3 leading companies in RI and AI technologies. Thirteen of the 22 pharmaceutical companies also provided responses to a subsequent informational survey.
This study elucidated potential value proposition, barriers, and risks to integrating AI into the RI field. Twenty of the 22 participating companies consider that AI offers significant opportunity for RI activities of data processing (mining, searching, monitoring, alerting). Thirty-two percent of companies envisage use in data synthesis (combining different types of information across formats), 36% in data analysis (trends, patterns, predictive analytics), and 23% in decision making. Additionally, results of this research provided insights about the potential role of precompetitive consortia, which may enhance future actualization.
Opportunity presents for AI to enhance quality, speed, and efficiency of RI activities. This assessment of the current technology landscape revealed a lack of fully developed AI tools; however, the RI community demand is beginning to be recognized. Therefore, now more than ever, the timing to advance AI within the RI field is right.
制药公司依靠监管情报（RI）来分析来自内部和外部来源的信息。为了促进监管情报活动，公司正在寻求利用技术来优化其能力。具体而言，人们对利用人工智能（AI）来加强监管情报活动的兴趣与日俱增。然而，探索人工智能及相关技术的潜在效用将是为监管界开启这些工具的关键。
为了确定这些技术的潜在发展路径，我们采访了22家制药公司的30多位全球监管负责人以及3家监管情报和人工智能技术领域的领先公司。22家制药公司中的13家还对随后的信息调查做出了回应。
本研究阐明了将人工智能整合到监管情报领域的潜在价值主张、障碍和风险。22家参与公司中有20家认为人工智能为监管情报活动中的数据处理（挖掘、搜索、监测、警报）提供了重大机遇。32%的公司设想将其用于数据合成（整合不同格式的各类信息），36%用于数据分析（趋势、模式、预测分析），23%用于决策制定。此外，本研究结果还提供了关于竞争前联盟潜在作用的见解，这可能会促进未来的实现。
人工智能有机会提高监管情报活动的质量、速度和效率。对当前技术格局的评估表明，缺乏充分开发的人工智能工具；然而，监管情报界的需求已开始得到认可。因此，现在比以往任何时候都更适合在监管情报领域推进人工智能的发展。
