There is a lot happening in the pharmaceutical industry. From drug pricing reforms and acquisitions to conversations around accelerated approval, 2023 is already proving to be a year filled with pending questions. One question definitely rising in importance is how can artificial intelligence drive the future of the industry? Like all other aspects of the industry, this is particularly pertinent to pharmaceutical manufacturing. In this post, we examine two of the ways in which AI is impacting conversations in the sector.
The Future of AI and Regulatory Guidance
If pharmaceutical investing news reflects anything, it is that there is “spiked demand for a tech update in pharmaceutical manufacturing,” as Claire Rychlewski writes for Axios. For instance, Rychlewski reports that Apprentice.io, a cloud-based platform for pharmaceutical manufacturing, recently raised $65 million. Alongside cloud technology, AI is clearly another leading tech pursuit. So much so that it led the FDA’s Center for Drug Evaluation and Research (CDER) to publish a discussion paper on the subject earlier this month.
The CDER recognizes that AI has the potential to advance pharmaceutical manufacturing in countless ways, therefore it is seeking insight that could serve policy development in the future. In addition to areas such as cloud and IoT applications, the paper requests input on what kind of AI functions experts in the field are looking to, how current regulations may affect such innovation and implementation, what practices exist for validating and managing AI models, etc. In a demonstration of how much there is still to know and subject to change, the paper also asks if there are other aspects missing from its contents and worthy of consideration.
AI and Industry 5.0
While AI sparks regulatory discussions, it is contributing to an even larger exploration around the next era in pharmaceutical manufacturing as well. In an opinion piece for Contract Pharma, Heather Coglait and Dan UpDyke posit that AI will continue to play an important role as the industry enters what is known as Industry 5.0. Whereas Industry 4.0 produced Pharma 4.0, which was defined by better data quality and visibility thanks to AI and machine learning, the European Union has determined that 5.0 will utilize those technical advances to create a “more environmentally conscious, sustainable, human-centric and resilient industry,” as Coglait and UpDyke describe.
A significant benefit to Industry 5.0 and AI’s part within it is that it establishes more of a partnership between teams and the tech that they are using. If organizations can successfully integrate reliable AI that streamlines manufacturing, then operators can focus their energy on new developments in pharmaceutical production that meet evolving needs. Of course, this will come with challenges. But, considering the trend, it’s likely that AI will influence the solutions too.
Sources:
- “5 questions facing the pharma industry in 2023” – Christopher Newman & Jonathan Gardner, Biopharma Dive
https://www.biopharmadive.com/news/pharma-trends-questions-outlook-2022/639898/ - “Apprentice.io raises $65M for life sciences manufacturing” – Claire Rychlewski, Axios
https://www.axios.com/pro/health-tech-deals/2023/03/20/apprenticeio-65m-life-sciences-manufacturing - “FDA calls for comments on artificial intelligence in drug manufacturing” – DLA Piper (Geoffrey Levitt, Daniel Tobey, Bethany Hills and Keo Shaw), Lexology
https://www.lexology.com/library/detail.aspx?g=e4b968d8-2d5c-4780-962a-607b6859007a - “How Industry 5.0 Might Benefit Pharmaceutical Manufacturing” – Heather Coglaiti & Dan UpDyke, Contract Pharma
https://www.contractpharma.com/contents/view_experts-opinion/2023-03-17/how-industry-50-might-benefit-pharmaceutical-manufacturing/
