In this episode of the IT/OT Insider podcast, David sat down with Toni Manzano, a veteran in the pharmaceutical industry and co-founder and Chief Scientific Officer at Aizon. We delve into how IT/OT convergence concepts can be applied to the pharmaceutical industry, an area where precision, regulation, and innovation intersect in complex ways.
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The life sciences industry, encompassing sectors like pharmaceuticals, biotechnology, and medical devices, has an impact on all of us. They are pivotal in advancing global health by innovating and producing therapies, diagnostics, and treatments that improve and save lives. This industry represents a significant portion of the global economy, with the pharmaceutical sector alone generating approximately $1.6 trillion in global revenue in 2023.
Let’s delve into this super interesting sector and discover how digital solutions are transforming the way medicines are developed and produced!
From Astrophysics to Pharma
Toni began by sharing his intriguing transition from teaching astrophysics to spearheading software innovation in the highly regulated pharmaceutical industry. He reflected on his contributions to the development of Laboratory Information Management Systems (LIMS) and Manufacturing Execution Systems (MES). "Twenty years ago, LIMS and MES were something ‘wow’, and today it's still ‘wow’," Toni noted, emphasizing the continuous relevance of these systems, but also the slow adaptation.
AI in Pharma: Beyond the Buzz
We discussed the current hype surrounding artificial intelligence (AI) in pharma. Toni describes AI as a "cocktail" with power computing, algorithms, maths, and crucially for pharma, quality data as ingredients. "The secret sauce of this cocktail in pharma is the quality data. Without quality data, you cannot bring AI to fruition," Toni explained.
Toni shared a story about handling human plasma. Unlike other raw materials where quality non-compliance could simply lead to a batch rejection, human plasma represents a unique and invaluable resource that cannot be discarded. Here, Toni illustrated how AI can play a critical role. He described a scenario where, despite the high quality of operations, fluctuations in the quality of plasma can affect the final product. This complexity is where AI excels—by integrating vast amounts of operational and quality data to optimize processes that traditional methods cannot. This example not only underscores the complexity inherent in pharma manufacturing but also highlights the transformative potential of AI in managing such complexities, ensuring that every batch of product meets quality standards without wasting precious resources.
Challenges and Conservatism
Addressing the conservatism in the pharmaceutical industry, Toni pointed out the paradox of massive profitability discouraging rapid innovation. "If the industry is earning a lot of money with the status quo, there's less perceived need to evolve," he said. This highlights a significant barrier to adopting new technologies in an environment where traditional methods continue to yield high returns.
Regulatory Insights and the Path Forward
We also talked about the critical role of regulations in pharma, which ensure the safety, quality, and efficacy of medical products. Toni illuminated the evolving nature of regulatory frameworks which are increasingly accommodating modern computational methods, including AI. "Regulatory bodies are promoting innovation and the modernization of the pharmaceutical industry," Toni stated, suggesting a gradual but inevitable shift towards more advanced, data-driven manufacturing processes.
Outlook
As we wrapped up our conversation, Toni expressed optimism about the future of IT/OT convergence in pharma, driven by societal demands for rapid innovation and a generational shift in executive leadership towards tech-savviness. "Young executives understand and live with digital technology daily. It's not something strange; it's necessary," he remarked.
Find Toni on LinkedIn: https://www.linkedin.com/in/tonimanzano/
Interested in finding out more about Aizon? Visit https://www.aizon.ai/
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Digital and AI in Pharma: Insights from Toni Manzano, CSO at Aizon