AI integration in biotech's regulatory affairs and CMC is advancing rapidly, but governance frameworks are struggling to keep pace.
Artificial intelligence (AI) is increasingly being adopted in regulatory affairs and Chemistry, Manufacturing, and Controls (CMC) within biotech companies. Many organizations are utilizing AI for tasks such as drafting documents, summarizing data, and developing responses to health authorities. However, this adoption often occurs without fully established governance protocols, particularly in smaller biotech firms that are under pressure to expedite development timelines.
Kelsey Hoontis, a regulatory affairs and CMC strategy consultant, notes that while larger pharmaceutical companies have made strides in creating governance frameworks, smaller firms frequently find themselves in pilot phases. This fragmentation leads to inconsistent usage across teams, where different AI tools are employed without centralized oversight, creating risks such as inaccuracies in AI-generated content and challenges in understanding how outputs are generated.
Hoontis emphasizes the importance of a cross-functional approach to AI governance, suggesting that organizations inventory their AI use cases to identify risks and establish appropriate governance measures. Existing frameworks like ALCOA+ remain relevant, but AI introduces complexities that require additional controls for human review and traceability. As organizations navigate these challenges, they must ensure that their documentation and processes are inspection-ready, demonstrating accountability and control over AI-assisted outputs.
As the biotech industry continues to embrace AI, the focus should be on establishing robust governance models that align with the unique demands of regulatory workflows. Companies can start by increasing visibility into their current AI applications, ultimately paving the way for more effective and responsible integration.