Generative AI (GenAI) has been touted as a potential game-changer for the biopharma industry, particularly in the realm of regulatory operations. However, while GenAI can undoubtedly streamline certain processes, it is not a one-size-fits-all solution. Biopharma companies must approach the technology with caution, as the risk of hallucination and other issues could lead to serious consequences in such a heavily regulated industry.
To effectively leverage GenAI in regulatory operations, biopharma companies should adopt a measured approach. This involves carefully evaluating the capabilities and limitations of the technology, and implementing it in a way that complements, rather than replaces, human expertise. By striking the right balance between automation and human oversight, biopharma companies can harness the power of GenAI to improve efficiency and accuracy, while mitigating potential risks.