AI and Regulatory Compliance in Pharma Communications
Communicating about pharmaceuticals involves strict regulations from entities like the FDA and FTC. Even seasoned professionals find it challenging to ensure compliance. However, Artificial Intelligence (AI) can streamline this process, reducing fatigue and confusion in drafting content.
Matthew Snodgrass, AI innovation lead at Syneos Health Communications, is developing a custom AI model to create drafts that comply with regulations. He emphasizes that AI is a tool to enhance human oversight, not a replacement.
The idea stemmed from the need to navigate complex regulatory frameworks while creating compliant and efficient communication. The clinical trial side of Syneos handles sensitive patient information, adhering to strict privacy and data policies. Snodgrass aims to merge regulatory expertise with AI to analyze content before it reaches clients.
Currently, regulatory teams often return content for adjustments due to compliance issues. Snodgrass’s tool aims to provide a preliminary evaluation, allowing faster and more accurate submissions. He envisions using AI for drafting while preserving the irreplaceable human touch in strategy and creativity.
Feedback from clients varies. Some embrace AI for innovation, while others, particularly smaller firms, hesitate due to limited resources or internal resistance. Concerns about AI stem from skepticism over its output and decision-making capacity.
Snodgrass’s project is in the alpha phase, with continuous training of the AI model. He actively tests and updates the system to refine its understanding of regulatory standards. His goal is to eventually deploy a useful tool for both internal teams and clients.
For those interested in AI’s impact on communications, upcoming conferences, like Ragan’s AI Horizons Conference, will provide further insights.
