Navigating Regulatory Complexities

Navigating the complex web of FDA, FTC, and other regulatory requirements surrounding pharmaceutical communications is a daunting task that can overwhelm even the most seasoned professionals. The silver lining? Artificial Intelligence (AI) never tires, rarely succumbs to confusion, and can evolve at the click of a mouse.

Matthew Snodgrass, the AI innovation lead at Syneos Health Communications, is at the forefront of this transformation, piloting a custom-built Generative Pre-trained Transformer (GPT) that aims to streamline the creation of regulatory-compliant content. Still, he emphasizes that AI cannot and should not replace the critical eye of human judgment.

The Birth of a Revolutionary Tool

In regulated sectors like pharmaceuticals, one of the most significant hurdles communicators face is deciphering what can and cannot be said legally. Snodgrass shares his journey towards creating this cutting-edge GPT and outlines how it works.

At Syneos, half of their operations focus on clinical trials, where strict regulations govern the handling of patient information. The communication side, despite having some leeway, must still adhere to these rigorous requirements. Snodgrass's dual roles within the organization enable him to merge regulatory knowledge with practical innovation.

He explains, "By consolidating existing regulations with my understanding and interpretation, I envisioned creating a tool that mirrors these interpretations, enabling us to evaluate proposed content before it reaches the client."

Streamlining the Review Process

Typically, medical-legal-regulatory (MLR) teams at pharmaceutical companies scrutinize content for compliance, often sending drafts back for numerous revisions. Snodgrass aims to circumvent this back-and-forth by developing a tool that generates a cleaner, more compliant draft, effectively enhancing the quality and speed of the review process.

“This approach doesn't replace human oversight; it just facilitates delivering a more polished product to clients,” he asserts. Snodgrass encourages a cooperative dynamic: “Think of AI as a draft tool—trust it, but always verify.”

Concerns about AI consuming human roles persist, but Snodgrass addresses this point, stating, "The collaboration will involve a balance between the efficiencies AI brings and the irreplaceable human elements like strategy, creativity, and nuanced content development."

Client Reactions and Industry Perspectives

The rollout of this GPT is encountering mixed reactions from clients. Likening it to the initial hesitance over social media 15 years ago, Snodgrass notes that while some clients are eager to experiment with AI, others, especially smaller biotech firms, remain focused on R&D and lack the resources to engage with AI effectively.

Interestingly, some clients express outright resistance to using AI in their projects. "Frequently, it's a matter of skepticism, or they’ve had a poor experience with AI tools that led to subpar results. In others cases, it’s intelligent marketing teams facing pushback from their legal counterparts," he explains.

Current Development Stage and Future Prospects

Currently, Snodgrass and his team are in the alpha phase of development for their regulatory GPT. They’ve crafted a comprehensive document detailing the interpretations of FDA, FTC, and U.S. Code of Federal Regulations, which is continuously being tested and refined.

"I keep pushing the system with queries," he elaborates. "If it produces an incorrect response, I revisit and update our foundational document." The process is iterative, akin to fine-tuning a brain, as he describes it, gearing up for an eventual internal rollout.

As healthcare communications advance, the collaborative future of AI and human insight promises to revolutionize the way client drafts are produced, ensuring compliance while enhancing efficiency—a game changer in the industry. Stay tuned to see how AI continues to disrupt traditional practices, speeding up innovation and improving patient care through clearer, compliant communication.