SPEAKERS:
William McCully, Co-Founder & Director, Aithena
Hank Du, Co-Founder & Director, Aithena
KEY TAKEAWAYS:
· Pharma content approval averages 15 days per asset with £1.5M annual affiliate costs
· AI pilots demonstrate 90% total review time reduction saving approximately 75 hours per asset
· Technical review achieves 61% time savings with linear scalability processing 100-200 claims
· Other industries such as financial services have reduced compliance review time by 98% using AI rule-checking systems
· Human signatories retain full accountability for AI-reviewed content, supported by a structured oversight framework
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The pharmaceutical industry has a content crisis hiding in plain sight. "When I was having my breakfast this morning, I went on the top 10 pharma websites and looked at your product pages. Six out of 10 of them said down for maintenance or content coming soon," William McCully told the audience at Reuters Events: Customer Engagement Europe in London.
This isn't a technology problem, it's a compliance bottleneck.
"The average time it takes to get one piece of material out to customers is about 15 days. Half that time is in review, half that time is the back and forth re-edits," McCully said. The Medical Legal Regulatory review process was designed to ensure patient safety and regulatory compliance. But it's become the thing that stops commercial teams from moving fast.
The £1.5 Million Question
The economics are stark. "The average affiliate probably spends around about 1.5 million just on review time alone. That's not outsourcing to a third party. That's not the cost of re-edits with a creative agency, and it's certainly not the opportunity cost to teams spending too much of their time in review," McCully said.
Here's the kicker: two-thirds of PMCPA breaches come from preventable errors. Missing mandatory information, outdated data, unsubstantiated claims. The system is slow and imperfect.
Marketing spend is projected to grow 10% year-on-year over the next five years across Europe. AI content generation and omnichannel strategies are multiplying content requirements. Organizations already struggling with current volumes face an impossible choice: exponentially grow review teams or fundamentally redesign the process.
"We've seen some really positive results in our early pilots with an average 90% reduction in total review time. That's equivalent to roughly 75 hours or just over nine days time saved per asset," Hank Du reported.
But the time savings do not come from AI reading faster. They come from eliminating review idle time. Du explained further, “What we actually realised is that reviewers spend a relatively small amount of time in the MLR system doing the review itself. They spend much of their time on MLR-related activities, such as reading references or aligning with brand teams on brand messages.”
While all of that is happening, the content effectively sits in a queue waiting for someone to pick it up, and that queue time drives much of the latency. “That is not a problem for AI,” Du noted. “An AI review can begin immediately and can run continuously in the background, processing one piece of content after another without waiting for a human reviewer to become available.”
Where AI Actually Excels
Technical review is one of the most labour-intensive parts of MLR review. “It is a highly demanding, laborious process and costly; this stage is often outsourced to third parties,” Du said. Large language models (LLMs) can interpret complex scientific documents, identify factual statements and claims that require substantiation, and automatically link them to supporting evidences. “In our pilots, we see materials containing more than 100 or even 200 discrete claims, and the AI has been able to understand them, label them appropriately, and detect technical errors with an impressive degree of accuracy,” Du explained.
"AI is not simply picking up missing subscript or superscript in your text. It is actually understanding the information, applying the right references to the claim."
Compared with traditional human-only review, we estimated a 61% reduction in technical review time when using AI support. In addition to the raw speed improvement, the real advantage lies in how AI scales. “When you work on a large document, every additional page and every additional claim or reference adds disproportionate complexity for a human reviewer. For AI, the workload scales in a more linear way,” Du said.
Need five email variations instead of one? Human review complexity explodes with each additional claim, reference, and context dependency. AI processing time increases proportionally. Same accuracy, predictable scaling.
Financial services has already been down this road. Some organizations have cut compliance review time by 98% using AI to navigate rules and regulations. Same stringent requirements, massive efficiency gains.
Teaching Compliance, Not Just Catching Errors
Traditional MLR review works as a quality gate. Content comes in, reviewers find problems, content goes back for fixes. This concentrates compliance expertise with senior signatories while content creators learn through trial and error.
Explainable AI changes that dynamic. "When you think about compliance, you can think of it as an iceberg. There are surface level issues that are easier to detect, like prescribing information or job code. People without extensive compliance training can identify them, but we know those are not the ones that trip up the MLR review," Du said. "AI surfaces all, including nuanced issues, at the beginning, leveling that playing field, no matter what your experience is."
"Explainable AI, when built correctly, can help the content creator not only see the error, but explain exactly why it is wrong, why it matters and how to fix it," Du said. Over time, content creators will internalise these principles and error rates in initial submissions should drop.
It also brings fundamental questions to the surface much earlier. Du recalled his own experience: “I remember working on a piece of content that had already been through several rounds of review and was close to approval when someone said to me, ‘Hang on a second, should this even be promotional?’ That is not the sort of conversation you want to be having when the content is about to go live.”
For global organisations, this democratises expertise across markets. "We can have global to local frameworks so a global team can create a whole series of campaigns, for example an omnichannel campaign, and now approve it for every local market at source," McCully said.
Who Signs Off?
The workforce question comes up in every implementation discussion. If AI automates the junior MLR review tasks that traditionally build expertise toward signatory roles, how do you develop future compliance leaders?
"Having been a signatory before, you earn your experience as a reviewer, then over time you become experienced enough to be a signatory and take on that responsibility to sign off materials," McCully acknowledged. Roles will likely shift toward orchestration - defining campaign strategy, managing AI oversight, making nuanced risk decisions.
But the accountability framework stays the same. "The accountability sits squarely with the person who's signing off the content. So whilst the AI can identify and pick up issues along the way, it is ultimately the person who's signing off the material that's accountable," Du said clearly.
"You should think of AI as a tool, but not as a replacement for human judgment. A well designed system with the right safeguards to serve up compliance risks for human intervention.
The future vision goes beyond faster approval. "We're going to have agentic compliance workflows. You're going to have a compliance agent, a marketing agent, a regulatory agent, all working in tandem behind the scenes," McCully said. These workflows could automatically update content when SmPCs change or new clinical papers are published.
"When we start to adopt AI content generation, we can couple that with AI compliance and now we can have compliant content at source. Again, this is a pace of marketing that we've never seen before," McCully said.
"This isn't necessarily about speed of approval, this is about the speed of impact. And MLR review may not be the most glamorous topic, but it's the engine that drives content through to our stakeholders," McCully concluded.
The pilot data suggests the technology is ready. The real question is whether organisations are ready to redesign decades-old processes around capabilities that promise both speed and quality at the same time.
To get you highlights of Pharma Customer Engagement EU faster, we are using generative AI technology to summarise the transcripts of the sessions. If you have any feedback about the summary, please contact lucy.fisher@thomsonreuters.com.
Discover more on this topic at Pharma 2026 (22-24 April, Barcelona) - the global collaborative network for leading pharma innovators. Visit the website here.