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From Hype to Impact: AI in Consumer Health R&D and RWE
Dr Volker Spitzer, VP, Global Consumer Health R&D/RWE, IQVIA Consumer Health
Dr. Ines Rocha, Associate Director, Global Consumer Health R&D / RWE Services
Matt Stewart, Associate Director, Global Marketing, IQVIA Consumer Health
Aug 29, 2025

Artificial Intelligence (AI) is no longer a futuristic promise for consumer health companies across their broader R&D activities. It is becoming a practical engine for innovation, helping brands develop consumer-centric products faster and smarter.

But AI’s impact goes beyond efficiency. It has the power to reshape how we understand health, create solutions, and bring them to market. Some tools are already in use, others are emerging. Here’s how this transformation is unfolding.

Finding Ideas That Matter

Imagine knowing what consumers will want before they do. AI can scan millions of data points, from social media to purchasing patterns, to surface emerging needs and overlooked problems. The result? Ideas grounded in real life, not just creative brainstorming.

Take probiotics as an example: AI can analyse microbiome research, competitor activity, and consumer sentiment to shape a product idea with high relevance and market fit. The same applies to pain relief, sleep, nutrition, and beyond.

Designing Products Consumers Trust

Once an idea is defined, AI can help turn it into a physical product. Machine learning can aid formulation by modelling how ingredients interact, predicting combinations that are effective, stable, well-tolerated, and acceptable to regulators.

For example, when developing a magnesium supplement for muscle recovery, AI can compare clinical outcomes, user reviews, and bioavailability data to recommend the ideal magnesium form, dose, and complementary nutrients. This reduces manual trial-and-error and shortens time to market.

Yet, AI models are only as inclusive as the data behind them. If training data under-represents certain groups like children, women, older adults, or minorities, the resulting recommendations may fall short for those groups. Also, AI tools can obviously not bear legal responsibility, so human experts must ultimately validate and approve all development steps.

Navigating the Regulatory Maze

Regulatory landscapes are complex and constantly evolving. AI can keep teams up to date, scanning global databases for new requirements and enforcement trends. This foresight can help companies adjust strategies early, avoiding costly delays. Also, it can reduce the time spent gaining local regulatory knowledge across different geographical regions.

AI has the potential to drafts sections of dossiers, prepare summaries, and automate repetitive tasks-freeing up regulatory experts for high-value decision-making. For instance, a company preparing to launch a vitamin D supplement across the EU could use AI to detect updated regulatory requirements (e.g. country-specific maximum daily doses, approved health claims) and generate compliant documentation in less time (when, and if needed).

In this context we need to consider that new laws like the EU AI Act i and evolving FDA frameworks ii are raising the bar. These frameworks increasingly demand risk assessments, transparency, and human oversight - especially when AI influences product safety or claims.

Seeing the White Spaces

AI does not just analyse what exists - it reveals what doesn’t. By mapping competitors’ portfolios against consumer needs and health trends, it highlights white space opportunities where new products can stand out.

Using AI tools to analyze social media data can help identify white space opportunities and support powerful strategies by, for example, uncovering unmet consumer needs or missing indications. Taking the OTC digestive health category as an example, AI might identify unmet demand for faster-acting, travel-friendly antacid formats. It could suggest a chewable, individually wrapped product with natural ingredients-based on consumer reviews, sales patterns, and lifestyle data. These insights are hard to find manually and can take weeks to assemble without AI.

AI’s Benefits for Clinical Research

Clinical research has traditionally been slow, complex, and expensive. AI is starting to shift that paradigm. It presents opportunities from site feasibility, study design, trial analytics, to consumer recruitment.

For example, AI can potentially support smarter protocol design by analysing past studies and real-world data to recommend study designs, endpoints, and eligibility criteria with higher chances of success. Predictive models improve recruitment by identifying ideal locations and populations -addressing one of the biggest bottlenecks in trial design today.

Dr. Volker Spitzer, VP, Global R&D & RWE Services - IQVIA Consumer Health

Furthermore, AI can also enable real-time monitoring - flagging safety concerns or deviations early to protect study integrity - while chatbots and personalised reminders can drive participant adherence and motivation.

Finally, AI can streamline analysis and reporting by processing large datasets quickly and identifying key trends.

The result: trials that are faster, more efficient, and better aligned with real-world needs.

Connecting to Real Life through Real World Evidence

Like clinical research, RWE generation is becoming faster, more efficient, and more actionable with AI. AI supports protocol design, predicts recruitment feasibility, and processes data from sources like EHRs, pharmacy records, surveys, and wearables. It helps identify meaningful endpoints, monitor safety signals in real time, and determine which subpopulations benefit most.

By integrating structured and unstructured data-using techniques, such as natural language processing, AI surfaces insights traditional methods can often miss. Automated reports and summaries allow teams to focus on strategy, not data preparation. The outcome is deeper, real-life insights that build trust and guide smarter decisions.

In this context, we must consider that while AI-driven RWE tools are powerful, they risk over-representing digitally connected populations. Insights may skew towards smartwatch users or urban health optimizers, for example, potentially leaving out groups that could benefit most.

Keeping Consumers Safe

Safety remains non-negotiable and AI can help enhance consumer health pharmacovigilance by scanning reports and consumer feedback in real time, spotting safety signals earlier and across broader data sources.

Important elements of post-market monitoring – such as processing call handling and management processes - can also be improved by using AI. These include real-time transcription and translation of calls, sentiment analysis to monitor quality, and call triage to route inquiries efficiently. Additionally, AI supports Agents by surfacing relevant content, detecting adverse events and product quality complaints, and automating case creation by extracting key data from transcripts. These AI-driven features streamline communication workflows, improve customer experience, and ensure regulatory and operational efficiency. Moreover, AI-powered chatbots and virtual assistants are supporting both HCPs and internal teams with 24/7 access to information.

In an age of instant information, proactive safety monitoring builds consumer confidence and regulatory trust. And while AI can flag early signals, it cannot be held liable for decisions. Ultimately, human experts must validate outputs and take accountability for safety, efficacy, and compliance.

Crafting Scientific Stories That Resonate

In science, how you communicate can matter as much as what you discover. AI helps teams turn complex data into clear, compelling narratives.

It supports manuscript and abstract development, aligns messaging with regulatory standards, and improves credibility with healthcare professionals. It can also contextualise new findings against the existing literature-saving time and strengthening the scientific story.

Embedding AI across the value chain—from drug discovery and clinical trials to regulatory processes and commercial operations is evolving rapidly from a promising tool to a strategic pillar.

What’s Next?

AI’s potential is seemingly limitless. We are already seeing frontline employees in consumer health companies adopting AI in their daily work – whether drafting summaries, analysing studies, or automating repetitive tasks. Yet most organisations trail behind in formal adoption.

Why? Because companies hesitate to define clear AI strategies. Concerns around data privacy, compliance, loss or exposure of their intellectual property (IP), and technical capability often create inertia. As a result, innovation thrives at the edges but rarely scales. Companies will need to adopt strong data governance - and perhaps even explore models where consumers are compensated for sharing personal health data.

At the same time, AI is evolving rapidly. In healthcare and life sciences, foundational principles -scientific rigor, regulatory compliance, and trust - remain essential. But the emergence of agentic AI marks a step change. life

Unlike traditional AI that just automates a single command, an AI agent can proactively plan, make decisions, and take a series of actions to achieve a complex goal. These AI agents are no longer just automating tasks – they are transforming the fundamentals of operations across the life sciences value chain.

From autonomously generating product formulation proposals to drafting market-specific filings in regulatory affairs, agentic AI is orchestrating decisions, predicting outcomes, and accelerating value across disciplines. In commercialisation, it can optimise launch sequences, tailor engagement strategies, optimize sales strategies and monitoring, to individual consumer journeys.

What’s changing is not just the pace of innovation - it’s the very architecture of how we work. Traditional workflows built on human-led, siloed functions are giving way to blended models of expert-human and agent collaboration. Technology infrastructure must be rebuilt to support this dynamic landscape. Meanwhile, economic models will evolve toward outcomes and consumption-based structures, better aligned with the scale and impact of AI.
Inês Rocha, Associate Director, Global Consumer Health R&D & RWE Services.

But the core still holds. Evidence standards, ethics, and transparency remain non-negotiable. AI can augment and accelerate, but human oversight is critical to ensure safety, trust, and accountability.

Beyond business and ethics, environmental impact matters too. Training advanced AI models is energy-intensive - raising questions about the carbon footprint per formulation or regulatory filing accelerated.

While AI is a powerful enabler, it does also come with limitations and risks, especially when it comes to data quality. AI systems are only as good as the data they are trained on. Hence, having healthcare-grade AI is key.

How Should the Industry Respond?

To thrive in an AI-powered world, consumer health companies need to act now:

  • Start small but smart. Pilot AI in areas like literature reviews or formulation to build internal confidence.
  • Invest in data quality. AI is only as good as the data behind it.
  • Upskill teams. The future will favour scientists, marketers, and regulatory experts who can partner with AI. Smaller, cross-functional expert teams may replace large functional silos.
  • Integrate AI into workflows. Make it part of daily decisions, not a side project.
  • Collaborate wisely. External AI partners bring speed, scale, and expertise.

As powerful as AI is, relying on validated approaches is essential. AI-generated insights must be accurate and explainable. Limiting hallucinations and maintaining transparency is key to building stakeholder trust.

Change management will be the make-or-break factor. Companies must embed change leadership into their transformation strategies-establishing AI centers of excellence, redefining KPIs, rearchitecting roles, and driving enterprise-wide learning. Agility is no longer optional. Feedback loops, modular adoption, and flexible governance must be built into the fabric of the organisation.

AI is not about replacing human expertise. It is about expanding what’s possible. For consumer health companies, the question is no longer whether to adopt AI - but how fast they can harness it to lead in a rapidly evolving market.

Human oversight remains non-negotiable. Aligning with global standards - like the WHO’s 2024 AI ethics guidelines - can help ensure your strategy meets evolving expectations around transparency, access, and fairness. Aligning proactively with global standards like WHO’s can position companies ahead of regulatory curves and strengthen consumer trust.

References

  1. https://commission.europa.eu/news-and-media/news/ai-act-enters-force-2024-08-01_en
  2. https://www.mindfoundry.ai/blog/ai-regulations-around-the-world
  3. https://www.who.int/publications/i/item/9789240084759

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