Insight

How AI is reshaping drug development in Pharma: 3 high-value use cases

Published September 16, 2026

  • Life Sciences
  • Data & AI

Bringing a new drug to market takes on average 10 to 15 years and over $1 billion in investment, with no guarantee of approval since fewer than 1 in 10 drugs entering Phase 1 ever reach regulatory approval. Drug development is one of the most complex, costly, and regulated processes in any industry, where a single inefficiency anywhere along the pipeline can compound into significant financial and timeline impact and delay a life-changing treatment by months or years.

Yet across Wavestone’s pharmaceutical client engagements, we consistently find the same structural challenges, whether in literature search, safety modeling, or regulatory reporting. The 3 use cases below are drawn from actual Wavestone projects, with figures based on detailed business cases we built and client leadership approved.

Taken together, they are expected to impact over 10,000 end users, with a combined annual value that can reach several hundred million dollars at a large organization. We chose to feature three use cases with different scales: two are enterprise-wide, and one covers a single department, with a smaller value but the lowest build cost. The figures below show annual value at maturity, once the capabilities are live and used across the organization. Investment keeps growing through the proof of concept (POC), minimum viable product (MVP), and scale-up, as the platforms expand and adoption increases.

Key takeaways:

  • AI can accelerate drug development by reducing manual work across research, safety, and regulatory processes.
  • High-value use cases deliver measurable impact, including faster decision-making and improved regulatory outcomes.
  • Trusted data, traceable AI outputs, and strong governance are essential for adoption in regulated environments.
  • The greatest returns come from scaling reusable AI capabilities across multiple business functions.

Use case #1:
Scientific literature analytics

Context: Published literature is the most credible and trusted source of scientific knowledge in pharma, an industry where evidence quality directly shapes drug development decisions.

Persona: A broad scope of scientists performing literature search across drug development, from drug discovery to post-market surveillance.

Challenge: Scientists spend significant time manually querying internal and external databases using keyword-based searches, then analyzing and synthesizing results one by one across literature and non-literature databases.

 

Solution: An AI conversational search with semantic capabilities, letting scientists retrieve relevant information based on the meaning of their query rather than exact keywords. It draws on critical external sources such as PubMed, FDA and EMA regulatory databases, and patent databases, as well as internal documents including clinical trial files and proprietary reports. Built internally to better enforce data governance rules, the platform produces comprehensive summaries with reliable sources so users can dig deeper into any finding as needed. To meet the pharmacovigilance team’s GxP compliance requirement, outputs were designed to be fully traceable and explainable, with a clear audit trail of queries and precise data sources. The platform also extracts relevant quantitative tables from the identified literature.

Value: $150M+ in annual value, driven primarily by the acceleration of drug time to market.

  1. Shortened critical path activities, through faster and better literature analytics.
  2. Reduction of manual workload from internal teams, by automating repetitive tasks, thus allowing them to focus on activities requiring their domain expertise.
  3. Reduced reliance on external vendors, by automating manual literature search tasks that previously required external support.

With thousands of scientists each spending a meaningful share of their time on manual search, even small time savings compound quickly across the organization.

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Use case #2:
Predictive safety & risk modeling

Context: Drug efficacy has historically been the primary focus in pharma, though increasing regulatory pressure from the FDA and EMA, along with the high cost of late-stage safety failures, has rebalanced priorities. Drug safety now needs to be tackled earlier and more rigorously across the development lifecycle.

Persona: A broad scope of scientists focused on safety across drug development, including Toxicologists, Risk Managers, and Pharmacovigilance Scientists.

Challenge: A stronger safety profile requires both greater volume and earlier insight availability. Today, this is hard to achieve due to fragmented information across teams, inconsistent data quality, and advanced analytics tools that remain not easily accessible to non-technical scientific teams, resulting in a largely reactive approach to safety.

Solution: A knowledge platform acting as a central hub for reliable safety information across the organization. It draws on critical sources including toxicology databases, clinical trial documents, real-world data such as electronic health records and patient registries, and internal repositories. Non-technical scientists can access predictive models built by analytical teams and run scenario analyses and virtual simulations with customizable parameters on drug benefit-risk profiles without requiring technical expertise, enabling a more proactive approach to safety decision-making. It includes a dashboard view pulling together the key components: AI-generated safety insights, predictive analytics, and mechanistic models such as physiologically based pharmacokinetic (PBPK) modeling.

Value: $300M+ in annual value, driven primarily by an increased probability of regulatory success.

  1. Stronger drug safety profile at the point of submission, with safety risks detected and remediated earlier in development.
  2. Acceleration of drug time to market, through faster go/no-go decisions across the process with better data, thereby giving confidence to both internal teams and external regulators to move forward faster.

Avoiding a single late-stage failure can save more than the entire investment in the platform.

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Use case #3:
Automated document authoring

Context: Pharma companies are required to submit a growing number of periodic safety reports to health authorities such as the FDA and EMA. These submissions are high-stakes documents, where inconsistencies or errors can trigger requests for clarification and delay approvals, making the authoring process a critical requirement across clinical development and post-market surveillance.

Persona: A more limited scope than the previous use cases, focused on Periodic Reporting and Pharmacovigilance teams, including Global Safety Officers (GSOs), working specifically on 3 core regulatory documents: the Safety Evaluation Report (SER), the Periodic Benefit-Risk Evaluation Report (PBRER), and the Development Safety Update Report (DSUR).

Challenge: Today, each function writes its contribution to each report independently, starting from a blank page every time. Since the SER and PBRER are developed in parallel, the same information is written and reviewed multiple times across documents. When an update is made in one report, it is not automatically reflected in the other, creating gaps between documents and inconsistencies in the final submissions.

Solution: A centralized self-service hub built on an internal platform already in use elsewhere in the organization, avoiding any net-new build efforts. It uses data extraction, AI summarization, and quality assurance capabilities to generate a strong first draft for each report, based on critical sources including historical regulatory submissions, clinical safety data, Reference Safety Information (RSI) and Benefit-Risk Assessments (BRA). Functions always review and complete that draft to ensure accuracy and comprehensiveness of the output before submission.

Value: $3M+ in annual value, driven by expanded output coverage for internal teams and lower external vendor costs.

  1. Expanded output coverage, by automating repetitive authoring tasks, freeing internal teams to focus on higher-value scientific work and produce additional regulatory tables that are not being generated today for lack of time.
  2. Reduced reliance on external vendors, through internal platform capabilities that absorb a higher volume of tasks previously requiring external support.

Across large pipelines and high document volumes, these savings add up, even within a narrower scope than the first two use cases. Running on an internal platform already in place also keeps the build cost low.

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Conclusion

AI is not reshaping drug development by replacing scientific expertise. It is removing the operational frictions that slow it down. Across literature search, safety modeling, and regulatory reporting, the underlying issue is the same: teams with deep scientific knowledge are spending disproportionate time on manual, fragmented, and repetitive processes that technology can now support. When that time is recovered and redirected, the impact compounds across the entire pipeline.

The 3 use cases above show that this is not a future ambition. It is happening now in large organizations with measurable financial returns.

The companies that benefit most treat AI with the same discipline as drug development: clear goals, strong data foundations, analytical rigor, and validated value before scaling.

David Winkler, AI & Data expert, Wavestone

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