Did 2025 deliver? Pharma industry observers reflect on tech-enabled progress over the last year

Digital transformation experts had high hopes for this year. Did these forecasts bear out, or have AI and a volatile economy proved a distraction? Sue Tabbitt, senior writer at Sarum Life Sciences, looks back.

Few would argue that 2025 has been a challenging year in life sciences, as global economic volatility and the sharp rise in AI use have disrupted strategic agendas.

“2025 has been a year where both geopolitics and the promise of AI have influenced the dynamics in this industry,” says Frits Stulp, partner for life sciences at Implement Consulting.

“On the one hand, there has been an increase in reorganisations and layoffs. On the other, the current pressures are driving process improvements in the development and approval of new medicines.”

Remco Munnik, owner and founder of Arcana Consultancy, believes the prevailing market conditions have highlighted the potential of advanced technologies.

“The power of AI is undeniable,” he says, noting the potential to change the way regulatory teams work.

“What once required custom-built data mining tools (e.g. robotic extraction of SmPC and Module 3 sections) is now standard functionality in modern AI platforms.

This shift from bespoke tooling to scalable intelligence is a game changer for regulatory operations.”

That the regulators themselves are keen to accelerate processes adds to the momentum, Munnik notes.

This has become palpable in Europe with purposeful strides towards using structured data to manage review and approvals processes, ahead of expectations.

“EMA’s agile delivery has accelerated dramatically in 2025, with real progress in connecting systems based on the ISO IDMP standards,” he says.

“It’s not perfect – but it’s a clear signal.

“Meaningful global alignment is evident beyond the EU, too, as evidenced by WHO-UMC advancing the rollout of Global Substance Identifiers and Pharmaceutical Product Identifiers.”

Although momentum is building, there have also been missed opportunities in 2025, Munnik says.

The planned rollout of eCTD 4.0 in the EU could have had a stronger emphasis on leveraging structured data and principles encouraged by IDMP/SPOR standards – unlocking true interoperability across regulatory systems.

“The technology is ready; what’s missing is coordinated implementation,” he comments.

Megha Sinha, managing partner and CEO at Kamet Consulting Group, points to the missed opportunity to make machine-interpretable submissions a reality, despite a tangible shift by regulators to file formats more suited to automation.

“Many organisations are still wrestling with fragmented data, due to PDFs/scanned documents and inconsistent metadata,” she notes.

“Until regulatory data is structured, linking operations, supply chain, regulatory strategy and technology remain cumbersome.”

For the global programmes Kamet Consulting oversees – involving legal-entity changes, site transfers, SKU migration – this is hampering speed, Sinha says.

Gens & Associates tracks the advancement of life sciences’ product data management via periodic global surveys.

Where leading companies have put the data work in to enrich their regulatory data, founder Steve Gens is observing a shift towards dossier module automation as the next target for process improvement.

Here, companies are looking beyond individual document generation to multipurpose automation across investigational, new marketing, variation and other use cases.

“The focus this year has been on clinical, safety and CMC document generation, along with health authority query ingestion automation,” he says.

Combining document generation, document quality control and translation automation constitutes the next level of regulatory information management transformation, Gens says – with an implementation tipping point expected in 2026/2027.

That’s once companies understand and address any remaining gaps in quality, structuring and governance.

“Where companies have struggled to produce ‘immediate’ AI benefits, they have found that having a clear data strategy with strong data governance practices cross-functionally is paramount to maximising AI potential.

“This is good news, long term,” he says.

Beena Wood, a drug safety specialist and chief product officer at Qinecsa Solutions, agrees that 2025 has seen a reality check about groundwork that can no longer be skimped on – and that this extends to the domain of pharmacovigilance too.

“We’ve seen a realisation that you can’t fix problems you won’t acknowledge.

“The impressive organisations have stopped chasing shiny AI pilots and started investing in boring foundations: data quality; standardisation and governance,” she says.

“They’re not deploying fancy agentic systems yet – but they’re positioned to succeed when they do.”

Technology-wise, agentic AI has dominated many event agendas in 2025.

This latest iteration of AI involves the autonomous coordination of goal-driven AI agents (specialist AI tools).

Each applies its own intelligence, experience and reasoning to fulfil its assigned role optimally, coordinated and governed by an orchestrator layer – often highlighting untapped potential in the process.

Already, Kamet Consulting has started to see life sciences start-ups apply an agentic orchestration model to solve specific, high-value problems.

“Some are now connecting all development tools into a unified system or database that allows teams to control, modify and track documents from a single console,” says Sinha.

Kamet foresees opportunities to link regulatory requirements with supply chain, operations, quality, legal and commercial functions – with a positive impact on wider life cycle management, as well as the execution of mergers and acquisitions.

Through their early deployments of AI, companies have learnt a lot about what’s possible – and appropriate.

This is allowing them to be bolder and more intentional in their application of the technology, in whatever form they are ready to deploy it.

“While GenAI can save time in initial drafting, summarising, data analytics and so on, there is still a significant need for quality assurance and human oversight,” notes André Cerbe, CEO of Schlafender Hase.

“That the technology seems to finally fit into validated pharma environments is exciting, because it moves the conversation from ‘Can we use AI?’ to ‘How do we best use it safely and effectively?’,” he says.

Qinecsa’s Wood believes that in the drug safety space, a good balance has now been struck between preparing for the next level of process automation potential and getting carried away by the hype.

“It’s still early days for true agentic AI in production pharmacovigilance,” she says.
“What has impressed me this year has been the industry maturing beyond inflated expectations to an understanding that data quality is a prerequisite, not parallel work; that trust requires transparency built from day one; and that, although teams are ready for AI, enterprise systems aren’t there yet.”

Out on the patient frontline, meanwhile, there are more serious challenges.

For every success that pharma companies have in bringing important products to market more efficiently, and tracking and improving their safety, external forces are influencing public expectations and sentiment – presenting new challenges to the industry and its regulators.

Jessica Steier, a doctor of public health and CEO of Unbiased Science, laments the oversimplification in the US of complex medical topics into binary ‘good versus bad’ categories under the current political administration.

The trend became more pronounced during 2025, she says.

Take “the continued scapegoating of medical interventions as causes of autism: first vaccines, now acetaminophen,” she notes, voicing her concern about the impact on parents trying to act in the best interests of their young children.

The scientific and medical community is fighting back, however.

Steier cites the formation of the Governors Public Health Alliance in October, for instance.

This saw 15 US state governors form a non-partisan coalition committed to science-based public health guidance.

Then there’s the Vaccine Integrity Project, launched in April by the Center for Infectious Disease Research and Policies (CIDRAP) – “a powerful example of academic institutions stepping in to provide evidence-based vaccine recommendations when traditional channels falter,” Steier says.

For the pharma industry, the need for clear, targeted and optimised communications to counter mis- and disinformation has never been greater.

As 2025 gives way to 2026, what lessons can companies take forward?

For Implement’s Stulp, the potential now is to rethink the substance of the work being done, and the outcomes of any transformation – e.g. for patients.

To that end, his firm is tracking developments such as those around cloud-based “Trusted Regulatory Spaces”, designed to accelerate global drug approvals by fostering more dynamic and streamlined collaboration between pharma companies and regulators, as advocated through Project PRISM – an initiative born out of (but not exclusive to) the FDA.

Says Stulp, “The scope here to accelerate process and system improvements is considerable, and goes hand-in-hand with the promises of process optimisation through AI.”

Niche applications of AI will continue to build interest and spark new ideas, meanwhile.

One area being transformed is local literature monitoring – a critical activity within overall global pharmacovigilance, given that new safety signals often present via local reports before reaching higher-profile international medical journals.

Improved data structuring and advanced “crawling” techniques are already transforming automated browsing, “scraping” and indexing of content from target websites and publications, notes Nicole Baker, CEO and co-founder of Biologit.

“AI then adds a layer on top of that, making it possible to search all of that content and very quickly and identify safety events, in one fell swoop.”

The main takeaway this year though is perhaps the recognition that, ultimately, culture and strategy matter more than technology sophistication.

Qinecsa’s Wood notes one of her biggest disappointments in 2025 has been insufficient investment in people and digital mindset transformation – something that applies across most industries.

“Billions have been poured into AI technology yet companies have underfunded the human capability development required to make it work,” she says.
“That now needs to change.”