Alive in ’25!

Reflections and predictions – our luminaries look across the pharmaverse with conclusions and curiosity

From harnessing next-generation AI to transform clinical, regulatory and safety processes, to rethinking communications strategies from the earliest stages of product conception, life sciences organisations are heeding the call to do things differently – with a view to delivering better results, and boosting efficiency, for patients.

As 2024 gives way to 2025, we assess the progress being made and the emerging challenges and opportunities for the coming year, including a need to ramp up data science capabilities.

Across life sciences, the drive to be more efficient while complying with the latest standards for product quality and safety, is increasing the impetus for process transformation.

Smarter and more strategic use of data; targeted applications of next-generation AI technology; and more fluid, farther-reaching collaboration, are among the goals companies are working towards – supported as much by change management and skills realignment as by modern computing platforms.

Much of this ‘transformation’ remains a work in progress, but this is not to downplay the strides being made, the constructive lessons being learnt, nor the promise of next developments in 2025. Here are how some of the main themes are playing out.

“The way regulatory affairs operates and evolves is imperative now,” comments Preeya Beczek, a regulatory affairs and compliance expert and managing director of consulting firm Beczek.COM.

AI and automation will continue to be important facilitators in 2025, she predicts. “It no longer makes sense for so much of skilled professionals’ time to be taken up by the basic operational tasks –e.g. writing documents from scratch, performing document checks, reconciling duplicate data entries, finding information,” she explains.

She adds: “On top of the potential to automate the generation of first drafts of documents, I see great scope for AI in transforming information searches, sourcing insights from diverse sources.

“Those could include assessment reports from health authorities, for instance, and competitive intelligence/information at a therapeutic area level (to compare product claims, how long Health Authority reviews and approvals have taken, and so on).”

Renato Rjavec, a senior product director at ArisGlobal, which provides advanced technology-based solutions to the life sciences industry, supports this view. “Pharma regulatory teams are at breaking point, such is the scale and intensity of their workload, and this has tipped the balance toward the adoption of AI and ‘generative AI’,” he says – though there are still some signs of hesitancy that now need to be overcome.

He concludes: “A recent regulatory AI survey we conducted with senior RA professionals left no doubt of AI’s perceived potential, but it also revealed some evidence of continued inertia as companies almost wait for their competitors to move first.”

This wait-and-see mentality could be harmful if it persists into the coming year, Rjavec warns. “In the meantime, regulatory teams are despairing and efficiencies are being missed,” he says. “In 2025, a further build-up of pressure will make the situation unsustainable, leading to bolder rollouts of advanced automation for regulatory teams, as any final barriers are shown to be addressed.”

Technology alone can’t deliver the scale of change now needed at a regulatory level, however. Beczek says: “Advanced technology presents an opportunity to do things differently. The roles of medical writers, publishers, regulatory leads, for example, can and must evolve now.

“That’s as technology helps release more of their time for qualitative tasks, from content review and quality control, to data monitoring, and data analysis and stewardship for compliance. Data analytics alone is huge now, demanding not only more time but also new or updated skills,” she notes.

“Next-generation technology also makes it possible to review what is outsourced,” Beczek adds. “This could be a chance to reabsorb publishing, for instance – now that the compilation of dossiers, even hyperlinking and bookmarking, can be automated. Publishing specialists will have more time to review bookmark links, and check for validation errors in pending submissions.

She concludes: “Through these combined efficiencies, regulatory functions may find they can cut the publishing lead time significantly. My advice concerning new technology adoption would be that, as long as the tools are fit for purpose and add value to key business processes, there are considerable benefits to be had by embracing them now. So often, the best way to start learning is by doing.”

For André Cerbe, CEO at Schlafender Hase, which provides proofreading software for regulated industries, 2025 will be the year of ‘end-to-end digital compliance’. “2024 has been the year of AI-driven compliance and data management,” he says. “With increasingly complex regulatory frameworks, companies are adopting AI to streamline oversight and proofing.”

Although progress isn’t uniform (plenty of organisations persist with laborious manual processes), Cerbe has been surprised by the rapid adoption of digital compliance tools.

“Many companies have recognised the need for digital transformation in managing regulated content now, significantly boosting accuracy and efficiency,” he says. “The rise in regulatory tech solutions, and AI investment, in pharma and biotech shows how essential these tools have become for handling vast compliance data.”

He insists: “Companies need cohesive, integrated compliance platforms that handle everything from data management to proofing. Of all the regulated industries, pharma and biotech firms will likely lead the way in 2025, advancing their workflows with holistic solutions.”

For pharma R&D organisations to feel the full benefits of process transformation, they must first extend their expectations beyond immediate functional or company-specific boundaries, according to Tobias Hitziger, a management consultant at MAIN5, which specialises in organisational and digitally enabled change in life sciences.

“In 2025, these companies need to be bolder in their process transformation,” he says. “Up to now, across regulatory affairs, quality and pharmacovigilance/drug safety functions, process rigor has been linked primarily to standard operating procedures (SOPs) – snapshot definitions of processes which do not, of themselves, foster efficiency.”

He elaborates: “Even if they are improved over time, the benefits are typically confined to the immediate context. In 2025, that must change, if companies are to see the hoped-for step changes in productivity and in compliance. Whatever the strategic goals, there needs to be closer alignment between processes, systems and data, to ensure tangible transformation.”

Drug safety and pharmacovigilance (PV) activities have become a huge target for new process efficiency, as health authority demands continue to rise, and as the volumes and diversity of potential data points continue to multiply.

Technology is proving a critical enabler here, enabling not only an increase in speed and throughput, but also a step change in accuracy in identifying, distilling and processing valid insights (true signals).

ArisGlobal, which is pushing the boundaries of what AI technology can do here, has seen soaring interest in targeted solutions for coping with escalating data volumes, for example advanced automation tools for safety case intake.

Says Aman Wasan, the company’s CEO, says: “Life sciences is becoming the industry to watch for its application of GenAI and large language models (LLMs). A 2024 industry survey we commissioned found that more than two-thirds of pharma R&D organisations already use advanced automation, while a similar proportion plan to expand business process automation over the next 18 months.”

Arriello, which provides risk management and compliance solutions and services to pharma, has witnessed the same trend. “If there has been one overriding theme that has dominated in 2024, it has been the use of technology – especially AI – to support process,” says Sam Tomlinson, the company’s vice-president of global drug safety.

“Covid brought an awareness that data volumes will only increase so that technology is the only solution,” she notes.

But when advanced capabilities are underpinning core safety activities, the pressure on the technology’s reliability, transparency and ‘explainability’ is enormous. Wasan at ArisGlobal, notes: “Where patient safety is concerned, there can be no tolerance for ‘black box’ mystery; regulators must be able to assess outcomes for their reliability and consistency.”

In 2025, he says, the emphasis for life sciences-specific AI technology developers will be as much on demonstrating that consistent trustworthiness as on targeted applications geared to industry-specific process pain points.

Safety skill sets will also need to be adapted so that teams can fully harness the benefits of advanced tools. Says Arriello’s Tomlinson, “There is an urgent need for training and education to upskill PV teams to support this new technology-driven approach.”

GenAI has been a particular focus in 2024, because of its scope to transform the way companies filter and process huge quantities of knowledge and content, deriving and summarising new insights from the data it contains.

But the technology’s potential is dependent on the reference sources made available to it. The more specialised and purpose-designed those sources, the more powerful and trustworthy the findings.

In 2025, we are likely to see the emergence of pharma-specific AI reference models (LLMs), which in turn will accelerate the release of tools for next R&D use cases.

The field of drug discovery is a major target for AI, as long as any distilled insights stand up to scrutiny. “2024 was undeniably the year of AI and machine learning in drug discovery,” says Daniel Jamieson, CEO of Biorelate, a company breaking new ground in this space, to help pharma companies to both accelerate drug development and improve success rates.

Biorelate’s platform blends GenAI, LLMs and ‘knowledge graphs’ to track causality as AI helps identify potentially important discoveries from across a wealth of data and literature.

“This supports the delivery of results that are not only innovative but that also align with the scientific community’s standards for accuracy and traceability,” Jamieson notes. “In 2025, we’ll see a concerted effort to rigorously test AI for biases, ensure compliance with ethical standards and foster stronger partnerships with regulatory bodies.”

For Will Gordon, senior VP for safety product management at ArisGlobal, all of this activity reinforces the need for R&D organisations to keep pace with developments, rather than waiting to see what unfolds.

A big part of the challenge, he notes, is that no one really knows what will come next, or how quickly, so closing the gap sooner rather than later makes good sense.

“No one foresaw the impact OpenAI’s ChatGPT would have when it was unleashed in the world two years ago,” Gordon says. “Yet all the signs are that a similar shock is imminent: OpenAI recently announced $6.6 billion in new funding, a figure that would never be justified by incremental product improvements. Whatever is coming is going to be huge.

“Already, it feels impossible for businesses to keep pace with AI’s development, he adds. “But there are ways that companies can capitalise on what’s possible here and now, and be ready for what’s coming next.

“For 2025, recommended approaches include hiring a hire a GenAI transformation team or champion; ‘scattering’ AI-savvy people at every level of the business; and establishing a futureproof, plug-and-play architecture and development approach.”

All process transformation initiatives depend on smarter use of data, but this in turn demands that the quality, scope/range, accuracy and currency of that data is as good as it can be.

Industry standards (such as identification of medicinal products), designed to harmonise data and maximise its reliable reusability, are part of that solution. So too is robust data governance, the ability to draw from a broad range of reputable data sources and the skills to interpret or validate what the data is saying.

“As life sciences companies move towards a data-centric approach, demand for partnerships to increase their available data sources should grow significantly, especially for drug discovery and personalised medicine,” notes Michiel Stam, a management consultant and senior regulatory expert at MAIN5.

He adds: “In the near future we can expect to see companies form new partnerships to build comprehensive, secure and compliant data ecosystems that integrate real-world data, clinical trial data and patient-reported outcomes. But to be successful, they will need to establish robust data governance and interoperability at all levels – legal, technical, semantic and organisational.”

In 2025, teams across the pharma product life cycle will also need to hone their data science capabilities, and not just in a laboratory environment or in a safety context. In a world of increasing disinformation and distrust, pharma companies need to think laterally about the data they collect, and be more discerning in the way they use it.  That’s if they want to strengthen the credibility of their messaging as they start preparing and educating the market, and building product demand.

“Data science is going to rise sharply up the agenda in 2025; it has to,” says Dr Jessica Steier, CEO of Unbiased Science, a specialist in evidence-based science communication. “Data scientists ideally need to be involved from initial product conception, so that the real-world impact of a new product is considered right from the beginning.”

She adds: “That means thinking about the data, the information that needs to be collected – and the logistics of doing that – to paint a picture of safety, of efficacy. The alternative is to put out a product that is less than ideal, or without the proper data to communicate its value.”

A further theme for 2025 concerns communications strategies in their own right – beginning with the need to transcend organisational silos, for example between clinical, commercialisation, marketing and medical affairs functions.

Michelle Bridenbaker, Unbiased Science’s COO, reflects: “This is so that the company’s messaging and interactions with healthcare professionals and patients become more consistent and joined up (e.g. in terms of presentation of the latest disease state information, or treatment guidance) – whether at a clinical trials’ stage or preceding/during real-world treatment; and individuals’ engagement tracked across the product life cycle.”

William Hind, founder of Alpharmaxim, believes behavioural science will have an increasingly important role in shaping market communications, as pharma propositions become more sophisticated and need to be positioned differently for clinicians, patients and their families.

Alpharmaxim helps cross-functional teams communicate effectively about new medicines or alternative treatment regimens, and their potential to improve the patient experience, supported by relevant scientific evidence.

Hind predicts that the urgency around this will intensify in 2025, not least as a result of the US Inflation Reduction Act, which is compounding existing pressures on cost containment, forcing ambitious companies to adapt the way they frame and measure success.

“There are fantastic developments in science, such as the gene therapies for beta thalassaemia and other rare and complex diseases, yet few of the appropriate patients get them,” he explains.

Given the relative cost of each treatment, and the comparatively small target populations, companies need to frame the benefits differently – for instance, in relation to the long-term payback (of a single, effective treatment), and the bearing on a patient’s quality of life.

He concludes with a sage prophecy which we could all do well to remember: ‘Communications developed with a behavioural science focus are more likely to achieve their goals, moving companies away from the old maxim of “half of my communications budget is wasted, I just don’t know which half!’

Sue Tabbitt is a technology and business journalist, and senior writer at Sarum Life Sciences. Go to sarumlifesciences.com