What theme(s) dominated the life sciences landscape in 2024?
Cost containment and risk aversion have been a key theme over the past 12 months. William Hind, founder of Alpharmaxim attributes this to ongoing global conflicts, the economy and in particular the Inflation Reduction Act (IRA) that was passed in the US.
“Across the sector, the result of having price containment enforced in the US has been a metaphorical sharp intake of breath and a knee-jerk reaction to save costs across the whole sector –from reducing clinical trials, to travel, to the level of communications spend,” Hind says. He adds, “The other big theme dominating the sector has been AI – folk need to work out better how to use it and how it can add value to their activities.”
Agnes Cwienczek, director of product management at ArisGlobal, says, “For me, 2024 was the year when the EU regulatory ecosystem finally started to interconnect its various initiatives and data; when the eCTD 4.0 standard began to mature beyond draft specifications; and when global health data interoperability gained the required attention and importance.”
Cwienczek highlights that significant changes to compliance standards – whether related to data or documents – are advancing now, towards a more concrete implementation phase. “This will lead to a steady rise in activity in 2025, intensifying further in 2026/27, with peak adoption in 2028,” she says. “The upshot for companies that have lost momentum around the new standards is that they must restore activity now, and as a matter of some urgency.”
What surprised you in the industry last year?
Jens Marburg, Principal Consultant at MAIN5, comments that many companies have been surprised by the speed at which they need to adopt Pharma 4.0, a movement which promotes digitisation and interconnected systems, and the need for computer software assurance (CSA) and AI-enabled tools. “Validation teams are now required to not only meet compliance standards, but also to embrace new development during project runtimes, making such transitions challenging but essential to deliver leading-edge projects and leverage outcomes and results,” he says.
Strategically, Hind at Alpharmaxim is surprised at the lack apparent urgency to do things differently in the face of the US Inflation Reduction Act. He highlights the implications of this, in the context of new modes of biopharma treatment: “There are fantastic developments in science, such as the gene therapies for beta thalassemia and other rare and complex diseases, yet few of the appropriate patients get them,” he notes. “The complexity of pricing what could be a once-a-lifetime treatment (compared to a chronic treatment) has not been addressed widely, and new models with affordability and warranty of effect need to be more commonplace. This is where pharma’s behaviour needs to change.” It means thinking differently about positioning and messaging, as well as drug economics, for instance.
For Alexander Tryba, Managing Partner at MAIN5, the relatively poor state of training and digitalisation continues to be puzzling in an industry manufacturing products with such a significant impact on human health and lives. “This is particularly striking given that this industry boasts some of the strongest financial resources compared to others,” he says, contrasting life sciences with other industries he has observed closely.
“For instance, in the automotive industry, it is common to see dedicated training academies with full-time trainers and learning teams. Additionally, they often have offline training stations that replicate production line steps in a safe training environment, and operate completely paperless production sites.”
Calling for a more robust and modern approach to training and digitalisation across life sciences, Tryba concedes that there are moves in the right direction: “We have seen clients increasingly adopting Just-in-time Learning (JIL) methodologies and related analytics, which deliver targeted training content when and where it is needed.”
What have you been most encouraged by, in the changes your clients are making to their strategies?
Hind at Alpharmaxim welcomes the scientific breakthroughs that gained prominence in 2024, from curative gene therapies for rare and complex disease, to progress with disease-modifying agents for some of medicine’s last great challenges, including neurodegenerative diseases like Alzheimer’s and Parkinson’s.
He adds: “I am also encouraged by an increasing willingness to look at different ways of funding this (to overcome bankrupt healthcare systems) and to bring in real-world data. Hopefully, these combinations of actions, together with an increased use of behavioural science in communications to ensure the right focus, will see more of these therapies reach the right patients at the right time.”
To accelerate IT-based operational enhancements, meanwhile, Marburg at MAIN5 has observed clients increasingly move away from exhaustive traditional computer validation processes, to more targeted, risk-focused strategies. “This change is significant as it allows for more efficient use of resources, and faster project timelines,” he notes.
What are companies still at risk of getting wrong?
Preeya Beczek, a regulatory affairs and compliance expert and managing director of consulting firm Beczek.COM, believes that while there is a great opportunity for AI and automation to continue to be an important facilitator of regulatory affairs operations in 2025, companies must address AI adoption in a broader context if they are to realise the technology’s full potential.
“Companies continue to strive for speed, efficiency and productivity, and need tools to enable that. But real step changes in performance also need consideration of people and their skills, of processes, and of the overall operating model,” she warns, noting that advanced technology presents an opportunity to do things differently. “The roles of medical writers, publishers, regulatory leads, can and must evolve now,” she explains. “That’s as more of their time is released for qualitative tasks – from content review and quality control, to data monitoring and data analysis and stewardship for compliance. Data analytics alone is a huge area now, demanding not only more time but also new or updated skills.”
If 2025 is to be the year of Y – what is Y?
Marc Chaillou, Head of Sales at Schlafender-Hase believes that 2025 will be the year of data quality. ”I would say, with increased maturity of AI, more people will realise how important clean and standardised data is before any “AI magic” can take place. The exponential benefits of AI solutions will render the huge efforts of data clean-up and standardisation worth it.”
ArisGlobal’s CEO Aman Wasan highlights that a recent ArisGlobal survey found more than two-thirds of biopharma R&D organisations already use advanced automation, while a similar proportion plan to expand business process automation over the next 18 months. Initial target use cases range from safety case intake to significantly streamlined regulatory submissions, and early pilot applications are yielding significant step changes in productivity, output accuracy, and cost-efficiency.
Wasan says: “In 2025, I expect to see more test use cases entering production. But companies shouldn’t wait before taking action. To keep pace with developments, they really need to move purposefully now, consulting industry-specific tech experts and networking with peers, then identifying a main pain point to address with a partner.”
Dr. Jessica Steier, CEO, Unbiased Science, a Vital Statistics Consulting company, believes 2025 will be the year of data science: “Data science is going to rise sharply up the agenda in 2025; it has to. All too often, life sciences organisations involve research data scientists too late in the development process. This impedes their ability to communicate the right messages to the market when the time arises – because they haven’t captured the right insights along the way. I expect and hope to see that start to change now.
“Data scientists need to be involved at the ground level, even from initial product ideation and conception, so that the real-world impact is considered right from the beginning. 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.”
Kate Coleman, VP of regulatory affairs, quality and compliance at Arriello, has identified a focus on planned expansion into the UK, Brazilian and Middle Eastern markets: “We recently surveyed biotech companies’ strategic expansion plans, specifically those of organisations based in the US and those based in Ireland, and found some striking differences in current plans versus those of five years ago.
“Two notable trends emerge. First, the effect of Brexit has elevated rather than reduced the perceived importance of entering or expanding into the UK, so that this at least as important a market as Canada now (where five years ago, Canada was a greater priority). The renewed focus on the UK for expansion makes practical sense, following the market’s separation administratively from the EU. But the finding also reconfirms the UK’s continued strategic importance as a destination market.
“Secondly, two further markets have risen to new prominence. Brazil is now deemed an immediate priority, along with the Middle East (which is also a strong interest for the near future, if not imminently). But complexity around geographic expansion has not eased, whatever local efforts may be in place to simplify processes. This suggests companies will need to apply greater scrutiny and more careful regulatory strategy and commercialisation planning in 2025.”
Michelle Bridenbaker, COO at Unbiased Science, believes 2025 must be the year when communications sharing credible scientific insights become more effective : “In 2024, there has been a big push for AI and particularly Generative AI (GenAI) in a pharma commercialisation/medical Affairs context, where the technology promises to free up teams to be more creative in their communications. This will be important in 2025, as the industry strives to be heard and get across credible, evidence-based scientific insights amid an ocean of public health disinformation.
