Inside Pharma and Biotech’s Shifting Landscape and the Direction Leaders Are Giving for 2026 

The year 2025 pushed the pharma and biotech industry to rethink how science moves through drug development. Sponsors faced a challenging mix of regulatory shifts, compressed budgets, ongoing data and trial complexity, and a wave of interest in artificial intelligence (AI) that created both momentum and uncertainty.  

Against this backdrop, one theme that has emerged strongly from MMS leadership insights is a pressing need for clarity to guide decision-making and execution. Sponsors are seeking partners who can help them manage change while staying firmly grounded in science. 

Mohamad Zahreddine, Chief Information Officer at MMS, described 2025 as a year shaped by significant external pressure combined with remarkable opportunity. He noted that shifting priorities, constrained funding, rapid AI adoption, and an extraordinary regulatory environment all contributed to a complex and rapidly evolving dynamic across pharma and biotech. And, based on numerous conversations and industry perspectives, his view captures shared sentiment of sponsors worldwide.  

AI Interest Rose Faster Than Readiness 

One of the clearest industry-wide patterns was the dramatic rise in curiosity around AI. Leaders across pharma expressed a desire to innovate, yet many had limited clarity on how AI should be implemented. 

Zahreddine described the situation as “an overwhelming wave that sometimes added fog instead of insight. Many organizations knew they needed AI but had no clear path for starting or scaling.” 

This was a phenomenon we witnessed across sponsors of all sizes. Teams wanted efficiency, but they also wanted security and governance. They wanted to harness the potential of AI and intelligent automation yet also wanted assurance that these tools would not undermine established workflows or create new risks. True to our Michigan roots, in many ways, it was like adopting a powerful new car—everyone wanted the speed, but only if the brakes, seatbelts, and airbags were guaranteed to work just as reliably. 

This tension defined much of the year, and AI conversations grew louder in medical writing, for instance. As detailed in our recent articles and webinars on AI-enabled medical writing, it’s clear that many organizations have explored a variety of AI use cases, and in many cases (including at MMS) those tools have already delivered measurable gains in speed and quality. However, our webinar polls revealed that the broader journey is still emerging, with only 13% of respondents reporting adoption of AI in medical writing across multiple use cases. The industry overall reflects this pattern: enthusiasm and ambition are high, but many organizations still lack mature workflows, and a strategy for scaling adoption. 

That gap between ambition and operational readiness reflects a deeper challenge for sponsors across the clinical data life cycle, where technology alone does not guarantee speed or certainty. Implementation with the right partner who has the expertise needs to be planned, purposeful, and paired with process, people, and regulatory awareness to translate potential into progress. 

Regulation Created Urgency and Uncertainty 

Across the US and international markets, regulation continued to shift. Sponsors had to make decisions inside environments that changed faster than many had anticipated. 

Dr. Uma Sharma, CEO of MMS, noted that “sponsors wanted thought and execution partners who could help them align scientific, operational, and data-driven strategies in an unpredictable space. From our experience, regulatory flux made that alignment even more pressing.” 

In this environment, alignment across regulatory, statistical and data strategy became a key value driver—helping sponsors avoid delays caused by incomplete data or unclear evidence packages and better positioning them for expedited pathways.  

MMS’s experience across high-impact, complex programs demonstrated how powerful this alignment could be in practice. 

Dr. Sharma added, “We helped clients implement flexible, tech-enabled models that reduced sponsor burden and maintained the necessary regulatory rigor. Our data accomplishments in the public domain with Gates Ventures and Friends of Cancer Research (FOCR) allowed the industry to harmonize data streams to accelerate decision-making and eventually support submissions backed by stronger, real-world insights. This work supports drug development at large beyond individual sponsors and paves the way for science to evolve through knowledge and data sharing.” 

The Market Paused, Then Reset 

The industry also watched as investment behavior shifted early in 2025.  Ben Dudley, Chief Commercial Officer at MMS, described 2025 as “a game of two halves,” with early-year prudence giving way to renewed momentum as confidence returned. Commenting on that initial caution, Dudley noted, “It was natural for many in our industry to pause and assess the landscape. Flexibility became the guiding principle for sponsors in early 2025, whether in research and development strategy, timelines, or decisions around investment.” 

Reflecting on how MMS built solutions to solve clients most pressing challenges, Dudley highlighted several meaningful capability investments: “We added new capabilities in REMS and Datacise® , drove statistical and simulation growth for our global clients through the acquisition of Exploristics and their simulation tool KerusCloud®, strengthened therapeutic expertise in evolving areas like psychedelics and particularly in CNS and oncology, and advanced our overall technology and AI roadmap.” 

In an environment of cautious investment, simulation became more critical than ever for stress-testing development plans and reducing uncertainty around key decisions. Now, by late 2025, the industry has regained clarity, keeping science, safety, and strong evidence at the forefront of industry progress drivers. 

Technology and Data Integration Took Center Stage 

The pharmaceutical and biotech industry made clear progress in its understanding of how technology and data integration can accelerate development in 2025. This was not limited to AI. In fact, smarter data review, better protocol planning, more efficient study design, and cleaner visualization were all key factors. 

According to Michelle Gayari, EVP of Global Operational Excellence & Innovation at MMS, clinical trial sponsors increasingly sought “technology-driven and efficiency-focused solutions to find new ways of operating.”  

MMS has advanced both Datacise® and KerusCloud® to meet those expectations. Datacise® enhances clinical operations through near real-time visualizations that strengthen operational oversight and safety decision-making across studies. KerusCloud® delivers sophisticated clinical trial simulations that help teams de-risk studies at the design stage. And through our partners at TrialAssure®, MMS now supports AI-powered document authoring to accelerate submissions.  

 Reflecting on what worked in 2025, Gayari noted, “The old playbook won’t cut it anymore. Success now demands creativity, agility, and the confidence to build while we move. With the right tech, strong processes, and exceptional talent, we at #OneMMS won’t just meet client expectations—we’ll set the pace for the industry at these times.” 

Chris Schoonmaker, Chief Operating Officer at MMS, added, “In an increasingly data-rich landscape, specialized regulatory and biometrics expertise remains a cornerstone of modern drug development. Sponsors need partners who can adapt quickly, apply technology to accelerate execution, and provide clear analytical insight at every stage of a trial. MMS is purpose-built for this role—not as a transactional service provider, but as a tech-enabled, insight-driven partner that strengthens the path from development to approval.” 

Keep This in Mind for 2026 

As 2026 approaches, leaders across MMS agree on the following:  

1. Build Programs That Can Absorb Change: Change is inevitable across regulation, funding, and macro-economic conditions. Programs perform better when they’re structured to flex, using aligned planning, adaptable technology, and strong partner models that can adjust as requirements evolve.
2. Use AI Thoughtfully and Transparently: Leaders across pharma and biotech want AI that is practical, explainable, and aligned with real clinical needs. Start with a clear use case, educate teams early, and ensure that a human remains firmly in the loop to guide judgment and maintain accountability.
3. Gain Value from CROs as Scientific Partners: Stay focused on he outcomes and think of CROs, like MMS, as strategic extension of your team or ‘thought partners’. These strong collaborations improve clarity, reduce risk, and strengthen decision making.
4. Invest in Evidence That Stands Up to Scrutiny: One familiar truth will always hold weight in the pharmaceutical and biotech industry: strong science and high-quality safety data remain the foundation of progress.
5. Prioritize Efficiency Through Better Design and Better Data: Our industry will remain firmly rooted in an ongoing shift toward technology-driven efficiency and the need for creative approaches to future programs.

The organizations that succeed in 2026 will be the ones that stay adaptable, invest in strong evidence, and build partnerships that keep science moving forward. To connect with an MMS executive, Get in Touch.