Future glances: More change, more tech, more harmonisation

According to Deloitte’s 2026 Life Sciences Outlook Survey, the life sciences sector might be becoming increasingly borderless, but only 41% of responding biopharma and medtech executives felt optimistic about the health of the global economy. Future harmonisation will potentially come, and with it both global momentum and local resilience – but this, respondents thought, will require investments to be made, at a time of considerable regulatory and economic change, and further, more secure implementation of AI and emerging technologies put in place.

As we head towards the close of 2025, pharmaphorum spoke with experts from Ledger Run, Medable, and Veristat about their thoughts on this year and also their predictions for what’s to come in 2026. From site-centricity to AI and notably agentic AI, as well as regulatory changes catching up and ameliorating access in the ever-more-complex rare disease treatment landscape – 2026 looks set to pose further challenges, certainly, but also open up broad possibilities, including financial growth.

Jenna Lucchesi, executive director of contracts at Ledger Run

Next year, site-centricity – not technology or more staff – will drive faster study start-up.

WCG's 2025 Site Challenges report highlights that Clinical Trial Complexity, Study Start-Up (especially contracts, budgets, and coverage analysis), and Site Staffing/Recruitment are the top hurdles, alongside issues with technology. Sites are struggling with administrative overload and longer timelines, and demanding streamlined processes, better tech (like AI) and for sponsors to meet them where they are, rather than forcing them into sponsors workflows. And while this has been true for years, the competition for sites has reached an all-time high, with fewer clinicians entering the workforce and experienced investigators refusing to manage new trials due to the administrative hassles.

Sponsors have no choice but to recognise that the fastest path to study activation is built on collaboration, transparency, predictability, and fewer administrative hurdles for sites.

The industry is shifting toward study start-up models that prioritise site experience as much as speed. At Ledger Run, we see this crystalising specifically in contract and budget negotiations with increased commitment to cleaner contracts, upfront budget clarity, and better support systems that genuinely reduce effort, rather than add it. Sites want partnership, and collaboration built on transparency, predictability, and shared goals.

Operationally, meaningful efficiency gains are finally within reach. AI-enabled contract review, template harmonisation, and real-world cost benchmarking will reduce contract and budget cycle times in 2026, especially in global trials where variability has historically slowed negotiations.

Andrew Mackinnon, executive general manager at Medable

In 2026, we’ll look back on this moment as the tipping point where the industry finally admitted that the clinical-trial engine was broken and decided to rebuild it with real technology. Cycle times kept climbing, white space kept expanding, and studies were drowning under the weight of manual work and fragmented systems as trials ballooned to millions of data points and became impossible to manage with human effort alone.

The breaking point now converges with the rise of agentic AI – systems that don’t just answer questions, but act, orchestrate workflows, monitor data across every platform, and learn how to better manage trials over time. As these agents shoulder the administrative burden, eliminate months of dead air, and surface real-time next steps, we will finally get to focus on strategic, value-generation plus site- and patient-focused activities instead of chasing paperwork. And as AI-driven drug discovery accelerates upstream, these agents will prove to be the only way the downstream clinical trial funnel keeps pace.

In 2026, agentic AI becomes the partner that unlocks the first truly modern clinical-development lifecycle – and the only realistic path to bringing the next wave of therapies to patients at the speed science now makes possible.

Veristat

For Patrick Flanagan, CEO of Veristat, optimism will drive new financial growth.“The coming year will mark a new era of selective optimism, where biotech companies will raise, partner, and transact on a more secure footing than at any time since the pandemic,” said Flanagan.

“There will also be a selective, but not insignificant, IPO and tactical revival of the industry,” he continued. “After several cycles of limited capital, companies that were able to weather the storm emerged stronger, with more robust pipelines and targeted business models, leaving leadership teams more confident and ambitious. With valuations reset and crossover capital back, the IPO window will swing, especially for biotechs that can back science with execution and clear value.”

“On the other hand, with several large drugs nearing the end of their patents, big pharma is under pressure to prepare to satisfy future pipeline needs,” Flanagan noted. “Near patent expirations will compel big pharma to pursue an active and selective level of M&A, having to look for late-stage, de-risked assets and platforms displaying evident potential.”

Meanwhile, for Kim Boericke, chief operating officer at Veristat, AI will reshape research biometrics in subtle, but powerful ways.

“This will enhance data integrity and streamline analysis without being the star of the show,” said Boericke. “In the coming year, clinical development teams will increasingly rely on AI to modernise the most labour-intensive parts of data management and statistical work. Transformation will unfold behind the curtain, where AI boosts the precision, efficiency, and depth of trial insights.”

“Importantly, AI won’t replace the seasoned expertise required in clinical research,” noted Boericke. “It will strengthen it by giving biometrics and data teams clearer, faster, and more trustworthy information to elevate the quality of decisions across the board. The leaders in 2026 will be those who harness AI to refine study design, speed early trial processes, and deliver more dependable data throughout the entire clinical development journey.”

On AI, Cindy Henderson, chief strategy officer at Veristat, believes that, in 2026, the most significant AI advancements in clinical trials will be driven by strong relationships between key stakeholders, rather than more regulations.

“As sponsors and CROs spend the first part of 2026 incorporating specific language about AI into master service and operational agreements, even the most expertly drafted language is not likely to keep up with the fast-paced changes happening with AI,” explained Henderson. "Rather than locking themselves into a rigid set of requirements, clinical teams will migrate towards adaptable policy frameworks built on openness, flexibility, and strong communication that can evolve with the AI’s rapid advances.”

And, for Daphne Smyth, global VP of regulatory at Veristat, the focus is on rare disease programmes.

“In 2026, rare disease programmes will move more rapidly toward approval as the FDA begins fully operationalising new regulatory frameworks,” she said. “Accelerated approval will be bolstered by clearer guidance on acceptable evidence packages, expanded Food and Drug Omnibus Reform Act (FDORA) authority to ensure timely completion of confirmatory trials, and newly proposed review pathways for ultra-rare genetic diseases where substantial evidence may be supported by a single study supplemented with biomarker, target-engagement, or natural-history data."

“At the same time, oncology, cell therapy, and gene therapy will dominate the 2026 approval landscape,” continued Smyth. “The strongest activity will continue to centre on targeted oncology treatments, immuno-oncology agents, antibody-drug conjugates, bispecific antibodies, and cell and gene therapies across neurology, rare disease, and haematology. As the FDA refines and strengthens its accelerated pathways, more of these advanced modalities are expected to cross the finish line, defining 2026 by scientific precision and regulatory momentum.”

About the interviewees

Jenna Lucchesi is executive director of contracts management at Ledger Run where she is responsible for bringing structure, clarity, and forward-thinking strategy to the contracting process while keeping the human element at the forefront. Lucchesi has nearly a decade of experience managing global site contracting and navigating the complexities of country-specific requirements. Prior to Ledger Run, she led site contract teams at PRA Health Sciences, Syneos Health, and KCR.

Andrew Mackinnon is Medable’s global executive general manager. He is responsible for ensuring that customers can successfully run efficient digitally enabled clinical trials. Mackinnon has more than 20 years of experience in managing clinical trials at large pharmaceutical, biotech, and CRO companies, most recently as a senior executive at Covance. From his key role in one of the earliest deployments of decentralised methodologies, Mackinnon has remained passionate about their benefits and looks to leverage his broad operational expertise to improve how this approach is utilised globally.

Patrick Flanagan is chief executive officer of Veristat, where he leads the company’s strategy, operations, and financial performance, including the successful integration of multiple acquisitions. He brings deep experience driving growth and global expansion across healthcare, consulting, and software, with prior leadership roles at Certara, A.T. Kearney, Baxter International, Allegiance Healthcare, and Oracle. He holds a BSc from Penn State University and an MBA from Northwestern University’s Kellogg School of Management.

Kim McLean Boericke is chief operating officer of Veristat, where she leads the company’s operations and financial performance. She brings deep experience in leading organisations and teams delivering global drug development, clinical research, device and diagnostics, and decentralised clinical programmes from early development through market authorisation, product launch, and life cycle management across all therapeutic areas. She has held leadership roles at THREAD Research, ICON, Quintiles (IQVIA), i3 Research, INC Research, ClinTrials, DCRI, and Becton Dickinson, and has a BSc from Duke University.

Cindy Henderson is the chief strategy officer at Veristat, a full-service clinical research organisation specialising in complex and unique trials. With over 30 years of industry experience, including more than 15 at Veristat, she leads company strategy, drives customer-centric growth initiatives, and oversees AI/ML integration to enhance operational efficiency. Her leadership spans commercial strategy, technology infrastructure, and global client engagement. Prior to Veristat, she held senior roles at Averion and Parexel, where she advanced SOP development, data management technologies, and international trial execution.

Daphne Smyth is a recognised regulatory and drug development leader with more than 35 years of experience working at pharmaceutical companies and contract research organisations, including Bayer and ICON. Smyth is a successful leader and mentor of global regulatory teams, with expertise and experience from early development through clinical development and market approval to commercialisation. She currently leads the global regulatory function at Veristat and is based in Ireland.