How will preclinical discovery and clinical trials change in the coming year? And what role will regulators play? Diana Turner asks industry leaders for their predictions for 2026.

A number of innovations are predicted to influence R&D in 2026, in both preclinical and clinical trials, including structural biology, real-world evidence and hybrid study formats.

Dietrich Stephan, Executive Chair of Enhanced Genomics, sees functional genomics presenting the industry with new therapeutic opportunities: “Key advances in functional genomics are now providing us with powerful tools to finally unlock decades worth of genomics data and illuminate new causal biology. This progress is opening up greenfield opportunities for the development of new truly disease-modifying therapies for common and devastating diseases, and we anticipate great progress in this area over the coming years.”

Whereas Miao Li, Market Development Manager, Pioneer Antibody Discovery Platform, Life Science Group at Bio-Rad Laboratories, emphasises structural biology, epitope mapping and phage display technology: “Recent advances in structural biology and high-resolution epitope mapping are revealing cryptic binding sites on established targets involved in cancer development, such as HER2, PD-1, and TNF-α. Looking ahead to 2026, the integration of a custom antibody phage display platform with nanomembrane technologies using reconstituted membrane proteins has the potential to streamline antibody discovery and characterisation. This approach enables rapid, specific in vitro antibody selection early in the discovery process.”

Dr Michael Chen, Co-Founder and CEO, Nuclera thinks that “cell free protein synthesis (CFPS) will become a staple of the protein scientist’s toolbox in 2026 and beyond for recombinant membrane protein production.”

“CFPS has rapidly matured for proteins that challenge traditional expression systems. Bernhard and colleagues at Goethe University Frankfurt have reported high resolution cryo EM structures of the full length human β1 adrenergic receptor and the human histamine H2 receptor. Liu and colleagues at the State Key Laboratory produced a functional human potassium channel, KV1.5. In partnership with the Diamond Light Source, we generated cryo EM structures of the ABC transporter MsbA in only five days using CFPS. Adoption of CFPS for membrane protein production will accelerate, enabling more structures and more drug discovery programs built on cell free derived proteins. CFPS will also advance antibody and antibody fragment screening through simple automation and a rapid 24 hour readout. Watch this space,” Dr Chen says.

Turning to the clinical stages, in 2026, the industry sees clinical trial methodology increasingly adopting multi-dimensional assessments that are more patient centred. “By integrating efficacy, safety, and quality-of-life outcomes within a unified analytical framework, these methods move beyond single endpoints to reflect the true balance of benefits and risks as perceived by patients,” says Sebastien Coppe, CEO at One2Treat. “Approaches such as generalised pairwise comparisons enable quantitative evaluation of these trade-offs, providing a more comprehensive view of treatment value. This evolution will foster trial designs and decision-making processes that are both scientifically rigorous and genuinely patient-centred.”

Many leaders expect real-world evidence (RWE) to play a greater role, including Billy Amzal, Head of Strategic Consulting at Phastar, who says: “Drug development will integrate earlier and better RWE and use AI and advanced modelling to process multi-modal data and pave the way for precision medicine. When transitioning from early to late-stage trials we need to broaden the probability of technical success concept to capture more value-based metrics such as differentiation, relative effectiveness, and societal unmet needs.”

Chip Parkinson, CEO of Gifthealth, agrees that RWE data will become a key driver for R&D prioritisation, adding: “As the market moves towards integrated direct-to-patient models we are increasingly unlocking new insights to inform development. By bridging the gap between scientific breakthrough and real-world outcomes, this patient access data will allow R&D teams to make better, more informed decisions from the lab to the patients’ home in 2026.”

“In 2026, clinical trials will show meaningful improvement toward more efficient, patient-centric models,” argues Meri Beckwith, Co-CEO of Lindus Health. “We will see hybrid study designs become standard, combining site-based visits with remote follow-up. Better use of RWE streamlined recruitment engines, and AI-driven monitoring will begin to reduce delays and cost overruns.”

Craig Rhodes, Head of Partnerships at Qureight, sees pharma beginning to leave caution behind in the adoption of AI for clinical trials: “AI-powered approaches such as our models for lung and heart diseases are being adopted more broadly to support clinical trials, for example. When we can show a return on investment from novel AI-based solutions, calculated based on positive changes to a trial, we will inevitably start to see a shift in practices across the board.”

Others predict that 2026 will be the year that digital twins finally hit the mainstream. “Throughout 2025, sponsors have increasingly explored how digital twin technology can optimise protocol and trial design, reduce costly amendments, and accelerate timelines. Yet uncertainty around regulation for digital trial arms has slowed broader adoption,” says Dr Gen Li, Founder and President of Phesi. “That’s now changing. Regulators including the FDA are expanding their AI frameworks, finalising risk-based guidance and credibility assessments to ensure tools are safe and effective in clinical development. This will create new opportunities to integrate digital twins into trial design and execution.

“Continued collaboration and feedback loops between regulators, sponsors and technology partners will be essential to ensure digital twins deliver on what matters most: faster, more patient-centric and more equitable clinical trials.”

Regulation and the rise of NAMs

Changes at the US Food and Drug Administration (FDA) over the last year will continue to influence global regulation. Dr Eric Hardter, Director of Regulatory Affairs at Boyds, points to the influence of changes in FDA leadership: “Since his appointment as FDA Commissioner, Dr Marty Makary has unveiled multiple initiatives aimed to get new drugs to market more quickly. While laudable, these nascent programmes represented forward-thinking blueprints as opposed to immediately actionable plans.”

Many industry figures predict the use of NAMs will have a significant impact in 2026, fuelled by moves from regulators to phase out reliance on animal testing. “This definitive shift has positioned technologies such as organ-on-a-chip (OOC) centre-stage in the drug discovery and development sector, says Dr Paul Brooks, CEO of CN Bio.

He adds: “This shift in adoption comes at a critical time for the industry. Biotech companies, particularly those with early-stage assets, are under increasing pressure to generate data that proves the viability of their candidates and attracts investment.”

Steven Bulera, Corporate Vice President, Chief Scientific Officer: Safety Assessment, at Charles River Laboratories, expects this increased use of NAMs to make drugs safer due to the use of models that are more relevant to humans: “Instead of writing off drug candidates based solely on animal tox data, companies will continue to use NAMs as an investigational tool to generate safety signals that prove or disprove human relevance breathing new life into compounds previously shelved as ‘too risky.'”

Expect new regulatory scrutiny and a wave of thoughtfully reconsidered assets re-entering the pipeline. One area likely to benefit from evolving regulatory frameworks is cell and gene therapies. “The agency’s adoption of flexible trial designs, acceptance of real-world evidence, incorporation of Institutional Review Board (IRB) approvals for small populations, and platform-based approvals are accelerating pathways to market,” explains Michelle Fraser, Head of Cell and Gene Therapy at Revvity. “However, realising the full promise of these therapies hinges on developing sustainable, accessible pricing models, lest these groundbreaking treatments remain out of reach for many.”

Hardter concludes: “As science evolves, regulatory approaches must evolve, too. That the FDA acknowledges a wide swath of current unmet needs, and are acting accordingly, is a step in the right direction.”

Regulators are also getting up to speed with the greater role for AI in drug discovery, with new AI guidelines and procedures coming into force. Anita Modi, Co-founder and CEO on Peer AI, sees this shift having a particular influence on how companies work in 2026: “Last year, teams ran pilots and ROI tests. Next year, they will embed AI across regulatory, medical-writing, and data-management workflows. The urgency comes from both directions. Regulators are proving they can use AI responsibly, and boards are demanding measurable efficiency gains. The focus will shift from persuasion to execution: setting governance, unifying workflows, and choosing partners that can move at enterprise speed. Success will depend less on model novelty than on clarity, provenance, and disciplined human oversight.”

Dr Deborah O’Neil OBE FRSE, Chair, ONE Life Sciences and BioAberdeen says that “2026 will signal a shift towards place-based research and development.”

“Rather than concentrating activity in a small number of global hubs, organisations are beginning to recognise the advantages of regions that combine deep scientific skills, modern laboratory capacity, and coordinated support structures. In this environment, early-stage ideas can move more rapidly through proof-of-concept and into commercially viable programmes. North east Scotland’s growing cluster of university spinouts and innovative SMEs underscores this trend. Here, proximity translates into faster access to shared expertise, smoother collaboration between discovery scientists and clinicians, and a culture that supports iterative, real-time problem solving. Innovation launchpads are strengthening this dynamic further, providing companies with integrated support including mentoring, access to regulatory and commercial expertise, and founder-to-founder learning,” Dr O’Neil added.

Read more expert predictions on drug discovery in 2026, as well as on the impact of AI on drug discovery in 2026 and what we can expect from CGTs.

About the author:

Diana Turner is Deputy Editor at DDW. She Diana brings over 10 years’ experience in both print and digital editorial roles for B2B publications dedicated to the life sciences sector, including medical and pharmaceutical industry journals/magazines.