Christopher Cole

Novo Nordisk symbol and lettering on a mirrored skyscraper front, an illustrative editorial 3d rendering | Image Credit: Maxim - stock.adobe.com.

The FDA approval of the Wegovy pill (once-daily oral semaglutide 25 mg) on Dec 22, 2025 marks a significant milestone for pharmaceutical manufacturing and development professionals, as it represents the first oral GLP-1 receptor agonist approved for weight management (1). This development underscores several critical shifts in drug formulation, manufacturing strategy, and market demand.

1. Shift in dosage form and manufacturing strategy

For professionals in solid dosage manufacturing, the Wegovy pill represents a massive technical achievement: delivering weight loss results (16.6% mean weight loss) that are similar to the injectable 2.4 mg version (1).

This approval signals a shift for many developers from parenteral and injectable manufacturing to solid/semi-solid dosage forms. This aligns with broader industry trends identified by experts where 

 is increasingly driving solid dosage innovation because oral routes are more convenient than injections.

Manufacturing an oral version of a peptide like semaglutide requires overcoming significant absorption challenges (1). This reinforces the importance of 

 in pharmaceutical formulation and the use of 

The approval necessitates a rapid scale-up for large-scale oral solid dosage production. With a US launch expected in early January 2026 (1), manufacturing facilities must already be optimized for high-volume output.

 for such "blockbuster" treatments often leads to supply chain pressures. Industry trends show that companies are already 

 capacity and advanced packaging facilities to meet rising demand for such treatments.

With submissions pending at the European Medicines Agency (2) and other regulatory bodies, development teams must manage multi-compendial compliance and varying regulatory expectations across different regions (1). The hopeful FDA approval of a higher dose of Wegovy injection adds additional complexity (3).

The development and manufacturing of the Wegovy pill likely benefited from the same "progressive technologies" currently trending in the industry:

• Automation and AI: The industry is moving toward 

" to optimize manufacturing efficiency and process control. Professionals in QC/QA are increasingly using 

advanced analytics and digital transformation

 to boost quality and scalability for complex molecules.

 (Chemistry, Manufacturing, and Controls) process is essential for drugs of this caliber to ensure that quality is not sacrificed for speed to market.

The Wegovy pill's entry into the market is a central event in what industry observers call the "

FDA's recent strategy of utilizing rapid drug review programs

 and integrating AI into agency operations to accelerate the availability of high-impact treatments.

Manufacturing teams should also prepare for potential line extensions, as semaglutide is already being explored or approved for related conditions like MASH (4) and cardiovascular risk reduction (5).

The transition of a major biologic from an injection to a pill is like miniaturizing a complex piece of machinery into a pocket-sized device; it requires the same core functionality but demands entirely different engineering, materials, and production logic to remain effective in a new environment.

Novo Nordisk A/S: Wegovy Pill Approved in the US as First Oral GLP-1 for Weight Management

Novo Nordisk A/S: More Efficacious Dose of Wegovy Recommended by the European Medicines Agency Can Help People with Obesity Achieve an Average of 20.7% Weight Loss

Novo Nordisk Files for FDA Approval of a Higher Dose of Wegovy Injection 7.2 mg

Novo Nordisk A/S: Wegovy Approved in the US for the Treatment of MASH

FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

Articles

The FDA's approval of the Wegovy pill, an oral GLP-1 receptor agonist for weight management, marks a pivotal advancement in pharmaceutical manufacturing. This approval highlights a shift from injectable to oral dosage forms, driven by patient preference for convenience. The development of the oral semaglutide required overcoming significant absorption challenges, emphasizing the importance of advanced formulation techniques. The approval also necessitates rapid scaling of production and supply chain readiness. The integration of AI and automation in manufacturing processes is crucial for maintaining quality and efficiency in this competitive landscape.

How the Wegovy Pill Approval Reshapes Solid Dosage Manufacturing Strategy

Frits Stulp, Implement Consulting, discusses the exciting potential of AI and “trusted regulatory spaces” for drug discovery and delivery.

Harnessing Data and Secure Cloud Environments for Global Pharma Solutions

 recently spoke with Frits Stulp, Partner Life Sciences, Implement Consulting Group, to get his perspective on trends that shaped pharmaceutical development and manufacturing in 2025 and where things are headed in 2026. In this part 1 of our two-part interview, Stulp—who has more than 25 years of experience in the life sciences sector—emphasizes a shift from purely technical information systems to a focus on the human element within organizational processes. Having spent a decade in the industry before moving into consultancy, Stulp now works with the Denmark-based firm to actively internationalizie its approach to organizational change management and process performance. He is particularly passionate about optimizing the relationship between regulators and the life sciences industry through improved data, technology, and closer cooperation.

A central theme of Stulp's insights is the transition from traditional administrative hurdles to "trusted regulatory spaces," particularly the US-based PRISM research collaboration, which utilizes a secure cloud environment where regulators and industry applicants work side-by-side on license applications. Stulp views this as a vital “partnership for patients,” designed to accelerate the delivery of medical products by fostering faster discussions and transparency while maintaining rigorous regulatory oversight. This collaborative model aims to move beyond the perception of industry as being purely profit-driven, highlighting its role in solving global health issues.

Stulp also highlights AI as a transformative force. While he supports using AI to alleviate the industry’s "administrative burden," he notes that this is not the most exciting application, colorfully remarking that "AI will get bored with us" if limited to such tasks. Instead, the true potential of AI lies in discovery. By analyzing massive datasets—including real-world evidence and existing product information—AI can uncover new therapeutic possibilities. Stulp eagerly anticipates the future, asking, "When can we get new medicines based on the power of AI on existing data?" Achieving this requires balancing innovation with a "safe environment" that protects confidentiality.

Ultimately, these advancements suggest a more integrated ecosystem. Trusted regulatory spaces function like a communal digital workshop where the regulator and the inventor refine a product together in real-time, ensuring safety and efficiency are addressed long before the product reaches the patient.



Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Thank you for this opportunity. My name is Frits Stulp. I have been working in life sciences for the past 25 years and a bit. I did work in the industry for 10 years and actually after that I joined consultancy, worked for some big consultancies, had my own consultancy, which I sold at some point.

And over the past year I have been working at a company called Implement Consulting Group, based mostly in Denmark but actively internationalizing: very interesting company. Instead of some of the bigger companies that I've worked for, not so much focused on the information systems landscape, but on the role of the human in the process.

And that means a lot of organizational change management, really looking at process performance and preferably looking at innovation in many of those fields. I have myself been heavily involved over the last 15 years with the relationship between the regulator and the industry and seeing where there are optimizations that we can achieve sometimes through data, sometimes through technology, sometimes just by working better together. And that's what I'm most passionate about and enjoy.

In regulatory affairs over the past decade or so, we've been looking a lot at standardized data. A topic called identification of medicinal products (IDMP) is a topic very close to my heart that I've been heavily involved with, and yes, it's making progress, and yes, we see the first results coming out.

But there's also like a parallel movement going on at the moment, and that has actually been coming from a research collaboration project in the US called PRISM [precision FDA Regulatory Information Service Module]. And it is what is known as trusted regulatory spaces. And in short, it's making a cloud environment in which the regulator and the industry—the applicant for the license—can work much closer together than they've ever done before. It's a secure space. They work together on the same things. They have their discussions faster. And it really is a way to accelerate basically what they're doing as an industry and a regulator to get products to patients. I strongly believe that, a “partnership for patients” is a term I like. You can't just look at the industry as one that's just trying to make money over health issues. No, we're actually trying to solve health issues, and you have to be partners in that by keeping the regulations, keeping us all straight, and at the same time allow and support the innovation that it takes.

Of course, the word AI will come back in some of our conversation. And there is a lot of room for AI in this field, but this trusted regulatory spaces as a concept, I think really is changing the ballgame. A few pilots have taken place, and I'm very curious to see how we can do more in 2026.

Good question. I think I would repeat at least letters AI, like so many people do nowadays. AI is something that I think is extremely intriguing right now. We are in a field—as industry that tries to get products onto the market and keep them on the market—that is very admin heavy because we're a very regulated industry. And that makes it very tempting to apply all sorts of automation, AI-based working on that administrative burden. And I'm totally in favor of that, but it's not the exciting part. Because AI will get bored with us there as well. And actually I think where the real strength is, if you look at all the data that we have on products, both on the market and the ones in development, and you look at the big data, the real-world data that you're getting back from the world, and you start overseeing some of that, I'm expecting a lot of discovery can take place using AI. And that does mean that you have to allow it, and that will be one of the key things that we're looking at. How do you make a safe environment where you do take care of the confidentiality needed, but you still allow for discovery to take place?

So, I think that's where industry is also really looking at to get benefits, not just on the process efficiency side. And that's also what I'm looking forward to. When can we get new medicines based on the power of AI on existing data?

Videos

 Harnessing Data and Secure Cloud Environments for Global Pharma Solutions

connected recently with Megha Sinha, CEO, Kamet Consulting Group to look ahead into what’s in store for the industry in 2026. Sinha explores how the pharmaceutical sector is leveraging intelligent orchestration layers and AI-driven decision engines to navigate complex geopolitical risks and manufacturing inefficiencies. The discussion focuses on utilizing digital twins and unified knowledge layers to integrate regulatory intelligence and supply chain data, thereby accelerating speed-to-market. Additionally, Sinha highlights the necessity of cultivating a digitally fluent workforce capable of supervising these automated systems to manage end-to-end product lifecycles.

PharmTech: How is the sector reimagining supply chains to protect against geopolitical disruptions?

Sinha: By 2026, I expect leading organizations to design supply chains around tariffs and geopolitics as encoded rules, not just risks on a slide. The shift I see is from static network maps to living decision engines: platforms that connect products, SKUs, licenses, sites, tariff exposure, and regulatory requirements in one knowledge layer and then let you simulate, 

“If this lane fails or this tariff goes live, which tech transfers, marketing authorization holder changes, label updates, and tenders are affected, and what’s the fastest viable plan B?” 

Practically, that means regionalized but orchestrated networks: dual or backup sites, local finishing, and pre-baked regulatory pathways, all managed by an orchestration layer that can re-route both physical product and regulatory work when the next disruption hits.

What role do AI and digital technologies play in improving drug discovery and manufacturing efficiency?

AI is starting to look less like a collection of pilots and more like an embedded reasoning layer. In discovery, AI will increasingly sit on top of curated scientific and clinical knowledge, prioritizing what to explore—targets, molecules, indications—rather than “replacing” the science. In manufacturing, the real step-change will come from agentic systems that combine digital twins, process data, and regulatory rules to recommend parameter changes, highlight risks, and propose implementation plans instead of just flagging anomalies. The blockers are familiar: fragmented data, weak knowledge models, and clunky user experience. Until organizations invest in a structured lifecycle knowledge layer and interfaces that feel like a co-pilot—“Here is the proposed plan, here are the assumptions, accept/change/reject”—AI will stay powerful in pockets rather than truly end-to-end.

How can organizations bridge the widening skills gap created by rapid digitalization of pharmaceutical manufacturing?

I think the skills gap is often framed in the wrong way. The goal is not to turn operators, scientists, or regulatory experts into software engineers; it’s to help them understand the cross-functional nature of their own business and work effectively with digital systems. The leading organizations will:

Create T-shaped “orchestrators” and translators, people deep in tech ops, quality assurance, regulatory affairs, or supply who also understand how the business fits together end-to-end and who can work with AI-generated impact assessments, task lists, and critical paths.

Train teams to supervise agents, not configure tools, teaching experts how to interrogate a system-generated lifecycle or supply plan (

“Why did you sequence countries this way? What happens if the US site is delayed 3 months?”

), rather than expecting them to build workflows from scratch.

Embed learning in live programs, using real rebrands, site moves, or portfolio clean-ups as “labs” where people learn how to work with orchestration engines and refine the underlying rules.

The goal isn’t a workforce of software engineers; it’s a workforce fluent enough in their own cross-functional reality to collaborate with intelligent systems that are orchestrating work on their behalf.

Which recent innovations have had the broadest impact on cost, quality, or speed-to-market in manufacturing operations?

The most powerful innovations join plant-level optimization to lifecycle and market decisions. Digital twins and advanced analytics are already improving yield, stability, and cycle times. The next frontier is when those same models plug into a knowledge-driven orchestration layer that understands products, markets, licenses, and change rules. For example, when a process change or site move can automatically trigger a proposed set of filings, label updates, and implementation waves by country, complete with timing options and trade-offs. That’s where I see the broadest impact: when process innovation, regulatory intelligence and execution planning sit on one backbone and AI can propose end-to-end paths from “idea” to “product released in 40 markets,” with humans focusing on judgment calls, not stitching spreadsheets together.

The pharmaceutical industry is evolving with AI-driven decision engines and intelligent orchestration layers to address geopolitical risks and manufacturing inefficiencies. Digital twins and unified knowledge layers are being utilized to integrate regulatory intelligence and supply chain data, enhancing speed-to-market. A digitally fluent workforce is essential to manage these systems and oversee product lifecycles. AI is becoming an embedded reasoning layer in drug discovery and manufacturing, while organizations must bridge the skills gap by creating T-shaped orchestrators and embedding learning in live programs to work effectively with digital systems.

Megha Sinha, Kamet Consulting, explains how pharma can adopt AI orchestration and living decision engines to mitigate geopolitical risk and boost speed-to-market.

Orchestrating the Pharmaceutical Future: Living Decision Engines and AI Integration

On December 19, 2025, FDA approved Myqorzo (

), marking a significant milestone in cardiovascular medicine and a foundational achievement for the drug’s sponsor Cytokinetics, Incorporated (1). The drug is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve symptoms and functional capacity. The approval highlights critical developments in small-molecule innovation, regulatory compliance, and complex safety monitoring strategies (1).

What are Myqorzo’s clinical profile and mechanism of action?

Myqorzo is an allosteric and reversible inhibitor of cardiac myosin motor activity (1). In patients with oHCM, the heart muscle becomes abnormally thick, leading to hypercontractility and left ventricular outflow tract obstruction. By inhibiting myosin, Myqorzo directly addresses this underlying hypercontractility to reduce obstruction and improve the heart’s pumping function.

FDA's decision was based on results from the pivotal Phase 3 SEQUOIA-HCM clinical trial. Data published in the 

 demonstrated that patients treated with Myqorzo for 24 weeks experienced a statistically significant improvement in exercise capacity, measured by an increase in peak oxygen uptake of 1.8 mL/kg/min compared with baseline, while the placebo group saw no improvement (2). The treatment effect remained consistent across subgroups, including age, sex, and the use of background beta-blocker therapy.

 significance is tied to Myqorzo’s approval?

The approval of Myqorzo underscores the importance of risk evaluation and mitigation strategies (REMS) (1). The drug’s prescribing information includes a Boxed Warning regarding the risk of heart failure due to reduced left ventricular ejection fraction.

To manage this risk, the Myqorzo REMS Program mandates several operational requirements (1):

• Certification: Both prescribers and pharmacies must be certified through enrollment in the REMS program.

• Monitoring: Patients must undergo regular echocardiogram assessments to monitor for systolic dysfunction before and during treatment.

• Controlled Distribution: Wholesalers and distributors are permitted to provide the drug only to certified pharmacies.

This level of oversight is a prime example of the intersection between patient safety and pharmaceutical quality systems.

What does Myqorzo’s approval mean for drug development and global reach?

The approval also highlights advancements in dosage form design and pharmacokinetics (1). Myqorzo was engineered for a predictable exposure response and rapid onset of action, available in 5 mg, 10 mg, 15 mg, and 20 mg tablets to allow for flexible dosing.

 perspective, Cytokinetics is expanding its footprint rapidly. The drug received approval in China on December 17, 2025 (3) and recently gained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, with a European Commission decision expected in early 2026 (4).

What does Myqorzo’s approval matter to industry professionals?

The launch of Myqorzo—expected in the US in late January 2026—serves as a comprehensive case study, touching upon API and excipient interactions, specifically noting that the drug is primarily metabolized by CYP2C9 (1). This requires careful management of drug-drug interactions, as certain inhibitors or inducers can lead to heart failure or loss of efficacy.

Furthermore, the milestone reflects a broader trend in the industry toward specialty cardiovascular biopharmaceuticals and the successful translation of muscle biology research into approved therapies (1). For professionals involved in manufacturing, process scale-up, and supply chain security, the global rollout of a myosin inhibitor with a restricted distribution model provides valuable insights into modern drug commercialization.

Cytokinetics Announces FDA Approval of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms

Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy

Cytokinetics Announces NMPA Approval of MYQORZO® (aficamten) in China for Patients with Obstructive Hypertrophic Cardiomyopathy

Cytokinetics Announces Positive CHMP Opinion of MYQORZO® (aficamten) for the Treatment of Obstructive Hypertrophic Cardiomyopathy. Press Release

The FDA's approval of Myqorzo (aficamten) marks a pivotal advancement in cardiovascular medicine, specifically for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Myqorzo functions as an allosteric and reversible inhibitor of cardiac myosin motor activity, addressing hypercontractility and improving cardiac function. The approval was supported by the Phase 3 SEQUOIA-HCM trial, demonstrating significant improvements in exercise capacity. The drug's approval emphasizes the importance of risk evaluation and mitigation strategies, with a REMS program in place to manage potential heart failure risks. Myqorzo's global expansion reflects advancements in specialty cardiovascular biopharmaceuticals.

FDA approve Cytokinetics’ Myqorzo for oHCM. The required REMS for heart failure risk aligns with key regulatory and safety foci.

FDA Approval of Cytokinetics’ Myqorzo Reflects Specialty Cardio Drug Trend 

What are the biggest sustainability issues facing pharmaceutical manufacturing?

The biggest sustainability issues in pharma manufacturing are massive energy/water use, GHG emissions (especially Scope 3 from supply chains), complex waste (plastics, APIs in water), and pharmaceutical pollution (PPCPs) contaminating ecosystems, alongside challenges like strict regulations, costly green tech integration, and ensuring equitable access to medicines. Key areas needing focus are decarbonizing supply chains, improving waste management, adopting green chemistry, and reducing water stress.

How can pharmaceutical companies be more sustainable?

Pharmaceutical companies can become more sustainable by embracing green chemistry, optimizing manufacturing with renewable energy and water conservation, designing eco-friendly packaging, building resilient and ethical supply chains, and implementing take-back programs for unused medicines, focusing on circular economy principles and reducing waste and emissions across the entire product lifecycle.

How are pharma companies being more sustainable?

Pharma companies are becoming more sustainable by adopting green chemistry (safer solvents, better catalysts like enzymes), boosting energy efficiency (renewables, better equipment), cutting waste via circular economy models (recycling, reuse), conserving water, using sustainable packaging, optimizing digital processes with AI, and ensuring responsible supply chains by pushing suppliers for better ESG practices, all aiming to reduce carbon footprints and resource use across the product lifecycle.

What are the environmental impacts of pharmaceuticals?

Pharmaceuticals impact the environment through manufacturing pollution (carbon footprint, hazardous waste, emissions) and usage/disposal, leading to residues in water and soil, harming wildlife (endocrine disruption, reproductive issues), contaminating drinking water, and driving antimicrobial resistance (AMR). Sources include human/animal excretion, improper disposal (flushing), manufacturing effluent, and manure, affecting aquatic life, soil health, and creating persistent pollutants that resist degradation.

What is environmental control in the pharmaceutical industry?

Environmental control in pharma is the strict regulation of conditions (temp, humidity, airflow, particles, microbes) in manufacturing areas (like 

) to prevent contamination, ensuring drug safety and effectiveness, achieved through monitoring air/surfaces/people and using controlled HVAC systems, vital for GMP compliance. It's a documented program ensuring the environment supports product quality by detecting issues before they become problems.

What is ESG in the pharmaceutical industry?

In the pharmaceutical industry, ESG (Environmental, Social, and Governance) is a framework assessing how companies manage their impact on the planet, people, and ethical practices, focusing on areas like drug access, pricing, clinical trial ethics, carbon footprint, waste, supply chain sustainability, and transparent governance, balancing profit with patient well-being and environmental responsibility for long-term success and stakeholder trust.

Pharmaceutical manufacturing faces significant sustainability challenges, including high energy and water consumption, greenhouse gas emissions, and complex waste management issues. Companies can enhance sustainability by adopting green chemistry, optimizing renewable energy use, and implementing circular economy principles. Environmental impacts of pharmaceuticals include pollution from manufacturing and improper disposal, affecting ecosystems and contributing to antimicrobial resistance. Environmental control ensures drug safety through strict regulation of manufacturing conditions. ESG frameworks guide companies in managing environmental, social, and governance impacts, balancing profitability with ethical and environmental responsibilities.

With pharma sustainability regulations in most of the world getting stricter and partners requiring sustainable practices, it’s important for industry professionals to know the basics.

FAQ: Sustainability in Pharma

 connected recently with Dr. Eva-Maria Hempe, Executive Director Public Sector EMEA, NVIDIA, to look back at 2025 and ahead into 2026. Hempe discusses the significant impact of AI, digital technologies, and agentic systems on the pharmaceutical value chain. A central theme of the interview is the versatility of these technologies, especially agent-based platforms, which have moved beyond hype to practical use in areas like scientific literature search and automating internal business processes. The discussion highlights dramatic improvements in preclinical research, where AI reduces drug discovery timelines from years to months by serving as a "flashlight" to survey the extensive chemical space of potential compounds. Looking ahead, while fully achieving the seamless "lab-in-the-loop" integration of physical and digital environments remains a barrier, Hempe expects the momentum behind AI adoption to continue growing through 2026, driving increased automation and efficiency across research and operational processes.

See a visual summary of our discussion in the infographic; the interview continues below.

PharmTech: Which 2025 trends impacted the pharmaceutical industry the most?

Hempe: During the past year, agentic, or agent-based, technologies moved beyond the hype to being used in practical, versatile ways across the industry. Agentic platforms have been especially important for research assistance, making it much easier to search through scientific literature to find relevant findings from past studies and from novel research hypotheses. They’re also moving into areas like finding the right patients for clinical trials and automating internal business processes. Overall, it’s the versatility of these agent-based systems that’s made the biggest difference along the entire pharma value chain.

What role do AI and digital technologies play in accelerating drug discovery and manufacturing efficiency?

AI and digital technologies are increasingly impacting the whole pharmaceutical value chain. One of the most dramatic improvements has been in preclinical research, where timelines can be reduced from years to months by using AI to survey the huge chemical space of possible drug compounds. AI serves as a sort of flashlight in that space, helping researchers orient themselves and explore new possibilities that would have been missed with just experience or intuition.

In clinical development, AI helps identify patient care gaps, which means finding untreated or undiagnosed patients much faster, something that benefits both patients and the companies running trials.

In commercial and manufacturing areas, AI is helping optimize how factories are planned, modeled virtually, and managed, reducing costly mistakes before anything is built. There’s also a lot of work being done to automate quality checks, like using machine vision to spot faulty vials on the production line instead of relying on manual inspection.

One barrier that remains is the full integration of physical and digital environments. While progress is happening, achieving that seamless "lab-in-the-loop" workflow, where digital and real-world systems continuously interact and update each other, is still an evolving capability.

What strategies are most effective in attracting and retaining top talent as tech advancements shift roles?

Investing in upskilling and reskilling has become key, especially as technology changes what’s required of frontline and technical staff. It's important to help people develop expertise at the intersection of the physical and digital so they can function in both realms. Creating a culture that prioritizes innovation and lifelong learning, and actively helping employees build these new skills, is what’s really working to attract and retain talent. And of course, you have to provide state-of-the-art AI tools and environments that allow employees to rapidly prototype their ideas and scale what works.

Which recent innovations have the broadest impacts in manufacturing operations?

The use of AI in preclinical work stands out for shrinking drug discovery timelines by mapping the chemical space more efficiently. Automating patient recruitment with digital tools has also significantly impacted speed and access in clinical trials, which is critical as recruiting patients can consume a substantial share of the overall development timeline and is becoming increasingly time-consuming. In manufacturing, the shift toward virtual factory planning and automating product quality checks, like identifying faulty vials with machine learning, has made the biggest difference in cost, speed, and quality.

Which trends do you see driving innovation and drug development in 2026?

The momentum behind AI adoption will keep growing across the industry. There will be more virtual and digital approaches to both research and manufacturing and increasing levels of automation in clinical and operational processes, particularly around the automated and, at some point autonomous lab. The patient-centric approach, with digital tools improving diversity and inclusivity in clinical trials, will continue to gain importance. As supply chains and manufacturing play a bigger strategic role, digitization and the use of smart systems will keep driving change in 2026, leading to efficiency gains and lower costs.

AI and digital technologies are revolutionizing the pharmaceutical industry by enhancing efficiency across the value chain. Agent-based systems have transitioned from hype to practical applications, significantly impacting research, clinical trials, and internal processes. AI accelerates drug discovery by reducing preclinical research timelines and optimizing manufacturing operations. Despite challenges in fully integrating digital and physical environments, the momentum for AI adoption is expected to grow, driving further automation and efficiency. Strategies for attracting talent focus on upskilling, fostering innovation, and providing advanced AI tools to support evolving roles.

Dr. Eva-Maria Hempe, NVIDIA, looks back at 2025 and ahead to 2026, noting that AI accelerates pharma overall, particularly in manufacturing and business operations.