Dr. Asma Patel, VP of Global Commercial and Scientific Consulting-Drug Product, discusses the impact of patient-centric formulations and other trends shaping drug development ahead for 2026.

Patient‑centric drug development continues to reshape formulation strategies while emphasizing patient needs, convenience, and better clinical outcomes. According to Dr. Asma Patel, the growth of complex modalities including oral peptides has intensified demand for CDMOs with specialized scientific expertise. 

The shift toward patient‑centricity requires tailored solutions for pediatrics and rare diseases, including taste masking, flexible dosing, and advanced delivery systems. Additionally, AI-based technologies can further enhance predictive modeling, reduce failures, and streamline development.

"CDMO partners now increasingly act as strategic collaborators with integrated capabilities, including adaptive GMP manufacturing, rather than transactional vendors." she comments.

CDMOs increasingly engage early—often in preclinical stages—to conserve scarce API, navigate regulatory challenges, and build patient‑ready formulations faster. The role of a trusted and experienced CDMO is essential in orphan drug development, especially, when factoring needs including small‑batch drug product manufacturing, global regulatory compliance, and accelerated pathways granted from regulatory bodies.

Looking ahead, Dr. Patel expects strong growth in outsourcing as AI, automation, and integrated platforms transform formulation design and development efficiency. For more insight, continue reading the full Q&A on PharmaTech.

Matthew Paterson, Chief Strategy Officer, contributes to Pharm Tech's, Industry Outlook 2026: Navigating AI, Sustainability, and Operational Resilience.

Pharma industry experts indicate that strategy in 2026 is shifting to agentic AI, sustainable efficiency, and resilient supply chains to manage tariffs, regulations, and digitalization.

When asked about the impacts of geopolitical trends, Matthew observed that biotech and pharma clients are "optimizing and diversifying their geographic footprint" to mitigate the effects of political instability. Many organizations are adopting a multi-region strategy, qualifying facilities in both the United States and the United Kingdom to ensure continuity of supply for life-altering medicines.

Read the full article on Pharm Tech's website here.

In this Q&A with European Pharmaceutical Manufacturer, John McDermott, Vice President of Scientific Consulting, explores how Translational Pharmaceutics^® is reshaping the journey from preclinical development to first-in-human trial.

When asked how Quotient Sciences’ integrated approach to drug development, Translational Pharmaceutics^®, expedites the transition from preclinical development to first-in-human clinical trial, John says:

"Quotient Sciences’ approach is integrated. In our case, integration is bringing the CDMO service world close to the CRO service world. It is horizontal integration, providing breadth of service, being both a CDMO and CRO – as well as vertical integration bringing depth of service, and deep acumen in each of the areas we support within formulation, manufacturing, and clinical testing.

Through Translational Pharmaceutics^®, our integrated drug development platform, we bring formulation development, drug product manufacturing, and clinical testing into the same program of work, managed by a single project manager. That means we can manufacture batches of drug products in our facility, release them, and dose them in our clinics to trial volunteers in less than seven days.

Translational Pharmaceutics^® is proven to accelerate early development studies by taking scale up of drug product and long-term stability studies off the critical path for dosing. These two aspects alone can save four to six months of time getting to the first subject, first dose."

When asked what benefits recent collaborations bring to Quotient Sciences as a company, John states:

Collaborations are one avenue that we have used this year to extend our science and services. Earlier this year, we announced a joint venture with CPI, the UK Centre of Process Innovation, to advance the development of mRNA based therapeutics.

It is known that mRNA therapies have a complex supply chain, often requiring multiple providers for synthesis, LNP formation and clean up, and sterile fill-finish let alone the cold chain requirements for these drugs.

The mRNA-based vaccines created to address the COVID-19 pandemic are a great example of how these development programs can be accelerated. However, those were unprecedented times, and normal operating modes have now for the most part returned.

The lessons-learned and pace of COVID-19 vaccine development we hope can be applied to regular therapeutics, and we know in our case Translational Pharmaceutics^® has shown that kind of speed. For almost two decades, we’ve consistently shown how we can streamline the supply chain, taking a molecule from API to human-ready dosage form and through Phase I trials in accelerated time by eliminating unnecessary steps that create distance between the drug product manufacturer and the clinic. We're very excited to be working in this space to bring our Translational Pharmaceutics^® platform into mRNA manufacturing.

The second collaboration is a partnership with Biorasi, a US-based CRO that is focused on global patient trials. We have made this move as a response to increasing industry trends that we've observed in terms of getting efficacy data in the first in human study. Yes, we're a contract manufacturer, but we're also a contract research organization, and we’ve built a body of work over the last 20 years running first in human studies and accelerating those programs demonstrating safety, tolerability, and pharmacokinetics in healthy volunteers.

The key question is, what about efficacy? Is the drug actually working? The trend that's starting to emerge, again, is back to having a quick win or fast fail.

By bringing patients into a first in-human study, we get to evaluate that drug during its first year of clinical development to assess whether it actually has an impact, and if not, provide our clients with the data so they can confidently choose to cease investment or pursue other paths. 

Read the full Q&A article on the European Pharmaceutical Manufacturer website here.

Summary: Dr. Andrew Lewis, Chief Scientific Officer at Quotient Sciences, examines trends and news that shaped drug development in 2025. He highlights how global policy changes, accelerated regulatory frameworks, and rapid advances in artificial intelligence reshaped R&D productivity, clinical trial design, and decision‑making. Dr. Lewis discusses how AI‑enabled modeling, data integration, and automation are redefining early‑phase development and improving the speed and efficiency of taking new therapies to patients. 
 

One thing that has been a constant through my career has been the ever changing landscape of our industry, and when I look back at 2025 there have been some huge shifts fueled by the macro environment, the rise of digital technology and capital markets  that will no doubt have significant implications for years to come.

With the USA as the largest pharmaceutical market, perhaps the most significant cause of change has been the policies of the Trump administration designed to protect the US industry, reduce healthcare costs and increase resilience. The pharmaceutical industry responded rapidly with around $360 billion of investment committed to build manufacturing capacity by various companies and drug pricing deals made on both sides of the Atlantic. One policy that is likely to have significant long term implications is the reduction in the NIH budget by $18 billion (40%). The NIH is the world largest funder of basic science and I would expect not only will it reduce scientific discoveries, and the potential creation of new biotech companies, but will also have a significant impact on the development of new talent.

While there has been some recovery and optimism in biotech funding it is far from the heights of 5 years ago and it remains a challenging funding environment. Even so, there seems to be a trend for fewer companies to raise larger investments with several firms securing over $100 million each this year - such as Braveheart Bio, Pelage Pharmaceuticals, and RayThera – so there is still an appetite to fund the most promising innovations. One development this year I found particularly striking has been the rise of the Chinese biotech industry. A report from Jefferies issued in July showed that China represented 32% of outlicensing biotech deal value in Q1 2025, up from 21% in 2024-2023. Since 2022, biotechnology companies in China have developed 639 first-in-class drug candidates, a 360% increase from 2018-2021. The country has started more clinical trials than any other country this year, surpassing the USA for the first time and it is estimated that a third of the clinical trials conducted globally in 2024 were in China. This trend is reshaping the entire biotech landscape, and its effects may be long-lasting.

Above all, for me 2025 stands out as the year of AI. Whilst it has been already used for many years in drug discovery – and we have supported the development of multiple compounds discovered using AI – this year has seen its applications expand throughout the drug development process. From 2026-2022, the US FDA received more than 300 applications that incorporate AI or ML in drug development; over 90% of those came in the past two years and most were for the use of AI in clinical development.

Here at Quotient Sciences, we've just announced a strategic partnership with Intrepid Labs building on a long-standing collaboration. Intrepid Labs’ technology uses active learning with Bayesian optimization to learn the relationship between formulation composition and performance. This means it can learn on relatively sparse data sets, so is ideal for early development and perfectly synergizes with our Translational Pharmaceutics platform. In our testing to date it reduced the number of formulations screened to obtain target in vitro performance by 30 – 50% - reducing API demands in early development, and reducing time spent in formulation development. Furthermore, it effectively builds an in silico model of the relationship between composition and performance in real time to enhance data-driven decision making. In 2026, we plan to further explore the potential of this technology and how it complements our established modelling and simulation capabilities with select clients.

For all its benefits, I am reminded that the successful use of AI in drug development is not a magic solution, nor a complete replacement for human decision-making, innovation, and creativity. As presented by Christine Allen, CEO and Founder of Intrepid Labs, and myself at AAPS in San Antonio, TX, the effective application of AI necessitates deep domain expertise, high-quality data quality input into tailored algorithms, and thorough experimental validation. While AI acts as a powerful catalyst to advance scientific innovation, the knowledge and judgment of the individuals and teams implementing these tools remain essential for formulating relevant questions, validating output, and interpreting predictions.

The evolution of the pharma/biotech landscape we have seen this last year reveals some underlying structural shifts that have been building up over several years and accelerating innovation that may well have revolutionary impact on the way new medicines are developed.

But as we move into the new year I’m reminded of a quote, I think from Socrates, that said, “The secret of change is to focus all of your energy, not on fighting the old, but on building the new.”

Wishing you all a very happy and prosperous new year.