Matthew Paterson, Chief Strategy Officer, Contributes to Clinical Leader's article, "Optimizing The Path From First-In-Human To Proof-Of-Concept"

The traditional, siloed approach to drug development is increasingly at odds with a market demanding faster results and higher capital efficiency. In the conventional model, the "white space" between CMC, manufacturing, and clinical pharmacology creates a structural tax on programs, leading to months of lost momentum during critical handoffs. As the industry moves toward a reality where first-in-human (FIH) studies must provide deep, decision-grade insights rather than just basic safety data, the need for a continuous learning engine has never been greater.

True acceleration stems from an integrated framework where drug product manufacturing and clinical testing operate as a single, responsive system. This alignment allows for real-time formulation adjustments based on emerging clinical data, effectively compressing development timelines by nearly a year. When supply chain and clinical execution move in the same rhythm, the focus shifts from managing logistical gaps to interpreting scientific signals. Adopting this integrated strategy ensures that programs reach proof-of-concept with the clarity and flexibility required to survive modern R&D pressures.

Read the full article on Clinical Leader's website here.

At the 2024 ISSX-JSSX Joint Meeting, researchers from Quotient Sciences and Bristol Myers Squibb presented a poster exploring how modeling can be used to predict the impact of permeability enhancers on drug absorption.

Titled “Physiologically Based Biopharmaceutics Modeling of the Effect of a Permeability Enhancer on the Absorption of a Highly Soluble and Poorly Permeable Small Peptide in Humans”, the poster reviewed work performed on a highly soluble, poorly permeable small peptide with low distribution volume and high protein binding. To better enable oral delivery of the compound, researchers formulated an enteric-coated (EC) tablet with sodium salcaprozate (SNAC), a permeability enhancer.

Read highlights from the poster below, authored by Ricardo Diaz de Leon-Ortega, Ajay Saxena, Jonathan Brown, Dannielle Ravenhill, Kevser Sevim, and Zoe Kane. Download the poster to see additional findings.    

Program objectives and design

In this study, the objective was to build a physiologically based biopharmaceutics (PBB) model that could simulate the effect of SNAC on Compound A absorption, while also accounting for variability in dissolution lag times.

To enable oral delivery of Compound A, researchers formulated an enteric-coated (EC) tablet with SNAC. Using PKSim/MoBi software, the team developed a model that linked SNAC concentration in the duodenum to changes in Compound A’s paracellular permeability. This allowed them to simulate how variability in dissolution timing affects drug absorption and exposure.  

Key findings from the program

The model accurately predicted plasma concentration-time profiles for two EC tablet formulations (20 mg and 40 mg Compound A + 600 mg SNAC) in healthy volunteers. Predicted oral bioavailability (%F) ranged from 0.001% to 0.8%, aligning with preclinical observations in dogs and cynomolgus monkeys.

A linear relationship between SNAC concentration and paracellular permeability was used to simulate absorption, with longer dissolution lag times resulting in reduced permeability and lower drug exposure.

The model also successfully simulated IV administration of Compound A to estimate systemic exposure and validate oral predictions.

This modeling approach provides a valuable framework for predicting the pharmacokinetics of poorly permeable compounds that rely on permeability enhancers. It supports formulation optimization and helps explain inter-subject variability in clinical studies—ultimately accelerating the development of challenging oral drug candidates.

Download the poster to see additional findings and learn more about modeling & simulation services provided by Quotient Sciences.  

Brad Rowe and Robert Cornog contribute to Pharma Phorum's piece, "Navigating Development in a Complex Molecule World"

For decades, the pharmaceutical industry has relied on accelerated development and manufacturing timelines to bring new therapies to patients quickly. Regulatory agencies worldwide offer numerous expedited approval pathways. These include the US Food and Drug Administration (FDA)'s Fast Track and Breakthrough Therapy designations, as well as a new National Priority Voucher program introduced in 2025; the European Medicines Agency (EMA)'s PRIME priority medicines designation; and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) Sakigake program for early practical application of innovative medicinal products.

While therapies for rare and orphan diseases, as well as specialized areas like oncology, are most likely to use accelerated pathways, they frequently involve molecules with extreme handling, formulation, or manufacturing requirements. These therapies may require highly potent active pharmaceutical ingredients (HPAPIs), which present unique risks to personnel and the environment for consideration during product development, manufacturing, and scale-up. Understanding the timing of disease onset and diagnosis is another key early-stage consideration of patient populations (e.g., age, complications from disease state, etc.) that dictates the required dose forms and manufacturing technologies.

Reducing risk through integrated development and early decision-making

For many years, accelerated development and manufacturing timelines have pressured developers to move new therapies to market quickly, while still maintaining a balance of risk/benefit assessment for patients. As development moves rapidly through proof of concept, the demand for having a robust, scalable, commercial-ready drug product approaches faster than generally anticipated. If a company fails to properly characterize and understand the APIs properties early on, they risk advancing a sub-optimal dose form into FIH studies, potentially leading researchers to incorrectly conclude a viable product is ineffective.

Guidance on meeting new regulatory expectations

When pursuing an expedited approval pathway for a molecule, drug sponsors must seek partners that embrace shared ownership for success and possess deep expertise in mitigating technical and regulatory risks. A proactive and collaborative team approach enables more nimble, faster, and calculated actions when rapid changes in development programs become necessary.

Read the full article on the Pharma Phorum website here.

Strengthening the UK’s Competitiveness in Early-Phase Clinical Trials Through Regulatory Reform

In recent news, The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator for medicines, medical devices and clinical trials, has announced major reforms that impact early-phase clinical research.

These changes represent some truly transformative news and a significant step forward for the UK. They strengthen the UK’s position as a leading destination for early-phase clinical development and, importantly, create new opportunities for us and our customers and partners worldwide. 

Why This Matters

Over recent years, the MHRA has navigated several challenges, from resourcing constraints to the operational impact of Brexit, which have collectively contributed to longer timelines.

However, the MHRA now reports that Phase I trial activity is increasing in the UK, a sign of growing international confidence in the UK as a place to launch new research. This follows on from recent announcements that the MHRA is reviewing 99% of clinical trial applications on time with most completed well ahead of target.

The new reforms mark a pivotal turning point. They reflect a renewed commitment from the MHRA to create a faster, more agile and more internationally competitive environment for early-phase research.

What’s Changing?

The MHRA has made a commitment to reintroduce a 14-day initial assessment timeline for Phase I trials.

After several years of extended MHRA review timelines for Phase I, this will make the UK once again one of the fastest places in the world to set up phase I trials.

Our colleague Kate Darwin, VP, Regulatory Affairs, comments:

“The commitment to accelerate assessment of phase I trials will allow studies to start sooner, remove bottlenecks and ultimately speed up patient access to new medicines.”

Patient benefit is at the heart of these reforms. The MHRA is also introducing streamlined regulatory processes to fast-track trials in patients. Patients will benefit sooner as the journey from scientific discovery to first-in-human evaluation to therapeutic trials is accelerated. This is not just a regulatory improvement: it is a meaningful shift with real-world impact.

A Global Win  

While this announcement is UK-led, it strengthens Quotient Sciences’ global offering. Faster, predictable timelines in the UK give us greater flexibility and competitive strength and enhance our ability as a global team to provide customers with the optimal pathway, wherever that may be.

Years of Collaboration Behind This Moment

Although the announcement is newly public, it is the product of years of advocacy and collaboration across government, industry groups and companies like ours.

Our teams have driven numerous discussions with regulators to ensure that our perspective and the needs of our partners were clearly understood. This has included direct engagement with key decision-makers at the MHRA.

This achievement is shared across our community. It reflects the impact we can have when we engage collectively and persistently.

What Comes Next

Implementation timelines are not yet finalized, but a pilot scheme will be in place imminently, with expectations that many, if not all, UK Phase I trials should benefit from shorter timelines by the end of 2026.

The reforms arrive at a crucial moment for the global life sciences sector. The UK has always had a strong reputation for safe, high-quality clinical trials. By accelerating timelines, the UK will once again be positioned as a highly attractive destination for early-phase research.

This gives Quotient Sciences a tremendous opportunity to reinforce the value we bring: our expertise, voice and role as a trusted partner in shaping the future of early-phase development. 

PHILADELPHIA, PA – February 26, 2026 – Quotient Sciences, a leading integrated CRDMO (Contract Research, Development and Manufacturing Organization), is pleased to announce an extended commercial supply partnership with Ipsen, a global biopharmaceutical company, to manufacture a treatment for Fibrodysplasia Ossificans Progressiva (FOP), an ultra-rare disease affecting fewer than 1,000 people worldwide.

This collaboration reinforces Quotient Sciences’ commitment to supporting the manufacture of niche and smaller volume commercial products often overlooked by larger CDMOs. Sohonos (Palovarotene), approved by the FDA in 2023, is a highly potent molecule which requires specialized handling and containment to protect both the facility and manufacturing operators.

As part of the partnership, Ipsen has invested in new equipment at Quotient Sciences’ Boothwyn, PA facility, including a Pneumatic Closed Transfer System, which ensures safe material transfer without impacting blend segregation, and a Flexible Dispensing Isolator, which enhances operator safety and eliminates special cleaning requirements. Quotient Sciences brings a world-class facility, an experienced team, reliable supply capabilities, and the ability to manage global shipments, ensuring seamless delivery and operational excellence throughout the partnership. These additions expand Quotient Sciences’ capabilities for handling and manufacturing highly potent API (HPAPI) drug molecules and products, with known OELs at or below 1 µg/m³, while enabling seamless integration with existing equipment.

The partnership will ensure sustained commercial supply for FOP therapy and broaden capabilities to handle multiple highly potent compounds at commercial scale, addressing critical needs in rare disease treatment.

Marlene Leuenberger, VP and General Manager, Quotient Sciences, Philadelphia commented: “This significant investment in advanced containment and manufacturing technology at our Boothwyn facility underscores Quotient Sciences’ unwavering commitment to supporting patients with ultra-rare diseases. By expanding our capabilities in handling highly potent compounds, we are not only ensuring a reliable supply of critical therapies like Sohonos (Palovarotene) for the FOP community, but also reinforcing our promise to deliver flexible, high-quality solutions for our partners with specialized needs especially for highly potent compounds .”

About Quotient Sciences

Quotient Sciences is an integrated CRDMO (contract research, development and manufacturing organization) providing services across the entire drug development and clinical pathway. Our flagship platform for drug development, Translational Pharmaceutics^®, has been trusted for integrated drug product formulation development and manufacturing with clinical testing activities for over 17 years. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.