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Impact of Differences in Regional Bioavailability on IVIVC Development for Modified Release Drug Products

Scientific Posters , Modified Release

Impact of Differences in Regional Bioavailability on IVIVC Development for Modified Release Drug Products

18 December 2025
Overview

The assessment of an IVIVC for a Modified Release (MR) dosage form is a key goal for a development team. If established, the benefits include the use of biowaivers in lieu of bioequivalence (BE) studies for managing change, improved justification of drug product
specification and an enhanced quality by design (QbD) understanding of the product and process. 

Here we describe the optimization of an IVIVC for a small molecule (Cmp-1) using a combined understanding of human regional bioavailability, intravenous pharmacokinetics (IVPK), oral PK and pharmaceutical data for several MR prototypes

 

 

 

 

 

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Date
18 December 2025

Utilization of RapidFACT® strategies to evaluate and develop an In Vitro - In Vivo Correlation (IVIVC) for Modified Release Formulations of Lorcaserin HCl

Scientific Posters , RapidFACT®

Utilization of RapidFACT® strategies to evaluate and develop an In Vitro - In Vivo Correlation (IVIVC) for Modified Release Formulations of Lorcaserin HCl

18 December 2025
Overview

A RapidFACT® study was conducted to identify and optimize an MR formulation of lorcaserin. This presentation describes the clinical processes and data analyses involved in establishing an IVIVC for a series of prototype MR lorcaserin formulations. 

The slowest release rate formulation was selected for further development.

 

 

 

 

 

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Date
18 December 2025

Application of PBPK modeling to elucidate factors that limit systemic exposure

Scientific Posters , PBPK modelling

Application of PBPK modeling to elucidate factors that limit systemic exposure

18 December 2025
Overview

This case study illustrates how information such as bioavailability (F), fraction absorbed (Fabs ) and fraction surviving gut metabolism (Fg ) generated from a clinical study, can aid development and validation of a PBPK model, which can help formulation design and decision making during clinical development.

 

 

 

 

 

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Date
18 December 2025

A PBPK based simulation study to predict potential gastric transit time and permeability driven drug-drug interactions caused by Rybelsus®

Scientific Posters , Modelling & Simulation

A PBPK based simulation study to predict potential gastric transit time and permeability driven drug-drug interactions caused by Rybelsus®

18 December 2025
Overview
Watch
Date
18 December 2025

Matt Paterson - Chief Strategy Officer

Matt Paterson

Matt Paterson

Chief Strategy Officer

Executive Leader
About

Matt Paterson is Chief Strategy Officer at Quotient Sciences. With over 27 years of global experience in the pharmaceutical industry, Matt has held leadership roles spanning business development, marketing, and corporate strategy in CRO/CDMO businesses. 

Matt has a keen interest in early clinical research and has been instrumental in advancing Quotient Sciences’ capabilities in this area.

Thierry Van Nieuwenhove featured commentary with Manufacturing Chemist on the role of UK's future in drug development

Articles & Publications , Thierry Van Nieuwenhove

Thierry Van Nieuwenhove featured commentary with Manufacturing Chemist on the role of UK's future in drug development

Hexagons on blue gradient background with Quotient Sciences logo

In this featured commentary, Thierry Van Nieuwenhove, CEO of Quotient Sciences, discusses the role of clinical trials and manufacturing in the UK.

In light of Merck and AstraZeneca UK investment pull back, Manufacturing Chemist explores the role of CDMOs in driving agility, innovation and technical expertise could redefine how and where drugs are made.

With these Big Pharma pausing UK investments, contract development and manufacturing organisations (CDMOs) are positioning their agility and technical depth to fill the gap. 

Quotient Sciences CEO Thierry Van Nieuwenhove says clinical trial bottlenecks have been a drag, but notes approvals are now moving faster—around 41 days for initial MHRA reviews—strengthening the case for UK-based development and manufacturing.

Continue reading the full article on Manufacturing Chemist.

Lindus Health and Quotient Sciences Partner to Accelerate Drug Development from First-in-Human to Pivotal Trials

News & Announcements

Lindus Health and Quotient Sciences Partner to Accelerate Drug Development from First-in-Human to Pivotal Trials

BOSTON, Dec.11, 2025 – Lindus Health, the "anti-CRO" running radically faster, more reliable clinical trials for life science pioneers, and Quotient Sciences, a leading global clinical development and manufacturing accelerator, have announced a strategic partnership to enable innovative biotech and pharma sponsors with enhanced patient recruitment for Phase I-IIa clinical studies and a seamless pathway from first-in-human (FIH) to proof-of-concept (POC) trials. 

The drug development process has traditionally required companies to engage multiple vendors across pre-clinical and clinical phases, creating inefficiencies, knowledge gaps, and operational delays. Lindus Health and Quotient Sciences partnership directly addresses this industry challenge by combining Quotient's specialized early clinical and drug development capabilities with Lindus’ proven patient recruitment expertise and later-stage trial delivery. The outcome is a cohesive development continuum for customers, championed by trusted, experienced partners who are agile and committed to accelerating the delivery of new treatments to patients. 

Quotient Sciences conducts more than 70 Phase I studies per year across its clinics in the US and UK, specializing in FIH to POC programs and a range of clinical pharmacology studies. The company's unique Translational Pharmaceutics® model integrates drug product development with early clinical capabilities, enabling rapid progression from formulation to FIH. 

Early phase studies increasingly require specific patient populations, including challenging cohorts that extend beyond traditional healthy volunteers. Through this partnership, Lindus provides comprehensive patient recruitment support with an omni-channel approach, access to over 40 million electronic medical records (EMRs), and a widespread site network. Lindus Health has an established track record of delivering 73% faster enrollment across all studies, enabling Quotient Sciences to execute efficient, high-quality Phase I-IIa trials involving patients.

Lindus Health brings extensive Phase II trial experience and end-to-end trial delivery capabilities across the US, UK, and Europe, spanning multiple therapeutic areas, including respiratory, neuropsychiatry, cardiometabolic, dermatology, and more. Together, the companies offer a streamlined approach to clinical development, eliminating the need to independently source and vet separate Phase I and later-stage CROs. The result is reduced administrative burden, accelerated timelines, and more focus for sponsors on advancing their science rather than managing vendors. 

"This partnership underscores our commitment to removing bottlenecks in the clinical development lifecycle," said Michael Young, Co-CEO of Lindus Health. "By collaborating with Quotient Sciences, we are creating a comprehensive development pathway that allows biotech companies to move through a contiguous experience from FIH studies through to pivotal trials. Sponsors get the specialized Phase I expertise they need at the beginning, with recruitment support from the same proven end-to-end CRO partner ready to scale their programs as they progress.”

“Early-phase programs increasingly demand patient cohorts and rapid iteration, and Quotient is addressing this industry need. By pairing Lindus Health’s recruitment engine with our early clinical development expertise and Translational Pharmaceutics® platform, sponsors can move seamlessly from first-in-human into later-stage trials with fewer handoffs, clearer decision-making, and materially shorter timelines,” said Matt Paterson, Chief Strategy Officer, Quotient Sciences.

This collaboration is essential to eliminating traditional barriers in patient recruitment and reducing friction when transitioning between development stages and CRO partners, ultimately accelerating the delivery of breakthrough treatments to patients.

 

About Lindus Health

Lindus Health is the anti-CRO running radically faster, more reliable clinical trials for life science pioneers—bringing ground-breaking treatments to patients more quickly. By aligning incentives through fixed-price, milestone-based contracts, combining a world-class clinical operations team with a unique software platform, and leveraging access to over 40 million Electronic Health Records, Lindus Health delivers trials designed for speed, reliability, and impact.

The company removes the biggest bottleneck in healthcare—clinical trials—through end-to-end study execution powered by technology and forward-thinking approaches to clinical operations. Lindus Health works with leading biotech, medical device, diagnostics, and consumer health companies to accelerate the development of innovative therapies and products. Its impact has been recognized with prestigious accolades, including the Fierce Biotech CRO Awards for Outstanding Patient Recruitment and Retention and inclusion in the PM360 Elite 100.

To date, Lindus Health has delivered trials across the US, UK, and Europe in conditions ranging from diabetes and asthma to major depressive disorder, hypertension, and chronic fatigue syndrome. The company has raised over $80M from investors including Balderton, Peter Thiel, Creandum, Firstminute Capital, and Seedcamp.

About Quotient Sciences

Quotient Sciences is a clinical development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast, because humanity needs novel therapeutic solutions, fast. Quotient Sciences has been recognised as a multi-year winner of the CRO Leadership Awards in 2021, 2022, and 2024 and of the CDMO Leadership Awards in 2023. For more information, visit quotientsciences.com.

Quotient Sciences and Intrepid Labs form Strategic Partnership to Accelerate AI-guided Formulation Development

News & Announcements , Nottingham, UK

Quotient Sciences and Intrepid Labs form Strategic Partnership to Accelerate AI-guided Formulation Development

Nottingham, UK - 4th December 2025  – Quotient Sciences, a leading global drug development, research and manufacturing accelerator, and Intrepid Labs, the AI leader in pharmaceutical formulation science, today announced a ground-breaking multi-year strategic partnership to advance the use of artificial intelligence (AI) in early drug development. 

Under the new agreement, Quotient Sciences will have access to Intrepid’s machine learning model, ANDROMEDA, the first AI platform to develop and optimize clinical performance of drug products.  

ANDROMEDA supports rapid exploration of formulation options, helping reduce experimental burden, minimize drug substance demands, and enhance data-driven decision making. It uses an advanced, proprietary machine learning algorithm, not a large language model, and has the potential for client-specific or aggregated multi-client models for enhanced predictivity.  

The partnership builds on an existing collaboration where Intrepid’s AI model was incorporated into Quotient’s Translational Pharmaceutics® platform to help accelerate the identification of optimal formulation compositions and reduce the time to transition new drug products into clinical development with even greater chances of success.  

Customers will benefit from Quotient Sciences’ extensive experience in formulation development, GMP manufacturing, and early clinical testing, alongside Intrepid Labs’ deep expertise in formulation science and AI-guided approach to designing drug products. 

Thierry Van Nieuwenhove, CEO of Quotient Sciences, commented: “This is a truly unique offering. It blends Quotient’s decades of experience in drug product development and accelerated clinical testing using Translational Pharmaceutics® with Intrepid’s cutting-edge AI capabilities to reduce drug substance requirements in early development, shorten development cycles, increase speed to clinic, and deliver more informed decision-making for pharmaceutical companies.”  

“It reflects our continued commitment to innovation and removing barriers that slow down drug development.”

Andy Lewis, Chief Scientific Officer at Quotient Sciences, added: ”AI is opening new opportunities in drug development. With Intrepid’s technology, we can develop formulations and in silico models of their performance more rapidly, helping us design and manufacture drug products more efficiently and make more informed decisions for taking molecules into and through clinical development.”

Each project will be supported by a secure, independent AI instance, ensuring strong data protection, confidentiality, and alignment with industry standards. Initial pilot projects comparing traditional and AI-assisted methods will begin immediately, followed by a wider rollout.

Christine Allen, CEO and Co-Founder of Intrepid Labs, said: “Our goal is to help the industry design better formulations with greater confidence and speed. Working with Quotient Sciences allows our technology to have an immediate impact, reducing time, material use, and the uncertainty that often accompanies early formulation work.”

This collaboration comes as the industry continues to adopt advanced digital tools to improve efficiency in R&D. Recent analysis from Boston Consulting Group suggests that AI-enabled approaches could reduce time and cost in early development by 25–50%. 

Both Quotient Sciences and Intrepid Labs plan to explore additional applications as the partnership continues to evolve. 

Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, they save precious time and money in getting drugs to patients. Everything they do for their customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast, because humanity needs novel therapeutic solutions, fast. Quotient Sciences has been recognized as a multi-year winner of the CRO Leadership Awards in 2021, 2022, and 2024 and of the CDMO Leadership Awards in 2023. 

Intrepid Labs

​​Intrepid Labs is the AI leader in pharmaceutical formulation science, dedicated to designing fit-for-purpose formulations faster, smarter, and more efficiently. Powered by decades of experience in formulation science and AI-driven automation, Intrepid Labs accelerates therapeutic development through its Valiant™ platform. This AI-driven, robotic lab compresses timelines from months to days, exploring the full formulation design space to deliver optimized, data-driven solutions supported by proprietary AI algorithms. The company is led by CEO and Co-Founder Dr. Christine Allen, a global expert in drug formulation with over 180 peer-reviewed publications. Together with co-founders Dr. Pauric Bannigan (Chief Scientific Officer) and Dr. Riley Hickman (Senior Director of Engineering), Intrepid’s leadership team leverages expertise in drug delivery, laboratory automation, and AI-driven pharmaceutical development. With multiple strategic collaborations and a growing pipeline, Intrepid sets a new standard for excellence in formulation, enabling faster, more precise, and cost-effective paths to transformative therapies. ​ 
 

Quotient Sciences Supports First-in-Human Study of Novel Cancer Therapy with Larkspur Biosciences

News & Announcements , Customer Milestone

Quotient Sciences Supports First-in-Human Study of Novel Cancer Therapy with Larkspur Biosciences

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Larkspur Biosciences has announced the dosing of the first participant in its Phase 1 clinical trial of LRK-4189 with Quotient Sciences - Nottingham.

LRK-4189 is a first-in-class targeted protein degrader designed to treat microsatellite stable colorectal cancer and other solid tumors. This milestone marks an important step toward addressing one of the most challenging cancer subtypes, accounting for approximately 85% of all colorectal cancer cases in the U.S.

The study, conducted by Quotient Sciences at our Nottingham clinic, will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics (PK/PD) of LRK-4189 in healthy volunteers. By starting in healthy participants, Larkspur aims to define a biologically meaningful dose before moving into patient studies.

Quotient Sciences is proud to play a critical role in this program, managing the clinical trial and overseeing recruitment of healthy volunteers. Our integrated approach accelerates early-phase development, helping innovative companies like Larkspur Biosciences bring transformative therapies to patients faster and improve patient outcomes.

Read the press release from Larkspur.

Video Interview with BioPharm International: Integrated Services for the Whole Drug Development Pathway

Translational Pharmaceutics® , Thierry Van Nieuwenhove

Video Interview with BioPharm International: Integrated Services for the Whole Drug Development Pathway

Video Interview with BioPharm International: Integrated Services for the Whole Drug Development Pathway

In this video interview, Thierry Van Nieuwenhove, Chief Executive Officer of Quotient Sciences, discusses how Translational Pharmaceutics® combines drug product formulation with clinical pharmacology, overcoming the typical industry separation between these services to accelerate the development pipeline for both large and small pharma. This integrated model delivers significant time savings, often between nine and twelve months, and provides a faster path to proof of concept (PoC). 

To meet the industry challenge of continued acceleration, Quotient Sciences is enhancing this capability by integrating AI algorithms to reduce formulation time by 50% and by adding patient cohorts to reach PoC even faster within a single clinical trial. Having successfully applied this methodology across more than 600 products over 18 years, Quotient Sciences is now applying Translational Pharmaceutics® to the biologics space.

Watch the full interview on the BioPharm International website here

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