Get to know the people behind Quotient Sciences in our colleague Q&A series. 

What’s your current role at Quotient Sciences?

My current role within the company is IT Service Manager.

How did your career journey here begin?

Initially, I joined the company back in 2016 as an IT Support Apprentice, juggling my time between Quotient Sciences and college. It was a fantastic way to get my foot in the door, and I quickly discovered how much there was to learn.

What roles or career moves have you made since joining?

After completing my apprenticeship, I was promoted to a full-time Desktop Support Technician in 2017. The following year, I took on the role of IT Support Specialist, and then became IT Service Supervisor in 2020. Most recently, in April 2025, I stepped into my current position as IT Service Manager. It's been a journey full of growth and new challenges at every turn.

What have you enjoyed most about your career at Quotient Sciences?

One of the things I’ve enjoyed most about my time at Quotient Sciences is the incredible people I get to work with. Both within the IT department and across other areas of the business, I’ve been lucky to be surrounded by positive influences and great colleagues — those day-to-day interactions are often the best parts of my job.

What’s one achievement you’re proud of?

Looking back, one achievement I’m particularly proud of is retaining my supervisor role. Taking on line-management responsibility at just 23 was definitely daunting, but I pushed myself to overcome challenges and areas where I lacked confidence. Now, I feel a real sense of accomplishment about how far I’ve come since then.
 

What’s helped you progress or develop the most?

What’s helped me progress the most has been the opportunity to start at Quotient Sciences when I was just turning 18. It helped me mature quickly and, importantly, I was able to learn from senior colleagues who passed on valuable soft skills that have been crucial for my development.

What advice would you give to someone wanting to progress their career at Quotient Sciences?

For anyone looking to progress their career at Quotient Sciences, my advice would be to embrace every opportunity to learn from those around you. Don’t be afraid to ask questions, take on new responsibilities, or step out of your comfort zone. The company is full of fantastic mentors and supportive colleagues who genuinely want to help each other succeed—take advantage of that.

I’ve been lucky to be surrounded by positive influences and great colleagues—those day-to-day interactions are often the best parts of my job.
– Joe Linley

In a BioPharma Boardroom expert opinion, Andy Lewis (Quotient Sciences) and Christine Allen (Intrepid Labs), discuss the potential of machine learning to speed up formulation development.

The article outlines the ways that ML methods, when working collaboratively, can assist formulation and early clinical planning without replacing scientific expertise. 

They discuss how Intrepid Labs proprietary machine learning (ML) platform accelerates formulation development while also generating deeper insight into the relationships between composition and performance.

Read the full article on BioPharma website.

In this article by Pharma's Almanac Andy Lewis discusses how the AI is providing the real value in drug product development and explains why it is embedded into scientific workflows.

Andy highlights the AI-driven formulation design, modeling and decision support that allows accelerated high-risk early decisions such as formulation selection, thereby reducing the burden of experimentation, speeding iteration, and using actual human data.

He notes that Intrepid Labs AI integration into Quotient Sciences' Translational Pharmaceutics® platform is a clear example of measurable speed‑to‑clinic and API savings.

Read the full article on Pharma's Almanac website.

Christine Allen (Intrepid Labs) and Andy Lewis (Quotient Sciences) discuss their strategic collaboration and the role of AI and machine learning in speeding early drug product development.

A new Contract Pharma feature discusses the strategic multi-year partnership that we share with Intrepid Labs and how we are leveraging the use of AI in formulation development, and thereby accelerating the decision-making process earlier in the pipeline. 

Combining the expertise of Quotient Sciences; which offers integrated drug product development, manufacturing and clinical testing services; with the ANDROMEDA machine-learning platform from Intrepid, we aim to decrease experimental burden-halving time and the amount of API utilized in some formulation development programs by ~50%, whilst still aiming to optimize for clinical performance at the outset.

Read the full article on Contract Pharma website.

Enteral feeding tubes (EFTs) are crucial for adult and pediatric patient populations that are unable to swallow oral medicines due to conditions like dysphagia, neurological disorders, or critical illness. 

Although widely used, EFTs present significant formulation challenges that impact safety and efficacy across both adult and pediatric populations. 

Recent research in Advanced Drug Delivery Reviews highlights that medicines given to children via EFTs are often unlicensed for this route and must be manipulated, for example by crushing tablets. This adds risk for the patient that can range from dosing errors and tube blockages to altered bioavailability and safety concerns.  

Pharmaceutical and biotech companies are increasingly adopting early, data-driven in vitro testing to support EFT administration and prevent off-label use, but a lack of harmonized regulatory guidance for pediatric drug product EFT administration remains a challenge.

In 2021, the US Food and Drug Administration (FDA) issued draft guidance, providing a framework for systematic testing and labelling, formalizing expectations for demonstrating oral drug suitability for EFTs. However, this guidance left room for interpretation. More recently, the European Medicines Agency (EMA) has detailed requirements for studies confirming the feasibility of EFT administration. The EMA guidance, effective January 2026, integrates EFT considerations within broader quality and lifecycle management.

The EMA is signaling that regulators will increasingly expect EFT compatibility to be built in from the start, not added later. This progress in regulatory approaches, with clearer expectations on generating and documenting data, and labelling. Careful formulation design, excipient selection, and dose flexibility, all supported by robust data, will be key to meet evolving regulatory demands.  

In our recent whitepaper, we review key factors for effective administration of drug products via EFTs for pediatric populations, highlighting chemical compatibility, interactions with tube materials, physical stability and tube patency, and clear labelling and instructions for use. Download our recent article to continue reading. 

Dr. Andrew Lewis and Matthew Paterson and Featured in European Pharmaceutical Review Article, "Pharma Horizons: Trends in Pharmaceutical Manufacturing"

Along with other contributing industry experts, they discuss key trends in pharma manufacturing, delving into key topics including supply chain, regulation, and drug development.

Key topics of discussion include:

• How the major developments in 2025 could impact the pharma industry in 2026
• What to expect on the innovation, quality and global medicines front in 2026
• Expert insight into current industry pressures including manufacturing, security of supply, global tariffs, the increasing innovations in technology and drug modalities, and more
• How the continuing onshoring of manufacturing to the US could affect the pharmaceutical supply chain long-term
  The evolution and potential future of pharma’s collaborations

Read full article on the European Pharmaceutical Review website here.

Optimizing Drug-Drug Interaction Studies: Insights from a Decade of Research and Emerging Trends

Drug-drug interactions (DDIs) remain one of the most critical considerations in clinical pharmacology. Mismanaged or unrecognized DDIs can lead to serious consequences, including increased morbidity and mortality among patients. As the pharmaceutical landscape evolves, so too must our strategies for assessing and mitigating these risks.  

In this blog, Emily Dodds, Research Fellow, Scientific Consulting, explores the fundamentals of DDIs, best practices for study design, and how Quotient Sciences supports clients to conduct safe and effective DDI clinical pharmacology studies.

What is a drug-drug interaction?

Drug-drug interactions occur when one drug alters the pharmacokinetics and potentially the pharmacodynamics of another, commonly by impacting the absorption, distribution, metabolism, or excretion (ADME) of one or both compounds in the body.  

Since these interactions can compromise drug efficacy and safety, DDI studies are an essential component of regulatory submissions and can be used to inform prescribers about necessary dose adjustments to ensure patient safety.

What determines the need for a DDI study?

The first question is simple: Do we need a DDI study?  

Drug developers are ultimately looking to understand if a drug is either influenced by interaction or the source of interaction. Early in vitro assessments often reveal whether a drug is affected by ("object") or causes ("precipitant”) such interactions.  

Key indicators include:

• Enzyme involvement: If a specific enzyme contributes more than 25% to drug elimination, it warrants investigation
• Transporter pathways: Hepatic, biliary, or renal elimination routes exceeding 25% signal the need for transporter studies
• Polypharmacy considerations: Understanding patient comorbidities and likely co-medications can highlight real-world interaction risks

How are effective DDI studies designed by Quotient Sciences?

Quotient Sciences have been conducting Phase 1 clinical pharmacology programs for over 35 years, and we have consulted on and conducted over 80 DDI studies in the past decade at both our Nottingham and Miami clinics. While DDI studies often follow a standard schematic, optimizing study design is crucial for efficiency and accuracy.  

A typical DDI study involves monitoring trial participants through several phases of clinical testing:  

• Reference Period: Single-dose administration of the object drug
• Washout: Clearing the drug before the next phase
• Steady-State Dosing: Multiple doses of the precipitant to achieve maximal inhibition or induction
• Test Period: Co-administration of both drugs to assess pharmacokinetic changes

Most studies use an open-label, two-period crossover design in healthy volunteers. However, nuances such as probe selection, dosing strategies, and duration depend on regulatory guidance and literature evidence.

What are cocktail DDI studies?  

Cocktail DDI studies allow simultaneous assessment of multiple enzymes and or transporters by administering a combination of probe drugs. Validated cocktails such as Geneva, Basel, and Cooperstown have been developed to ensure no interference between probe drugs. This approach reduces the need for multiple separate studies, saving time and resources, whilst still prioritizing data quality.

However, recent research reveals a disconnect between validated cocktails and real-world practice. Of 122 cocktail studies published between 2014 and 2024, only 17 matched validated combinations. This gap illustrates the current trends in cocktail DDI design, and suggests opportunities for greater alignment between regulatory recommendations and clinical implementation.

What are some trends and challenges in DDI research?

Our systematic review of the past decade uncovered several notable trends:

• Enzyme-focused studies dominate: CYP enzymes are far more frequently assessed than transporters, reflecting historical priorities and the availability of transporter-specific probes
• Declining trial numbers: Cocktail DDI studies have decreased over the past decade, influenced by COVID-19 disruptions, evolving regulatory guidance, and economic pressures. Cocktail DDI studies may not form a part of every molecule’s development; however, we would often advise drug developers to adopt this study type when a critical data review indicates efficiencies could be made compared to standard DDI approaches.      
• Funding constraints: Drug developers increasingly favor targeted studies over exploratory designs, relying on in vitro data to prioritize critical pathways
• Application of silico pharmacokinetic (PBPK) modelling: A promising development is the adoption of PBPK modelling, enabling researchers to simulate DDI scenarios without conducting full-scale clinical trials, reducing costs and timelines whilst maintaining scientific rigor

Case study: Optimizing DDI study design  

Quotient Sciences are often approached by clients looking to conduct complex, multi-part study requests. In one instance, a client proposed three separate clinical pharmacology DDI studies for the evaluation of their molecule, a therapy for use in a rare disease, involving two cocktail designs and one single-object investigation. If conducted separately, the studies would span 21 months and require approximately 36 participants.

By consolidating the two cocktail studies into one single study part and running it alongside the object cohort under a single protocol, we reduced timelines to six months and significantly cut costs. This optimization underscores the importance of strategic design in accelerating development without compromising data integrity.  

Additionally, we recently worked on a project to build a PBPK model for belomosidil, based on published ADME and bioavailability data for the drug. The model was validated against observed clinical results. The model accurately predicted outcomes for strong and moderate CYP3A inducers, demonstrating its value in scenario testing and regulatory decision-making. For more information, download our recent poster.

The future of DDI research

DDIs will remain a cornerstone of clinical pharmacology, but the methods we use to assess them are evolving. Improved in vitro assays, cocktail combinations that have been better validated, and advanced PBPK modeling offer pathways to more efficient, cost-effective research.

Quotient Sciences are committed to leveraging these innovations to deliver high-quality data packages that safeguard patient health and support regulatory success. Interested to learn how we can support your next DDI study? Speak with our team to explore a tailored clinical program for your therapy.