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Reflecting on Scientific Achievements in 2023

Dr. Andrew Lewis , Translational Pharmaceutics , Drug Product , Drug Development Consulting , Clinical Pharmacology , Peptides

Reflecting on Scientific Achievements in 2023

Reflections - Quotient Sciences

Summary: Dr. Andrew Lewis, Chief Scientific Officer at Quotient Sciences, highlights the company’s annual scientific milestones for 2023. This included posters and presentations at industry events, and peer-reviewed publications co-authored among the Quotient Sciences' scientific team and with pharma/biotech customers. These achievements reflect Quotient Sciences’ commitment to advancing drug development through scientific excellence, global collaboration, and thought leadership across the pharmaceutical industry.

The last twelve months have certainly continued to be challenging for anyone working in the global pharmaceutical and biotech industry.

Venture funding into biotech shrunk from a peak of $53.9 billion in 2021 to $24 billion in 2023 (1), the number of biotech IPOs plummeted (2), and the collapse of Silicon Valley Bank that many biotechs relied on sent shock waves through the industry, while also being marked as the second largest bank failure in U.S. history. (3) 

Even the largest pharmaceutical companies have been affected, with Pfizer announcing $4 billion of cost cuts following plummeting demand for its COVID-19 products. (4) 

With this backdrop of financial insecurity and rising inflation, all drug development companies have had to rationalize their investments and bring even greater focus on how best to spend their funds to select and advance their molecules through development as quickly as possible.

One major takeaway from 2023 was evident: with the best science, it’s possible to weather the storm and make truly ground-breaking advancements. 

After a down year in 2022, the FDA approved 55 novel therapeutics in 2023, just under the largest-ever record of 59 approvals set in 2018. (5) Among them included the world’s first medicine using CRISPR gene editing technology, Vertex Pharmaceuticals’ Casgevy, for the treatment of sickle cell anemia – a step change for the treatment of this disease. (6) 

Furthermore, positive data was published on GLP1 analogs’ protective effects on the heart, signaling the start of a revolution in the treatment of obesity with huge potential benefits to millions of patients globally.

At Quotient Sciences, we’ve always maintained that the quality of our science is the key to our – and our customers’ – success.

As a reflection of this, this year we have presented over 25 posters and 5 podium presentations at scientific conferences around the world, 4 papers in peer-reviewed journals, and numerous interviews in relevant industry publications. 

My colleagues presented on topics including 14C drug substance synthesis at the 26th Workshop of the IIS; modified release dosage form development at the Controlled Release Society; and clinical evaluation of a gastro-retentive formulation at AAPS. Data from numerous first-in-human studies was presented at conferences such as ESMO, the European Cystic Fibrosis Conference, and the International Parkinson’s Disease Conference to name a few. 

Additionally, our team hosted 14 seminars and 8 webinars to demonstrate our expertise through success stories and partnerships with companies including Ensysce Biosciences and Charles River. 

I am incredibly pleased to see my colleagues sharing their work with the wider scientific community. I’d like to say a huge thank you to them and to our collaborators for taking the time to do so.

What really strikes me is not the number but the variety of subject matter that our team showcased over the past year. The diverse subject matters of these publications reflect our unique Translational Pharmaceutics® platform that integrates conventionally siloed specialisms required to develop medicines.

It was a tremendous recognition and reflection of our relentless focus on customer service, quality, and world-class science to be honored as part of the 2023 British Made Awards, the 2023 Pharma Innovation Awards, and the 2023 CDMO Leadership Awards. 

We support our customers with a breadth of expertise that we believe is unrivaled in the pharma services sector, and our focus on saving both time and cost in the development of medicines is something particularly prescient in the current climate.

Looking back at the year, I’m inspired by the resilience and tenacity with which we achieved these milestones amidst unprecedented challenges. 

From drug substance design and custom synthesis, drug product development and manufacturing, through to clinical testing, I am incredibly proud of the science we deliver, and I’m truly excited to see what we will achieve together with our customers and our partners in the coming year.

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Dr. Andrew Lewis from Quotient Sciences reflects on 2023 company milestones and achievements

References:

(1) 48% of biotechs relying on Big Pharma for funding: ICON survey

(2) VC funding trends in biotechnology

(3) The Silicon Valley Bank Collapse Explained

(4) Pfizer shares sink after it resets 2024 COVID expectations

(5) 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds

(6) FDA approves world's first CRISPR-based medicine for sickle cell

Volunteer Centricity in Early Clinical Development: How Quotient Sciences Enhances Study Outcomes through a Focus on Volunteer Advocacy and Feedback

Clinical Pharmacology , Nottingham

Volunteer Centricity in Early Clinical Development: How Quotient Sciences Enhances Study Outcomes through a Focus on Volunteer Advocacy and Feedback

For sponsors developing early‑phase programs, volunteer and patient experience, compliance, and retention are not peripheral concerns — they directly influence timelines, data quality, and regulatory confidence. Selecting a CRO partner that places volunteers at the heart of their clinical programs offers several advantages: The CROs that are most committed to ensuring a positive and safe experience directly impacts retention rates, compliance, and the overall quality of clinical data. 

Quotient Sciences has a long history of success in early development, across more than three decades and over 1,300 Phase I programs at our clinical sites in Miami (US) and Nottingham (UK). Our teams conduct first-in-human to proof of concept as well as a range of clinical pharmacology studies—including food effect, drug-drug interaction (DDI) and human ADME assessments.  

With over 35,000 active healthy volunteers and specialized recruitment teams, we support a range of study designs, including those involving special populations, always aiming to deliver high quality data with an emphasis on safety, compliance, and operational reliability. Above all, volunteer satisfaction and safety throughout every trial.

According to Clare Preskey, Executive Director, Clinical Operations, “What differentiates our approach is not individual initiatives, but a formalized, long‑standing framework that embeds volunteer feedback into how studies are designed and delivered across both our US and UK clinics.”

A culture of volunteer centricity and advocacy

Inspired by patient centricity discussions happening at an industry-wide level, we’ve put a focus on healthy volunteer centricity for well over a decade and now the focus is back to include patients. At both of our clinics, our volunteer centricity group is made up of staff and volunteers who work to provide ongoing, independent feedback on procedures and documentation through open forums and regular input.  

Our goal is to maintain a consistent approach that reflects volunteer perspectives in how studies are conducted, and strive for continuous improvement related to:

  • Recruitment rates – 99% of our studies start on-time with full cohorts  
  • Volunteer retention on studies – >98% of our studies complete with full cohorts  
  • Volunteer well-being
  • Volunteer satisfaction, resulting in a high proportion of repeat volunteers  
  • Compliance and treatment adherence  
  • Clear and concise documentation that is well understood by our volunteers

Group members work diligently to gather feedback from volunteers, review materials such as patient information sheets, and consider and act upon suggestions, offering feedback when appropriate. Both of our clinics follow a similar approach, ensuring consistency in the quality of studies and volunteer experience across our sites.  

Our volunteers have expressed their appreciation for our teams taking their feedback into account and have highlighted to us the positive impact of these changes and benefit to overall well-being throughout their time participating in our study programs.  

We routinely make improvements based on volunteer feedback. Our new, state-of-the-art facility, Lee House, at our Nottingham campus, features entertainment including dartboards, re-felted pool tables, new Xbox consoles, and new board games. We significantly updated our Nottingham clinic in 2024, with renovations including refreshing paint and flooring, as well as new mattresses, pillows, and linens. Additionally, we added a new outdoor space for volunteer enjoyment.

Similarly, our patient-centric practices complement our volunteer-centric initiatives. We have made adaptations in clinic processes to accommodate patient cohorts; for example, offering chaperones, offering remote participation when possible, adjusting clinic layouts to make room for additional equipment.

We take great pride in ensuring our volunteers have a positive experience working with us and are proud of the fact that volunteers have told us directly that our culture of volunteer centricity makes us a number one choice for volunteers wishing to participate in trials in the UK. In 2025, 100% of volunteers said they would come back to do another study and 100% would recommend us to a friend or family.

Diversity and inclusivity in clinical trial practice

As a global company, we value representing the communities we serve and our goal is to develop a diverse volunteer panel. For example, cultural adaptations for Japanese bridging studies have included providing on-site translators as well as translated menus, reading materials.  

To enhance outreach to diverse and underrepresented populations, we offer targeted recruitment strategies including:  

  • Strategic partnerships with community organizations, faith groups, and local leaders
  • Inclusive advertising using diverse imagery and culturally relevant messaging
  • Multilingual materials and staff trained to communicate in participants’ preferred languages
  • Simplified, plain-language documentation to improve accessibility and understanding
  • Financial and logistical support such as travel stipends, childcare assistance, and flexible scheduling

Our team undergoes regular cultural competency training to reduce unconscious bias and improve participant experience. We also monitor diversity metrics throughout recruitment to identify gaps and continuously improve our approach.  

While early phase trials typically involve small sample sizes and are not intended to be demographically representative of the patient population, they play a critical role in generating foundational safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. We uphold a strict non-discrimination policy in line with all applicable laws, and our recruitment practices are designed to be fair, transparent, and inclusive. In accordance with UK Health Research Authority (HRA) and US Food and Drug Administration (FDA) guidance, we ensure that no individual is excluded unnecessarily. Where we identify inclusion criteria that may inadvertently exclude specific sub-populations, we proactively raise this with the sponsor to support more inclusive protocol design.  

By embedding inclusivity into our recruitment strategy, we not only uphold ethical standards but also support our sponsors in meeting regulatory expectations and enhancing the robustness of their clinical development programs.  

Adapting to the needs of our sponsors

Common sponsor questions to our teams are often focused on volunteer wellbeing, compliance, retention, and diversity. These factors are key elements considered by sponsors in decision-making, and our staff ensures processes are optimized in each of these areas.  

In a recent clinical trial, to accommodate a sponsor’s request, our team took extra measures to ensure our volunteers were able to get outside for a walk and some exercise around the country park as often as possible to enhance their wellbeing and mental health whilst on trial.

Taking Part

We pride ourselves on our altruistic approach that underpins everything we do. By actively seeking and integrating volunteer feedback into study design and delivery, we aim to not only improve volunteer satisfaction but foster trust and engagement among participants. This approach leads to smoother study operations, higher rates of repeat volunteers, and greater regulatory confidence, ultimately supporting sponsors in delivering successful early-phase programs.

Want to learn more about our work in early clinical development or interested in taking part in one of our upcoming clinical studies? Visit our volunteer website for more information or don’t hesitate to contact our team today. 

  pool tables at Nottingham clinic  bingo hosted at Nottingham clinic35th anniversary of Quotient Sciences cards at Nottingham clinic

 

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

Clinical Pharmacology

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

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. 

Expert Perspectives on Metabolic Drug Development

Clinical Pharmacology , Phase 1 Trials , Dr. Andrew Lewis

Expert Perspectives on Metabolic Drug Development

Summary: In this Q&A with Dr. Andrew Lewis, Chief Scientific Officer, Matt Paterson, Chief Strategy Officer, and Dr. Andreas Reichl, Senior Drug Development Consultant, we discuss developments in this space and how we support clients to address drug product formulation and clinical testing of these therapies.  

Interest in the development of new therapies to treat endocrine and metabolic diseases has skyrocketed, driven in part by increased commercial success and medical efficacy of GLP-1 agonists and other incretin hormones used to treat obesity in recent years.

As a result, research and development spending in metabolic disease therapies is now on par with oncology, making it one of the most sought-after areas in the pharmaceutical industry.

Q: What is fueling the tremendous growth of the metabolic drug market?

Dr. Andreas Reichl: Obesity rates have soared globally, tripling for women and quadrupling for men since 1975. The industry is responding, and there is currently a pipeline of over 300 obesity treatments in development. The market for obesity therapies alone is projected to surge from $2.4 billion in 2022 to as much as $100 billion by 2030.

Dr. Andrew Lewis: The success of GLP-1 agonists and incretin hormones in treating obesity is now being applied in other areas. Beyond obesity, there’s a broad spectrum: diabetes remains a common comorbidity, and cachexia (“wasting syndrome”), which often also affects cancer and HIV patients. 

Q: Developing these therapies sounds complex. What are the main formulation and delivery challenges for new therapies to treat endocrine and metabolic diseases?

Dr. Andrew Lewis: Although injectable GLP-1 therapies work very well, they have faced hurdles in recent years. There have been various news stories regarding supply chain disruptions and challenges with maintaining patient adherence over extended time periods. 

As I’ve discussed in past articles and at conferences, oral drugs are preferable for patients and are easier to produce, but oral GLP-1 have historically been tougher to formulate because of poor solubility or bioavailability. Many oral GLP-1s need permeation enhancers, and finding the right ratio and dosing schedule can be a challenge. Achieving effective plasma levels with once-daily dosing can take extensive testing.

Dr. Andreas Reichl: Another key challenge is bridging the gap between animal models and human results, especially for pharmacokinetics. It takes ingenuity and rigorous science to get it right.

Q: How do clinical trials in this space differ, and what strategies help ensure success for new therapies to treat endocrine and metabolic diseases?

Dr. Andreas Reichl: Trials often run for long periods, as safe weight loss and body composition changes take time. Patient retention is a big concern, and there are of course instances where adverse events and slow results discourage participation.

We use trial designs like lead-in phases and dose escalation to build tolerance, plus pharmacodynamic endpoints for early efficacy reads. Engaging patients through support groups, dietary counseling, and proactive communication is vital for retention.

The overall patient experience must be front and center. Minimizing burdens and improving engagement increase both participation and the value of trial data.

Q: What sets Quotient Sciences’ services apart from other CDMO or CRO addressing metabolics?

Matt Paterson: Quotient Sciences has supported metabolic drug development for a number of years. Taking a fully integrated approach has been one aspect constantly setting us apart from other vendors, with formulation development, manufacturing, and clinical capabilities within the same organization.

We’re among the few industry partners able to offer developers a fully integrated model—Translational Pharmaceutics®, our platform for accelerated drug development that we’ve applied to client programs for almost two decades.

How we bring together multidisciplinary teams is another point I’d raise that sets Quotient Sciences apart. Drug development consultants, formulation scientists, regulatory and quality assurance specialists, and data science professionals are among the Quotient Sciences colleagues who are assembled to support a project. They are all coordinated by a dedicated project manager, and this model ensures activities can run in parallel and stay coordinated.

Dr. Andrew Lewis: Oral peptides is an application where Translational Pharmaceutics® has stood out, and our experience in this space continues to evolve. We’ve worked on over 14 oral peptide programs over the last decade, and that has included evaluating 10 different permeation enhancers, including modeling & simulation studies on the effect of a permeation enhancer.

It’s worth adding that our expertise in overcoming CMC challenges for both injectable and oral peptides, and our proficiency in clinical pharmacology, played a critical role in supporting development of Novo Nordisk’s Rybelsus®.

Matt Paterson: We’ve often heard from clients how seeing Translational Pharmaceutics® applied is a real eye-opening experience. When compared to “traditional” methods of development, we’re able to support clients in achieving milestones faster, with greater precision and confidence.

For more insight about Quotient Sciences’ experience, download our recent whitepaper, “How to Capture Growth in the Expanding Metabolic Drug Market.

i Baekdal TA, Donsmark M, Hartoft-Nielsen ML, Søndergaard FL, Connor A. “Relationship Between Oral Semaglutide Tablet Erosion and Pharmacokinetics: A Pharmacoscintigraphic Study.” Clin Pharmacol Drug Dev. 2021 May;10(5):453-462. doi: 10.1002/cpdd.938. Epub 2021 Mar 22. PMID: 33750044; PMCID: PMC8251533.  https://pubmed.ncbi.nlm.nih.gov/33750044

Recovery in MHRA approval times for Phase I trials in the UK: Q&A with Kate Darwin

Regulatory , Phase 1 Trials , Clinical Pharmacology

Recovery in MHRA approval times for Phase I trials in the UK: Q&A with Kate Darwin

Summary: Kate Darwin, Vice President of Regulatory Affairs at Quotient Sciences, discusses the recovery of MHRA approval times for Phase I trials in the UK. Despite initial delays due to resource shortages, MHRA approval times have improved and consistently meet statutory timelines as of mid-2023. Kate explains the Combined Review process, which streamlines regulatory and ethics reviews into a single application. Quotient Sciences has successfully managed numerous applications under the UK MHRA Combined Review process, ensuring efficient trial approvals and maintaining high standards in clinical research. 

*MHRA timelines and data cited were current as of publication date on January 17, 2025

Why the UK remains a great place to do Phase I research

From discussions with clients over the last 6 months, it’s become clear that there are many misconceptions about UK clinical trial review timelines since the introduction of the Combined Review process. 

In this blog, we speak with Kate Darwin, Vice President of Regulatory Affairs at Quotient Sciences, who dispels the myths and explains why the UK remains a great place to do Phase I research

Q: What is Combined Review? 

A: In January 2022, the UK introduced Combined Review (CR), a new process for obtaining regulatory approval for clinical trials. The key feature of CR is that an applicant makes a single application and obtains a single opinion from the MHRA and an independent Research Ethics Committee (REC). It’s a much more streamlined process than having separate applications and approvals. 

Q: What is the application process under Combined Review? What are the timelines?

A: Applicants manage CR applications via an online system called IRAS (short for the Integrated Research Application System), and upload supporting documents in simple PDF format. Regulatory and ethics reviews are done in parallel. If more information is required, a single, joint request for further information (RFI) is raised by the MHRA and REC, the applicant responds, and a single decision is issued. By law, the initial review must be done within 30 days, and the final outcome must be issued within 60 days.

UK Combined Review (CR) takes up to 30 days for the initial review with a final decision issued within a maximum of 60 days from submission.

UK Combined Review (CR) takes up to 30 days for the initial review with a final decision issued within a maximum of 60 days from submission.

For trials involving exposure of participants to ionising radiation (e.g. ADME studies), IRAS also generates an application form for Administration of Radioactive Substances Advisory Committee (ARSAC) review. 

Substantial amendments are managed via CR and reviewed within 35 days.

Q: There are rumours that UK timelines for trial approval are very long – is that true?

A: No. A few months after the successful launch of CR in 2022, MHRA review timelines did increase, peaking in Q2 2023. The prolonged approval times weren’t caused by CR, but by a shortage of MHRA resources. 

In summer 2023, the MHRA made clinical trial authorisations its highest priority, redeployed resources, harnessed external resources and improved processes to clear the backlog. 

Since September 2023, the MHRA has consistently met its commitment to meet statutory timelines, and there have been no delays to regulatory approvals for UK clinical trials. 

In summary, UK approval timelines have recovered and have been within statutory limits for well over a year.

Q: What is Quotient Sciences’ experience of UK Phase I clinical trial approval timelines under Combined Review?

A: Quotient Sciences’ regulatory team manage CTA applications for over 80% of the clinical trials in our Nottingham, UK clinic, and make about 25% of annual UK Phase I trial applications. We’ve made over 70 successful submissions under CR, and over 30 ARSAC applications in the last 2 years.

Since the decisive action taken by the MHRA in summer 2023, we’ve submitted over 25 clinical trial applications – all were reviewed within 30 days. 

Our average approval timelines are shorter than both the statutory 60-day limit and timelines achieved by our sponsors, with some of our approval times as short as 36 days. Our highly experienced Regulatory Affairs team of CMC and clinical experts specialises in early phase applications, and our high volume of submissions allow us to quickly understand and adapt to the latest thinking at the MHRA and RECs and advise sponsors on how to avoid RFIs. 

Q: What are current UK timelines for approval of clinical trials and how do they compare internationally?

A: Each month, the MHRA publishes metrics on its performance. The latest metrics show average review timelines (across all clinical trial phases) of 28 days for initial trial applications and 29 days for amendments, with 100% of reviews within statutory timelines.

When comparing UK timelines with other jurisdictions, it’s important to make a fair comparison. For example, the headline FDA timeline for IND review is 30 days; however, unlike UK CTAs, US INDs must be submitted in eCTD published format, which can add 2 weeks to a submission timeline and extend the overall regulatory process. 

We’ve increasingly seen sponsors taking a more conservative approach to addition of protocols to open INDs and requesting start-up timelines of up to 90 days to mitigate against FDA questions. 

UK approval times compare favourably with those in the EU, where CTA approval timelines, assuming no validation queries, are up to 91 days.4

Q: What are the advantages of doing Phase I trials in the UK?

A: The UK is one of the top destinations for delivery of high-quality commercial early phase clinical trials2, with high scientific, data integrity & ethical standards. We have strong scientific and medical expertise and many highly experienced, MHRA-accredited Phase I units, such as Quotient Sciences’ Nottingham clinic, with a proven track record in delivering internationally accepted trial data, with excellent safety and quality standards overseen by the MHRA. Those units are underpinned by an established Phase I clinical trials infrastructure, including supporting services such as licensed, GMP-compliant manufacturing of high-quality investigational medicinal products, laboratories, monitoring and pharmacovigilance. The attractiveness of the UK business environment is backed up by strong rankings in both the Ease of Doing Business and Global Innovation Index rankings (globally 8th and 4th, respectively)3.

CR provides a straightforward, streamlined application process for clinical trials, with robust regulatory and ethical review, giving sponsors confidence in the quality of their investigational medicinal product, the supporting toxicology, and the scientific integrity and ethics of the trial. Furthermore, the UK’s approachable, respected regulator offers rapid, informal advice and targeted scientific advice. And the UK’s deferral process provides a favourable balance of transparency with commercial protection.

The UK’s robust and pragmatic regulatory environment, coupled with its Phase I infrastructure, enables innovative new medicines to move rapidly from bench to bedside. 

Q: Why place UK Phase I clinical trials at Quotient Sciences?

A: Quotient Sciences have been running Phase I clinical trials at our Nottingham clinic for over 30 years. Aspects that set Quotient Sciences apart from our competitors were recently discussed by our Chief Operating Officer and Nottingham, UK site head, Denise Sutton. 

In summary, we offer sponsors an accredited, GCP-compliant Phase I clinic that meets the MHRA’s stringent safety and quality standards, with a wide range of pharmacodynamic and safety tests, and integrated GMP manufacturing. The clinic is supported by a multi-disciplinary team, including a large medical team with highly experienced Principal Investigators. We have broad experience across a range of study types, including first-in-human single/multiple ascending doses, human ADME studies, drug-drug interaction studies, ethnic bridging and formulation optimization, and employ adaptive, flexible trial designs. Our real-time electronic data capture system generates GCP-compliant data that meets international ethical and data integrity standards, and is accepted by global regulators, including the FDA and EU authorities. And our high-quality regulatory submissions coupled with our experience in participant recruitment, large volunteer database and volunteer-centric approach ensure rapid recruitment and favourable, reliable trial timelines.

Quotient Sciences have collaborated with our regulators to reposition the UK as a robust, reliable and competitive environment for clinical trials. We’re committed to working with sponsors to ensure the fastest route to clinic.

Get more information about Phase I trials at Quotient Sciences

References

  1. Independent report. Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report. 26 May 2023 (Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report - GOV.UK (www.gov.uk))

  2. ABPI. The road to recovery for UK clinical trials, December 2024. The road to recovery for UK industry clinical trials

  3. HM Government Life Sciences Vision, 2021 (Life Sciences Vision (publishing.service.gov.uk))

  4. EMA. CTIS Evaluation Timelines. CTIS training programme, version 2.1, September 2024.

Spotlight on Nottingham: Q&A with Denise Sutton, Chief Operating Officer and Site Head - Nottingham, UK – Part 2

Translational Pharmaceutics , Clinical Pharmacology , Denise Sutton , Nottingham , Denise Sutton

Spotlight on Nottingham: Q&A with Denise Sutton, Chief Operating Officer and Site Head - Nottingham, UK – Part 2

Summary: Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences, Nottingham, UK, shares insights into the site's growth and strategic direction. She highlights investments in facilities, equipment, and talent to support integrated drug development services. Denise emphasizes the importance of cross-functional collaboration, innovation, and customer focus in delivering high-quality outcomes. Her leadership fosters a culture of continuous improvement, ensuring the Nottingham site remains a key contributor to global pharmaceutical development.

In the second of this two-part series with Denise Sutton, we discuss Quotient Sciences’ clinical pharmacology offering in Nottingham.

Denise also highlights how we stay ahead of an evolving regulatory landscape, and how we work with our customers to determine the right program for their needs. 

Missed the first part of this series? Read it here.

What types of clinical pharmacology programs does Quotient Sciences deliver?  

At Nottingham, we offer comprehensive clinical pharmacology services that can be conducted either conventionally, with the drug product provided by the customer or a third party, or integrated with our drug product manufacturing capabilities as part of a Translational Pharmaceutics® program.  

In Nottingham, we’ve been delivering a full range of healthy volunteer studies for over three decades, including first-in-human, single and multiple ascending dose (SAD/MAD), relative and absolute bioavailability, bioequivalence, drug-drug interaction (DDI), food effect, taste masking, ethnic bridging, ADME, and thorough QT cardiac safety studies.  

Our customers benefit from consistent and seamless delivery by our experienced, multi-disciplinary teams led by a strong project management function and supported by wrap around data sciences services.

How do you deliver clinical programs in Nottingham? Why should a customer choose Quotient Sciences for their clinical program?

One of the things that I believe makes us unique is the strength of our knowledge and the consultation that we offer from our scientific, medical, and regulatory affairs teams. We work with each of our customers to provide the right level of support needed for their program, using the knowledge we gain from the wide range of projects that we work on.  

In some cases, a clinical design will already have been mapped out, and our role is to perform a review and provide suggestions. In others, we might be presented with a development challenge or a regulatory requirement, plus background data on the molecule. The team enjoys these challenges and the opportunities to review the information, consult with colleagues, and propose a clinical design.  

Once we are in the delivery phase of the program, the team continues to support the customer as they progress through regulatory approvals, clinical delivery, and reporting. We know that quality, time, and cost are key factors, and our experienced project management team works hard to ensure competitive timelines and on-time full delivery. I am proud of our strong track record of consistently delivering on our promises to our customers.

Of course, we couldn’t do any of this without the wonderful people who volunteer to take part in our trials. We have a robust volunteer database, including many repeat volunteers, and those who have referred friends and family members to take part in trials following their positive experiences coming to Quotient Sciences. Our volunteer recruitment and screening teams process over 3,000 volunteers a year and do a phenomenal job in ensuring our studies enroll on time and in full, recognizing the importance of this key milestone in the success of our trials. With our volunteer centric approach, we also work hard to make our volunteers’ stays in the clinic as enjoyable as possible and have an excellent volunteer retention record.

Finally, I couldn’t describe our clinical services without acknowledging our wonderful clinical and medical teams. These groups show incredible commitment and flexibility to ensure we have the right resourcing for each project, data quality, and, of course, volunteer safety in mind. They are guided by our Principal Investigators who have over 70 years of combined Phase I experience. They are truly experts in Phase I trials and take a hands-on approach to designing and delivering trials in our unit. I sleep soundly at night knowing these talented and dedicated teams oversee our trials and volunteers.  

One of the things that I believe makes us unique is the strength of our knowledge and the consultation that we offer from our scientific, medical, and regulatory affairs teams.

What differentiates a traditional clinical pharmacology program from a Translational Pharmaceutics® program with Quotient Sciences?

The Translational Pharmaceutics® platform integrates real-time manufacture of drug product with dosing in the clinic, and as a result, delivers significant time and cost advantages when drug product considerations are a key factor. 

For example, a formulation switch may be required, flexibility in unit dose or dose level may be needed, or the customer may have a limited amount of API. In any of these cases, on-demand drug product manufacturing with clinical testing from our facilities, effectively combining our CRO and CDMO capabilities into one program, makes a lot of sense.  

In a traditional clinical pharmacology program we receive drug product from the Sponsor or their partner CDMO as any conventional CRO would.  

Ultimately, the needs of the customer and their molecule are our priority and help shape whether we do a traditional clinical pharmacology program or a Translational Pharmaceutics® program. Whatever type of program, we take the time to fully understand our customers’ scientific, financial, and strategic requirements. We are happy to offer suggestions and explore different paths as required to optimize delivery.  

What are your thoughts on the UK regulatory landscape and how are you addressing with this?

I consistently hear from our customers that navigating an evolving regulatory landscape in the UK can be incredibly challenging. I find this extremely frustrating, but I have complete confidence in our teams’ ability at removing this barrier. We are always happy to talk with customers about any questions or concerns they have regarding doing their Phase I research in the UK. Our experience is that getting to first subject first visit can be as fast (and often faster) in the UK as other regions. Our high performing multifunctional teams are skilled at accelerating through the critical path milestones.

Our in-house regulatory team is based in Nottingham and has strong relationships with the MHRA and the Health Research Authority (HRA). The senior team, in particular, is actively involved in reviewing and shaping new guidelines. We also engage with the authorities and trade associations to keep current with emerging trends and ahead of regulatory changes.  

I am extremely proud of the fact that around 25% of the applications submitted to the MHRA each year come from Quotient Sciences. This high volume of submissions allows us to quickly understand and adapt to current thinking, both at the MHRA and within ethics committees. It also means that we have built a very talented team with extensive experience. As evidence of the practical impact of this, our approval times are consistently ahead of statutory timelines.  

In a follow-up article, our VP of Regulatory Affairs, Kate Darwin, will provide more information on the UK regulatory process and the benefits of doing Phase I research in the UK.

Our experience is that getting to first subject first visit can be as fast (and often faster) in the UK as other regions. Our high performing multifunctional teams are skilled at accelerating through the critical path milestones.

Any closing thoughts to share about the capabilities or team at Quotient Sciences - Nottingham?

At Nottingham, and at all our facilities, we’re focused on delivering the highest quality of service and making a meaningful contribution to our customer's programs. We know that the difference we make is in how we lend our expertise and dedication to accelerating the next generation of medicines toward their ultimate destination: patients.  

Our customers repeatedly tell us how outstanding it is to witness project teams pull together to deliver their projects. They recognize the genuine team spirit and mutual respect between our colleagues who, for every program, set up to deliver quickly, embrace and resolve challenges as they arise, and provide consistently high service. Customers often comment that our teams really care.

These frequent testimonials are one of the many pleasures of my job, and I take great joy in sharing this feedback with my teams so we can all appreciate the impact that we have on customers’ Phase I programs. 

Whenever possible, we also share stories of the successful continuation of a molecule. It is so powerful to show the team that worked on a Phase I study, the direct impact that their work had on a patient who now has access to a new medicine.

Whatever type of program, we take the time to fully understand our customers’ scientific, financial, and strategic requirements... Our customers repeatedly tell us how outstanding it is to witness project teams pull together to deliver their projects.

 

Learn more about Quotient Sciences - Nottingham in part one of our interview with Denise Sutton

Get more information about our clinical pharmacology services or catch up on the first part of this two-part series where you can read about Denise’s background, the evolution of the Nottingham facility, and more information on the Translational Pharmaceutics® platform. 

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Spotlight on Nottingham: Q&A with Denise Sutton, Chief Operating Officer and Site Head - Nottingham, UK – Part 1

Translational Pharmaceutics , Denise Sutton , Nottingham , Clinical Pharmacology

Spotlight on Nottingham: Q&A with Denise Sutton, Chief Operating Officer and Site Head - Nottingham, UK – Part 1

Summary: Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences, Nottingham, UK, discusses the site's evolution and its role in integrated drug development. She reflects on the site's legacy, its expansion in capabilities, and the collaborative culture that drives innovation. Denise emphasizes the importance of customer-centricity, operational excellence, and team empowerment in delivering high-quality pharmaceutical solutions that support global patient needs.

Quotient Sciences – Nottingham offers our clients a powerful combination of drug development capabilities and phase 1 expertise underpinned by a strong scientific heritage.

This facility was the origin for Quotient Sciences’ Translational Pharmaceutics® platform, a unique offering not seen elsewhere in the pharma services sector combining on-demand GMP drug product manufacturing with healthy volunteer clinical trials in an integrated program of work led by a single project manager (PM). 

Designed to disrupt conventional drug development industry siloes to achieve significant time and cost efficiencies, Translational Pharmaceutics® is unparalleled in how it helps advance the next generations of medicines to market.  

In our two-part spotlight, we speak with Denise Sutton, Chief Operating Officer and Site Head for our Nottingham, UK facility, about her background, the evolution of the Nottingham facility, and the Translational Pharmaceutics® platform. 

Tell us about your background and how it led you to your current role at Quotient Sciences.

I joined the Nottingham site back in 1999 when the business was Pharmaceutical Profiles, a spin out from the University of Nottingham.  

I had completed my Ph.D. and post-doc in Biochemistry and was attracted by the novel science emerging from Nottingham under Dr. Ian Wilding, Dr. Steve Newman, and Professor Bob Davis. This team was helping drug development experts diagnose challenges in getting their product to the right location, at the right time, and at the right concentration. They were deploying gamma scintigraphic imaging studies to understand how drugs performed in humans under the banner that “a picture tells a thousand words.” It was ground-breaking science, and I joined initially as a Project Leader to help customers manage their programs on challenging molecules. This was a hands-on role in which I gained experience in drug product manufacturing, clinical activities and data analysis/reporting. There’s no better way of getting to know a business and I learned so much!

Since then, I’ve held many roles within the company spanning operations, project management and commercial. I feel extremely lucky to have been given so many learning opportunities and to have gained such a deep understanding of how these typically disparate activities can be integrated in a way that has a very positive impact for our clients’ programs.  

How has the Nottingham site transformed from when you first started to what it is today? 

We were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90% of our work focused on gamma scintigraphic imaging. Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed.  

At the end of 1999, we moved our headquarters to a purpose-built, two-story facility—now known as Trent House on our now much larger Nottingham campus. We built three GMP manufacturing suites on the top floor and three clinical wards on the bottom floor. In effect, this was the very early start of our Translational Pharmaceutics® platform.

We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, we approached the MHRA with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics® platform, and we haven’t looked back since.  

Today, our Nottingham site has expanded to a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds where we conduct healthy volunteer Phase I clinical studies, and many talented colleagues covering our spectrum of CRO and CDMO services.  

What has remained unchanged all these years is that Translational Pharmaceutics® is our flagship platform for drug development that empowers our clients with unparalleled flexibility.  

We apply Translational Pharmaceutics® across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and human ADME programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics®, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of emerging data that impacts the success of their molecule.  

As a leader at Quotient Sciences, what does a typical day look like for you? 

No two days are the same which keeps life interesting.  

Quotient Sciences is a scientifically rich, customer-responsive organization. We know that great service starts with listening to our customers and having great people with a strong team ethic to respond rapidly to the changing demands of early phase research. I therefore ensure much of my time is spent listening to customers, connecting with our project teams and challenging how we can continually improve to find time and cost savings for our customers.

What would you say are the key strengths of the Nottingham site, and how do you support customer programs? 

We’ve discussed Nottingham’s capabilities and strengths of Translational Pharmaceutics®, but I haven’t yet spoken about our project management team.

Nowhere else would a single PM oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company would be delivered from within multiple operating areas (in larger CDMOs and CROs) or through using a combination of 3rd party vendors.  

Challenges will arise, but working with the project team, the PM works to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers, so the project Gantt chart is our PM team’s guiding light. I believe our PM team is truly world-leading; they communicate well, show great compassion, and lead with integrity.  

I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, working collaboratively to deliver the best possible service. After 25 years at Quotient, I still really enjoy going to work. I am indebted to my many colleagues for helping me continue to feel like this. 

For more information about Translational Pharmaceutics®, John McDermott, VP of Scientific Consulting, explains how the platform works in a recent video.

Read part two of our interview with Denise

In the next part of this two-part series with Denise Sutton, we discuss highlights of Quotient Sciences’ clinical pharmacology offering, and how we work with our clients to design the best program for their needs. Read the second part of this series.

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Exploring GLP-1 Agonists: How they work and what the future holds for this promising treatment

Translational Pharmaceutics , Clinical Pharmacology , Peptides , Modified Release , Formulation Development , Dr. Andrew Lewis , Dr. Stuart Mair

Exploring GLP-1 Agonists: How they work and what the future holds for this promising treatment

Summary: We explore the growth of GLP-1 agonists, what they are, how they work and their benefits, and how Quotient Sciences are helping companies tackle challenges in the development of these therapies, including oral formulations. GLP-1 agonists, originally developed for Type 2 diabetes management, have shown promise in treating obesity and other metabolic disorders. While traditionally administered via subcutaneous injection, efforts are underway to develop oral formulations to improve patient compliance. 

The surge in demand for GLP-1 agonist therapies will boost the biotech sector, driving innovation and growth in the years to come. 

In the United States alone, it is projected that the number of GLP-1 users will hit 30 million by 2030, or approximately 9% of the U.S. population, according to data collected by J.P. Morgan Research. 1 This rise in demand reflects the growing global challenge of managing chronic metabolic conditions such as diabetes and obesity.

The Centers for Disease Control and Prevention (CDC) estimates that the prevalence of obesity in the U.S. has grown from 30.5% in 1999–2000 to 41.9% in 2017–20202. On a global scale, obesity has more than tripled since 1975.3  

The need for more effective treatments that improve patient outcomes and adherence is growing. Ten GLP-1 agonist drugs, including semaglutide (RYBELSUS®, Ozempic® and Wegovy®) and tirzepatide (Mounjaro® and Zepbound®) have already received FDA approval for managing Type 2 diabetes and weight loss. In an increasingly competitive space, companies are looking for alternative and more patient-friendly methods to administer these therapies other than by subcutaneous (SC) injection.  

In this article, we explore the growth of GLP-1 agonists, what they are, how they work and their benefits, and how Quotient Sciences are helping companies tackle challenges in the development of these therapies, including oral formulations. For more insight, be sure to sign up for email news and updates from Quotient Sciences.

What are GLP-1 agonists and how do they work? 

GLP-1 (glucagon-like peptide-1) and GIP (gastric inhibitory peptide) are key incretin hormones involved in regulating glucose metabolism. Both are produced in the gastrointestinal tract in response to food intake, specifically glucose and fats. 

When a person consumes food, GLP-1 is released from the intestines into the bloodstream, where it performs several key functions. It signals the pancreas to produce insulin, which helps lower blood sugar levels, and simultaneously tells the liver to reduce glucagon secretion, a hormone that typically raises blood sugar levels. The incretin analogues mimic the action of the naturally occurring hormones, but have been designed to be more potent and longer circulating.

Another function of GLP-1 is its ability to slow gastric emptying. By delaying the passage of food from the stomach to the small intestine, GLP-1 ensures that glucose is released into the bloodstream more gradually, preventing sharp spikes in blood sugar levels. It is also known that GLP-1 has a direct effect on reducing appetite via receptors in the brain. 

What conditions do GLP-1 agonists treat?

In recent years, much attention has been placed on the use of GLP-1 agonists as a treatment for obesity. Research from Harvard Medical School indicates that newer generations of GLP-1 agonists can achieve an average weight loss of 15–25%, significantly surpassing the efficacy of earlier treatments.

As research in this area continues, the industry is seeing that GLP-1s can offer significant benefits for patients, beyond blood sugar control and weight loss. 

For example, large-scale cardiovascular outcome trials (CVOTs) have demonstrated that GLP-1 receptor agonists (GLP-1RAs) can significantly reduce the incidence of major adverse cardiovascular events, including heart attack and stroke. GLP-1 drugs have also shown recent potential in protecting kidney function, as evidenced by their ability to reduce albuminuria and slow the decline of the estimated glomerular filtration rate (eGFR), a critical indicator of kidney health.

Despite benefits, like all drugs, GLP-1 agonists are not without side effects, such as nausea and vomiting, which tend to subside over time.3

Are oral solid dose formulations the future of GLP-1 therapies?  

Typically, most approved peptide-based medicines are administered via injection, which may be a drawback for some patients. Maximizing systemic absorption and achieving therapeutic drug levels of a peptide following oral administration is a challenge for drug developers due to degradation in the digestive tract and low, and often variable, absorption. Addressing these problems is crucial as research progresses from preclinical to clinical stages.  

Following decades of research in both academia and industry, innovations in peptide chemistry and drug delivery are enabling more peptides to be optimized for oral administration, making it easier for patients to start and continue their treatment. In addition a number of small molecular weight compounds targeting the GLP-1 receptor are in development and the availability of oral alternatives is likely to significantly change the therapeutic landscape.

Quotient Sciences' capabilities in GLP-1 development 

As the scope of GLP-1 agonists continues to expand, their therapeutic potential is evident, opening new avenues for pharma and biotech companies and their outsourcing partners to explore. 

In clinical trials, the effects of combining GLP-1 agonists with other compounds to act synergistically is being investigated, presenting an exciting opportunity for innovation, enhanced efficacy, and broadened therapeutic applications. At Quotient Sciences, we can help make this process smoother with our integrated clinical pharmacology programs. From early drug development to Phase I trials, we provide the insights and support you need to make critical decisions faster and more effectively. 

Quotient Sciences' drug product formulation development, oral peptides and oral drug delivery expertise including extensive oral peptide experience can help your company harness the full potential of your molecule. 

References:

  1. https://jpmorgan.com/insights/global-research/current-events/obesity-drugs
  2. https://ncbi.nlm.nih.gov/books/NBK551568
  3. https://mayoclinic.org/diseases-conditions/type-2-diabetes/expert-answers/byetta/faq-20057955#:~:text=Doctors%20do%20know%20that%20GLP,longer%2C%20so%20you%20eat%20less
  4. https://health.harvard.edu/staying-healthy/glp-1-diabetes-and-weight-loss-drug-side-effects-ozempic-face-and-more 

Ozempic®, Wegovy®, and RYBELSUS® are registered trademarks of Novo Nordisk A/S.

Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company. 

Interview with Thierry Van Nieuwenhove: On Quotient Sciences' Growth and Role in Accelerating Drug Development

Thierry Van Nieuwenhove , Translational Pharmaceutics , Integrated Programs , Drug Product , Clinical Pharmacology

Interview with Thierry Van Nieuwenhove: On Quotient Sciences' Growth and Role in Accelerating Drug Development

Summary: Thierry Van Nieuwenhove joined as CEO of Quotient Sciences in 2023. Thierry discusses the company's unique approach to accelerating drug development through Translational Pharmaceutics® platform, a platform that integrates CRO and CDMO services that are traditionally provided by siloed vendors, thereby streamlining the drug development process. He highlights Quotient Sciences' commitment to delivering innovative drug development programs and the dedication of its colleagues across the UK, US, and Europe in supporting clients' success. 

Quotient Sciences' growth as a CRDMO and role in accelerating drug development

In this interview with Thierry Van Nieuwenhove, Quotient Sciences' Chief Executive Officer, we talk about the unique factors that set the company apart, the strategic growth plans aimed at enhancing the delivery of innovative drug development programs, and how the dedication of our colleagues across the United Kingdom, United States, and Europe is instrumental in helping our customers accelerate drug development every day.

Since joining Quotient Sciences in October 2023, what have been your impressions of the company so far? 

Thierry Van Nieuwenhove (TVN): It was humbling to see the impact that Quotient Sciences’ Translational Pharmaceutics® platform has delivered for our customers such as Ensysce Biosciences , DayOne Therapeutics, Oxilio, and many others over the past 16 years. The relationships that we have built, both with small biotechs and with large Fortune 100 pharmaceutical companies, have been impressive to see.

Each program we’ve supported has come with its own development story, but all ultimately resulted in expedited delivery of medicines to patients—an important goal that we always keep in mind and share with clients. 

There is not a CDMO or CRO out there today that offers a platform quite like Translational Pharmaceutics®, let alone one proven to remove a year or more from conventional drug development timelines in the way that Translational Pharmaceutics® can when it comes to integrating drug substance, drug product, and clinical testing activities. 

We’ve supported over 500 drug development programs via Translational Pharmaceutics® for a broad range of clients, including many repeat customers. I am proud to be part of a company that is not only delivering drug development in a unique way for our customers but with a track record of impactful time and cost savings that ultimately helps increase the success rate of new medicine approvals. 

Did anything surprise you about the company? 

TVN: Quotient Sciences is known for its reputation of providing deep technical and scientific consultation in the design and manufacture of small-molecule drug products, with proven formulation development expertise. As a company, though, we offer even more than some may realize to make us a more holistic CDMO/CRO outsourcing partner with integrated capabilities.

Capabilities and expertise for drug substance API synthesis and manufacturing from our Alnwick, UK facility, and complimentary services through our partnership with Charles River Laboratories provide early opportunities to partner with customers coming out of candidate and preclinical development. Additionally, we are expanding our preclinical development services this year with new capabilities being added at Nottingham.

From our Miami, FL, and Nottingham, UK facilities, we offer clinical pharmacology services, including the ability to conduct Phase I clinical programs with healthy volunteers and support services for data science and analytics. Downstream, we can scale up drug products for later-stage trials, although we don’t have a hand in conducting those trials directly with patients, and can commercially supply drug products for marketed products.

Thierry Van Nieuwenhove

Ultimately, no matter how a customer chooses to work with us and where they work with us, I want our customers to know that the dedication and expertise of our more than 1,300 colleagues will help deliver success.

How does Translational Pharmaceutics® add value in drug development?

TVN: Translational Pharmaceutics® integrates formulation development, on-demand and adaptive GMP manufacturing, healthy volunteer clinical testing and data analysis within a single organization. A unified project management team helps coordinate all activities.

In that sense, Translational Pharmaceutics® transforms the traditional outsourcing model, where a combination of CDMOs and CROs are usually required with handovers at different points throughout a drug program. In doing so, the platform offers significant success rates linked with time and cost efficiencies. 

Translational Pharmaceutics® helps clients access information faster so they can make more informed decisions based on emerging human clinal data, gives flexibility to optimize formulation compositions within a study, and reduces drug substance consumption by up to 85%.

A recent application of Translational Pharmaceutics® was our collaboration with YourChoice Therapeutics, a pioneer of hormone-free family planning products. 

Having established a scale-up-ready synthetic route for the YCT-529 API at our Alnwick, UK facility, our team developed the initial product formulation and the first-in-human (FIH) clinical protocol in parallel. Once approved, this allowed our Nottingham, UK facility to perform on-demand drug product manufacturing for precision dose escalation, removing extensive and costly upfront product manufacturing. 

The YourChoice team also complemented our relationships with UK regulatory bodies, which helped navigate and overcome regulatory hurdles to bring YCT-529 to clinical testing sooner. 

Looking ahead, what are some of Quotient Sciences' top priorities?

TVN: Although 2023 was a difficult year for the entire industry, CDMOs such as Quotient Sciences continued to thrive by providing innovative solutions, a deep understanding of science, and strategic partnership to clients. In 2024, we’re seeing signs of recovery, with some increased biotech industry funding again to support the growing number of new molecules in the development pipelines. 

The expansion of our Translational Pharmaceutics® platform in the US remains one key objective. Many of our customers are based in the United States where we currently have three manufacturing facilities that complement our facilities in the United Kingdom. 

Our Garnet Valley, PA facility develops simple and complex small molecule oral drug products supporting programs from the preclinical stage to clinical proof-of-concept. A nearby facility in Boothwyn, PA offers scale-up to late-phase manufacturing and commercial drug product supply. From there, our clinical pharmacology facility in Miami, FL allows us to conduct first-in-human Phase I clinical trials on-site with healthy volunteers and features a compounding pharmacy. 

Applying Translational Pharmaceutics® under US regulations complements capabilities already offered from our Nottingham, UK facility, so US-based clients have flexibility in where they choose to work to realize the time- and cost-saving benefits that Translational Pharmaceutics® delivers.

Ultimately, no matter how a customer chooses to work with us and where they work with us, I want our customers to know that the dedication and expertise of our more than 1,100 colleagues will help deliver success.

Colleague Stories: Alejandra Ugalde

Careers , Miami , Clinical Pharmacology

Colleague Stories: Alejandra Ugalde

Alejandra Ugalde is the Screening Manager at our Miami, FL facility.

Alejandra supports volunteer screening and volunteer recruitment for our Phase I clinical trials. In this interview, she shares a day in the life of her role. 

What I enjoy most about my role is the people, including working with patients or volunteers, our screening team, and our whole Miami team. I really enjoy the patient care aspect of my nursing education and the ability to apply that here at Quotient Sciences.

-    Alejandra Ugalde

What does a screening Manager do at Quotient Sciences?

As a Screening Manager, I oversee all screening activities and volunteer recruitment on a day-to-day basis, providing guidance and support to the screening team. Our main priority is to ensure that all ongoing or new clinical trials are enrolled in full and deadlines are met on time.

What does your typical day look like?

A typical day within the screening department means that we can process around 10 to 30 volunteers a day. We are the first faces that the volunteers get to see when they come to Quotient Sciences - Miami, so we try to make their experience memorable and make sure that any issues or queries get resolved. We are also responsible for reviewing the informed consent for any trial that they’re here to participate in, conducting a thorough medical history and physical exam, and coinciding with the protocol restrictions for these screening procedures (like vital signs, ECG, and specimen collection for laboratory processing.)

How has your career progressed since joining Quotient Sciences?

At Quotient Sciences, we believe in fostering career growth. I have had the opportunity to expand my skills and responsibilities significantly since joining the company. I would say that my interpersonal skills have been sharpened, and my leadership skills have improved. I also didn’t come to Quotient Sciences with managerial experience, but I have been very hands-on and have learned on the go about what it takes to lead a successful team. My team has been so patient and understanding; I’m very thankful for all their support, especially as we’ve navigated a high influx of trials to meet enrolment deadlines and expectations of our sponsors.

What experience did you have before Quotient Sciences?

Prior to working as a Screening Manager, I worked at Quotient Sciences a few years back as a data entry coordinator. My main responsibilities were data entry and cleansing, and resolving any queries arising from the EDC or our eSource system, which we use for volunteer management and operations in Miami. I left this role and enrolled at Florida International University where I completed my Bachelor of Science in Nursing. My nursing background helped me return to Quotient Sciences in my role supporting the various aspects of volunteer screening and recruitment for our Phase I clinical trials.

What learning or qualifications have you gained since being here?

To be a Screening Manager, the qualifications were either having a registered nurse’s license or a Bachelor of Science in nursing with at least two years of clinical research experience. Since I have been with Quotient Sciences, I am grateful that the company supported my continuing education and training, and I have been able to acquire my Advanced Cardiac Life Support Certification (ACLS). Also, I have been able to apply leadership skills like conflict resolution and mentorship to ensure that the team always feels supported, motivated, or guided through any issues we encounter.

What do you enjoy most about your role?

What I enjoy most about my role is the people, including working with patients or volunteers, our screening team, and our whole Miami team. I really enjoy the patient care aspect of my nursing education and the ability to apply that here at Quotient Sciences in a lot of different ways, from conducting a medical history and assisting technicians with vitals and ECG, to doing volunteer check-in with our registration coordinators and assisting our volunteer recruiters.

What aspects do you find most challenging?

The team is comprised of many different roles including research technicians, volunteer recruiters, and front desk coordinators. Not every day is going to be easy, but we all support each other and get through our challenges. One of the more difficult aspects of being a Screening Manager is delivering bad news. That usually means telling a volunteer when they are ineligible for a trial, which can be for several reasons, such as the person may not be healthy enough to participate at this time, or trials may be moved or canceled. I’m responsible for making sure that volunteers are informed when there are changes, to let them know that they may be eligible in the future and that we can stay in touch.

What advice would you give to someone applying for a role in your team?

Be prepared for a fast-paced environment—this really lives up to our manifesto at Quotient Science, “Molecule to cure. Fast.” We all need to be mindful of working efficiently while upholding the utmost quality throughout all of our clinical trials.

What do you like most about working at Quotient Sciences?

There is always an opportunity to learn, whether directly from a colleague or from learning what a department as a whole does and the impact that it has on the company, like project management, clinical, medical, database programming, data sciences—the list goes on. It’s really nice to see that we can all get together and understand each other’s roles, and how each person and function impacts a clinical trial’s success. 

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