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

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

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

Why This Matters

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

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

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

What’s Changing?

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

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

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

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

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

A Global Win  

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

Years of Collaboration Behind This Moment

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

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

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

What Comes Next

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

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

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

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

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.

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

• Read more about our Nottingham, UK site in this recent article from our Chief Operating Officer and Nottingham, UK site head, Denise Sutton

• Browse our Clinical pharmacology services

• Learn about Translational Pharmaceutics programs

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.

In this interview, we speak with Clare Preskey about her day-to-day in the Nottingham clinic. 

Clare Preskey is Executive Director of Clinical Operations, responsible for the oversight of day-to-day activities that take place in our Nottingham Phase I clinic. This includes volunteer screening and management, oversight of our clinical laboratory and pharmacy teams to ensure on-time project delivery, and driving continuous improvement and innovation initiatives.

Looking back to when you were first starting your career, was your goal to be where you are now?

I have always held a passion for science and the study of physiology and pharmacology. I started my career at Quotient Sciences in 2010 fresh out of university as a Clinical Scientist. My key responsibilities were ensuring the well-being of our volunteers and the collection of clinical data.

Later, I moved into Project Management, where I gained valuable experience in customer management and developed a broader understanding of our business. I held several roles within Project Management, last as a Team Lead prior to moving into a clinical operations role. I have always held a passion for clinical sciences and operational excellence, so my current role is a great fit. 

What are some of the biggest changes and improvements that you have seen over the years at Quotient Sciences?

When I first joined the company, we were a much smaller business: one building containing a 30-bed clinical unit, a GMP suite, and approximately 100 employees. The people at Quotient Sciences are at the heart of the business; we have a great culture and tight-knit teams. Close teamwork is imperative when managing complex and integrated projects in short timeframes for our customers. 

Quotient Sciences has always had a focus on continuous improvement and high-quality standards. The biggest change has been the expansion in facilities and capacity, including the evolution of our Translational Pharmaceutics platform, over the last 10 years. Despite our growth, the ethos of who we are and what we do has not changed. We’ve been able to retain our core values, agility, and integrated processes.

We never stand still; we are always pushing boundaries, trying to do things better and more efficiently! I am privileged to work with such committed, talented teams. 

How do the different functions work together to deliver Translational Pharmaceutics programs?

Teamwork is key to any Translational Pharmaceutics program and establishing cohesive communication channels across departments. Our processes have been built over many years, with SOPs and protocols geared to be adaptive. Planning is also an essential practice that is embedded in our operational processes (e.g. kick-off meetings) to ensure the highest quality project delivery that is the right first time.

What do you enjoy most about your role and why?  How do you see your role evolving as the business grows?

The environment at Quotient Sciences is dynamic and fast-paced. Every day brings different challenges and opportunities! 

We work with so many different customers, molecules, and study designs. My colleagues are incredibly passionate and dedicated to every one of our projects and customers. We learn and grow together, expanding our knowledge and gaining new skills. Getting things right the first time is very important to me.

I love what we do and I always feel energized to come to work, ready to learn and take on the next challenge. 

For most compounds, the route from preclinical to clinical is clear. In oncology drug development, the path is different. 

Traditionally, early-stage cancer drug trials involve patients due to potential safety concerns. However, newer targeted treatments with better safety profiles can be tested on healthy volunteers. Conducting Phase I trials in healthy volunteers can speed up development and reduce costs, while still providing valuable safety and effectiveness data. This article discusses how healthy volunteer studies offers benefits like consistent results, easier recruitment, and simpler study logistics.                

For many new molecules, a comprehensive safety preclinical toxicology package is generated and the data from that package is used to design the first-in-human (FIH) study in a healthy volunteer panel. This Phase I study will test the safety and tolerability of the compound, as well as its pharmacokinetics in single, and multiple ascending doses. The data study from the Phase I study provides the springboard for the rest of the drug development program.

In oncology drug development, however, the path can be somewhat different. 

Traditionally, drugs that have oncology indications have poor safety and tolerability profiles, to the point that dosing them in healthy volunteers presents too much risk, and could be considered unethical. This coupled with the vast unmet patient need for effective oncology treatments means that the FIH study changes from dosing healthy volunteers to dosing directly in patients.

The benefits from this strategy are plain to see; preliminary efficacy data far earlier than the traditional route, safety and tolerability assessments which are directly relevant to the expected patient group, and giving patients earlier access to new treatments. Regulatory agencies require a reduced preclinical data package for straight-to-patient studies compared to the healthy volunteer route for oncology drugs, saving the drug developer time and cost.

Equally, there are acknowledged challenges with performing Phase I trials of any type in a patient population. Subjects involved in these studies are patients for whom no current efficacious treatment is available. Severe comorbidities, the presence of multiple diseases or medical conditions, can cloud the safety profile of the new test products. The disease state of these subjects also brings with it inherent variability into the drug’s pharmacokinetics, often due to hepatic or renal impairment. This further complicates assessments of safety, tolerability, and efficacy because the exposure of the compound from subject to subject can vary significantly. Furthermore, recruiting and conducting these studies can be logistically challenging, requiring multiple sites and a much longer study duration than a Phase I study in healthy volunteers.

In the last 5 years alone, we've performed over 50 Phase I studies of various types, all with a goal to reduce the time and cost of the development of oncology molecules.

Where safety allows, there can be compelling drivers for using healthy volunteer trials to develop oncology molecules. Recent improvements in drug discovery have led to a new generation of oncology-targeted molecules that are more specific and rely less heavily on general cytotoxicity. New generations of molecules known as molecularly targeted agents (MTA) usually have a favorable safety profile that can make them suitable for dosing in healthy volunteer studies. 

There are significant, tangible benefits for studying oncology molecules in healthy volunteer studies, for example:

• There is less variability within a healthy volunteer population. By their nature, healthy volunteers have more consistent physiology specifically regarding clearance routes, leading to less variable pharmacokinetic data. The absence of co-morbidities makes assessing drug-related adverse events clearer.
• Healthy volunteer studies, typically, have less challenging logistics. Studies in healthy volunteers can be run at any Phase I clinic with experience translating oncology molecules into healthy volunteers. Studies can usually be conducted at a single site, and healthy volunteers are ubiquitous to the general population, leading to simpler, faster recruitment.

In the last 5 years alone, we've performed over 50 Phase I studies of various types, all with a goal to reduce the time and cost of the development of oncology molecules, including:

• First-in-human clinical studies where a molecule has presented significant biopharmaceutic challenges and formulation selection to ensure adequate bioavailability have been uncertain
• Relative bioavailability studies to optimize formulation compositions that were previously dosed only in oncology patients
• A full spectrum of clinical pharmacology studies, including food effect, human ADME, and drug-drug interaction studies

Getting preliminary information on efficacy as early as possible is of significant importance to oncology compounds in order to ensure that any patients taking the compound are not being exposed to ineffective or sub-therapeutic levels of the drug. With a healthy volunteer study, this understandably becomes more difficult, but not impossible. Healthy volunteer studies can still deliver meaningful pharmacodynamic data. 

An understanding of the pharmacology of the drug can allow for the use of clinically relevant biomarkers, for example, in the following paper, inhibition of basophil activation was used as a substitute marker for efficacy for a drug that targeted the PI3K delta pathway, and the data generated from this study helped to inform on the recommended Phase II dose.

While the majority of oncology development is geared towards patient studies, traction is building in the use of healthy volunteers for the Phase I drug development program.

Unlike other indications, translating an oncology molecule into a healthy volunteer study has a unique set of challenges, which is especially true for FIH studies. A medical review of the safety data will be required to assess whether the drug is suitable for healthy volunteer studies, following which a gap analysis of the preclinical safety package needs to identify if the regulatory agencies will require additional studies beyond what would be expected for a direct-to-patient route.

While the majority of oncology development is geared towards patient studies, traction is building in the use of healthy volunteers for the Phase I drug development program. Contact us to find out more about our latest oncology drug development updates.

The role of clinical operations is key in the delivery of successful clinical trials and plays an important part in the overall drug development process. 

Core responsibilities for clinical operations include ensuring volunteer safety, smooth delivery of clinical trials in accordance with the protocol, and adherence to Good Clinical Practice (GCP) guidelines at all times.

We have a proven track record in clinical pharmacology spanning over three decades and over 1,300 Phase I studies completed. With expertise in first-in-human studies, our industry-leading medical directors are able to rapidly recruit large groups of healthy volunteers.

In this article, Ian Nisbet shares more about our approach clinical operations.

Where do you conduct clinical studies at Quotient Sciences?

We are a world leader in the delivery of clinical pharmacology studies. Our Phase I studies are run at our clinical unit in Miami, FL (144 beds and integrated pharmacy compounding capabilities included), and from our clinical unit in Nottingham, UK, where we have 85 beds available.

We have highly experienced medical/clinical teams on both sides of the Atlantic that includes Principal Investigators and Sub-Investigators. Across our clinical teams, we have colleagues dedicated to volunteer safety and the successful delivery of clinical studies.

Each of our clinics can be fully integrated with our global formulation development and manufacturing capabilities, through our unique Translational Pharmaceutics® platform.

What types of clinical studies are conducted at Quotient Sciences, and what is the purpose of each study type?

We conduct a range of Phase 1 studies, including:

• Translation Pharmaceutics programs, which integrate drug substance, drug product manufacturing, and clinical testing activities to accelerate development timelines
   
• First-in-human studies (FIH studies), which evaluate the safety, tolerability, and pharmacokinetics (PK) of a new drug in healthy volunteers
   
• Drug-drug interaction studies (DDI studies), which assess if the safety and efficacy of a drug are altered when it is taken alongside other drugs
   
• Food effect studies, which investigate the effects of food on the rate and extent of absorption of a drug when it is taken shortly after a meal (fed conditions) compared to when it is taken under fasting conditions
   
• Thorough QT studies (TQT studies), which test the cardiac safety of a drug
   
• Bioavailability studies, which determine whether a drug can reach the systemic circulation and its intended site of action while minimizing undesired side effects
   
• Bioequivalence studies, which compare two drugs, or two sets of formulations of the same drug, to show that they have equal bioavailability, either for generic drugs or when a formulation of a drug is changed during development
   
• 14C human ADME mass balance studies, which obtain a comprehensive picture of the absorption, distribution, metabolism, and excretion of a drug in the body using radiolabeling
   
• Japanese bridging studies, which compare the safety and efficacy of a drug in different ethnic groups

When conducting FIH studies, what types of samples are usually collected and how is this done?

Typically, safety and tolerability are the primary objectives for FIH studies, where we capture safety data including vital signs, electrocardiograms (ECGs), blood parameters, and adverse events across a wide range of single and multiple doses. Often, we may also collect additional cardiac data via telemetry or Holter monitoring.

Our clinical units have all the necessary clinical equipment available to perform safety monitoring and data collection in accordance with the clinical protocol.

We also collect blood and/or urine and fecal samples for analysis, so that PK or pharmacodynamic (PD) profiles can be generated to provide an understanding of how the drug is processed by the body. On occasion, it may also be necessary to collect genotype samples to help assess whether the metabolizer status impacts on drug absorption.

How are samples processed in the clinic?

Samples are collected on the ward and transferred to our sample processing laboratories to be processed. We have a barcode tracking system in place to track the samples through the collection/processing pathways, which typically include centrifugation followed by plasma/serum isolation.

Our in-house laboratories have the capability to perform PD sample processing, including the collection and processing of peripheral blood mononuclear cell (PBMC) samples for isolation. There are several processing techniques available that may be utilized during sample processing, with Quotient Sciences typically using the Cell Preparation Tube (CPT) or LeucoSep methods. PBMC collection and processing require specific blood collection tubes, reagents, and equipment to be available and for each step in the method to be followed accurately to ensure isolation of the cells can occur.

Samples are processed in accordance with the Lab Manual for appropriate storage until they are shipped to the nominated bioanalytical laboratory for analysis. Once analyzed, the data is returned to the data sciences PK function for PK analysis to be performed.

How does Quotient Sciences ensure the safety of study volunteers?

All studies conducted at Quotient Sciences are risk-assessed to ensure we can determine the appropriate levels of oversight and monitoring needed to safely conduct the study. We meet regulatory GCP requirements by having best practice procedures that encompass the highest standards for protecting trial volunteers.

Our clinical teams are made up of experienced physicians, nurses, and clinical technicians. Clinical staff are trained in Basic and Immediate Life Support, with all of our physicians trained in Advanced Life Support. Our clinical units have all the necessary emergency equipment and medicines available to handle any medical emergency.

How do you ensure that Quotient Sciences volunteers have a positive experience while they take part in clinical studies?

Our volunteer-centric approach takes into account the key touchpoints at each stage of our volunteer’s journey and includes feedback questionnaires. 

Our Volunteer Centricity group is specifically focused on ensuring feedback is acted upon and priorities around volunteer wellbeing are considered. The group engages with a Volunteer Advocacy panel, made up of some of our long-standing volunteers, to ensure that feedback is sought on topics such as the wording of patient information summaries, admission times, transportation to the site, and study design.

Additionally. our clinical units have recreational and dining spaces for our volunteers to relax and unwind, and our Volunteer Liaison Officers are responsible for arranging activities and providing a comfortable environment for them. 

I am proud of our highly skilled teams and the steps that they take to ensure volunteers feel safe, valued, and looked after while participating in a trial with us.