Featured Interview with Mark Egerton, CEO of Quotient Sciences with Global Business Reports

Can you provide an introduction to Quotient Sciences?

With operating facilities in both the UK and US, we deliver uniquely integrated programs or a range of tailored services that allow our customers to accelerate their development timelines and get life-changing medicines to patients faster. Approximately 12 years ago, we created a new innovative platform called Translational Pharmaceutics™ which integrates disciplines around drug product manufacturing and clinical testing that are traditionally found in different silos in the outsourcing industry. By integrating these activities and very closely aligning workflows around manufacturing and clinical testing, we demonstrated that we are able to save at least 12 months on the drug development timeline. This translates into helping customers accelerate new medicine development, save time, money and give a better chance of a good outcome from the development program. If you take those 12 months and translate that into economic value to a customer, it comes out at around US$200 million for every molecule that makes it to market. The financial benefits were quantified in a 2020 publication written by the Tufts Center for the Study of Drug Development.

What are some of the ways in which Quotient helps clients conserve cash?

The integrated approach that Quotient has developed allows for a rapid “make-test” cycle that is under a single flexible clinical protocol. This enables you to manufacture a formulation and dose it in a clinical study to see the impact of that formulation and how it works to deliver the active substance. Then you can modify the formulation composition to improve the delivery by using real-time clinical data. This can be done in 14-day test cycles. Therefore, as the clinical program is developing, we can iteratively use clinical data to deliver an optimal drug product composition. We can then seamlessly take that product all the way through to proof-of-concept and on to commercial manufacture if the molecule is successful.

What was the Impetus for Quotient’s acquisition of Arcinova?

What interested us in Arcinova is their expertise in early-stage drug substance and bioanalysis work, accompanied by their isotope labelling capabilities that are complementary to our existing 14C ADME services. With regard to drug substance, we see a great opportunity in integrating drug substance services into our platform. There are many occasions where we cannot start our program on the planned timeline because the customer is not able to deliver their drug substance to us. Therefore, we feel it is a great opportunity to integrate drug substance, drug product and clinical testing capabilities. Both Arcinova and Quotient both are able to work on the molecules early, just as they are coming out of discovery.

What is Quotients approach to hiring and retaining top talent?

Human talent is the fundamental ingredient for any service organization like ours. As the industry pipeline has expanded, the funding has expanded, the number of molecules expanded, and, as a result, there is more work to do. Talent management and talent acquisition have become crucial aspects of business development. From my perspective, there are some simple ground rules for how we develop the business. First, we must be an exciting place to work, because talented people want to work in places where they feel they can make a difference, not just in how they do their job, but in what the company is trying to contribute into the general initiative around healthcare and wellbeing. We have always strived to have this differentiated position and that has served us well in terms of attracting talent. Secondly, career growth and personal development is essential. When talent comes to Quotient, you must give people the space to develop and spread their wings and achieve their potential, because if they achieve their potential, then that is only going to benefit the business. Employees put their trust in companies to help their careers, and if companies cannot support them to develop, then employees will go somewhere else.

Read the report

Summary: John McDermott, Vice President of Scientific Consulting at Quotient Sciences, explains how Translational Pharmaceutics® accelerates oncology clinical trials by integrating formulation development, manufacturing, and clinical testing as a seamless program. Translational Pharmaceutics® has been applied to support first-in-human programs, formulation optimization, and more efficient ADME studies. 

Finding novel approaches to improve oncology drug development 

Data from the World Health Organization (WHO) estimates that cancer accounted for nearly 10 million deaths in 2020 with the most common cancers occurring in the breast, lung, colon/rectum, and prostate. The growing demand for new and improved treatments is clear, as is the need to streamline oncology drug development so new treatments can reach those in need, faster. 

The limited effectiveness of existing oncology drugs requires novel approaches to accelerate the clinical trial process. Accelerated approval pathways, which allow the NDA application process to commence from Phase II onwards, require the early submission of a high-quality chemistry, manufacturing, and controls (CMC) package. This push to expedite timelines only increases the risk of commercializing a drug product production process that is not fully optimized or scalable.

Benefits and challenges with emerging oncology modalities

Emerging modalities of oncology treatments, such as immunotherapy, and new chemical entities (NCEs) present increasing challenges in physical form, morphology, and chemical complexity. Therefore, selecting a drug development partner with proven experience in delivering these types of programs is crucial. 

Quotient Sciences' approach involves an early understanding of the biopharmaceutics (DCS classification) during the drug development process, combined with expertise in process chemistry, analytical technology, and formulation development. We mitigate risks in subsequent development phases by gaining early insight into the compound's druggability, guaranteeing a high-quality CMC package that aligns with the accelerated approval process for oncology trials.  

How Translational Pharmaceutics® accelerates oncology therapies

For almost two decades, the Quotient Sciences Translational Pharmaceutics® platform has been able to remove extra time and steps from oncology drug development. Translational Pharmaceutics® consolidates drug product and clinical testing within a single program of work to help reduce the burden of outsourcing while providing a resource-efficient approach to clinical trials. 

Other benefits of applying Translational Pharmaceutics® include scaling an optimal drug product, with the ability to modify dosage forms for additional areas of need, such as pediatric patients. 

In one customer's recent oncology program, we applied a rapid method for conducting first-in-human studies with a single ascending dose (SAD) study. Multiple formulations were developed within a single formulation design space in the same study, allowing a leading formulation to be identified and validated for patient trials in just 12 months.

Quotient Sciences first brought meaningful innovation to the pharmaceutical industry in 2008 with Translational Pharmaceutics®, a trusted platform for nearly two decades for driving innovation in drug development. Contact us to discuss how it can be applied to your next program.

Nick McEntee, Executive Director, Head of UK GMP Operations at Quotient Sciences discusses strategies for flexible, on-demand manufacture of clinical trial materials (CTMs) with Contract Pharma.

Clinical trials are a critical component in drug development. They require complex and careful planning to be carried out at the highest standards. Manufacturing of clinical trial materials (CTMs), the products used in clinical studies, is one of the key challenges when designing the trials successfully.

Nick's article with Contract Pharma explores the importance of CTM manufacturing and outlines how flexible, on-demand processes improve clinical trial efficiency at Quotient Sciences.

In recent years, physiologically based pharmacokinetic (PBPK) modeling has become an increasingly important part of drug development programs. Quotient Sciences uses GastroPlus® PBPK modeling software to provide unique solutions for overcoming our customers’ product development challenges, making it vital to assess the software’s ability to perform simulations with adequate precision.

At the Pharmacokinetics UK (PKUK) conference in November 2022, Quotient Sciences’ Modeling and Simulation (M&S) team presented a poster about their project to qualify the GastroPlus software and demonstrate the predictive performance of PBPK models in various clinical situations.

A repository of case studies was collated, covering a wide range of drug types, formulations, and clinical scenarios. Using GastroPlus, individual predictions for the diverse clinical scenarios were compared to observed clinical data, and the prediction performance was evaluated.

The results demonstrated the ability of the GastroPlus PBPK modeling software to predict observed outcomes with adequate precision. This project enables Quotient Sciences to offer customers a qualified PBPK modeling platform for the scenarios contained within the qualification data set. Over time, the repository will be expanded to include a more diverse range of drug types and scenarios.

Poster authors

• Quotient Sciences: Kevser Sevim, Alison J Wilby, Shriram M Pathak, Christine Meddes
• University of Nottingham: Daniel Vaughan

Access poster

Lipid-based formulations are known to enhance the oral bioavailability of lipophilic drugs with poor aqueous solubility.

At the Pharmaceutics, Biopharmaceutics, and Pharmaceutical Technology (PBP) conference in March 2022, Quotient Sciences presented a poster analyzing formulation and clinical data from multiple pharmaceutical development programs conducted by Quotient Sciences over 16 years to understand the drivers for, and outcomes from, selecting and dosing different lipidic formulations. The poster also discusses the challenges in using in-vitro characterization methods to predict in-vivo behaviour, and the benefits of using Quotient Sciences’ unique Translational Pharmaceutics® platform to integrate real-time adaptive Good Manufacturing Practice (GMP) manufacturing and clinical testing for the rapid screening of multiple lipidic formulations in Phase I pharmacokinetic (PK) studies.

Data from 34 lipid formulation programs were analyzed for the following features: formulation application, Biopharmaceutics Classification System (BCS), and in-vitro characterization methods. Various lipid-based dosage forms were developed, including solutions, suspensions, spray-dried dispersions (SDDs), and modified-release (MR) tablets.

The poster highlights how lipidic formulations can successfully be used for solubilization, enhancing oral bioavailability, and reducing food effects for BCS Class II and IV drugs. The analysis shows that conventional in-vitro testing methods for different lipidic formulations are poor predictors of in-vivo performance, whereas Quotient Sciences’ integrated Translational Pharmaceutics platform can enable the rapid identification of optimal lipidic formulations based on clinical performance in a reduced timeframe.

Poster authors

• Alaa Hosny, Wu Lin, Peter Scholes

Find out more about Quotient Sciences’ Translational Pharmaceutics drug development platform and solubility enhancement capabilities.

The quantification of insulin analogues and other large peptides, such as glucagon-like peptide-1 (GLP-1) receptor agonists, plays an important part in improving the outcome of downstream formulation development and clinical trial activities. However, this growing class of biotherapeutics is known to present sensitivity challenges when trying to measure trace levels of these types of compounds, thus requiring advanced technologies such as 2D ultra-performance liquid chromatography-mass spectrometry (LC-MS).

At Quotient Sciences, we have developed and supported numerous insulin analogue, human insulin, and peptide/protein assays in the discovery, pre-clinical, and clinical stages of development. In this article, Michael Blackburn, Head of Bioanalytical Method Development and Labs at Quotient Sciences, describes the bioanalytical strategy that we employ to best support clinical studies for these types of compounds and how our physicochemical-based approach enables us to accelerate the development of bioanalytical assays for insulin analogues.

What are insulin analogues, and what challenges do they present to bioanalytical chemists?

Human insulin has a molecular weight of 5,808 Da and is made up of 51 amino acids in two chains joined together by disulfide bridges. Insulin analogues are versions of human insulin that have been modified slightly, by the addition or substitution of amino acids, or the addition of a side chain such as a fatty acid. This is done to modify the kinetics of the insulin in the body, making it either rapid-acting (prandial) or slow-acting (basal). Their action also depends on the formulation (injectable form) in which they are dosed. Enzyme-linked immunosorbent assay (ELISA)-based (ligand binding) assays cannot always distinguish between different insulin analogues or their metabolites. Mass spectrometry can offer a means of analyzing them simultaneously in a single assay.

How do you measure insulin analogues using mass spectrometry?

The typical mass spectrometers used in bioanalysis have an upper mass limit of 2,000–4,000 Da, but insulin analogues have masses of approximately 6,000 Da. We can measure them due to the phenomenon of multiple charging, which occurs in electrospray. This multiple-charging effect is incredibly useful because it produces clusters, which due to their charging fall into the mass-to-charge range of the mass spectrometer. For an insulin analogue or any large peptide, we can select one of these multiply charged clusters, usually the largest one, for fragmentation. Peptides and proteins fragment in predictable ways around the peptide amide bond, going in different directions to produce characteristic product ions, which help us to identify these insulin analogues.

What are hybrid assays?

Hybrid assays combine LC-MS with an immunoaffinity-based extraction technique – for example, using commercially available mass spectrometric immunoassay (MSIA) pipette tips or antibody-coated magnetic beads. Immunoaffinity extraction is very specific and provides a clean sample for mass spectrometry. Although our hybrid assay worked very well, it relied on a regular supply of specific antibodies and tips being available, and this was not always possible. This presented a need to change our analytical strategy to a more robust and reliable approach.

Why might you use a physicochemical approach?

Recent developments in solid-phase extraction technology and improvements in mass spectrometers have made a physicochemical approach a viable option. High-performance mass spectrometers, combined with specific product ions, can lead us to lower quantitation levels than were previously possible.

Immunoaffinity extraction can give you a very clean extract, as you are only pulling out the thing that will bind to your antibody. A physicochemical approach, such as solid-phase extraction, even if it is quite specifically tuned to your analyte, will pull out anything with the broad physicochemical interaction you are looking at, so you need a cleaner sample.

At Quotient Sciences, our strategy is based on three steps. Firstly, clean the sample and disrupt protein binding with a protein crash with acetonitrile and methanol, which removes the big albumins and the immunoglobulins. This is then followed by solid-phase extraction of the supernatant using either an HLB Prime or anion exchange column to clean the extract further. The sample is then injected. Our high-performance Waters Xevo TQ-XS Triple Quadrupole mass spectrometers follow a 2D approach, where the sample goes through a trapping column before it goes on to the analytical column. This enables us to load more of the sample to get better sensitivity and helps with robustness, as it provides an extra clean-up and switching step before you reach the analytical column. By combining this with modern column technology, we can get better peak shapes. Physicochemical assays may be more precise than hybrid assays, but they are slightly less sensitive, as the clean-up is less specific.

What are the particular challenges that you see with LC-MS bioanalysis of peptides?

The first challenge is non-specific binding with hydrophobic peptides, which can be prevented by using carrier proteins and low-bind surfaces. Secondly, passivation of the analytical system, particularly the UPLC column, is required to improve the peak shape. You also need to keep the background low, which can be achieved using solvent blank injections. A final issue is anti-drug antibody (ADA) effects, where the body sees the introduction of a foreign protein and develops antibodies against them, which can cause complications in analysis and produce anomalous results. Loss of internal standard is a giveaway sign, and it may occur with both hybrid and physicochemical approaches. 

How do the results of LC-MS compare to ligand binding assays?

There is a general correlation between ligand binding assays and LC-MS, but do not expect an exact correlation. LC-MS measures concentration, whereas ligand binding assays measure activity. You need to consider what you want to measure – for example, total activity or specific concentration of the drug and metabolites. It may be faster to develop a mass spectrometry-based assay, as you do not need a specific antibody. However, if you do have a specific antibody, immunoassays may be more sensitive and may need a smaller sample volume. Pre-existing ADAs may interfere with both ligand binding assays and physicochemical assays, though to different degrees.

What key considerations should bioanalytical chemists be aware of for LC-MS of peptides?

LC-MS can give a fast and specific assay for large peptides and small proteins, particularly insulins, without the need for targeted antibodies. This makes it ideal for fast analysis in the discovery and pre-clinical phases of drug development. For the larger clinical phases, different considerations may apply – for example, sensitivity requirements or in-house facilities. You should also think about what you actually want to measure – for example, specific activity versus total activity. Generally, the two methods will give orthogonal and complementary data but are not exactly correlated, and you must bear in mind possible ADA effects. As a rule of thumb, most peptides or small proteins that are less than 10 kDa can now be readily quantified by LC-MS without the need for enzyme digestion or antibody-based clean-up. Larger proteins, such as monoclonal antibodies (mAb), usually require digestion before LC-MS analysis, which is a more complex workflow and can be less specific. There are new techniques, such as intact mass analysis using high-resolution mass spectrometry (HR-MS) or ion mobility, that may help to get around some of these issues of digestion.

To find out more about Quotient Sciences’ bioanalytical strategies for insulin analogues, and explore some recent case studies, watch Michael’s recent webinar entitled: "Bioanalytical Strategies for Insulin Analogues & Other Large Peptides Using LC-MS"

Learn more about how Quotient Sciences' bioanalytical services can support your drug development program by hitting the link below.

Bioanalytical Services

During clinical research studies, a significant amount of data is generated that needs to be carefully processed, analyzed, interpreted, and reported. 

To make crucial decisions during a clinical study, high-quality data is needed quickly. Quotient Sciences Data Sciences function supports clinical trials conducted at our Miami, FL and Nottingham, UK clinics, providing customers with rapid insight to help make better decisions about their drug programs. 

The key functions of data sciences at Quotient Sciences include:

Database Programming

The electronic Case Report Form (eCRF) is a collection of digital forms used in clinical research to collect data about study participants. The Database Programming team sets up and maintains eCRFs for all clinical studies carried out at Quotient Sciences, including making design amendments as required. 

Statistical Analysis Software (SAS) is also used to program complex data checks and load external data, such as safety laboratory data, for reconciliation with the eCRF.

Data Management

The Data Management Plan (DMP) is an important document outlining how clinical research data will be managed during and after a study. Data management is responsible for ownership of the DMP, data cleaning, reconciliation of serious adverse events (SAEs), external data, coding, and query issue and review. 

Another key task within data mangement is the database close/lock at the end of a clinical study. This prevents further changes to the database in preparation for data analysis. Finally, this team is also responsible for the generation of interim safety data listings for rapid dose decision meetings.

Statistics

The statistics function provides input on the clinical study protocol, including sample size calculation and randomization. The team also manages the Reporting and Analysis Plan (RAP), which describes all the planned data analyses and output requirements for a clinical study, and performs formal statistical analysis and interpretation of study data.

Statistical Programming

This function is responsible for programming Clinical Data Interchange Standards Consortium (CDISC) datasets, including Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and define-XML, as well as study listings, tables, and figures. Using SAS software, the team loads data from the analysis of clinical study samples conducted by our bioanalysis team or external vendors.

Pharmacokinetics

The Pharmacokinetics team derives PK parameters, which assist in characterizing how the drug is absorbed, distributed, metabolized, and eliminated from the body, such as the area under the plot of plasma concentration of a drug versus time after dosage (AUC) and the highest concentration of a drug in the blood after dosage (C_max), using Phoenix WinNonlin software. This data is used for interim and final PK reports. 

Medical Writing

The Medical Writing team are a core part of the Data Sciences department, responsible for writing the clinical study protocol, including any protocol amendments and the final clinical study report (CSR) for all the clinical studies carried out at Quotient Sciences. 

Data science experts work to global standard operating procedures (SOPs) and templates, and use industry-leading systems and software to drive data quality and reporting to meet customer expectations. On-study changes to early-phase trial designs and dosing are common, so we take a flexible approach to meet those demands. Faster data means that we can provide earlier interim data and pharmacokinetic (PK) reports for on-study dosing that aid in formulation development decisions.

All functions play a key role in delivering crucial clinical trial data in order to streamline the drug development process for our customers and accelerate their molecule to their next project milestone.To learn more or ask a question about our data sciences services, contact us today.

As drug developers approach the pivotal milestone of starting their early-phase first-in-human clinical trial, they must be aware of the possible challenges when preparing for clinical manufacturing of their investigational medicinal product (IMP).

Clinical materials manufacturing, involving supplying the right quantities of the IMP at the right time while maintaining high quality and safety standards, is crucial to maximize the likelihood of a successful clinical trial. The processes involved in clinical trial materials manufacturing require specific drug product manufacturing expertise, facilities and equipment, careful attention to planning, and a great deal of flexibility for success. 

Frequently asked questions about clinical manufacturing with our expert Kieran Edwards, Head of Manufacturing at Quotient Sciences

Quotient Sciences are experienced in clinical manufacturing, and partner with our customers to provide an approach to clinical manufacturing and supply that best reflects their clinical study design and timelines. 

Each clinical manufacturing program we offer is customized to meet the unique requirements of each program, using flexible manufacturing approaches to produce only the products needed, which adds efficiency and minimizes waste. Our expertise includes both non-potent and high-potency manufacturing, enabling us to assist our customers in progressing quickly through clinical development. 

Additionally, we can efficiently scale up production to meet the demands of later clinical trials phases, ensuring a smooth transition to larger-scale manufacturing and commercialization.

In this article, Kieran Edwards, Head of Manufacturing at Quotient Sciences, answers some frequently asked questions about clinical manufacturing.

What is clinical manufacturing, and how does it differ from commercial manufacturing?

Clinical manufacturing, also known as clinical trial material (CTM) manufacturing and clinical trial material, is the process of turning an investigational material/active ingredient into an IMP, for dosing within a Phase I, Phase II, or Phase III clinical trial setting.

Commercial drug product manufacturing batches, taking place post-Phase III clinical trials, are typically larger scale to create drug products for the market. In contrast, clinical trial material manufacturing is typically a smaller-scale process that may only need to be performed once. Flexibility is required, something which we excel at in Quotient Sciences, as there are many unknowns around the IMP and the scope of a project can change in an instant.

What are the regulatory guidelines for clinical manufacturing, and how do you comply with them to ensure safety and quality?

All clinical manufacturers must conform to current Good Manufacturing Practice (cGMP) guidelines and work in line with the regulatory authority in which the IMP will be dosed. These guidelines cover all aspects of the manufacturing process, from development to making, testing, and shipping a product.

Both safety and quality are built into the Quotient Sciences culture and systems by design. Our quality management systems (QMS) include quality policies, processes, and procedures, as well as teams of highly skilled workers, focused on continually improving and adhering to the latest regulatory guidelines. Quotient Sciences provides comprehensive training for personnel, performs numerous assessments and observations, and utilizes the latest flexible containment measures in order to protect both the employees and facilities, to highlight just a few areas.

How should a drug developer plan ahead for clinical manufacturing?

At the point that a project is signed, we keep an open mind and start thinking forward to later stages of development, clinical manufacturing and dosing requirements. We take a collaborative approach for study deliverables and early on in a project, identification is required for novel excipients and equipment, which will allow the correct routes of onboarding to be implemented. Any process that requires significant technical input will have the development and manufacturing teams working in tandem.

For clinical batches, we are expected to create and assign a study box with all required materials that is based on the bill of materials generated from the formulation development work. These will have to be fully released through Quotient Sciences' systems, with enough quantity and expiry to last the entirety of the study. Study-specific paperwork is also generated in parallel, based on all the information and knowledge gained from the process up to that point

What are the challenges of clinical manufacturing for global patient studies, and how does Quotient Sciences overcome them?

Clinical manufacturing for global patient studies presents unique challenges, many of them related to packaging and shipment, such as:

• Importation challenges into different territories
• Shipping lead times
• The formulation of the drug product
• Special considerations for shipping and handling radioactive or dangerous goods products, as well as for controlled temperature products

We address importation hurdles by staying informed about local shipping regulations and collaborating with approved couriers. During study start-up, the team works with customers to manage applications for import licenses and establishes brokerage services in advance.

Understanding the clinical study protocols and timing is another crucial part of navigating clinical manufacturing. This is especially the case for short lead times between manufacturing requests and patient dosing. For studies involving specific shipping lanes, such as those into the EU post-Brexit, careful logistical planning is essential to ensure efficiency and compliance with all regulations, particularly regarding products that may contain animal-derived ingredients. 

The specific formulation of drug products can necessitate shipping studies to evaluate their stability under transit conditions, especially for fragile items or those requiring controlled temperatures. We have validated shipping containers and temperature monitoring devices to maintain compliance during transit. For more sensitive products, such as radioactive or dangerous goods, a tailored approach is taken based on individual territory requirements. Additionally, for any territory that is new to Quotient Sciences, a shipping study will be considered on a case-by-case basis. 

For example, oral solutions contained in glass bottles that need to be shipped to a long-haul destination may warrant a shipping study to be performed to ensure that the product does not leak or to ensure that the pressure from air freight does not have an effect on the product. 

Our specialized team, dedicated to managing the global supply and distribution of clinical trial materials, ensure that studies proceed smoothly and that all materials are delivered as needed for ongoing projects. 

What are the benefits of integrating adaptive clinical manufacturing with formulation development and clinical testing?

Our history and expertise in integrating real-time adaptive manufacturing with clinical dosing enable us to manufacture, package, and release products in a matter of days or weeks rather than months. This means that we can maximize flexibility around the batch size and timing supply to the clinic in response to emerging clinical data, accelerating clinical development timelines.

The main benefit is reducing the time to get a drug product through development and into a clinical trial, ultimately providing significant cost savings for a customer. When services are closely integrated. the knowledge of the entire drug development process is kept whole. This is best demonstrated by the Quotient Sciences Translational Pharmaceutics® platform, which integrates drug product manufacturing and clinical testing within the same organization. 

Learn about the Quotient Sciences Translational Pharmaceutics® platform and download our latest info sheet.

Data Sciences are a critical part of drug development. During clinical research studies, a significant amount of data is generated, which needs to be carefully processed, analyzed, interpreted, and reported. In order to make crucial decisions during a clinical study, high-quality data is needed quickly. This is where Quotient Sciences’ integrated, in-house Data Sciences team comes in.

In this article, Dennis Henderson, Director of Statistics, gives an insight into what it’s like to be a Data Scientist at Quotient Sciences, the important role that Data Sciences play in clinical development, and what it takes to develop a successful career in this field.

What is your background and your current role at Quotient Sciences?

I joined Quotient Sciences 10 years ago as a Junior Statistician after completing an MSc in Mathematical Biology and Ecology. I’ve since progressed in my career within the company and now head up the Statistics function within the Data Sciences team. This group compromises Statisticians who are responsible for providing input into clinical study design and analysis methods, generating study randomization schemes, and carrying out formal analysis and interpretation of clinical data by employing statistical methods.

What initially interested you about a role in Data Sciences?

Applying mathematical and statistical skills to a meaningful role where you could directly see the benefit your work was providing was important to me. In addition, working for a contract research organization (CRO) has a great deal of variety and learning potential. You are constantly being exposed to a wide array of clinical study designs and endpoints, as well as clients from both large pharmaceutical companies and small biotechs, each with their own different requirements and demands. It’s a fast-paced environment, with many different activities ongoing at the same time, which means the job is never dull and you never stop learning.

How does Data Sciences support early clinical development?

Data Sciences support clinical studies through the entire lifecycle of the program at both of Quotient Sciences’ clinical sites in Nottingham, UK, and Miami, USA. Our colleagues play an influential role right from the start of a program, getting involved in the initial study scoping and design. Throughout the trial conduct, the Data Sciences team can support crucial in-study decisions and ad-hoc analysis requests with the provision of high-quality and timely deliverables. Our reporting teams then work together following completion of trial conduct to bring the key message out of the data to support the sponsor with further clinical development, all while delivering industry-standard tables, figures, and listings (TFLs), Clinical Data Interchange Standards Consortium (CDISC) datasets, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)-compliant reports.

What different roles are there within the Data Sciences team at Quotient Sciences?

Data Sciences at Quotient Sciences is comprised of six distinct functions (Database Programming, Data Management, Statical Programming, Statistics, Pharmacokinetics (PK), and Medical Writing), each with their own unique roles and responsibilities. While Database Programming and Data Management focus on the collection and quality of the data at our clinical sites, the Statistics, Statistical Programming, and PK functions are primarily responsible for the reporting, analysis, and interpretation of this study data. Our Medical Writing team then focus on bringing the study narrative and data together by authoring high-quality and industry-compliant clinical study reports.

How do the different functions within Data Sciences work together?

There is a great deal of collaboration between each department as the clinical study data flows through each of the distinct functions during the lifetime of the clinical study, from collection to reporting. The collaboration isn’t just limited to Data Sciences, as we often work closely with Clinicians, Pharmacologists, Bioanalysts, and Project Managers who also play a very important role in designing, delivery, and reporting a clinical study.

What would your advice be to a graduate looking to start their career in Data Sciences?

All roles across Data Sciences benefit someone who has great problem-solving skills, a keen eye for detail, and an inquisitive nature. To progress your career, it’s essential to be able to provide evidence of these skills and to always be prepared for unexpected or unplanned scenarios.

If you are interested in learning more about open positions in our Data Sciences department, please visit: Quotient Sciences' Careers

Find out more about Data Sciences

Summary: John McDermott, Vice President of Scientific Consulting at Quotient Sciences, outlines a smarter strategy for optimizing oncology drug products using Translational Pharmaceutics®. He explains how evaluating targeted oncology molecules in healthy volunteers—when safe—can accelerate formulation development, improve pharmacokinetics, and reduce variability. 

The Translational Pharmaceutics® platform can be applied in many ways to accelerate drug product optimization for oncology therapeutics.

To ensure downstream clinical success in patients, drug product optimization is often required, whether to increase oral bioavailability and solubility, reduce pharmacokinetic (PK) variability, overcome food effects, avoid adverse events, or reduce dosing frequency by switching administration routes or to a modified-release form.

For oncology drug development programs these challenges can be magnified, as dosing is typically performed directly in patients in Phase I, rather than conducting healthy volunteer studies to establish safety and PK data. The approach of going directly into patients is known to be inherently problematic when it comes to the speed and effectiveness of identifying improved formulations to deliver improved PK profiles.

Over the past decade, Quotient Sciences has delivered over 400 projects with oncology drugs, including 80 clinical programs in healthy volunteers. These clinical programs have included first-in-human single-ascending-dose/multiple-ascending-dose, relative bioavailability, and 14C human absorption, distribution, metabolism, and excretion (ADME) programs.

Using our flagship platform, Translational Pharmaceutics®, which integrates formulation development, Good Manufacturing Practice (GMP) manufacturing, and clinical testing, we reduce development timelines by more than 12 months while delivering significant cost savings and minimizing program risks.

Translational Pharmaceutics® removes wasted time and handovers in drug development processes by integrating real-time drug product manufacturing with clinical assessments, reducing stability data requirements and batch sizes, and accelerating program delivery. Rapid access to real-time human clinical data from one study period determines the formulation composition that is then made and dosed in the next.

The economies can be even more significant as multiple formulations can be evaluated with lean chemistry, manufacturing, and controls (CMC) data package, and if appropriate, formulation design spaces can be applied to provide a flexible range of drug product compositions to make and dose in the clinical study.

Studying oncology molecules in healthy volunteer studies, where safe to do so, can also mean:

• Study recruitment is not as complex and achieved faster
• Cohorts of subjects can be dosed together to improve formulation decisions
• There is less risk from co-medications and co-morbidities
• Variability in clinical data due to disease state is removed
• Study timelines are reduced, and studies are more cost-effective to conduct

Following rapid identification of an optimized drug product, Quotient Sciences is also able to scale up and supply the formulation into your next-stage global patient studies to provide seamless program continuity.

See how Quotient Sciences' expertise can help meet the challenges of oncology drug development.

Using Translational Pharmaceutics, drug products can be manufactured, released, and dosed in days rather than weeks or months.