Mark Egerton, CEO, Quotient Sciences: Interview with Global Business Report

Q: How was 2021 for Quotient Sciences, particularly within the US?

A: In February 2021, Quotient Sciences expanded its portfolio of services to include drug substance and bioanalysis capabilities by acquiring the Alnwick facility from Arcinova, a UK-based CDMO. Over the past year we have been focused on fully integrating these capabilities into our core Translational Pharmaceutics platform, saving our customers significant time and costs by integrating drug development and clinical testing services within a development program under a single clinical protocol. We also went through a series of organic investments at five of our seven sites, where we have been increasing drug substance, clinical trial manufacturing, and clinical testing space. These investments have either been completed or are ongoing and will be completed in 2022.
In recent years, there has been phenomenal investment in pharmaceutical R&D, and the number of molecules continues to grow. Aligned with this increase, Quotient Sciences’ customer base has grown to approximately 500 customers across the US and Europe. We have operating sites in both the UK and the US, but 80% of our revenues are generated from US-based customers.

Q: Can you explain the importance for drug developers to have a CDMO that can manage both drug substance and drug product in parallel?

A: Quotient Sciences wants to support our customers with their molecules earlier in the development process, from the point at which the drug candidate molecule is selected from the discovery program. By incorporating our scientific expertise and development technologies at an early stage we can help them make the most data-informed decision possible. We can then implement a seamless program of work that integrates drug substance synthesis and manufacturing into our Translational Pharmaceutics® platform to provide time and cost savings.

Q: Have you noticed an increased interest in the development of more targeted drugs?

A: Approximately 50% of drugs approved by the FDA over the past five years have been for orphan/rare disease indications. This presents a unique challenge and opportunity to the industry, as historically service providers and pharmaceutical companies looked for big blockbuster drugs that would be prescribed to millions of patients. Today, patient populations are becoming more targeted with an increased focus on rare diseases. To support this, supply chains must be more flexible. When we manufacture a product, the customer then delivers it to patients, either in clinical trials or on the market. In the case of products for orphan diseases, the customer can either make a significant upfront investment and manufacture a large amount of product with an extended shelf life, or wait until patients have been recruited and deliver the product on an almost just-in-time basis. Quotient Sciences has created the protocols and methodology to just-in-time manufacture, package, label, ship and deliver product to clinics within a two-week time frame. With this model, managing the supply chain and logistics is fundamental. We are currently looking at acquisition targets that will help us bridge more firmly into this space, given our belief that just-in-time manufacturing will play an integral part in the future of drug manufacturing, specifically in more specialized and targeted therapeutic areas.

Q: At what stage of the drug development process is the element of speed or integration most critical to customers?

A: Our principal focus is on the early phases of drug development, from the point of candidate selection through to proof of concept. Through the eyes of a drug developer, this phase of development is loaded with risk. This process is more difficult if the customer is working with multiple outsourced parties. The focus of our integrated Translational Pharmaceutics® programs is to provide the customer with a development platform capable of responding in real-time to emerging development data and maintaining an overall timeline to proof of concept.

Q: Quotient Sciences is investing US$8 million into expansion efforts for in-house API synthesis and manufacturing. What is the company’s goal with this investment?

A: We have seen increased demand towards local API production in both the US and the UK due to supply chain challenges caused by the pandemic and geopolitical issues. Our API capacity expansion will allow us to manage the drug substance and drug product supply chains in-house for our customers and ensure that APIs are supplied on time and at the right quantity and quality to drive the development program.

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Mark Egerton, CEO of Quotient Sciences has been featured in and article in Global Business Reports: A Shifting Landscape The outsourcing model is here to stay

In addition to speed, clients also want ease. Rather than working with several service providers along a product’s lifecycle, for example, it is much easier to work with just a few. To streamline the drug development process, Quotient Sciences’ CEO Mark Egerton sees value in CDMOs managing both drug substance and drug product in parallel. “Previously, customers would use service providers upstream from us and make decisions on which compounds to progress without much consideration of what would happen downstream,” explained Egerton. “The customer would sometimes manufacture the drug substance only to find out later they had made an error in the compound selection process. Having already made significant investment, they are reluctant to take a step back and thus start to make compromises for their downstream development plan.”

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Mark Egerton, CEO of Quotient Sciences has been featured in and article in Global Business Reports: "Keeping Up With Demands: CDMOs diversify their capabilities to meet their clients’ complex requirements."

"According to Mark Egerton of Quotient Sciences, pharmaceutical companies developing drugs to treat rare disorders have two options in terms of distribution. They can either invest substantially into producing large quantities of product with an extended shelf life or hold off until patients have already been recruited and then deliver the drug to this population in a near just-in-time fashion. The latter is often attractive when dealing with patient populations so small that the recruitment process for trials can be a long and unpredictable journey."

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In this roundtable with Pharma's Almanac, Mark Egerton, CEO of Quotient Sciences, answers the Question 'What’s the key to being a leader in the industry?

Featured Roundtable Interview with Mark Egerton, CEO of Quotient Sciences with Pharma's Almanac

Q: What’s the key to being a leader in the industry?

A: When I think about being a leader in our industry, I think about being a role model — one that inspires others to focus on the greater purpose that we serve and one who drives positive change. Developing new medicines with the potential to improve the quality of life for patients in need is an incredibly rewarding purpose and an important responsibility. This is why Quotient’s manifesto is focused on exactly that: “Molecule to Cure. FAST.”

The leaders that I admire have consistently had this focus at the front and center of their vision as their North Star. I’m fortunate to be surrounded every day by great leaders in Quotient and at our customers. Importantly, such leaders are not dictated by their position in an organizational hierarchy. They are colleagues that come from anywhere in the business and have the vision to deliver a real positive impact that is so powerful that it inspires those around them to mobilize and support. Strong leaders maintain that passion when things don’t always work out, which, unfortunately, we know happens all too frequently in drug development. But when it does work out, it’s an incredibly fulfilling experience.

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NOTTINGHAM, UK; September 29th, 2022 – Oxilio, a pioneering drug development company repurposing existing drugs to address unmet needs in cancer treatment, and Quotient Sciences, a drug development and manufacturing accelerator, today announced an update on the development of Oxilio’s OXL001 product.

Oxilio is pleased to announce that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its first Clinical Trial Application (CTA) with OXL001. Following initial formulation development by Oxilio in collaboration with its partner company, TRx Biosciences, Quotient Sciences’ integrated Translational Pharmaceutics® platform has been used to carry out the technical transfer and scale-up activities associated with this program and will continue to be used to support clinical trial material manufacturing and the investigation of the pharmacokinetics and safety of OXL001 in healthy volunteers.

Mark Egerton, Ph.D., CEO of Quotient Sciences, said: “We are delighted to be able to continue to assist Oxilio with their OXL001 program. By leveraging our unique, integrated Translational Pharmaceutics platform, Oxilio will have the flexibility to adjust doses based on emerging clinical data within their study, enabling us to improve their likelihood of success, reduce their development time, and ultimately get new medicines to patients faster.”

Dr. Simon Yaxley, Director of Oxilio, added: “Utilizing Quotient Sciences’ Translational Pharmaceutics platform has enabled us to successfully achieve this important milestone of receiving regulatory approval to undertake our first Phase 1 clinical trial with OXL001. We look forward to commencing this study within the next few weeks.

About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. For more information, please visit quotientsciences.com.

About Oxilio

Oxilio is a pioneering pharmaceutical drug development company improving cancer treatment through rapid, cost-effective drug development. Our mission is to identify, repurpose, and commercialize existing drugs to address unmet needs in cancer therapy. We find new uses for old drugs, a proven approach that involves less risk, time, and cost to bring a drug to the marketplace. Through repurposing, reformulation, and gold-standard modeling and simulations, we are fast-tracking disruptive drug development at speed and at low cost.

Oxilio Company Contact

[email protected]

Quotient Sciences’ Modeling and Simulation (M&S) team has recently completed qualification of GastroPlus, the software they use for physiologically based pharmacokinetic (PBPK) modeling. This 2-year project reflects Quotient Sciences’ commitment to conducting high-quality modeling work with regard to data integrity. In addition, this work proactively takes into account recently issued regulatory draft guidelines by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) around the conduct and reporting of PBPK modeling.

At Quotient Sciences, GastroPlus is routinely used to simulate dissolution and absorption processes and drug pharmacokinetics, in support of both integrated Translational Pharmaceutics® programs and as a stand-alone consultative service. The output from GastroPlus may be used to inform key formulation and clinical development decisions.

The GastroPlus qualification project involved collating and preparing data, building a GastroPlus database, executing drug records within the database, and analyzing the model output and performance. In total, 100 database records with a variety of different properties were compiled, and five instances of the software across different machines were evaluated. Overall, the performance of GastroPlus was shown to be qualified to predict real-life scenarios and provide reproducibility across machines. Sarah Stevens, Senior Vice President and Head of Early Development at Quotient Sciences, said, “We are delighted that the qualification of GastroPlus has been successfully completed. This important project will ensure that we continue to produce high-quality modeling data that aids in critical formulation decision-making, in order to best support our customers’ drug development programs.”

Quotient Sciences will be presenting on this project at the upcoming Pharmacokinetics UK (PKUK) conference in Canterbury Cathedral, UK, on November 2-4, where Kevser Sevim (Modeling and Simulation Research Fellow) and Alison Wilby (Director of Modeling and Simulation) will be presenting a poster entitled “Qualification of GastroPlus® Physiologically-Based Pharmacokinetic (PBPK) Modelling Software to Support Decision Making in Clinical Development”.

Get more information on Quotient Sciences’ Modeling and Simulation services.

GastroPlus® is a registered trademark of Simulations Plus.

Quotient Sciences has completed major investments and expansions at its Nottingham, UK and Reading, UK, facilities to support the delivery of fully integrated drug development programs.

Company increases laboratory and clinical capacity to meet demand for fully integrated drug development capabilities

NOTTINGHAM, UK; September 22, 2022 – Quotient Sciences, a drug development and manufacturing accelerator, has completed major investments and expansions at its Nottingham, UK and Reading, UK, facilities to support the delivery of fully integrated drug development programs through the Company’s flagship platform, Translational Pharmaceutics^®.

The new clinical pharmacology space and expanded development laboratories increase the Company’s capacity to conduct integrated Translational Pharmaceutics programs for global pharma and biotech customers.

Translational Pharmaceutics integrates drug substance, drug product, and clinical testing activities under a single outsourcing provider to accelerate development timelines and reduce costs. 

Developed in consultation with the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA), the platform employs rapid “make-test” cycles, where drug products are manufactured, released, and dosed in a clinical study in days rather than months.

In Nottingham, UK, Quotient Sciences has opened a 17,000 sq ft, MHRA-inspected clinical pharmacology facility, which includes 40 beds with ancillary volunteer lounges, processing labs, a dispensary, and controlled storage. The new facility is located alongside their existing formulation development, manufacturing, and clinical operations facilities at the Company’s Nottingham campus.

At their Reading, UK site, the firm has completed a £1.5 million expansion of its early development and manufacturing facility, which has doubled its formulation development and analytical footprint at the facility, with increased office space also part of the expansion.

“Quotient Sciences’ mission is to help bring new medicines to patients faster by breaking down traditional industry silos,” stated Mark Egerton, Ph.D., CEO of Quotient Sciences.

“Our unique Translational Pharmaceutics platform was launched over 15 years ago and has accelerated the development of close to 1,000 molecules for our customers. These expansions are consistent with our overall growth strategy and in direct response to feedback from our customers and the increasing demand for our services.”

About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

Gareth Jenkins, VP Science and Technology, Candidate Development Services at Quotient Sciences, Contributes to Chemistry Today Panel Discussion on Flow Chemistry. 

Read some of Gareth's contributions to this panel discussion with Chemistry Today July/August 2022 issue.

Learn more about Arcinova's capabilities for continuous manufacturing.

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For what types of reactions do you consider flow chemistry most useful?

Highly energetic and very fast reactions are more easily engineered and controlled using continuous processing than in batch. Similarly, if we are looking at a process with highly hazardous material and we want to minimize the risk, continuous processing can provide that basis of safety. We recently ran a process with liquid bromine that would have been much more complex to handle safely in batch than using the very simple set-up of a couple of pumps and a flow reactor.

Process analytical technology (PAT) and artificial intelligence (AI)-assisted methods are a growing topic this decade. Do you see advantages of implementing these technologies in flow compared with batch?

Flow reactors operate with minimal operator interventions. Flow rates are set on the pump controllers, the pressure is established using a back pressure regulator, and the temperature is established using temperature control units. As most of these process parameters can be interfaced into a process control system, it is very easy to also add PAT and use that to measure the output. The next logical step is to build a feedback loop from the outputs to control the process parameter inputs. Putting all of this into an algorithm means that it is possible to automate the screening of a variety of process parameters, such as temperature. We start with a particular residence time and reaction temperature and use an algorithm to assess what happens if we change the temperature in 5°C steps or if we change the residence time in 30-second steps. Using the very small-scale flow reactors based on narrow-bore, high-performance liquid chromatography (HPLC) tubing, it becomes very quick and material-sparing to rapidly screen a wide range of process conditions. This can help with our process understanding to identify where the edge of failure might be for a particular reaction.

What are the main barriers to wider adoption of flow chemistry in some sectors (e.g. the pharmaceutical industry)?

There has been considerable uptake in flow chemistry across the pharmaceutical industry over the past few years, with many companies establishing flow chemistry within their process development groups. With the recent ICH Q13 guidance on continuous processing close to being finalized, the perceived regulatory barrier is also much lower. Over time, we will see more APIs manufactured with at least one stage by flow chemistry.

Continue reading - Chemistry Today July/August 2022 issue

Emplicure AB reported dosing in the first Phase I pharmacokinetic study for EMPLI03, intended for the treatment of moderate to severe pain. The program is supported by Quotient Sciences Translational Pharmaceutics® platform.

Emplicure today reported dosing in the first pharmacokinetic study with EMPLI03, intended for the treatment of moderate to severe pain. 12 healthy subjects were given a single dose of an oral buccal tablet and blood samples were collected for analysis of Buprenorphine. Safety and tolerability were followed, and the subjects could leave the clinic after completion of the study as planned. Top line data will be available in the beginning of 2023.

The Emplicure group is developing innovative consumer and pharmaceutical products based on its proprietary bioceramic technology platform, Emplior.

EMPLI03 is being developed as an oral buccal tablet with extended release properties intended for the treatment of moderate to severe pain. The formulation is also designed to limit the potential for manipulation of the tablet for abuse. Supported by its Translational Pharmaceutics® platform Quotient Sciences has established the GMP manufacturing process of EMPLI03 and performed this first pharmacokinetic study for Emplicure.

"We have achieved one of our milestones in the development of a Buprenorphine product for the treatment of moderate to severe pain. With properties that limit abuse, EMPLI03 may contribute to a safer medical treatment", said Håkan Engqvist, CEO of Emplicure.

Pain is a major health issue globally and, in the US, as many as 20% of the population is estimated to suffer from chronic pain and in need of long-term pain relief. Widespread moderate to severe pain is a problem that is associated with high costs for society and individual patients. Opioids are, and will continue to be, an important part of pain treatment.

About Emplicure AB
Emplicure AB (publ) is listed on the Nasdaq First North Growth Market. Certified Adviser is Erik Penser Bank. Emplicure develops new and innovative products by combining existing and approved active substances with advanced materials science within ceramic biomaterials. The product portfolio is focused on chronic pain and on abuse-deterrent formulations. The subsidiary Amplicon AB develops consumer products with oral nicotine as the first product. The share is listed on Nasdaq First North Growth Market (EMPLI). Read more at emplicure.com.

Read Emplicure's Announcement

About Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. For more information, please visit quotientsciences.com.

A £6 million project expands Quotient Sciences' Alnwick, UK into a state-of-the-art drug substance manufacturing facility that can deliver integrated support for customers from candidate selection through to early clinical development and beyond.

NOTTINGHAM, UK; October 18, 2022 – Quotient Sciences, the drug development and manufacturing accelerator, has completed the expansion of its drug substance manufacturing facility in Alnwick, UK. The £6 million project results in a state-of-the-art drug substance manufacturing capability that can deliver integrated support for customers from candidate selection through to early clinical development and beyond.  

The expansion delivers multipurpose capacity of up to 15 GMP reactor streams with reactor volumes ranging from 5 liters up to 150 liters and tactical deployment of batch or continuous flow chemistry technologies to optimize drug substance manufacturing processes. The facility has been designed adopting Industry 4.0 principles, with the inclusion of a predictive process control system (PharmaMV) improving the transfer from small-scale process research and development (PR&D) into the manufacture of multi-kilogram quantities of drug substance for clinical use.

Mark Egerton, Ph.D., CEO of Quotient Sciences, said, “Since acquiring the Alnwick facility in 2021, our objective has been to incorporate drug substance services into our integrated Translational Pharmaceutics® platform combining drug product manufacturing and clinical testing. By working with customers at the point of candidate nomination, we can now design the most streamlined programs and significantly accelerate their development timelines.”

Quotient Sciences Alnwick currently employs 200 people across a range of scientific disciplines, including process chemistry, solid-state characterization, radiosynthesis, bioanalysis, and formulation development. The company will continue to expand its capabilities, capacity, and headcount at the site to meet the growing demand for outsourced development and manufacturing services. In 2021, the site was presented an award for “Most Inspirational North East (UK) Science Employer” from STEM Learning as part of the STEM Ambassadors program. 

About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. For more information, please visit quotientsciences.com.