Spotlight Interview with Harpreet Smith, Vice President & General Manager at our Miami, FL facility

Joining a great company like Quotient Sciences is a competitive effort on the part of new hires and we select only the top candidates to join our team.

-Harpeet Smith

What do you enjoy most about your role and why?

Knowing that we are helping to develop new medicines and get them to patients faster is exciting and very rewarding. What better mission can one have?

For any qualified candidates looking for a position at Quotient Sciences, what can they look forward to? 

Teamwork. Joining a great company like Quotient Sciences is a competitive effort on the part of new hires and we select only the top candidates to join our team. Team members can expect a collaborative and hands-on approach to delivering projects and a leadership team that encourages working together, driving for results, and operational excellence.

What else do you think differentiates Quotient Sciences from other drug development organizations?

Our clients rely on our expertise accelerate their drug development programs in a variety of ways. Uniquely, we provide both clinical pharmacology & research (CRO) services and pharmaceutical contract development & manufacturing (CDMO) services to the pharmaceutical and biotech industry. These services can be provided individually, or as an integrated service which has been shown to dramatically shorten development times, reduce outsourcing costs, and significantly simplify supply chains for customers. 

Jess Cumberland shares a glimpse into her day-to-day work at Quotient Sciences Nottingham, UK clinic.

How did you get into clinical research?

I worked as an Emergency Nurse in an NHS hospital before pursuing a career change to software development. Unfortunately, I lost that job during the pandemic, and I was searching for new opportunities to get back into nursing when I found an opportunity to join Quotient Sciences as a Clinical Research Nurse. Even though I had taken a year out of nursing, I found it easy to transition back into a healthcare environment. Quotient Sciences’ training and facilities helped refresh my clinical skills quickly. I gained new clinical research experience at Quotient Sciences that enabled me to return to a role within the NHS as a Cancer Research Nurse, where I worked for six months, but I ended up returning to Quotient Sciences as I preferred working in Phase I clinical research.

What does a Clinical Research Nurse do?

As a Clinical Research Nurse, I collect data from volunteers by doing ECGs, checking vital signs, and doing blood tests. Some complex studies have specialist procedures, such as spirometry. I also administer the investigational medicinal products (IMPs) to the volunteers in many different forms, such as tablets, IVs, subcutaneous injections etc. Nurses have extra responsibilities, such as completing vaccination training, giving infection control training to staff, and generally overseeing volunteer safety and ensuring best practice is being maintained in the clinic.

What is the first thing you do when you arrive on site for your shift?

On a normal day, I get to work at about 6:50 am and look at the schedule board, which tells me what study I’ll be working on that day. I could be working on multiple studies in one day. It’s then time to make a cuppa. At 7:00 am, I get a handover from the night shift staff to discuss what is happening on the study today to get an idea of how the day is going to play out.

What is a typical day like for a Clinical Research Nurse?

After the handover, I might cannulate and dose a group of volunteers. Dosing can take about an hour, sometimes longer. After that, I may do some rounds, which could involve taking an ECG or checking vital signs and carry out clinical procedures. In the afternoon, on a long day, I usually act as the shift lead (like a charge nurse) and coordinate the unit.

What do you enjoy most about your job? Are there any social aspects to your day?

I work in a lovely team, who are very social. We’re a close team and we enjoy going to the canteen together or sitting outside during our breaks. 

The team I work with have a great sense of humour. I’m able to work on different projects and different types of studies, so my workload tends to fluctuate, but the people I work with help me get through the day. I was recently promoted to Lead Nurse, which allows me to get more involved in the study set-up phase and help the Senior Nurse more, giving me more experience that will help me progress my career.

What is the hardest part about being a Clinical Research Nurse?

When I first started at Quotient Sciences, the hardest part about the role was adjusting from working with patients to healthy volunteers. It is a completely different set-up going from working in a hospital to a Phase I clinic, but the training that I have received and my team helped me get up to speed quickly. The pace of work is also different when transitioning from a hospital to a Phase I clinic. You have to work to strict deadlines and the day is structured with several studies happening at once. Adapting to the different pace can take time, but there is lots of support available to help. Finally, I have to say that I’ve been a nurse for 7 years now, and I still struggle to get up early! I’m just not a morning person!

What opportunities can this type of job lead to?

Getting into healthcare research can be difficult, but Quotient Sciences has given me the skills that I needed to make a successful transition. It’s an exciting time to join the company because the company is growing and global. A role as a Clinical Research Nurse can lead to roles within project management, a Clinical Trial Coordinator, or a Clinical Research Associate. It could also lead to academic roles, such as lecturing at a university.

What advice would you give to somebody considering a career in clinical research/nursing?

Acute nursing experience with previous experience in immediate life support (ILS) is beneficial but not necessary. If you know you want to work in research, there is no reason why you can’t come and join a Phase I clinic. To be successful in the role, it’s important to be proactive, be inquisitive, have good attention to detail, and be a self-motivated learner.

Quotient Sciences drug development experts are contributing co-authors in new biopharmaceutics textbook. 

Quotient Sciences experts Dr. Vanessa Zann and Chris Roe co-authored a chapter on permeability in the new textbook "Biopharmaceutics - From Fundamentals to Industrial Practice," published by Wiley. This work, edited by Professor Hannah Batchelor, showcases contributions from the UK's Academy of Pharmaceutical Sciences Biopharmaceutical Focus Group and examines tools and applications in drug development.

Biopharmaceutics - From Fundamentals to Industrial Practice" was written as a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. The permeability chapter discusses the importance of permeability and the tools that can be used to predict, assess, or observe oral absorption. 

The permeability chapter highlights the transporters and enzymes that are present within the gastrointestinal tract, both to aid digestive processes and to protect the body against the potential ingestion of harmful toxins. Membrane transporters can influence drug absorption by either increasing transport into the intestinal enterocyte via influx transporters or limiting transport into the cell via efflux back into the intestinal lumen. 

The impact of potential transporter-based drug-drug interactions on that drug's overall exposure and safety should be assessed during development. The provision of electrodes and functionality of the tissue membrane used within Ussing chambers additionally allows measurement of changes in ion transport across the membrane in the presence of drug compounds. Drug permeability is estimated from the rate of disappearance of drugs from the perfused intestinal segment.

Dr. Vanessa Zann has over 17 years industry experience providing biopharmaceutics support to discovery, development and clinical programs. Vanessa has previous experience at AstraZeneca as a permeability expert working in the Pharmaceutical Development dept. where she lead the global Caco-2 facility for development, liaising with discovery scientists to ensure selection of NCE with appropriate biopharmaceutical properties, introduced the IV microtracer technique and also provided biopharmaceutical support to both Discovery and Development programs. Vanessa joined Quotient Sciences in 2012 and has lead the implementation of Modelling and Simulation and been heavily involved in the Pharmaceutical Sciences in vitro characterisation strategy, as well as designing clinical studies and providing scientific support through clinical study delivery.

Chris Roe, Senior Research Fellow, joined Quotient Sciences in 2015, bringing over 20 years of experience across pharmaceutical sciences and biopharmaceutics through a series of previous technical and leadership roles at Sanofi, Pfizer, AstraZeneca and Walgreens Boots Alliance. His expertise ranges from early pre‑formulation and biopharmaceutical assessments ensuring appropriate new chemical entity selection, through development of a wide range of dosage forms including preclinical and early clinical inhalation, topical, oral immediate release and modified release formulations, to maintenance and life-cycle management of existing marketed products. Chris’ role at Quotient Sciences involves designing science­-­led, robust, clinical study programs which maximize output for clients, in addition to providing scientific support throughout study delivery. Chris holds a Bachelor of Science degree in Medicinal Chemistry from Newcastle University and Postgraduate Certificate in Education from Nottingham Trent University.

Quotient Sciences and Gubra begin Phase I clinical trial of Gubra's amylin agonist for the treatment of obesity

Gubra has announced that the first human subject has been dosed with a new long-acting amylin agonist (GUBamy) as a potential treatment for obesity. This first clinical trial is conducted with Quotient Sciences as a single ascending, dose-escalation, safety, and tolerability trial in healthy volunteers.

GUBamy (GUB014295) is a long-acting amylin agonist for once weekly subcutaneous (SC) administration. GUBamy is in development for weight management in people living with obesity. 

Quotient Sciences will support the Phase I, First-In-Human, randomized, single ascending dose trial, which will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of GUBamy administered in lean to overweight but otherwise healthy subjects. The study will be conducted in up to 48 subjects divided in 6 cohorts at Quotient Sciences in Nottingham in the UK.

Read the announcement from Gubra

Stuart McDougall Contributes to ‘Conference Report from the European Bioanalysis Forum Workshop: Toward Harmonized Implementation of the ICH M10 Guideline’ in Bioanalysis Journal

Quotient Sciences’ Principal Research Fellow of Bioanalytical Services, Stuart McDougall, is a representative on the European Bioanalysis Forum (EBF), which is an organization comprising bioanalytical scientists working within the pharmaceutical industry that provides a platform for discussions on science and regulatory issues. 

At the latest EBF workshop in November 2022, entitled ‘Toward Harmonized Implementation of the ICH M10 Guideline’, Stuart was one of 250 delegates representing 125 different organizations who attended. The purpose of the workshop was to discuss the final International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – Multidisciplinary Guideline N◦10 (ICH M10) after its publication in May 2022. Stuart moderated several plenary and breakout sessions on different chapters of the ICH M10 guideline and contributed to the resulting conference report as a co-author.

The ICH M10 is the culmination of many years of work by regulators and bioanalysts across the world to unify into a single global bioanalytical guideline and eliminate the regional and geographic differences. 

In the report, the EBF shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop. 

The focus of the discussions was to understand new, changed, or still ambiguous regulatory expectations in the guideline, as identified in feedback from the pre-workshop surveys or during the workshop. The proposals from the workshop aim at stimulating and helping a harmonized implementation of the guideline and using the EBF community as a sounding board during and after implementation to highlight areas of misalignment and to create a platform for continued sharing with the regulatory authorities in an effort to contribute to industry and regulators developing similar interpretations on guideline expectations.

"The ICH M10 is the culmination of many years of work by regulators and bioanalysts across the world to unify into a single global bioanalytical guideline and eliminate the regional and geographic differences," said Stuart. "However, the publication of ICH M10 is only the first step, as we need to ensure a consistent and agreed understanding and implementation across our industry. 2023 will be a very important year, as we live with ICH M10 during our day-to-day activities."

Delivering rapid bioanalytical data is critical to meeting milestones in drug development. Quotient Sciences are experts in the development, validation, and application of bioanalytical assays. Learn how we can help your next program with our range of bioanalytical services.

Quotient Sciences has been recognized as a multi-category award winner of Outsourced Pharma and Life Science Leader’s 2023 CDMO Leadership Awards.

Now in its 12th year, the CDMO Leadership Awards recognize the best contract development and manufacturing organizations (CDMOs) across categories including: Capabilities, Compatibility, Expertise, Quality, Reliability, and Service.

Winners are judged by customers as either exceeding expectations or as top performers and customers can only evaluate CDMOs with which they've worked with in the past 18 months. Primary market research conducted by ISR Reports is the basis of the awards. Sponsors provide their ratings of contract development and manufacturing organizations based on their recently outsourced projects. The feedback is then reviewed to determine leading CDMOs in these performance categories.  

CDMOs can win in up to three groups of outsourcing respondents including Big Pharma, Small Pharma, and Overall (combined Big and Small Pharma). For 2023, Quotient Sciences is the recipient of CDMO Leadership Award recognition in the following areas:

• Capabilities (Overall, Small Pharma)
• Compatibility (Overall, Small Pharma)
• Expertise (Overall, Small Pharma)
• Quality (Small Pharma)
• Reliability (Small Pharma)

See the full list of winners presented by Outsourced Pharma and Life Science Leader

Video: Live from the awards ceremony during DCAT 2023

In this featured video taken during DCAT 2023, Dr. Sarah Stevens, former Senior Vice President & Head of Early Development & Late-Stage Commercial at Quotient Sciences, comments on the importance of receiving this recognition.

The Pharma Innovation Awards 2023 recognizes Quotient Sciences’ FlowInova platform with an award for its ability to streamline the scale-up process for early-phase API development.

Born out of a collaboration with the University of Nottingham, the FlowInova platform utilizes high-throughput experimentation and modeling. As data accumulates and process knowledge grows, predictive process models enable virtual design of experiments, ultimately enhancing the overall efficiency and effectiveness of the development process.

This significantly reduces the time and material quantities required for scale-up within a laboratory setting. This translates to accelerated drug substance API development timelines, cost savings, and greater productivity for drugmakers.

Read the feature article on Pharma Manufacturing below, and contact us for more information about how the Flowinova platform could help accelerate your API development timelines.

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Quotient Sciences is one of the 2023 winners of the SME British Made Awards. The company was recognized as the Most Innovative Tailored Drug Development Company in this year's awards.

The awards are given solely on merit and are awarded to commend those most deserving for their ingenuity and hard work, distinguishing them from their competitors and proving them worthy of recognition.

We have been judged to show that we are always improving our skills and reach, contributing to elevating our industry, and ultimately enabling the UK drug development market to flourish further into the future.

Awards Coordinator Jack Ford commented: "The British Made Awards are here to celebrate those making waves in their industries not simply for the present moment, but for the near and distant future of the market in the UK."

We would like to thank all those at the SME for the recognition and this award.

Contact us about our award-winning tailored drug development services today.

Continuous flow manufacturing is taking off in the production of active pharmaceutical ingredients (APIs).

In a conversation with Outsourcing Pharma at CPHI Barcelona, Dr. Paul Quigley, former principal research fellow of drug substance at Quotient Sciences, explained how APIs are traditionally made using a method called batch manufacturing and continuous manufacturing is on the rise. 

Batch manufacturing can require hundreds of tons of raw material and the drug substance manufacturing process often takes months. Another major disadvantage of this process is that it can be difficult to perform safely and sustainably when hazardous reagents are used at high temperatures and pressures.

To overcome this obstacle, Quotient Sciences is part of a growing wave of companies exploring an alternative approach known as flow technology or continuous flow manufacturing. Flow technology has been around for centuries, the process is often used to mass-produce industrial chemicals using catalysts. This method continuously mixes reagents in tubes and requires much smaller amounts of hazardous reagents than batch processes.

Flow technology could reduce waste in the API manufacturing process and make it safer, faster, and cheaper.

In December 2022, Quotient Sciences completed the construction of a flexible, modular, kilo-scale drug substance manufacturing facility at our Quotient Sciences Alnwick site, a £6 million investment. This investment created 4 production suites, which can house a range of reactors, both continuous and batch, with the latter going up to 150 L in scale. Our Alnwick, UK, facility was perfectly placed for this expansion and it had both the available space and a wealth of local, expert scientific talent with an abundance of experience.

The impact of continuous flow manufacturing technology on the pharmaceutical industry is just beginning to be felt, and the World Economic Forum included them in its list of the 10 best new technologies of 2021.

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NOTTINGHAM, UK; October 24, 2023 – Quotient Sciences, the drug development and manufacturing accelerator, announced that it has made a major investment in the sterile fill/finish capabilities at its Alnwick, UK facility. This investment will increase the current capacity of the Annex 1 compliant facility to meet increasing industry demand for fully integrated drug development programs.

The company has state-of-the-art contract development and manufacturing (CDMO) facilities in both the US and UK, which are fully integrated with their clinical testing facilities in Nottingham (UK) and Miami (US) to deliver industry-leading cost and time efficiencies.

This latest investment provides a major boost to the Alnwick facility, increasing the number of Grade C cleanrooms from one to three.

As part of this expansion, the company has invested in a new isolator technology, enabling larger batch sizes and reduced cycle times per manufacturing campaign. The site also benefits from an integrated in-house microbiology team to accelerate testing and environmental monitoring, with further investment in the microbiology labs planned for next year.

Gareth Jenkins, VP Science & Technology at Quotient Sciences, said: “Navigating the development, analytical, and new Annex 1 regulatory requirements for sterile/aseptic drugs can be complicated, but with these enhancements, we have the specialized expertise and dedicated facilities to ensure successful and timely program delivery.

“With the demand for aseptic fill/finish continuing to grow across the pharmaceutical industry, and the requirements of Annex 1 that came into effect in August 2023, there is a greater global focus around regulatory requirements, commitment to quality, robust processes and containment strategies for CDMOs providing these services.

“The Alnwick site is a center of excellence for sterile product development, with ongoing recruitment and expansion of the team to ensure we meet growing market demand.”

Quotient Sciences has over 30 years of experience in the development of sterile parenteral drug products, from candidate development through to clinical trial manufacturing, including radiolabeled, high-potency, and cytotoxic compounds. The company’s flagship platform, Translational Pharmaceutics®, fully integrates drug substance, drug product, and clinical testing activities, which facilitates real-time decision-making based on emerging clinical data.  This approach provides flexibility to adjust formulations within a study, which accelerates development timelines, minimizes risk, and reduces costs.

Thierry Van Nieuwenhove, CEO of Quotient Sciences, added: "At Quotient Sciences, our mission is to help get new medicines to patients faster. Increasing our capacity for sterile fill/finish operations, investing in new technologies, and expanding our team, enables us to further support our customers with fully integrated Translational Pharmaceutics programs for sterile product development, which reduces development risks, shortens timelines, and improves the chances of success."

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.

Quotient Sciences Company Contact
Kieron Hall
SVP & Chief Commercial Officer
(TEL) +44 7900 896428
Kieron.Hall@quotientsciences.com