Quotient Sciences – Nottingham offers our clients a powerful combination of drug development capabilities and phase 1 expertise underpinned by a strong scientific heritage.
This facility was the origin for Quotient Sciences’ Translational Pharmaceutics® platform, a unique offering not seen elsewhere in the pharma services sector combining on-demand GMP drug product manufacturing with healthy volunteer clinical trials in an integrated program of work led by a single project manager (PM). Designed to disrupt conventional drug development industry siloes to achieve significant time and cost efficiencies, Translational Pharmaceutics® is unparalleled in how it helps advance the next generations of medicines to market.
In our two-part spotlight, we speak with Denise Sutton, Chief Operating Officer and Site Head for our Nottingham, UK facility, about her background, the evolution of the Nottingham facility, and the Translational Pharmaceutics® platform.
Could you tell us about your background and how it led you to your current role at Quotient Sciences?
I joined the Nottingham site back in 1999 when the business was Pharmaceutical Profiles, a spin out from the University of Nottingham.
I had completed my Ph.D. and post-doc in Biochemistry and was attracted by the novel science emerging from Nottingham under Dr. Ian Wilding, Dr. Steve Newman, and Professor Bob Davis. This team was helping drug development experts diagnose challenges in getting their product to the right location, at the right time, and at the right concentration. They were deploying gamma scintigraphic imaging studies to understand how drugs performed in humans under the banner that “a picture tells a thousand words.” It was ground-breaking science, and I joined initially as a Project Leader to help customers manage their programs on challenging molecules. This was a hands-on role in which I gained experience in drug product manufacturing, clinical activities and data analysis/reporting. There’s no better way of getting to know a business and I learned so much!
Since then, I’ve held many roles within the company spanning operations, project management and commercial. I feel extremely lucky to have been given so many learning opportunities and to have gained such a deep understanding of how these typically disparate activities can be integrated in a way that has a very positive impact for our clients’ programs.
How has the Nottingham site transformed from when you first started to what it is today?
We were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90% of our work focused on gamma scintigraphic imaging. Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed.
At the end of 1999, we moved our headquarters to a purpose-built, two-story facility—now known as Trent House on our now much larger Nottingham campus. We built three GMP manufacturing suites on the top floor and three clinical wards on the bottom floor. In effect, this was the very early start of our Translational Pharmaceutics® platform.
We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, we approached the MHRA with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics® platform, and we haven’t looked back since.
Today, our Nottingham site has expanded to a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds where we conduct healthy volunteer Phase I clinical studies, and many talented colleagues covering our spectrum of CRO and CDMO services.
What has remained unchanged all these years is that Translational Pharmaceutics® is our flagship platform for drug development that empowers our clients with unparalleled flexibility.
We apply Translational Pharmaceutics® across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and human ADME programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics®, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of emerging data that impacts the success of their molecule.
As a leader at Quotient Sciences, what does a typical day look like for you?
No two days are the same which keeps life interesting.
Quotient Sciences is a scientifically rich, customer-responsive organization. We know that great service starts with listening to our customers and having great people with a strong team ethic to respond rapidly to the changing demands of early phase research. I therefore ensure much of my time is spent listening to customers, connecting with our project teams and challenging how we can continually improve to find time and cost savings for our customers.
What would you say are the key strengths of the Nottingham site, and how do you support customer programs?
We’ve discussed Nottingham’s capabilities and strengths of Translational Pharmaceutics®, but I haven’t yet spoken about our project management team.
Nowhere else would a single PM oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company would be delivered from within multiple operating areas (in larger CDMOs and CROs) or through using a combination of 3rd party vendors.
Challenges will arise, but working with the project team, the PM works to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers, so the project Gantt chart is our PM team’s guiding light. I believe our PM team is truly world-leading; they communicate well, show great compassion, and lead with integrity.
I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, working collaboratively to deliver the best possible service. After 25 years at Quotient, I still really enjoy going to work. I am indebted to my many colleagues for helping me continue to feel like this.
For more information about Translational Pharmaceutics®, John McDermott, VP of Scientific Consulting, explains how the platform works in a recent video.
Coming soon! In the next part of this two-part series with Denise Sutton, we discuss highlights of Quotient Sciences’ clinical pharmacology offering, and how we work with our clients to design the best program for their needs.
Read the second part of this series here!
