This week, SpeakPharma interviews Denise Sutton, Chief
Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years.
In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services.
HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services
How has the Nottingham site
transformed from when it was founded, to what it is today?
Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). 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-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the 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, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) 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, we have expanded substantially. Our Nottingham site is 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 1 clinical studies), and many talented colleagues covering our
spectrum of CRO and CDMO services.
HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites
How is Translational
Pharmaceutics applied to drug development programs?
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 as a
part of human ADME (absorption, distribution, metabolism, and excretion)
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 the emerging data that impacts the success of
their molecule.
Over all these years, our flagship Translational Pharmaceutics
platform for drug development has remained unchanged in the way it empowers our
customers and offers them unparalleled flexibility.
HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control
What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs?
Nowhere else would a single project manager oversee such a broad
spectrum of activities, let alone be expected to ensure seamless, timely
progression across functions that in any other company (i.e. at other CDMOs or
CROs) would be delivered through multiple operating areas or through the use of
a combination of third-party vendors.
The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management 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, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way.
HIGHLIGHTS// project management team is truly world-leading/ high-performing,
supportive, cross-functional teams/ 25 years at Quotient
Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down.
Nonetheless, 2024 was a
challenging year. Data compiled by PharmaCompass indicates
that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots.
Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced
elimination of 1,800 positions.
View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)
US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to
10,000
Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000.
Novartis announced over 1,200
job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure
of sites in Munich and Boston. Similarly, Bayer announced significant
reductions at its US and Swiss facilities.
North America saw increased
retrenchments, especially at biotech hubs such as Boston, San Diego, and New
Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US
biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving
the numbers.
In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses,
significantly impacting the local biotech ecosystem. New Jersey was subject to
broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs.
The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled
back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally.
In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its
workforce by 65 percent (around 300 jobs).
That included the sale of a Massachusetts
manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as
part of a strategic revamp.
China emerged as another
focal point of workforce reductions in 2024. Global pharmaceutical giants, such
as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such
as Connect Biopharma, which is
transitioning to a US-focused company, also scaled back their presence in
the country.
View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)
Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in
clinical trials
Clinical trial failures were one of the most significant drivers of layoffs in 2024.
For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic
lateral sclerosis (ALS) therapy, Relyvrio, failed a
confirmatory trial. This led to a 70 percent reduction in its workforce,
leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs.
BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in
May.
FibroGen, once considered a
leader in oncology drug development, was among the most heavily impacted. The
high-profile failure of its anti-CTGF antibody in two late-stage cancer trials
led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce.
Lyra Therapeutics also implemented a 75 percent workforce reduction,
affecting 87 employees, after its chronic rhinosinusitis program struggled.
Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.
View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)
Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to
downsize
In addition to clinical
failures, funding constraints played a pivotal role in reshaping the biotech
landscape. Kronos Bio stood out as one of
the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash.
Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction.
The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified
this, choosing to focus on a handful of
promising candidates, while reducing discovery efforts.
Consolidation often results
in overlapping roles, leading to inevitable workforce reductions. Apart from
the MorphoSys layoffs by Novartis, Vincerx Pharma faced
job losses after it got acquired by
Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.
Amid ongoing reorganization
efforts, Gilead closed its Seattle,
Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also
announced that its Kite facility in Philadelphia, Pennsylvania (US), would
close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California.
Gilead also announced that its Kite
facility in Philadelphia would close by mid-2025.
Vir Biotechnology reduced its
workforce by 25 percent (i.e. 140 layoffs)
to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce
after the FDA demanded an additional clinical trial for its leukemia treatment.
Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped
commercial operations and transitioned back to being a clinical stage company.
View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)
Our view
It takes decades to build
innovation ecosystems. The concentration of layoffs in major biotech hubs has
raised concerns about the potential long-term impact on these ecosystems.
In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.
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