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
Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess
and collect fees from drug manufacturers to expedite the delivery of safe,
high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as
of November 14, 2024, 1,397 facilities had paid their registration fees for
financial year 2025. Of these facilities, 707 or 50.6 percent are active
pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage
forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs
and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO)
sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories.
Fiscal year
Facility Registrations
2016
1,425
2017
1,442
2018
1,269
2019
1,286
2020
1,300
2021
1,340
2022
1,385
2023
1,394
2024
1,447
2025
1,397
Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with
396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities,
while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share
of API manufacturing sites, outmatching the combined total of China (128) and
the US (83), which together account for 211 facilities. Among European
manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain
(30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites,
followed closely by India with 135 sites and China with 45 sites.
Country
API
FDF
Both
CMO
Total
India
214
135
21
26
396
US
83
143
13
89
328
China
128
45
12
12
197
Italy
59
3
2
19
83
Germany
25
4
1
15
45
Spain
30
9
1
4
44
Canada
7
17
13
37
Taiwan
9
6
5
4
24
Switzerland
15
4
4
23
France
16
6
22
Japan
18
1
19
United
Kingdom
12
1
2
15
Mexico
9
1
1
11
Ireland
5
5
1
11
Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates
increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA
III), continues with provisions that will last until September 30, 2027. In
July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API
facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2
percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent
for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO
facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4
percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug
applicants has increased by over 9 percent, compared to the 7 percent increase
seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility
registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were
new registrations (going
by Facility FDA Establishment Identifier numbers).
China led the way with 13 new facilities, followed closely by India with 11 new
facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six
facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas
Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF
facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility
each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging
Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility
for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among
these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina
(US), which is permanently closed. In fact, the geographical distribution of
non-renewals shows that 30 facilities were from the US, while India and China
accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued
strong presence of Indian manufacturers in the US generic drug market,
particularly in API production. However, China's leadership in new facility
registrations, especially in FDF manufacturing, suggests that the global
generic drug supply chain landscape may evolve considerably in the coming
years.
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