Patheon

A Message from Lord Pickles and Lord Blunkett, followed by Patheon's best practice article

The ability to listen and learn from one another has always been vital in parliament, in business and in most aspects of daily life. But at this particular moment in time, as national and global events continue to reiterate, it is uncommonly crucial that we forge new channels of communication and reinforce existing ones. The following article from Patheon is an attempt to do just that. We would welcome your thoughts on this or any other Parliamentary Review article.

Blunkett signature Rt Hon The Lord David Blunkett
Pickles signature Rt Hon The Lord Eric Pickles

www.patheon.com

43PATHEON A PART OF THERMO FISHER SCIENTIFIC |
BEST PRACTICE REPRESENTATIVE 2018
Luca Andretta, general manager
The Swindon site
Patheon, a part of Thermo Fisher Scientific, is a leading
global provider of pharmaceutical development and
manufacturing services, based in Swindon. With over 40 years
in the pharmaceutical industry, the site offers laboratory, business
and manufacturing expertise. General manager Luca Andretta
discusses their recent innovation and range of new partners.
Patheon is a unique and ambitious organisation, and we have undertaken vast
changes since we acquired the Swindon site in 1999. The changes have always
taken us forward and we are now experiencing growth in all parts of the business.
We have a range of tailored services and products, while our constant development
is securing a sustainable future for the business.
We are unique because we offer the Condominium Model, a dedicated suite
and manufacturing process, which is designed to meet clients’ specific needs.
The Condominium Model provides a runway from product development to
commercialisation for a range of complex products.
Assurance of quality
We put quality at the core of everything we do. We have earned the trust of
companies worldwide through our uncompromising quality and ability to sustain
client relationships and strategic partnerships. Our approach is to pursue improvement
in every area of the business, seek out and prevent problems before they occur and
continuously examine and refine systems and processes. Our objective is that the
pharmaceutical that reaches the patient is of the highest quality possible.
Our company culture is one of prevention, compliance and continual improvement.
We identify and surpass industry best practices, to promote safety and reducecosts.
FACTS ABOUT
PATHEON
A PART OF THERMO FISHER
SCIENTIFIC
»General manager:
LucaAndretta
»Based in Swindon, Wiltshire
»Services: Global provider of
pharmaceutical development
and manufacturing services
»No. of employees: 260 on-site
– 65,000 globally
»Won Best International CMO
in Asia award at the Bio
Manufacturing Asia 2018
Conference
Patheon
A part of Thermo Fisher Scientific
PATHEON – A PART OF THERMO FISHER SCIENTIFIC |
THE PARLIAMENTARY REVIEW
Highlighting best practice
44 | PATHEON A PART OF THERMO FISHER SCIENTIFIC
We are committed to the health and
safety of our employees and the
protection of our environment. We
keep current with emerging regulation
and progressive modernisation to
reduce and mitigate risk for people
and the planet. Since 2005, our
facilities have undergone more than
2,600 regulatory and client inspections
and we have had 33 pre-approval
inspections waived by the FDA.
EXPAREL is changing the way
we treat postsurgical pain
Poorly managed postoperative pain can
have a significant impact on a patient’s
recovery. It can put them at risk from
medical complications, as well as being
highly addictive because of the large
quantities the body has to ingest before
it reaches the intended area.
The most effective way to stop opioid
dependence is to eliminate the use of
highly addictive drugs – this was the
goal of Pacira Pharmaceuticals who
developed its injectable suspension,
EXPAREL®.
EXPAREL® is a local analgesic
administered at the time of surgery to
control pain and reduce or eliminate
the use of opioids for acute postsurgical
pain. When injected into the surgical
site, EXPAREL turns off the body’s pain
signals, numbing the area where surgery
has occurred for several days following
the procedure. To date, EXPAREL has
been used in over 3.5 million patients.
While all patients can benefit from
non-opioid postsurgical pain control,
EXPAREL is particularly beneficial for
patients who are at increased risk of
experiencing adverse events, and those
who are predisposed to substance
abuse or addiction issues.
The vice president of commercial
manufacturing and supply operations
at Pacira said: “We want to take the
new technologies we are developing
and place them into Patheon’s
facilities, so they can be colocated
with the people who are learning the
processes and understanding our drug.
Patheon provides the ability for us to
do that through the Condo model and
the footprint design they have in their
UK facility.”
The condo model design coupled with
the manufacturing agreement gives
Pacira a high level of confidence that
they not only picked the right partner,
but they would also be able to control
the intellectual property of their drug
product design and formulation.
“Other potential manufacturing groups
we were looking at did not have the
same type of model, nor did they have
the same ability to provide that type of
an operational environment where we
could transfer a very complex process
to them with the understanding of
how they would actually be able to
manufacture moving forward.”
As the next step toward creating an
even stronger relationship, Pacira and
Patheon are establishing a governance
relationship, where both companies
speak on a regular basis about topics
like how the UK facility is being
utilised and whether the product
is being fully commercialised in an
appropriate way.
“Patheon’s openness to the integration
of these types of technologies into
their network maximizes Pacira’s ability
to supply EXPAREL to patients, as well
as our future pipeline.”
Pacira facility
Patheon’s
openness to
the integration
of these types
of technologies
into their
network
maximizes
Pacira’s ability
to supply
EXPAREL to
patients, as
well as our
future pipeline
| PATHEON – A PART OF THERMO FISHER SCIENTIFIC
45PATHEON A PART OF THERMO FISHER SCIENTIFIC |
BEST PRACTICE REPRESENTATIVE 2018
“By having these strategic discussions
and agreements, it minimizes the cost
of manufacturing for both companies
and it maximizes the ability to provide
patients the quality drug products in a
very timely manner. Ultimately, that’s
what we want to be able to do, and
both companies are coming together
to make that possible.”
Transformative medicine
where it matters
Flexion Therapeutics is a
biopharmaceutical company focused
on discovering, developing and
commercializing innovative, local
therapies for the treatment of patients
with musculoskeletal conditions,
beginning with osteoarthritis (OA), a
type of degenerative arthritis.
In January 2018, Thermo Fisher
Scientific announced that Flexion
Therapeutics, Inc. is utilizing the
Swindon site to manufacture ZILRETTA®
(triamcinolone acetonide extended-
release injectable suspension), Flexion’s
US FDA-approved drug. Flexion
specifically chose Patheon to leverage
the custom condo model.
The condo model is ideal for new
products that have either a formulation
or production process that renders
it unique in terms of equipment and
facility design to create a manufacturing
runway from development to
commercialization. ZILRETTA employs
a complex proprietary microsphere
technology which requires highly
specialized manufacturing equipment
and methodologies.
Under this condo arrangement,
Flexion obtains a dedicated
manufacturing operation which it
can operate as needed to meet its
supply requirements while enabling
it to reduce capital and operational
expenses.
“Long before we reached
commercialization, we recognized that
it would be critical for us to have the
capacity to scale our manufacturing,”
said Michael Clayman, MD, president
and chief executive officer of Flexion.
“Patheon’s condo model is a strategic
solution that provides us with flexibility
and control. By taking this approach,
we can set our own production
schedules and be better prepared to
respond to increases in demand.
“This Condominium suite created
with and for Flexion is a tangible
example of out-of-box thinking in the
pharmaceutical services industry,” said
Michel Lagarde, President of Pharma
Services for Thermo Fisher Scientific.
Developing talent
During 2018 we have seen 89 new
starters joining our teams. As a
pharmaceutical manufacturer, we
experience a continuous need for
talented individuals from STEM
(science, technology, engineering and
mathematics) backgrounds. To ensure
that we attract a high standard of
talent, we have held open days and
attended recruitmentevents.
Last year we commenced our “Talent
of the Future” initiative and we are
now working towards developing a
future talent academy. As well as our
employees visiting local schools and
universities, we actively support local
schools through project initiatives,
work experience placements, tours of
our site plus course partnerships and
placements for college students.
This
Condominium
suite created
with Flexion is a
departure from
the build or buy
paradigm and
represents a
superior value
for our clients
»ISO 14001
We have been ISO 14001 certified since Feb 2017. The standard
requires the subscribing organisations to effectively manage their
environmental impacts through commitments to pollution prevention
and legal compliance. We have driven more efficient use of raw
materials that have enhanced our performance, which in turn has
led to cost reductions and business efficiencies. These include setting
high energy reduction and safety standards in the development of all
new manufacturing suites.
Flexion facility
PATHEON – A PART OF THERMO FISHER SCIENTIFIC |

www.patheon.com

This article was sponsored by Patheon. The Parliamentary Review is wholly funded by the representatives who write for it. The publication in which this article originally appeared contained the following foreword from The Rt Hon Theresa May MP.

The Rt Hon Theresa May MP's Foreword For The Parliamentary Review

By The Rt Hon Theresa May MP

This foreword from the then Prime Minister appeared in the 2018/19 Parliamentary Review.

British politics provides ample material for analysis in the pages of The Parliamentary Review. For Her Majesty’s Government, our task in the year ahead is clear: to achieve the best Brexit deal for Britain and to carry on our work to build a more prosperous and united country – one that truly works for everyone. 

The right Brexit deal will not be sufficient on its own to secure a more prosperous future for Britain. We also need to ensure that our economy is ready for what tomorrow will bring. Our Modern Industrial Strategy is our plan to do that. It means Government stepping up to secure the foundations of our productivity: providing an education system that delivers the skills our economy needs, improving school standards and transforming technical education; delivering infrastructure for growth; ensuring people have the homes they need in the places they want to live. It is all about taking action for the long-term that will pay dividends in the future.

But it also goes beyond that. Government, the private sector and academia working together as strategic partners achieve far more than we could separately. That is why we have set an ambitious goal of lifting UK public and private research and development investment to 2.4 per cent of GDP by 2027. It is why we are developing four Grand Challenges, the big drivers of social and economic change in the world today: harnessing artificial intelligence and the data revolution; leading in changes to the future of mobility; meeting the challenges of our ageing society; and driving ahead the revolution in clean growth. By focusing our efforts on making the most of these areas of enormous potential, we can develop new exports, grow new industries and create more good jobs in every part of our country.

Years of hard work and sacrifice from the British people have got our deficit down by over three quarters. We are building on this success by taking a balanced approach to public spending. We are continuing to deal with our debts, so that our economy can remain strong and we can protect people’s jobs, and at the same time we are investing in vital public services, like our NHS. We have set out plans to increase NHS funding annually by an average by 3.4 percent in real terms: that is £394 million a week more. In return, the NHS will produce a ten-year plan, led by doctors and nurses, to eliminate waste and improve patient care.

I believe that Britain can look to the future with confidence. We are leaving the EU and setting a new course for prosperity as a global trading nation. We have a Modern Industrial Strategy that is strengthening the foundations of our economy and helping us to seize the opportunities of the future. We are investing in the public services we all rely on and helping them to grow and improve. Building on our country’s great strengths – our world-class universities and researchers, our excellent services sector, our cutting edge manufacturers, our vibrant creative industries, our dedicated public servants – we can look towards a new decade that is ripe with possibility. The government I lead is doing all it can to make that brighter future a reality for everyone in our country. 

British politics provides ample material for analysis in the pages of The Parliamentary Review 
The Rt Hon Theresa May MP
Prime Minister