Pharmaceutical Commerce - May/June 2017 - 12

Business/Finance

A Conversation with

John Chiminski,

Catalent

Taking on the breadth of challenges in contract
development and manufacturing, globally
By Nicholas Basta

In April, Catalent, Inc., celebrated its 10th anniversary of
its inception, having been spun out of Cardinal Health in
2007 and acquired by Blackstone Group, a private-equity
firm. Later, in 2014, the company went public, traded on the
NYSE. Both while a collection of business units at Cardinal,
and in subsequent years, Catalent has acquired or developed a wide array of drug-delivery technologies, as well as methods for producing
biomolecules and other commercialization steps. These include:
* Soft- and hard-gel encapsulation, including RP Scherer, which invented the technology in the 1930s, as well as Optishell™, Optigel™,
Optiform™, Vegicaps™ and other encapsulation methods; most recently the company acquired another leading encapsulation services
provider, Accucaps.
* Zydis™ fast-dissolve technology for oral products, along with OptiMelt® hot-melt extrusion of solids; controlled release; coated and
other tablet formulations
* GPEx® mammalian-cell production, enabling commercial-scale cell lines to be created based on developers' genetic targets
* Advasept® parenteral technology for aseptic processing, combined with vial-filling and vial-locking mechanisms; prefilled syringes;
blow-fill-seal technology and FlexDoseSM stick-pack technology
* Proprietary systems for micronizing powders; inhalation sprays and powders.
With 8,500 employees and 30 manufacturing sites around the world, the company is a global player in contract manufacturing. Additionally,
a significant portion of its business base is in clinical research, including consultative work, trial drug manufacturing and clinical supply chain
management. It is one of the biggest contract development and manufacturing organizations (CDMOs) in the world.
John Chiminski, CEO, joined the company in that role in 2009, coming from a 20-year stint at GE Healthcare, including various
engineering, operations and leadership roles. Recently, he sat down with Pharmaceutical Commerce to discuss Catalent's role in the industry
and global biopharma's challenges in meeting future needs. Here's what he had to say.

1

Let's talk about the outsourcing
business generally first. As Catalent
has noted, only about one-third
of today's global pharma finished dose
form production is outsourced, even after
many years of contract manufacturing
advances. Why isn't more of the industry
doing outsourcing? Is there an inherent
limit to how much can be outsourced?

We believe that the trend toward
pharmaceutical innovators partnering
more with outside experts is strong and
continues to grow, with a majority of recent
FDA NDA approvals outsourced. Based
on this, plus increases in legacy product

outsourcing, we anticipate that finished
dose form outsourcing will grow to around
40% by 2020. This growth will be driven by
several key factors: new drug and biologic
treatments are increasingly complex to
formulate and deliver, and to reach targeted
clinical outcomes in patients, often requiring
enabling advanced formulation, dose form
or device technologies from companies like
Catalent will be required. Venture capitalbacked and small cap companies, which
outsource most of their production, are
driving much of today's pipeline, and
their products are growing faster than the
overall market. Even large companies, that
have substantial in-house development

12 Visit our website at www.PharmaceuticalCommerce.com May | June 2017

competencies, are experiencing budgetary
and bandwidth constraints in development
resources and in access to commercial-scale
manufacturing equipment that is suitable
for the small-batch, small-volume products
increasingly prevalent.
To successfully implement sophisticated
formulation and delivery strategies, with
increasingly accelerated timelines, requires
a great deal of experience, which we've
earned across hundreds of molecules.
Also, many of these par tnerships
cannot properly be called 'outsourcing'. A
lot of what Catalent does isn't routinely
done 'inside' our pharma and biopharma
partners. Most of them don't have in-house

capabilities for specialized technologies,
such as softgel or fast-dissolve, specialized
analytical or bioanalytical expertise, or
at times whole functions, such as clinical
product supply and logistics.
We have really focused over the last few
years on expanding our ability to provide
such solutions for our customers to solve
our customers challenging pipeline and
manufacturing challenges, with the right
technology and expertise, in the right
location. Our joint focus on developing
better, patient-centric treatments using our
combined skills and expertise is what helps
improve real-world outcomes and makes
for successful partnerships.


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Table of Contents for the Digital Edition of Pharmaceutical Commerce - May/June 2017

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Pharmaceutical Commerce - May/June 2017 - Cover2
Pharmaceutical Commerce - May/June 2017 - Table of Contents
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Pharmaceutical Commerce - May/June 2017 - Cover4
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