Dawn Von Rohr, Steven R. Hagen, Ph.D.
Building a premier contract research, development
and manufacturing services organization requires
an understanding of the marketplace, a long-term
strategy for both inorganic and organic growth and
the ability to effectively integrate acquisitions.
Nigel Walker
There is tremendous pressure on the pharmaceutical
industry to accelerate the development of novel
drugs that meet pressing unmet medical needs, from
treatments for widespread chronic illnesses to those
for rare diseases. At the same time, there is a clamor
for lower drug prices. The U.S. Congress has entered
the fray with the 21st Century Cures Act, while FDA
has implemented multiple accelerated approval pathways.
Sponsor drug companies are increasingly turning
to contract service providers for assistance and
many are seeking more collaborative relationships - either preferred or strategic partnerships - to ensure
success in a highly competitive marketplace.
Helmut Schneider, Ph.D., Keith Webber
Throughout the entire drug development
lifecycle, efficient and cost-effective
routes to candidate drug substances with
high potential for regulatory approval
are established. This work involves investigation
of the impact of numerous
parameters on process performance
(yield, selectivity, etc.) and product quality.
Timely access to accurate analytical
information is fundamental to completing
process development projects effectively
and efficiently. As a result, methods
are continually evaluated and optimized
as needed through all stages of the drug
development lifecycle for the purposes
of product characterization, or to be qualified
and validated as release assays.
John Moscariello, Ph.D.
The QbD concept has been
widely adopted as a standard
of practice for manufacturers,
including those in the
automotive, semiconductor,
electronics and chemical processing
industries. Regulators
have also embraced QbD as a means
to modernize the regulation of pharmaceutical
manufacturing and product quality
through manufacturing science, based
on methodologies proven across countless
applications. From their standpoint,
QbD-based processes hold great potential
in creating the efficient, agile and flexible
manufacturing systems required by biopharma
to reliably deliver safe, effective
high-quality drug products to patients in a
secure supply chain.
Kevin Haehl
Pharma’s next blockbuster is increasingly
hard to find and that’s shifting
the emphasis of R&D spending and the
traditional direction of innovation. According
to Tufts Center for the Study
of Drug Development, industry leaders
will spend $2.5 billion to get a drug from
conception to approval.1
Syed T. Husain
With considerable room for growth in
emerging markets, the surge in biopharmaceutical
drug development
and approvals, as well as merger and
acquisition activities that are helping
to further existing expertise, has left
the pharmaceuticals market poised
for growth.
Steve Kuehn, Cynthia A. Challener Ph.D., Emilie Branch, Carrie Cao, Ph.D.,, Jerry Sticker
At one point the future was more about
the drug — finding the compounds and
molecules that stopped the pain, killed
the infection or immunized humans
from history’s great diseases.
Steve Kuehn, Cynthia A. Challener Ph.D., Emilie Branch, Carrie Cao, Ph.D.,, Jerry Sticker
The primary function of drug delivery is
to facilitate active pharmaceutical ingredients
reaching the target site and
exerting a desired efficacy and safety
profile. Drug makers have been relying
heavily on drug delivery systems
(including excipients and formulations) to improve
solubility of drug compounds and achieve better bioavailability.
Poor solubility presents a major challenge
for the pharmaceutical industry. Approximately 40%
of marketed drugs and 80% of compounds in discovery
and development suffer from low solubility and/
or low permeability.1
Steve Kuehn, Cynthia A. Challener Ph.D., Emilie Branch, Carrie Cao, Ph.D.,, Jerry Sticker
As the population increases and the
number of regional markets entering
the global landscape continues to
mount, drug companies are feeling
pressure to bring drugs to market more
quickly. CDMO outsourcing remains
a key strategy for alleviating the pressures of development.
In particular, API manufacturing has maintained
a firm position as the most outsourced area for
drug manufacturers. This has led to robust growth associated
with the sector, which is expected to steadily
rise, especially over the short term.1
The API market is
expected to grow at a compound annual growth rate
(CAGR) of approximately 6.5% through 2020, when it
will have a forecasted value of $185.9 billion.2
Steve Kuehn, Cynthia A. Challener Ph.D., Emilie Branch, Carrie Cao, Ph.D.,, Jerry Sticker
For optimal pharmacokinetics, sometimes
it’s about getting the right amount
of a drug to the right place at the right
time. Whether a drug is delivered orally,
parenterally or through some other
method like inhalation, bioavailability
might be greatly enhanced when a drug is combined
with certain types of nanoparticles in development
today. These nanoparticles, when attached to small molecule
drugs, often act as vehicles to get the drug
where it needs to go, sometimes by getting it to where
it might not ordinarily be allowed to go. Thus, medications
that could help alleviate central nervous system
(CNS) disorders such as Alzheimer’s disease and
Parkinson’s disease are given the opportunity to work
more efficiently.1
Steve Kuehn, Cynthia A. Challener Ph.D., Emilie Branch, Carrie Cao, Ph.D.,, Jerry Sticker
Many of the most promising next generation
drug products are
based on biologic active pharmaceutical
ingredients that require
new technologies that enable their
manufacture, characterization
(identity, viability, purity, potency, viral safety) and
other testing (sterility, release, etc.) and distribution
at the large scales required for commercial drugs.
Tim Tyson
The landscape for contract manufacturing
organizations (CMOs) serving the pharmaceutical
industry is changing rapidly.
Most notably in 2015, the concept of contract
development and manufacturing
organizations (CDMOs) was fully realized.
Many conventional CMOs have actively
pursued acquisitions and internal investments,
some funded through initial public offerings, in
order to become CDMOs with the capability to support
the needs of pharmaceutical customers across the
entire development and commercialization cycle in an
increasingly integrated manner.
Christian Sauveur
The pace and therapeutic
achievements of the industry
are reaching new heights not
seen since the passing of the
blockbuster or “Pharma 1.0”
business model. Ernst & Young
(EY) analysts explain that to
help face mounting shareholder,
competitive, regulatory and social
headwinds, the industry has, over the past
decade, followed a strategy of diversifying
into a “Pharma 2.0” model around product
lines that are less exposed to R&D and
market risks.
Vince Ammoscato, Dr. Charles J. Stankovic, Ph.D.
Contract manufacturers with demonstrated
experience developing robust processes
and successfully navigating the approval
process for Fast Track, Breakthrough
Therapy and other special designation
products are in high demand. These service
providers help their pharma partners
meet both their aggressive deadlines
and regulatory requirements by implementing an
effective process qualification strategy.
Our comprehensive portfolio of standard and custom-designed
equipment, machinery and entire production lines includes benchtop
R&D solutions, completely integrated industrial-scale plant and both
batch-based and continuous processing technology.
RJ Palermo
Of the nearly 600 buyers of
equipment services responding
to the 2016 Nice Insight
Pharmaceutical Equipment
Annual Survey, 81% indicated
they report to either operational
or technical departments in their
organizations. When purchasing pharmaceutical
equipment, respondents
ranked “reliability” as their number one
priority. Regarding the attributes that
purchasers seek in their current and
prospective equipment suppliers, the
majority of respondents (55%) ranked
manufacturing / process integrity as the
top attribute they use to evaluate equipment
suppliers.
Matt Hicks
Investment Recovery for Pharma
Equipment,” the first of two-part
article, can be read in its entirety
in the Q2 Pharma’s Almanac. This
is a short synopsis of Part I, which
discussed the various affects that
both mergers and acquisitions,
and an ever-changing product mix,
have on pharmaceutical companies. Often
the result is two distinct challenges — one
is managing surplus inventory, and the second
is managing an effective capital equipment
investment recovery strategy that
addresses the surplus inventory challenge.
Filipe Gaspar, Márcio Temtem, Ph.D.
Growing Demand for Spray Drying
The application of sophisticated drug discovery
methods has led to much better, but
also more complex, chemical entities that
suffer from poor water solubility/bioavailability.
In fact, 40% of drugs currently on
the market and 90% of candidates in the
pipeline fall into this category.1
These complex
small-molecule drug substances require
enabling drug delivery technologies
to achieve the desired level of efficacy
Pere Vilanova
The ability to track and trace pharmaceutical product in
the distribution channel has always been a regulatory
imperative, but those regulations are evolving and
becoming more sophisticated to improve drug safety
and combat the threat of counterfeits in the supply chain.
In spite of the regulatory burden, the ability to accurately
track and trace product and manage the disposition
of stock after its sale can add business value beyond
efficiently demonstrating compliance.
The outlook for the pharmaceutical
equipment markets (production and
packaging) is quite positive. According
to PharmSource, the market size
for bio/pharmaceutical industry
spending on investment for new
plant and equipment was $18.6 billion
in 2013 and rose to $21.4 billion in 2014 — an increase
of 13%.1
Meanwhile, the pharmaceutical packaging
equipment market was valued by Markets and
Markets at $5.18 billion and predicted to grow at a
compound annual growth rate of 6.9% to reach $7.24
billion in 2020.2 In addition to general expansion of
the overall pharmaceutical market, the key driver for
growth of these equipment sectors is the need for
novel and flexible equipment to maintain competition.
Richard Snyder, Ph.D., Mark Bamforth, MBA
More than 500 companies are involved in
cell therapy technology,1
while the market
for gene therapy is predicted to be valued
at greater than $200 billion by 2020.2
Globally, there are over 2300 gene therapy3
and 372 cell therapy4 clinical trials currently
in progress targeting numerous cancers,
hemophilia, diabetes, cardiovascular,
neurologic, and many other acquired and
inherited diseases.
Haig Armaghanian
Acquisition has become a favorite tactic by contract
pharma’s most prominent players, but there’s more
than one path to sustained growth, especially for those
seeking the scale, global presence and technical acumen
the bio/pharmaceutical industry is demanding.
Inline buffer dilution (IBD) has been
recognized as a game changer and
a highly optimized solution to this
critical processing step. Kimo
Sanderson, Vice President of Marketing
and Client Services at Asahi Kasei
Bioprocess America, lends his leading industry
insights with Pharma’s Almanac to
better describe the methods behind this
crucial function.
Philippe Mougin, Ph.D.
The 2016 Nice Insight CDMO
Outsourcing Survey found that
66% and 50% of respondents’
businesses were engaged in
the development of new biologic
entities and biosimilars,
respectively.1
Further, global
spending on medicine in general
is expected to hit $1.3 trillion by 2014
— up approximately 30% from 2013 — and
the demand for biopharmaceuticals is increasing
in response to growth in emerging
markets and the surge in oncological
innovation.2
Nice Insight and the Pharma’s
Almanac editorial team would like to
thank all the companies participating
in this quarter’s edition.
The following are the profiles of
the industry-leading companies that
have appeared in this issue. These
companies make it their business
to energize pharma’s increasingly
complex supply chain and pursue
excellence every day in support
of the industry’s overall quality,
health and safety goals.
Contract packaging firms that offer low cost,
timeliness, flexibility and creativity, combined
with assured high quality, can add real
value by providing unique and differentiating
solutions while allowing brand owners to focus
on their core capabilities.
Cynthia A. Challener Ph.D.
The rapid changes occurring in the pharmaceutical
industry are placing mounting pressures on (bio)
pharmaceutical companies to accomplish more
with less. Outsourcing to access unique technologies,
lower costs and accelerate timelines is now the
norm. The winners are service providers and pharma
customers that form true partnerships based on
trust and understanding. In this fourth edition of the Pharma’s Almanac,
we explore different collaboration models and how both innovator firms
and CDMOs are applying them while they navigate changing pharma
industry dynamics and build strong foundations for future success.
Process design, measurement
and control for enabling continuous processing adoption
in the biotech and pharmaceutical industries – the
shift from batch to continuous production methods is
transforming the future of pharmaceutical manufacturing.
The potential economic gains from increasing
capacity utilization and reducing the length of process
development, product release times and capital costs
are driving the paradigm shift.