Sulaf Assi
Counterfeit medicines represent a global public health problem which
accounts for 10% of the world market including 50% in some countries.
Medicine counterfeiting can occur to any class of medicines, any
type of formulation and can be encountered anywhere in the world.
Consequently, rapid methods are needed to identify counterfeit medicines
at their site of origin. Handheld spectroscopic techniques offer
this advantage.
Cynthia A. Challener Ph.D.
Despite strong growth in the overall
biopharmaceutical market and the biopharma
contract services market, manufacturers of
biologic APIs and drug products face innumerable
challenges, from increasing cost pressures to
expanding regulatory requirements and limited
formularies. In this 3rd edition of the Pharma’s
Almanac, we provide in-depth discussions of the trends — positive and
negative — driving the biopharmaceutical market and the use of CROs/
CDMOs. Contract service providers representing the full value chain
also offer their unique insights into the practices and strategies that are
helping overcome the various challenges and enabling the accelerated
development of novel medications.
Guy Tiene, MA
Outsourcing is often critical to the success of a product and
partnership can be just as critical to the success of an outsourcing
relationship.
Guy Villax
In the last half-century, the two most
significant changes in the global
pharma sector have been the
emergence of a generic medicines
industry that fills more than 80%
of global prescriptions and the
ability of regulators to keep up with
science and — in over the last decade
— shape the drug approval pathway
to reflect policy.
Nigel Walker
The global biopharmaceuticals market
was valued at $162 billion in 2014 and predicted
by Persistence Market Research
to grow at a compound annual growth
rate of 9.4% from 2014 to 2020 to reach
$278 billion.
Erich Blatter
Biologic drugs are large molecules with
complex structures and product profiles
produced via a series of upstream and
downstream unit operations.
Kevin Haehl
It’s well established that children, seniors and
even cogent, non-impaired adults are prone to
use their prescribed medications incorrectly.
Rob Wilson
One way to help satisfy these
demands is to employ custom-engineered
enzymes as
catalysts in novel, efficient
manufacturing processes —
a technology introduced to
the industry over a decade
ago.
Cyrus K. Mirsaidi
Considering the increasing
pressures on the industry
to reduce clinical time and
cost, it is clear the industry
must find ways to improve
these dismal success rates
and speed the course of development.
Matt Hicks
Mergers and acquisitions among pharmaceutical
companies, as well as an everchanging
product mix, lead to surplus
capital equipment among pharmaceutical
manufacturing facilities.
Oliver Technow, Scott Doncaster, Heather Delage
Most pharmaceutical and biopharmaceutical companies
are establishing closer relationships with a few select service
providers that have unique combinations of capabilities
and demonstrated performance.
John Moscariello, Ph.D.
Several advances in scale-down models have made
great contributions to accelerating biopharmaceutical
process development.
Steve Kuehn, Cynthia A. Challener Ph.D., Marilyn Seiger, MA, MBA,
Is there a more exciting, dynamic sector of the pharmaceutical industry
than the biologics sector? There’s no need to answer, because the
question is entirely rhetorical; of course there isn’t. The journey that
a high-potential large-molecule drug must make to attain blockbuster
or biosimilar status is a long and winding one. The ecosystem that
nurtures and creates these biologic therapies is as complex as the
molecules they are developing.
Here novel molecules find their human
potential and begin translating discovery
into meaningful therapeutics
Bringing a promising molecule to
commercial, therapeutic reality requires
intensive focus on process development
and analytical and clinical validation
Bringing a biologic
therapy to commercial
reality takes an
absolute dedication to
operational, technical
excellence; contract
manufacturers are
increasingly providing
this capability.
Biopharmaceuticals continue to grow in
importance and number as pharmaceutical
research uncovers new treatment
options for new and existing conditions.
Growth in emerging economies with improved
living standards and a rapidly
growing middle class is also helping
to fuel this transition. Although the overall pharmaceuticals
market is expected to grow at a compounded annual
growth rate (CAGR) of 4%-7% to reach $1.3 trillion in 2018,1
significant challenges still exist in the market, including
patent cliffs that are already impacting legacy products,
mounting and changing regulations, increasingly complicated
development and manufacturing processes for
in-demand drugs (mainly biologics), and instability in the
emerging markets.
Vince Ammoscato, Sean Lapekas
While much of the emphasis
on safety in
the pharmaceutical
industry relates to ensuring
patient safety,
as should be the case,
often other crucial
aspects of safety — in
particular process safety — receive less
attention than is appropriate. With increasing
pressure to deliver faster turnaround
times and lower cost, the performance
of comprehensive process safety
evaluations, which are time consuming
and expensive, can be glossed over by
contract development and manufacturing
organizations (CDMOs), most often due to
a lack of awareness and understanding of
their importance. Inattention to process
safety can, however, lead to devastating
consequences.
Bruce Miles
Successful acquirers know what they are looking
for before they begin. They have developed insights
driven by thorough analyses of markets, customers,
competitors, regulators and internal capabilities
that lead them to identify a handful of very specific
acquisition criteria. Moreover, these criteria enable
a dispassionate evaluation of the target’s fit from a
strategic, financial and cultural perspective.
Mark Bamforth, MBA, Steve Kasok, MBA, Richard Snyder, Ph.D.
The cell and gene therapy industry
is in the growth phase
of its economic life cycle. Significant
research and development
expenditure by large
pharma / biotechs and cell and
gene therapy-focused biotechs
is driving new product
development. More than 500 companies
have been identified by Jain PharmaBiotech
to be involved in cell therapy alone,
and the gene therapy market is estimated
by Roots Analysis to be growing at 48.8%
per year to reach $11 billion by 2025.
Syed T. Husain
To attract and keep customers,
competitive CDMOs are
bolstering their offerings by
expanding areas of expertise.
In recent years, some
of these expanded capabilities
have been organic, while
others have been achieved
through strategic partnerships and mergers
with strong, capable partners.
Oriol Prat
Demand for injectable drug
products is increasing at
a healthy rate, due in part
to growth of the biologics
market and because injectable
formulations offer a
mechanism for increasing
the efficacy, while reducing
the side effects, of many small-molecule
drugs.
Bioavailability is of concern not
only to pharma but also to other
industries very close to pharma.
I think [controlled release is] one of
the most interesting opportunities
for life science companies because
you can leverage a combination
of drug substances with specialty
products.
Erich Blatter
Imagine that 10 years ago, even 5 years
ago, there was a lot of discussion about
biosimilars but there was not really a
successful breakthrough. I expect that
now biosimilars will gain, in the next
5-10 years, strong traction and I see
several companies which are jumping
into biosimilar development.
In my view, it might be understood because you need two sets of
skills for ADC development. [ADCs are a] huge challenge in terms
of manufacturing and capital investment because you have to build
both biologic and chemical synthesis capabilities.