Cynthia A. Challener Ph.D., Steve Kuehn, Dr. Andrew Warmington, Ph .D.
Innovation is at the heart of the pharmaceutical industry. Researchers develop innovative approaches to understanding biological processes, including the identification of potential new targets for which novel drug substances are developed.
New technologies are continually being introduced to improve the efficiency and productivity of discovery, development and manufacturing activities. And all the while, the goal is to provide safe and effective medicines to patients in need.
Adam Covitt
in the post-blockbuster era, pharma’s major
manufacturers are under pressure to increase the
cost efficiency of their manufacturing operations
and extend the service life of their processing
equipment. equipment investment recovery
strategies that include a well-planned and executed
redeployment process and the right partners can
add flexibility and extend asset utilization across
geographically dispersed operations.
Guy Tiene, MA
Nice insight is in conversation with uwe harbauer, senior vice president, pharma business unit, bosch packaging technology, to discuss how equipment upplier/pharma
Company relationships have changed over time, including the growing importance of longer-term, more strategic interactions.
As the cost of drug development continues to
mount in unison with the demand for safer,
more cost-effective drugs, the pharmaceuticals
market is in need of innovation in clinical trial
management and design to keep pace with the
demand for more effective trial data.
Contemporary, successful drug innovation
springs fundamentally from a well-managed
r&d effort, one increasingly reliant on
automation, robotics and high-throughput
analytical tools to identify the highest-
potential targets quickly and efficiently.
Guy Villax
Rx-360 is an industry consortium
founded in 2009.
Our mission is to ensure patient safety by enhancing the authenticity and quality of medicines around
the world.
Conrad Winters, Eunice Costa
There is growing demand for dry-powder inhalation
formulations of drugs to treat both respiratory and
systemic diseases. composite particle technology is
allowing the development of more efficient formulations,
even for challenging molecules. spray drying is an
enabling technology for composite particle preparation.
Formulators must be aware, however, of the tradeoffs
between properties that improve aerodynamic
performance in the lung but negatively impact
process yields or throughputs.
Congress passed the drug supply chain
security Act in 2013.
three years into
its phased implementation, industry
compliance activity continues, as this
benchmark ruling comes due in 2017.
With record-high drug approval rates,
and next-generation therapies that
operate via novel mechanisms of
action showing great promise in the
clinic, the likelihood of innovation
seems guaranteed as long as
numerous manufacturing challenges
are addressed.
Andrew Ferraro
Nice insight’s virtual panelists explore the deal-structuring shift in the pharmaceutical market from an investor perspective.
Philippe Dartiguelongue
Preventing patient risk is perhaps the most important
goal for any pharmaceutical manufacturer. The
quality of a drug substance or product is directly
linked to where and how it’s made. As a result of the
gravity of production, management must ensure that
process variation is eliminated, consistent quality is
guaranteed and there are no threats of defects that
may potentially harm patients or interrupt supply.
To assure quality, Servier takes a holistic approach,
bringing people, process and policy together to
create an efficient, agile QA/QC culture.
Guy Tiene, MA
Nice insight’s virtual panelists share their thoughts about the integral role that safer, simpler and smarter packaging plays in a compound’s success.
Nigel Walker
It absolutely has. Throughout our history,
Capsugel has been at the forefront of innovation
in hard capsules and polymer science,
and we have built great relationships
with customers in the biopharmaceutical
and consumer health and nutrition industries.
Over the past few years, we saw several
opportunities to offer our customers
even more — to complement our capsule
engineering know-how and establish ourselves
as a leading global provider of technology
platforms for the design, development
and manufacture of a wide range of
innovative dosage forms.
Ed Scholtz, Ph.D.
Acomprehensive understanding
of the properties of a drug
substance — its solubility in
solvents and buffer systems,
compatibility with excipients,
stability under different physiological
conditions, solidstate
characteristics, basic
physicochemical properties, etc.
Stephen A. Munk
Personalized medicine, precision
medicine, evidencebased
medicine and patientcentered
outcomes research
dominate the landscape today
and are driving the need for
significant change in manufacturing
strategies. Pressure
is mounting to accelerate the development
and commercialization of novel drugs with
greater efficacy than current treatments,
while also increasing their quality and
safety.
Syed T. Husain
According to the FDA, 64% of
all reported drug shortages
are caused by quality issues
(37% manufacturing, 27%
delays/capacity) and another
27% are due to raw materials,
so it’s not surprising
that the 2016 Nice Insight
CDMO Outsourcing Survey showed quality
as the most important factor when
selecting a new outsourcing partner.
Marga Viñes, Oriol Prat
For the foreseeable future, therapies
delivered via parenteral
routes will dominate advancements
in healthcare and patient
outcomes. Regulators, governments,
health systems and — most
importantly — patients are all
stakeholders, linked by dependence
on the safe, reliable and abundant
supply of sterile liquid drugs. There is little
dispute that this sector of pharmacopeia
represents a tremendous growing opportunity
for drug innovators and owners.
Nigel Walker
Small-molecule drugs continue to dominate the marketplace
and the drug pipeline despite growing demand
for biologics. Advances in combinatorial chemistry are,
in fact, leading to the discovery of novel, highly complex
and efficacious active pharmaceutical ingredients
(APIs). At the same time, there is a significant push to
employ synthetic routes that are not only feasible at
production scale, but also cost efficient, atom economical
and more environmentally friendly.
Within the past year, there have
been several new technologies introduced into SGS,
some of which have had an immediate impact, and
others expected to be more influential over a longer
term. One example that may fall into both categories
has been the introduction of a hydrogen-deuterium
exchange (HDX) service that,
Kevin Haehl
With the advent of another presidential
election cycle, we are caught up
in a familiar debate about the cost
of healthcare. Naturally, the pricing
of pharmaceuticals is front and
center — even more so than in previous
campaign years — due to the
recent media firestorm surrounding
the exorbitant price increases of some generic
medications. But there is another issue, one depriving
the U.S. healthcare system of billions of dollars, which
is not being addressed in an open forum.
Dr. Andrew Warmington, Ph .D.
Over the last 18 months, the Pharma’s
Almanac has attracted high-level commentary
and strategic analysis content from
some of the industry’s most respected
executives and operational experts. The
online answer to the quarterly publication,
PharmasAlmanac.com, is designed to be a
platform that inspires opinion, ideas and
collaboration. In addition to hosting articles
found in print, the site will offer content
exclusive to the web.
Boobalan Pachaiyappan, Ph.D.
Ease of molecular synthesis
and portfolio diversity enables
small molecules to be consistently
victorious compared
to other drug modalities. A
staunch focus on creativity in
chemical space and enriched understanding
of drug parameters are surefire ways
to spur innovation and a concomitant cure.
Nigel Walker
As the pharmaceutical industry undergoes
unprecedented levels of change,
there are significant opportunities for
the development and formulation of
breakthrough medicines that can dramatically
improve patient lives. To convert those
opportunities into successful new drug products,
however, numerous obstacles have yet to
be overcome.
Haig Armaghanian, Josh Dunn
In 2016, two drug-price-related “scandals” ignited
near-universal criticism of the pharmaceutical
industry, generating angry international
headlines sustained by the intense scrutiny of social
media. Regardless of the harsh rhetoric and political
posturing, drug owners and developers are compelled
to understand and consider an amazingly complex set
of factors and influences to craft an effective, profitable
pricing strategy in response — especially when attempting
to introduce a new standard-of-care therapy
that has no peer to help with its valuation.
Robert E. Chew
The business of drug development
and manufacturing has
fundamentally changed. On
the one hand, commercializing
and manufacturing new, classleading
drugs has become
increasingly cost-prohibitive.
Heather Delage
Biopharmaceutical companies with portfolios
heavily staked in the development
of therapeutics that require some form of
fermentation — namely many active pharmaceutical
ingredients (APIs), peptides,
antibodies and other small molecules —
face the challenge of creating medium- and
long-term production plans. Building a new
bioprocessing facility that is capable of
handling the development and manufacturing
of complex biotherapeutics can cost
anywhere from $50M to $650M, and may
require up to four years to complete.
Cynthia A. Challener Ph.D.
Most of the revolutions
that happened in
silico,” says Douglas
Krafte, Chief Scientific
Officer of Icagen, Inc.,
“happened in the subfields
such as biology
and chemistry, not in
the fully integrated design and generation
of new drugs.”
Janice L. Graff, KaShauna G. Rohlehr, PMP
In 2015, according to BioPlan Associates
the market for biopharmaceuticals
was valued at $200 billion and growing
at ~14% annually. Ten to 15 new biologic
treatments are expected to receive approval
each year, and the top products
already on the market have annual sales
of over $2 billion.
Magdalena Mejillano, Lijun Duan
Bioanalytical services accounted for the
largest share of the global healthcare analytical
testing services market in 2015,
reflecting the rising percentage of largemolecule
drugs in the pharma industry
pipeline — a trend that is expected to
continue for the foreseeable future. On
the other hand, the batch-release testing
segment is expected to grow more than
any other segment during the next five
years, according to Markets and Markets.
Michelle Najera, Ph.D.
For monoclonal antibodies (mAbs),
titers have increased almost 30-
fold over a 15-year period.1 In
addition, mAbs and other therapeutic
biologics represent the
fastest growing sector of the entire
pharmaceutical market with
many pipeline candidates reaching latestage
development, including 53 mAbs in
phase III trials as of late 2015.