Luiz Alberto Barberini, CQE, CPIM , MBA
We’ve all heard that Brazil is a giant. And, as we know from fairy tales,
a giant can have an own unpredictable nature that can make things
difficult. This analogy can be used in our logistics and supply world.
When in such a situation, what exactly happens and how do we
manage the giant’s bad mood?
Bikash Chatterjee
Supply chains now span the globe and are increasing in complexity
as organizations move away from regional business models to
manufacturing and distribution on a world scale. A critical byproduct
of good manufacturing practice (GMP), an unbroken cold chain ensures
product safety, efficacy and overall quality for patients.
Dave Dreifke
When working through the nuances of moving clinical supplies globally,
my mind often wanders back to a scenario that occurred several years
ago. During a meeting to determine a course of action to facilitate the
customs release of clinical supplies in a South American country, a
member of senior management entered the conference room to express
disbelief in the possibility of supplies being held by customs authorities.
“How can this occur? It’s simple, you grab the supplies, put them in a
box, label it, put together a packing slip and you’re done.” Wow, don’t
we wish it were that easy!
Kenneth Getz, Mary Jo Lamberti
By far the fastest growing area of R&D spending is outsourcing. Exceeding
$60 billion in 2016, sponsor company spending on contract R&D
services is growing at six times the annual rate of spending on internal
staff, infrastructure and technology support. Indeed, by 2017, according
to the Tufts Center for the Study of Drug Development (Tufts CSDD),
contract research services will overtake all other areas as the largest
category of R&D spending.
Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
For decades, the regulation and control of new drugs in the United
States has been based on the New Drug Application (NDA). Since 1938,
every new drug has been the subject of an approved NDA before U.S.
commercialization. This column summarizes details on all the NDAs
approved in the year 2015.
Eric S. Langer
Vendors to the biopharmaceutical manufacturing industry are seeing an
opportunity to offer valuable services that complement their products.
This is increasingly a strategic priority for introducing new products,
according to BioPlan Associates’ latest annual industry study, the 13th
Annual Report and Survey of Biopharmaceutical Manufacturing Capacity
and Production.
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This could be seen as a response to rising demand for
outsourced services, and comes as vendors are seeing growing business
from offering services.
Ed Price
The price of ensuring quality in chemical manufacturing goes far beyond
cost. Hopefully, quality problems are caught before they can affect patients
but even then, such problems can make or break a manufacturing
organization. In the U.S., while it takes significant effort to earn and maintain
cGMP standards, quality control can be the difference between a CMO’s
success and failure in the race to commercialize vital drugs.
Dr. Afshin Safavi, PhD
Critical reagents are essential components of ligand binding assays (LBA),
and include many reagent categories including antibodies, engineered
proteins, conjugated proteins, chemically synthesized molecules, complex
biologics, and solid-supported reagents.
Guy Tiene, MA
The global outlook for excipients looks bright, as the market is expected
to grow at an annual compound rate of of 7.6% from 2015 to 2020,
reaching $6.4 billion by 2020.1
The major factors driving market growth
are the growing demand for pharmaceutical products and functional
excipients, the increasing generic drug market, and the emergence of
new excipients. Drug manufacturers also rely on excipients to develop
value-added and distinct products at a lower cost without compromising
quality, such as extended-release formulations.