Bikash Chatterjee
Contract manufacturing organizations are our industry partners. There
are few strategic and tactical plans within the global life sciences that do
not include an outsourcing element. The maturation of the Indian and
Chinese markets has created opportunities to spread drug development,
manufacturing, and clinical trial management around the globe for the
developing markets outside of the U.S. in such rapid expansion.
Thomas M. Eckrich, Ph.D.
API outsourcing is increasingly predictable. Many companies provide
a range of services and technology types for pharmaceutical clients
who may need to outsource one API1, or they may need to outsource
many APIs over a long period2. Herein I describe criteria to select API
manufacturing companies, and methods to maintain those relationships.
Chuck Forsaith
The world is a far less certain place today than it was just a decade ago.
In this changing environment pharmaceutical companies have moved
from being regional to global entities, which have significantly increased
risks within our industry.
Denise Hager
Commercially marketed drug products are often used in clinical trials in
direct comparison with an investigational medicinal product. As defined
in regulatory guidance, a comparator is “an investigational or marketed
product (i.e. active control), or placebo, used as a reference in a clinical
trial."
Max S. Lazar
I recently read with great interest that ICH has embarked on some very
significant changes in structure and organization1. While change based upon
historical experience can improve effectiveness; some changes sometimes
undermine effective improvements. As a member of the Expert Work Group
that negotiated and wrote the only GMP guidance (ICH Q7) adopted by the
International Conference on Harmonization, I am especially interested in
sharing my opinion about the changes being proposed and implemented
by the organization.
Jeff Marra, Ph.D.
Attend any conference dealing with the pharmaceutical industry, from
new drug discovery to API and drug product manufacturing, and you
will hear presentations outlining successful programs and stunningly
brilliant research and development. These inspiring stories, whether
ours or someone else’s, punctuate why we became and remain engaged
in one of the most challenging and rewarding endeavors, the discovery
of safe and effective new drugs. But the very nature of pharmaceutical
research and development presents us with more failure than success.
Reactions fail to yield the desired products. Potential new compounds
fail in vitro profile screens. Promising candidates present unexpected
adverse effects in vivo. Synthetic routes collapse upon scale-up. In
reality, more things go wrong than as planned.
Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
Twenty one (75 %) NDA’s were for small molecules while the remaining
seven molecules (25%) were large molecules. Ferric pyrophosphate
citrate (Triferic), from its name, does not seem to be a typical large
molecule. It was considered as a large molecule because of its molecular
weight (1313 daltons). In this period, sixteen companies (47.4%)
receiving NDA approvals were large companies and the remaining
twelve companies (57%) were mid-sized and small companies. Only
Lenvatinib was granted Orphan Drug status (3.5%). Tablets (21.4%),
capsules (28.6%) and injections (28.6%) were the preferred dosage
forms, though an intrauterine device (IUD) to treat UTI’s was introduced
as well. Two products were introduced as extended release capsules.
Nine out of twenty-eight (32.1%) NDA’s were combination dosage forms
of which Rytary and Duopa both have a combination of Carbidopa and
Levodopa. Evotaz and Prezcobix both have a combination of a protease
inhibitor and pharmacokinetic enhancer, where the pharmacokinetic
enhancer is the same (Cobicistat).
Mollie Shields-Uehling
Globalized collaboration is forcing the biopharmaceutical industry
to find new ways to work across vast geographical and enterprise
boundaries. Companies co-develop products and form coalitions to
improve R&D. Clinical trials are outsourced to CROs, often working with
researchers and sites around the globe.
Sameer Thapar, PharmD
It began with a notion. Concentrating the flow of specialized medicines
through distinct channels maximized not only to the patient’s care but
also the distribution of the specialty medicines. Specialty pharmacy,
which once occupied only a small niche in the marketplace, has now
become the largest growth area in the pharmacy industry.
Xcelience offers a range of services, specifically preformulation, analytical
development services, release and stability testing, formulation
development, cGMP manufacturing, small-scale commercial manufacturing,
and global clinical supplies packaging and logistics.
Nicole Yingst
As the use of third party vendors continues to increase, the necessity
of a strong communication network is apparent. A 2015 article by
Cutting Edge Information stated that The Association for Clinical
Research Organizations estimates sponsor use of third party vendors
to support studies has increased by 44% from 2007 to 2011. Whether
a third party vendor is engaged to support a portion of a project or
a full project, it is imperative to establish a routine communication
plan that fosters transparency and clear goals. This communication
channel should also follow company standard operating procedures
and contain escalation pathway, to ensure any delays or issues are
managed proactively. A NAVEX Global survey of over 300 business
professionals responsible for ethics and compliance activities revealed
that 71 percent admitted they do not track information on some or all
of their third party relationships. This sets a company up for several
issues, including holes in metrics, missed deadlines and, most critical,
high risk for ethics and compliance issues.
Nigel Walker
Driven by time and cost pressures, the
pharmaceutical industry is increasingly
motivated to develop biopharmaceuticals
for pipeline security because these products
have demonstrated profitability. And as the
development of biologics grows in parallel
with the need to improve productivity and
lower costs, biomanufacturers continue to
embrace new technologies, such as singleuse
devices and systems, to streamline
biomanufacturing. More and more sponsors
are relying on CMOs with the appropriate
expertise in this area to manufacture their
biologics efficiently.