Business View - December 2015 43
we felt that we should be closer to them, and to provide
them the chance to know the company; to know the work
we do and to support them in their Phase 1 and Phase 2
clinical trials.”
Clinical trials are research studies that explore whether a
medical strategy, treatment, or device is safe and effective
for humans. These studies also may show which medical
approaches work best for certain illnesses or groups of
people. The federal Food and Drug Administration (FDA)
requires that all new pharmaceuticals be evaluated for
their safety and effectiveness through heavily regulated,
clinical trial protocols before they can be sold to the public.
Hovione’s part in the procedure is to manufacture the lim-
ited quantities of the new API, based on the developer’s
molecule, necessary for the trials. According to Gil, the
creation of a new drug is “a pretty risky business.” In fact,
in addition to being extremely time consuming and expen-
sive for a pharmaceutical company to process a new drug
through all three mandated clinical trial phases, the over-
AT A GLANCE
WHO:
Hovione LLC
WHAT:
International developer and manufacturer
of APIs (Active Pharmaceutical Ingredients) for its
customers in the healthcare and pharmaceutical
sectors
WHERE:
North American headquarters in
East Windsor, NJ.
WEBSITE
:
MANUFACTURING
