Daniel Ciriano, MD
Moving Clinical Development to emerging countries could
provide advantages to R&D companies. The availability of
trial- naïve patients and often treatment-naïve patients together
with less competition for enrollment, high quality of investigators and
lower costs, are considered key factors for this decision.
Marlene García Swider
This article explains the regulatory challenges FDA encounters with current manufacturers’ global outsourcing and the role and responsibilities for those participating in outsourcing.
C. Ray Goff, Jr.
The economic downturn of 2008 interrupted the growth of fuel
prices. In 2010 the fuel prices grew slowly. The future challenge
is how to deal with fuel price increases.
Kuntal K. Sinha
Today, more and more pharmaceutical companies are outsourcing and offshoring projects which require complexity and demands strict timelines.
Maria T. Cruañes, Adam Socia, Amitava Mitra, Steven Hu
This case study summarizes the expedient formulation approach taken
to enable Phase I clinical trials of a new chemical entity (NCE) of a
class known to have poor oral bioavailability in pre-clinical species.
Morrey Atkinson, Peter Soelkner, MBA, Johannes Reiter, Susan Dana Jones, Ph.D., Bradley Newman, Scott M. Wheelwright, PhD
MA:
The large companies with excess capacity are shedding that
capacity and looking for right-sized manufacturing. Drug
pipelines are inconsistent and it’s expensive to maintain idle capacity
for a pipeline that may or may not mature in the near term.
Don Ferry
JHP Pharmaceuticals is not a very familiar name in contract manufacturing.
Have you been at this a long time?