One of the inevitable consequences of political change is disruption to the global economic engine. Disruption can result from political instability, regulation, or even innovation. Now, from the portent of the coming Brexit storm, to the enactment ...
Thursday, October 04, 2018
Among the most remarkable technical advances seen within the healthcare sector over the last decade is the fast growing sector of regenerative medicine. Breakthrough technologies are empowering re- generative medicine through the introduction of new,...
The emergence of virtual biotech, specialty drug delivery companies and the increase in the number of in-licensed and collaboration development programs has spawned a new generation of Contract Manufacturing Organizations (CMOs) offering services ...
Monday, September 25, 2017
Over a decade ago I wrote an article advocating that industry and FDA truly embrace the 2004 FDA guidance, which supported a shift from a documentation - and testing framework for assessing quality and compliance to one predicated on scientific ...
Sunday, November 20, 2016
As we bid farewell to 2016 to face the opportunities and challenges of
2017, the global life sciences industry can be best described as being
on the cusp of great change. For the last ten years, U.S. market growth
has been transitory, with M&A ...
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 ...
Wednesday, September 30, 2015
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 ...
Ensuring supply chain integrity today in the global market requires integrating risk management for a physical and a virtual supply chain. An approach that ensures supplier quality and performance and supply chain integrity is very important. The ...