Πηγή: PharmExec Staff
An expert CPhI Worldwide panel has identified "the good, the bad, and the ugly" in its forecast for the pharmaceutical industry for 2015.
Among the "good" developments are the shift in FDA’s role from
“investigator” of products to “enabler” of better quality processes and
cultures within pharma manufacturing; breakthrough treatments for infectious
diseases; and growth across NCEs and biopharmaceuticals.
The bad will continue to be defined by shortages of popular drugs in western markets due to marginal pressures and reduced stockpiling; fears for pharma not ‘walking the talk'; and the challenging year ahead for virtual drug developers as pharma exercises closer inspection of the robustness of CMC regulatory packages.
The "ugly truths" pointed out by the panel include predictions that
outsourcing and related quality issues are unlikely to be reduced in the near
future (big Pharma may even, in some cases, repatriate key elements of the drug
development chain), and that the battle between IP protection and patient
access is set to further heat up.
Details of the panelists and some of their individual predictions are
further outlined below.