By Guest Blogger | Published: November 4, 2014
We hear it all the time these days: research processes have to undergo transformative changes in order for research organizations to thrive—or even survive. Controlled clinical trials take too long and cost too much. Regulatory review is blocking innovation. Research data must be shared transparently, drug manufacturers need to listen to the patient, reuse of real world healthcare data can improve and maybe replace clinical trials, and pre-competitive collaborations can solve our common problems.
Sometimes such talk leads to new ideas that stick. More often they are explored briefly by a valiant few, only to fizzle out in the end. Innovation is for the bold, but the pharmaceutical research industry is restrained by risk aversion and the perceived fear of regulatory repercussions—new ideas are fine as long as we don’t deviate from the tried, true, and duly SOP’d order sanctioned by our regulatory department and quality assurance auditors. So nice idea, young whippersnapper, but let it go—you’re less likely to drown if you don’t rock the boat. Read More »
By Pharm Exec | Published: November 4, 2014
Israel’s pharmaceutical market value will increase from approximately $1.9 billion in 2013 to $2.34 billion, a compound annual growth rate of 2.8%, by 2020, says UK research and consulting firm GlobalData. This modest growth will driven by “medical technology advances, high R&D expenditure and a robust economy”. Read More »
By Guest Blogger | Published: November 3, 2014
So now we know who is to do what on health issues in the new European Commission. Or do we?
The furor that the new boss of the commission, Jean-Claude Juncker, unleashed with the plans for his new team, weeks before it took office, is still reverberating around Brussels. Peter O’ Donnell reports on the fallout in this Applied Clinical Trials blog.
By Jill Wechsler | Published: November 3, 2014
A federal policy issued late last week appeared to deal a serious blow to continuing medical education (CME) programs supported by biopharma companies. But the specifics published by the Centers for Medicare and Medicaid Services (CMS) Oct. 31, 2014 actually continue to exempt independent CME funding from the Open Payments reporting requirements for transfers of value from manufacturers to prescribers. Read More »