Nidan.....Janet Woodcock has been championing the development of modern and effective clinical trials for some time and IMHO it is the drug industry that is clinging to the old way of developing drugs. The two major reasons for this is that it slows the development process down and by doing so it makes it harder to spring revolutionary advances from both a cost basis for the small bios and giving Pharma time to react by buyout and licensing. It also gives the older approved drugs a longer life.
The article makes this point:
"Industry must be persuaded to collaborate when they have been historically competitive, Jim Reilly, a vice president at Veeva Systems, a life sciences technology company, said in an interview with BioPharma Dive."
Until the patient is given priority, competitiveness will over rule collaboration. So while a competitive market will still be necessary to insure discovery and innovation...the regulators and industry must always maintain awareness that in medical drugs/devices, the human need is not discretionary but necessary
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