Few topics inspire more rants among drug developers and industry watchers than regulation.Â* Â*To be overly simplistic, industry veterans generally seem to feel that overly conservative regulators are squelching innovation, motivated largely by a desire to cover their own behinds. Â*Critics (I will resist, for now, the urge to use the term Pharmascolds) often contendÂ* that regulators aren't strict enough, and that medical product companies (who, critics believe, have more than earned their present enmity) warrant even greater supervision, and should be held to an even higher standard in their clinical studies.Â* Meanwhile, patients continue to suffer, and wonder why modern science
lv handbags hasn't produced the medicines they desperately need. Incredibly, there may actually be an answer to this that could potentially satisfy everyone.Â* The basic proposal – which has been Â*eloquently articulated by UCSF Chancelor (and former Genentech executive) Susan Desmond-Hellmann – is to turn drug approval from a discrete variable (yes/no) into a continuous one.Â* (Others, including a group of European regulators writing for themselves, have made similar arguments – as I've previously discussed here.) The fundamental problem with the current system, Desmond-Hellmann observes, is that regulators have only two options, when in fact, it might make a lot more sense for them to have a range of choices, permitting them to approve a drug for limited use, or use with limited promotion, following the presentation of initial evidence of safety and efficacy; permission for broader use, and less restrictive promotion, could be given after additional data are obtained. This solution makes sense on so many levels, and acknowledges: (a) the long time it can take to become familiar with a drug and learn some of it's more subtle effects – good as well as bad; (b) the importance of accelerating the time it takes to get potentially useful drugs into the hands of patients who might need them; and (c) the technologies available now to track the performance of new drugs and assess their performance.Â*Â* I suspect a whole army of entrepreneurs are eagerly waiting for the opportunity to tackle this task – one can imagine a system where provisionally approved drugs are dispensed with scannable labels, and a condition for patients receiving the provisionally-approved product is the willingness to report how it working, and contribute to a database. A particular advantage of such a system would be the emphasis it would presumably place on durable results, as full approval would presumably require not just success in a clinical trial, but continued demonstration of success under "real world" conditions.Â* Such a requirement would almost certainly stimulate the development of integrated "health solutions," a bundled assortment of patient- and physician-support systems accompanying the drug.Â*Â* The patient support offering accompanying J&J's lap-band is one obvious example of this sort of adjunctive program. While such patient support systems would seem to be a good idea even now, the business case has been difficult to make.Â* In the context of an offering that would need to succeed in order for a drug to be fully approved, the incentives are considerably more apparent, and would almost certainly stimulate interest in start-up companies striving to deliver the most effective patient support programs. A graduated regulatory approval process such as the one discussed here would not be perfect; however, it almost certainly would represent a significant step in the right direction. Additional notes: Dr. Desmond-Hellmann's talk is one in a series of freely available webcasts/podcasts from Stanford University's Entrepreneurial Thought Leader Seminar Series, talks which can be easily found on the web or downloaded from iTunes.Â* I've added this series to my list of favorite podcasts. I was also impressed by Dr. Desmond-Hellmann's talk on a panel about translational research at UCSF last summer Â*– I don't think a video is available, but the discussion is covered here (if you like drooling over VCs) and here (if you prefer more balance). Â*Â*One theme Desmond-Hellmann
gucci handbags touched on was the role of a university; I especially resonated with her view that the mission of an academic medical center (AMC) is both to create new knowledge and to ensure this knowledge is used to help patients.
Can progressive approvals cut regulatory's Gordian Knot ??? and stimulate innovation?
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