The big trend in Big Pharma R&D has been to cut back significantly in key areas where they felt they faced extraordinarily high risks--a particular problem in the central nervous system field, where trial failures have been more the norm than the exception.
Back in January, at the annual J.P. Morgan Healthcare Conference, across hotel lobbies and crowded hallways and standing-room-only cafes, one could hardly escape talk about the biotech IPO boom.
The notion that a party drug could be repurposed into a "miracle" cure for severe, treatment-resistant depression is an almost irresistible story line in the popular press. And there's no reason why it can't be recycled using results from the same small, short-duration study design that long ago attracted some of the world's largest research organizations still engaged in researching new drugs in one of the most difficult fields in R&D.
Thanks to genomic sequencing, some heart-healthy mutants and billions of dollars spent on R&D, rival drug developers are bearing down on a promising new way of treating the scourge of high cholesterol. And with the first FDA applications likely coming in the next year, the nascent field's trailblazers are vying for the top spot with blockbuster aspirations.
No matter how badly a drug fails in Phase III, investigators and the companies that employ them often bend over backward to highlight any positive sign of efficacy, no matter how weak the signal. And GlaxoSmithKline's team at the American College of Cardiology meeting over the weekend was in full spin mode with their heart drug darapladib.
In order to make sure we're devoting the kind of attention the rest of the world deserves, we're launching a weekly EuroBiotech Report, a regional news roundup done Fierce-style, on Friday.
Last week the parents of 7-year-old Josh Hardy managed to whip up a media tempest big enough to get the biotech Chimerix and the FDA to work out a pilot study so that their child could be treated after their compassionate use request was denied, alongside many others. Now the parents of another young boy afflicted by a terrible disease are using some interesting PR tactics in an attempt to achieve a much larger goal.
Chimerix will evidently have no trouble finding the 20 patients it is recruiting for the pilot study of its antiviral brincidofovir. And it still isn't willing to provide its therapy under the FDA's "compassionate use" regulations.
Last night I was a guest lecturer at an MIT class of biomedical PhD candidates. One of the professors had asked me to come and provide my take on covering biotech news, and I took it on for largely selfish reasons.
Anyone in the industry who knows Ken Moch, the CEO of a little biotech in Durham, NC, named Chimerix, is likely to describe him as personable, chronically cheerful and an outspoken champion of all things Chimerix.