(from NeuroPerspective July-August 2014)
1) Biometheus and the Placebo Response Gene: Biometheus has licensed IP related to a COMT gene polymorphism that they believe identifies patients prone to placebo-response. As they discussed in BioCentury, the developers have published work showing that this polymorphism–which may lead to elevated levels of dopamine in the prefrontal cortex–was associated with a doubling of the magnitude of the placebo response in Irritable Bowel Syndrome patients, and claim there is data indicating the same dynamic in pain patients. While NIR has some skepticism regarding the breadth of applicability of a ‘placebo gene’ anomaly–CNS life is rarely if ever that simple and clearcut–any test that could identify those vulnerable to a placebo effect in even a narrow bandwidth of disorders will be welcomed by drug developers.
2) RDoCs Operationalized: The NIMH team that has been working since 2009 on developing psychopathology categories based on observable behavior rather than Kraepelinian conjecture is going to have the opportunity to see if this approach provides practical benefit in clinical testing. Both Cerecor and Astra Zeneca are focusing upon acute suicidality as a behavioral endpoint in their ‘antidepressant’ trials, and given the challenges in obtaining valid and reliable measures of depression per se, progress in this kind of objective measure could be very useful in CNS drug development.
3) NeuroProsthetics for Memory: DARPA is providing up to $40 million to groups at UCLA and U.Penn (in conjunction with Medtronic and Neuropace) who are going to map neural activity patterns associated with memory functions in the hope of developing implantable devices that can improve memory in patients with TBI. The UCLA team will begin with patients who have already had devices implanted for the suppression of seizures. The grants cover four years, but we are reminded that Functional Neuromodulation has already fully enrolled their Phase II/III trial of their DBS device aimed at improving memory in Alzheimer’s patients–which might be considered an early HOC trial for the cognitive neuroprosthetic concept.
4) Inversion and Flags of Convenience: Perhaps it is trite and naive, but there is something unsettling about the notion that corporate ‘citizenship’ can be so baldly based upon, and moved towards, something as banal as an advantaged tax rate. But that is the current state of affairs, with pharma companies avidly pursuing ‘inversion’, moving (often) to Ireland as blithely as container ships sticking Liberian flags on their stern. This escape hatch will be closed eventually, with legislation that erases the loophole while, hopefully, addressing the disparity between tax rates.
5) Bring Back ‘Friends’: At the very end of 2013, Merck announced their plan to develop ‘innovation hubs’ in four geographical locations–Boston, London, San Francisco, and Shanghai (we are still waiting for some innovation in site choices beyond this comfort zone). JNJ and Pfizer have created hubs in the same locations, GSK has made a thus-far ill-starred stand in Shanghai, indeed only JNJ showed its willingness to bravely venture into new frontiers by adding one in….San Diego. This is an expensive breed of real estate redundancy, and given the cost-cutting emphasis at virtually all Big Pharmas, one might wonder why they aren’t sharing space. They might claim that they have valuable secrets that must be protected, but it is not as if they would have to decorate their cubicles with chemical structures, and if we were conducting industrial espionage in Cambridge or the Bay Area, we would be bugging the local sushi restaurants and wine bars. In any event, the concept of Pharma roommates could offer interesting comedic TV possibilities; consider what could be done with a combination of a anxious nerd, a slightly vacant blonde, a good-natured but not-too-bright jock, a neurotic control freak, and so forth. Anyone familiar with that mainstay of American situation comedy will get the picture, and the pharma industry can only dream of the ROI being enjoyed by the syndicators of Friends. And which pharma company should be played by which character? We are not going there.