Drop in Pharma R&D for CNS Opens Door for Devices

by Warren Grill, senior technical editor
March 2011

Recent reductions in research and development efforts by the pharmaceutical industry has created unprecedented opportunities for neurotech devices to step in to fill the forthcoming void of therapies for neurological disorders.

Nervous system diseases and disorders are a large and growing challenge. As technologies have advanced life expectancies, for example by treating heart disease, the incidence of “brain disease” has and will continue to increase. The U.S. Census Bureau projects that the number of Americans age 65 and older will grow from 40 million in 2010 to over 70 million by 2030, and that there will be almost 10 million Americans age 85 and older in 2030. However, this growth in need is coming at a time when the pharmaceutical industry is dramatically scaling back research efforts on drugs to treat CNS disorders.

Pfizer announced that it will cut its research and development budget by almost $1B from $9.3B in 2010 to $8.5B in 2011 and slash further to $6.5 to $7B by next year. Andrew Witty, CEO of GlaxoSmithKlein rationalized GSK's recent exit from two drug research and development facilities as, “Pain, depression, and anxiety are areas where we believe the probability of success is relatively low, and we think the cost of attaining success is disproportionately high.”

Indeed, the path of CNS drug development is challenging. As reported last year in Science , clinical development costs exceed $800 million for a new entity, the clinical testing and approval process takes almost nine years, and only about 8 percent of entities that reach the stage of clinical testing are eventually approved.

The impact of the decline in CNS drug research and development is well recognized. “There are very few new molecular entities, very few novel ideas, and almost nothing that gives any hope for a transformation in the treatment of mental illness,” stated Thomas Insel, Director of the National Institute on Mental Health.

Such an observation was one of the likely driving forces behind the proposed NIH National Center for Advancing Translational Sciences, which will invest $1B per year in cooperative drug development efforts. However, these efforts will not be restricted to CNS drugs and pale in comparison to the $65B invested in drug research and development by the pharmaceutical industry in 2009.

This environment of growing unmet medical need and a lack of investment by the primary competing approach to treatment—pharmaceuticals—represents an outstanding opportunity for device developers. The early success of deep brain stimulation for the treatment of depression has blossomed into two pivotal clinical trials—by two different companies at two different brain targets.

Another compelling example comes from Andres Lozano's group at the University of Toronto. Laxton et al. reported late last year in Annals of Neurology on the use of DBS to activate brain memory circuits and perhaps slow cognitive decline in Alzheimer's disease.
These are but two of the myriad opportunities facing neurotech device developers to address the rapidly growing challenge of CNS diseases and disorders.



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