Anything But Static: The Coming Era of Massive Paradigm Shifts

One of NIR’s favorite concepts–and one that almost invariably finds its way into our conference presentations and Innovation Reviews–is that of Treatment Paradigm Shifts. A TPS is a tangible and meaningful addition to the repertoire of what is available for the treatment of patients in the real world. In recent years, the roster of such Shifts in CNS has been sparse: The advent of oral immunomodulators for RRMS stands out, and there is the potential–not yet come to pass–for Belsomra and its orexin-targeting mechanism to become a TPS in insomnia. Acadia‘s Nuplazid/pimavanserin represents a probable TPS for the treatment of psychosis in patients with neurodegenerative disorders. The next few years are going to see a steadily increasing roster of efficacy trials that will validate–or invalidate–new Treatment Paradigm Shifts: Rapid Acting Antidepressants, procognitive adjuncts for CIAS, and IV CGRP-antagonists for migraine are just three such promising, potential Treatment Paradigm Shifts. Neuren‘s positive Phase IIb results for trofinetide in Fragile X (and encouraging data in Rett Syndrome) signal a potential TPS for these neurodevelopmental disorders.
It is not just in the treatment armamentarium that such transformation is accelerating: It is emerging in every facet of the neurotherapeutics industry. Both preclinical and clinical testing are moving towards full representation of female subjects, due to the obvious gender-based differences in response to many therapeutic interventions; the day of all or mostly male protocols, including mouse studies, is over. The paradigm for risk and cost-sharing in partnering is changing into something very different than the traditional model: Increasingly, larger companies now insist upon success-based terms, with payments to their partners contingent upon progression through clinical and regulatory development. Similarly, we expect that payor reimbursement in the marketplace will increasingly be tied to therapeutic impact, a healthier TPS in the US than the alternative of across-the-board price controls. One of these changes will eventually alter the commercial landscape of pharmaceuticals in the US; the status quo, which stands in stark contrast to the rest of the developed world, is not sustainable. This type of paradigm shift is less intrinsically appealing than adding novel treatment options, but it is no less inevitable.

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