Few areas of drug development are as complex or as underserved as neuroscience.
For decades, promising therapies have stalled — not for lack of good science, but because the path to approval has been too uncertain, too costly or too poorly incentivised to sustain traditional development models.
Yet neurological conditions are now the world’s leading cause of morbidity and mortality, making R&D innovation in this space more critical than ever.
New chemical entities in psychedelics and gene therapies are starting to reshape the picture, driving fresh dealmaking and investment activity throughout the broader neuroscience landscape.
At the same time, recent FDA initiatives are reshaping the clinical, financial and policy environment for rare disease R&D.
Advances in genetic testing, multi-omic technologies and plasma/CSF biomarkers are also helping researchers to identify enriched patient populations for clinical trials in neurologic and psychiatric diseases.
Dr Bruce Leuchter (pictured), CEO of Neurvati Neurosciences, a neuropsychiatrist and former biotech analyst at Goldman Sachs, has a unique vantage point on these shifts — from the lessons learned advancing rare neurodevelopmental disorder therapies to the private-equity investment model behind the company’s push to move more high-potential neurotherapeutics out of development limbo.
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