When an Endpoint is Just the Beginning: How Preclinical Endpoints Affect Clinical Success
In neuroscience drug discovery and development, there are two fundamental problems that researchers are acutely aware of: a high unmet need of successful therapies and a historic difficulty in bringing novel treatments to market. A study by BIO emphasizes the latter point; across all indications, only 9.6 percent of candidates in Phase I reached approval. For neurodegenerative diseases, that number is even smaller (8.4 percent).
One significant challenge in CNS is the disconnect between how preclinical programs are executed compared to how they are executed in the clinic.