Every October 10th, the world comes together to recognize World Mental Health Day, an initiative led by the World Health Organization (WHO) to raise awareness, break stigma, and promote mental well-being globally. To celebrate the day, we sat down with Adam Simmons, Premier’s Vice President, Program Strategy, Neuroscience, who is an industry veteran and leading…
Adam Simmons
Approximately 350 million people around the world live with major depressive disorder (MDD). While there are existing treatments, up to two-thirds of patients with MDD do not achieve remission following an initial adequate trial of antidepressant medications and nearly 70% experience residual symptoms with first line standard of care.1 There remains a critical need for…
The FDA’s Center for Drug Evaluation and Research issued a structured, meticulous roadmap to advance the clinical development of psychedelic drugs, highlighting key considerations in regulatory frameworks, ethical conduct, chemistry manufacturing controls (CMC), and clinical studies to ensure safety and efficacy in addressing psychiatric and substance use disorders. In this blog, Premier Research dissects the…
Across all indications, the primary source of trial failure has been—and remains—an inability to demonstrate efficacy.1 An analysis of 640 phase 3 trials with novel therapeutics demonstrated that 54% failed in clinical development. Among those that failed, more than half—57%—failed due to inadequate efficacy.2 In neuroscience indications, an estimated 85% of late phase studies fail,…