Expertise: Neuroscience 35 results
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...
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...
Neuroscience
Andreas Schreiner, M.D.
Clinical Development
Krista Armstrong, Ph.D.
Clinical research into neurological diseases is often hindered by a myriad of patient related problems. What can be done to overcome these issues and improve the efficacy of neuroscience trials? In the wake of the pandemic, new opportunities and challenges...
Recent research has focused on developing new antipsychotics, including those that address the need for efficacy without compromising psychiatric or physical well-being.
The gene therapy era can be said to have begun in 1990, when the first gene therapy clinical trial took place. Some 3,000 clinical trials have followed that first study, a resounding affirmation of innovators’ increasing recognition of gene therapy’s...
Gene therapy holds great promise as a potential treatment for Parkinson’s disease, a disorder for which currently available medications do not causally treat the underlying disease mechanisms. However, given the early stage of gene therapy research in this therapeutic area,...