WASHINGTON--(BUSINESS WIRE)-- In a continuation of its mission to address the crisis in CNS drug development, the International Society for CNS Clinical Trials and Methodology (ISCTM) will gather this month for its annual meeting in Washington, D.C. Despite large unmet clinical needs, CNS drugs continue to take longer to develop than other therapies, longer to be reviewed by the FDA, and are nearly 50% more likely to fail the most costly and time consuming step in development, Phase 3 clinical trials. Moreover, increasing concerns about conflict of interest have discouraged active collaborations among academic researchers, their pharmaceutical industry colleagues, and regulators. To address these systemic issues, ISCTM acts as a non-promotional forum for cross-disciplinary collaboration among these groups. Through ongoing working groups and semi-annual meetings, ISCTM strives to advance CNS clinical trials methods that are innovative, scientifically sound, ethical, and feasible.
“The 8th Annual Scientific Meeting in February is a reflection of our mission to facilitate research innovation and collaboration, and we are thrilled with the slate of participants,” noted Dr. Larry Alphs, President, ISCTM. The success of ISCTM can be attributed to the active involvement of leaders across FDA, NIMH, academia, finance, and the pharmaceutical industry who have embraced the Society as a place to address the on-going stagnation in CNS drug development through a shared focus on research innovation.
Drs. Rusty Katz, Tom Laughren, from the FDA’s Center for Drug Evaluation and Research, and Dr. Karl Broich, European Medicines Agency, will speak on clinical trial design issues in conducting trials for Alzheimer’s disease, schizophrenia, and other disorders. Other speakers include Dr. Rob Epstein, President, United BioSource Corporation and Chief Clinical R&D Officer, Medco, and Dr. Ken Davis, President and CEO, Mount Sinai Medical Center, addressing payers’ and health care administrators’ perspectives on CNS therapies; Dr. Juan Sanchez, Ladenburg Thalmann, will discuss the intersection of finance and science, addressing investors’ concerns in CNS drug development; Dr. Thomas Insel, Director, National Institute of Mental Health, will kick off a session on the challenges and opportunities in pediatric drug and device development for neuropsychiatric diseases; and Dr. Helena Kramer, University of Pittsburgh, will be part of panels exploring how to understand whether a new drug produces a clinically meaningful improvement in patients’ lives.
Carlotta McKee, Executive Director, 615-383-7688
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