Proceedings

Special Challenges in Pediatric Drug Development: First of Three Sets of Expanded Proceedings from the ISCTM Autumn Conference on Pediatric Drug Development
by Philip D. Harvey, PhD; Joan Busner, PhD; Gahan Pandina, PhD; H. Gerry Taylor, PhD; Meg Grabb, PhD; and Joohi Jimenez-Shahed, MD Dr. Harvey is with Department of Psychiatry, University of Miami Miller School of Medicine in Miami, Florida. Dr. Busner is with Signant Health in Blue Bell, Pennsylvania and Department of Psychiatry, Virginia Commonwealth […]

Implications of Pediatric Initiatives on CNS Drug Development for All Ages—2020 and Beyond: Second of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development
by Gahan Pandina, PhD; Joan Busner, PhD; Joseph P. Horrigan, MD; Christine McSherry, RN, BSN; Alison Bateman-House, MA, MPH, PhD; Luca Pani, MD; and Judith Kando, PharmD, BCPP Dr. Pandina is with Janssen Pharmaceuticals in Titusville, New Jersey. Dr. Busner is with Signant Health in Blue Bell, Pennsylvania and Department of Psychiatry, Virginia Commonwealth University School […]

Patient Centricity: Design and Conduct of Clinical Trials in Orphan Diseases: Third of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development
by Joan Busner, PhD; Gahan Pandina, PhD; Simon Day, PhD; Atul Mahableshwarkar, MD; Lucas Kempf, MD; Maria Sheean, MD; and Judith Dunn, PhD Dr. Busner is with Signant Health in Blue Bell, Pennsylvania and Department of Psychiatry, Virginia Commonwealth University School of Medicine in Richmond, Virginia. Dr. Pandina is with Janssen Pharmaceuticals in Titusville, New Jersey. Dr. […]

Outcomes Assessment in Clinical Trials of Alzheimer’s Disease and its Precursors: Readying for Short-term and Long-term Clinical Trial Needs
by Holly Posner, MD, MS; Rosie Curiel, PsyD; Chris Edgar, PhD; Suzanne Hendrix, PhD; Enchi Liu, PhD; David A. Loewenstein, PhD; Glenn Morrison, MSc, PhD; Leslie Shinobu, PhD; Keith Wesnes, BSc, PhD, FSS, CPsychol, FBPsS; and Philip D. Harvey, PhD Dr. Posner is with Pfizer Inc., New York, New York; Drs. Curiel, Loewenstein, and Harvey […]

CNS Summit 2016 Abstracts of Poster Presentations
Innov Clin Neurosci. 2017;14(1–2)3–23. A MESSAGE FROM THE EDITOR Dear Colleagues: Welcome to the annual CNS Summit Abstracts of Poster Presentations supplement to Innovations in Clinical Neuroscience. We are pleased to provide you with this reference guide to some of the innovative research that was presented during CNS Summit 2016, which was held October 27 […]

Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders
by the CNS SUMMIT DATA QUALITY MONITORING WORKGROUP CORE MEMBERS—David Daniel, MD; Amir Kalali, MD; Mark West; David Walling, PhD; Dana Hilt, MD; Nina Engelhardt, PhD; Larry Alphs, MD, PhD; Antony Loebel, MD; Kim Vanover, PhD; Sarah Atkinson, MD; Mark Opler, PhD, MPH; Gary Sachs, MD; Kari Nations, PhD; and Chris Brady, PsyD Dr. Daniel […]

Translational and Early Phase Strategies for Treatment Development: Report of ISCTM Autumn 2013 Symposium
by Jared W. Young, PhD; William Z. Potter, MD, PhD; Steve Riley, PharmD, PhD; Geert J. Groeneveld, MD, PhD; Bruce J. Kinon, MD; Mike F. Egan, MD; and Douglas E. Feltner, MD Dr. Young is with the Department of Psychiatry, University of California San Diego, La Jolla, California, and Research Service, VA San Diego Healthcare […]

Lessons Learned and Potentials for Improvement in CNS Drug Development: ISCTM Section on Designing the Right Series of Experiments
by Steven T. Szabo, MD, PhD; Bruce J. Kinon, MD; Stephen K. Brannan, MD; Andrew K. Krystal, MD, MSc; Joop M A van Gerven, MD, PhD; Atul Mahableshwarkar, MD; and Gary S. Sachs, MD Dr. Szabo is with Duke University Medical Center, Durham, North Carolina, and Veterans Administration Medical Center, Durham, North Carolina; Dr. Kinon […]

Taking Personalized Medicine Seriously: Biomarker Approaches in Phase IIb/III Studies in Major Depression and Schizophrenia
by Harald Murck, MD, PhD; Thomas Laughren, MD; Femke Lamers, PhD; Rosalind Picard, ScD; Sebastian Walther, MD; Donald Goff, MD; and Stephen Sainati, MD, PhD Dr. Murck is with Acorda Therapeutics in Ardsley, New York, and Phillips-University Marburg, Marburg, Germany (Dr. Murck was with Covance Inc., Princeton, New Jersey, during the preparation of this manuscript); […]
How Can Registries Contribute to the Development and Evaluation of CNS Therapeutics?
by Joanne B. Severe, MS, and Annette Stemhagen, DrPH, FISPE Ms. Severe is a research consultant in Rockville, Maryland, and Dr. Stemhagen is with United Biosource Corp. in Bethesda, Maryland. Innov Clin Neurosci. 2013;10(5–6 Suppl A):29S–31S