Translational and Early Phase Strategies for Treatment Development:Report of ISCTM Autumn 2013 Symposium

Innovations in Clinical Neuroscience

William Z. Potter¹  Geert J. Groeneveld¹  Jared W. Young¹  Mike F. Egan¹  Bruce J. Kinon¹  Steve Riley¹  Douglas E. Feltner¹ 

[1] Dr. Young is with the Department of Psychiatry, University of California San Diego, La Jolla, California, and Research Service, VA San Diego Healthcare System, San Diego, California; Dr. Potter is with the National Institute of Mental Health, Rockville, Maryland; Dr. Riley is with the Department of Clinical Pharmacology, Global Innovative Pharma Business, Pfizer, Inc., Groton, Connecticut; Dr. Groeneveld is with Center for Human Drug Research, The Netherlands; Dr. Kinon is with Lundbeck LLC, Deerfield, Illinois (Dr. Kinon was with Eli Lilly and Company, Indianapolis, Indiana, when this material was presented); Dr. Egan is with Clinical Neuroscience, Merck & Co, Inc, North Wales, Pennsylvania; and Dr. Feltner is with AbbVie Inc. Pharmaceuticals, Chicago, Illinois

关键词: Drug discovery;    pharmacology;    FDA;    pharmacokinetics;    decision-making;    proof of concept;    target rejection;   

DOI  :  

学科分类：精神健康和精神病学

来源: Matrix Medical Communications, LLC

【 摘 要 】

For decades, there has been a distinct disconnect translating a compound’seffects from basic neuroscience into clinical efficacy. This disconnect has not onlybeen in terms of generating approved compounds, but also in rejecting targets. Duringthe drug discovery process there are key points to be adhered to that wouldstrengthen the likelihood of a compound being translated to the clinic. These pointsinclude 1) the importance of translational pharmacology whereby preclinicalpharmacological data should predict clinical efficacy; 2) rigorous early phase drugevaluation to enhance early go/no-go decisionmaking; 3) using exposure responsemodeling to predict drug efficacy during proof-of-concept trials; 4) designing andconducting the appropriate proof-of-concept study; and 5) optimizing Phase II studiesto set the stage for success in Phase III trials. These topics were covered in TheInternational Society for CNS Clinical Trials and Methodology (ISCTM) Autumn 2013meeting on the topic of translational and early development strategies and tools ledby Drs. Potter and Feltner. This report comprises a review of those proceedings witha concluding summary to advance future clinical trials.

【 授权许可】

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