Friday, April 12, 2013

Laughren joins CTNI as director of Regulatory Affairs

Thomas Laughren, MD, has joined the MGH Clinical Trials Network and Institute (CTNI) as director of Regulatory Affairs. The MGH CTNI was established in 2007 by Maurizio Fava, MD, executive vice chair of the MGH Department of Psychiatry. It is an academic research organization conducting clinical trials funded by industry, foundations, and the National Institutes of Health. In his work with CTNI, Laughren will work closely with Fava and the CTNI team in advancing CTNI’s mission to  improve the quality of clinical trials through academic rigor and the use of innovative tools and methods.  “We are all truly honored and very excited by the opportunity to work closely with Dr. Laughren, whose tremendous expertise and experience can only enhance our ability to design innovative studies and develop regulatory approaches to the development of new psychiatric treatments,” Fava said.

Laughren  is recently retired as division director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at FDA. Prior to coming to FDA in September 1983, Laughren was affiliated with the VA Medical Center in Providence, RI, and was on the faculty of the Brown University Program in Medicine. He received his medical degree from the University of Wisconsin in Madison, Wisconsin, and also completed residency training in psychiatry at the University of Wisconsin. Laughren is board certified in general psychiatry. As division director for the Division of Psychiatry Products, Laughren oversaw the review of all psychiatric drug development activities conducted under INDs and the review of all NDAs and supplements for new psychiatric drug claims. He has authored and co-authored many papers and book chapters on regulatory and methodological issues pertaining to the development of psychiatric drugs, and is a frequent speaker at professional meetings on these same topics. Laughren has received numerous awards for his regulatory accomplishments.   

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