Trimentum™: Enhancing Neuroscience Drug Development through SPCD


DATE: November 20, 2014 | TIME: 2pm ET / 11am PT | DURATION: 1 hour

Neuroscience studies are prone to high placebo effect, lending themselves well to alternative designs. PPD offers biopharmaceutical companies an alternative model for conducting clinical trials known as sequential parallel comparison design (SPCD). This model, branded by PPD as Trimentum™, significantly reduces the impact of the placebo effect in clinical trials by using two stages of treatment and enriching the primary analysis population by re-randomizing subjects who are placebo non-responders which serves to increase assay sensitivity.

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Join experts from PPD and Massachusetts General Hospital Clinical Trials Network & Institute for a webinar addressing the benefits, applications and implications of SPCD.

FEATURED SPEAKERS:

Daniel Burch, M.D.,—Vice President and Global Therapeutic Area Head of Neuroscience, PPD


Daniel J. Burch, M.D., is PPD's vice president and global therapeutic area head for neuroscience. In this role, he leads the neuroscience area strategic team and serves as a key adviser and consultant to clients in developing and conducting clinical programs in this area. Dr. Burch brought 20 years of drug development experience with him when he joined PPD in 2012, having significant contemporary neuroscience drug development expertise in both biotech and pharma. In his most recent role as executive vice president and chief medical officer at CeNeRx BioPharma, he managed a portfolio of medicines focused on neuropsychiatric diseases.

Maurizio Fava, M.D.,—Executive Director, MGH CTNI; Executive Vice Chair, Department of Psychiatry, MGH; Director, Depression Clinical and Research Program, MGH; Slater Family Professor of Psychiatry, Harvard Medical School


Dr. Fava obtained his medical degree from the University of Padova School of Medicine, where he also completed a residency in endocrinology. After finishing residency training in psychiatry at the Massachusetts General Hospital, he has been Director of the Depression Clinical and Research Program there since 1990. Under Dr. Fava's direction, the Depression Clinical and Research Program has become one of the most highly regarded depression programs in the country, conducting research projects in a variety of areas, including pharmacotherapy of resistant depression, neuroimaging, genetics, neurophysiology, neuroendocrinology, novel pharmacotherapies, alternative medicine, and psychotherapy. Dr. Fava is an international expert in psychiatric clinical trials' methodology and has developed with Dr. David Schoenfeld the Sequential Parallel Comparison study design.

Thomas Laughren, M.D.,—Director, Regulatory Affairs, MGH CTNI


In addition to his position at MGH, Dr. Laughren is currently a consultant in psychiatric drug development in several other settings as well. He 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, Dr. 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.

Marc de Somer, M.D.,— Vice President, PPD


Marc de Somer, M.D. is a vice president of global product development at PPD and plays a critical role on the neuroscience team, particularly focusing on the growth of Trimentum. Joining PPD in 2014, Dr. de Somer has extensive biotech and large pharma experience, with a strong focus on CNS diseases. In addition, Dr. de Somer was with the World Health Organization and spent six years in academia.

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