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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We need to speed up the clinical trial process. So, improved trial design is to be welcomed. However, I'm not so sure that the focus on negating the impact of the placebo effect is the best way forward.

At the end of the day, every medical intervention delivers both organic and social/psychological effects that feed back with each other. Therefore, every therapy has a placebo component. Probably, many placebos have an unexpected truly efficacious effect; for instance, the act of giving data may lead to you taking better care of yourself in general.

My feeling is that we would benefit more from increasing the frequency of testing. To see why, consider two measurement strategies:
A, test at the beginning of the trial and at the end of a year, say. Suppose, by way of an example, A shows a 12% improvement
B, test every month. B shows a non-compounded 1% improvement each month.
Although both methods have the same final outcome, method B has more statistical power. With modern technology we can test every second of every day.

Increasing the frequency of testing also prepares the ground for the focus of the trial to be on the individual, rather than the cohort. The question to be answered is no longer whether therapy X works, but whether it works for me. If you were person B, above, would you want any more convincing that the treatment was right for you, even if everyone else's outcome was poor; perhaps you have a different type of PD.

Finally, this data driven approach lends itself to continuous testing. Testing is not limited to the trial, it continues indefinitely.

John

We need to speed up the clinical trial process. So, improved trial design is to be welcomed.
John
I agree with your comments on Placebo effect. We need methods of analyses that incorporate the benefits of placebo effect . Too many clinical trials have "failed" due to placebo effect. In my opinion, the research community failed to see the difference between animal experimentation and human clinical trials when designing the protocols. This webimar is one of the few that is trying to do something different and thats why I thought it would be interestingd. Increasing the frequency of testing would be good, provided we have good biochemical (bio) markers to monitor the progression of PD. I am not sure current UPDRS scores would tell us anything meaningful with increasing frequency of testing.

I couldn't possibly agree more. The need for good biomarkers as a test for progression is huge. UPDRS scores are almost worthless for testing progression unless the time periods are relatively extensive. That's why the Isradipine STEADY-PD study is 3 years. Short-term UPDRS changes are subjective, often influenced by outside factors, and essentially meaningless.

No doubt increasing the frequency of testing would help improve the reliability (although not necessarily the validity) of the tests. As would increasing the sample sizes and sample subgroup cohorts. However, the trial investigators all live in the real world where it's almost impossible to get funding for the studies as currently designed, as well as finding volunteers. Adding on more frequent testing, while great from a statistical viewpoint, just becomes that much more difficult in terms of funding and recruiting. I know we all complain about "big-pharma", and they should be able to fund any costs. However, most of the research that effects our area of science directly, is being conducted by small biotech companies and universities. Most don't have the required $ to conduct studies with the optimum trial design.