Unpacking the Innovation Pipeline in Substance Use Disorders (TIPS 2018)

Despite the potential for “digital therapeutics” to transform the treatment landscape in behavioral health, the path through the digital development process is complex and evolving—from identifying a problem or need, to innovating a potential set of solutions, to finding the one that will scale effectively, to gaining regulatory approval, to creating a product or service, each of which is fraught with potential risk for those performing the work, but also for their funders and the pipeline for future treatments. In this session, our speakers will unpack each of these stages, focusing on the area of substance use.

Themes/keywords: digital therapeutics; path to FDA regulatory approval; prevention and treatment for substance use disorders; real-world continuous assessment and just-in-time interventions.

This panel discussion, De-Risking Digital Development: Unpacking the Innovation Pipeline in Substance Use Disorders, was part of the 2018 Technology in Psychiatry Summit, an event sponsored by the McLean Institute for Technology in Psychiatry, which occurred November 1-2, 2018 at Harvard Medical School, Boston, Massachusetts.


Dawn Sugarman, PhD, is a clinical psychologist in the Division of Alcohol, Drugs, and Addiction at McLean Hospital. Dr. Sugarman’s research and clinical work focuses on gender-specific treatments for addictive behaviors, and the use of technology in effective treatment dissemination. As a member of the team that won the Partners’ Connected Health Innovation Challenge in 2017, she is working on developing a digital adaptation of an evidence-based treatment for individuals with co-occurring substance use and mood disorders. Dr. Sugarman also serves as the communications editor for the Harvard Review of Psychiatry.

David Epstein, PhD, is the chief of the Real-world Assessment, Prediction, and Treatment Unit at the National Institute on Drug Abuse. He established this unit in 2017 to bring NIDA’s treatment research into the age of predictive analytics and predictive medicine. His intent is to show that when addiction research moves forward, so do prevention and treatment. Dr. Epstein’s aim is to maintain a portfolio of studies that, taken together, address the whole continuum of causes of addiction, from the psychosocial to the neurobiological, and to use our wide in-house expertise to match the tool to the task for different kinds of patients.

Lisa Marsch, PhD, is the director of the Center for Technology and Behavioral Health (CTBH) and the Andrew G. Wallace Professor within the Geisel School of Medicine at Dartmouth College. CTBH is an interdisciplinary “center of excellence” supported by the U.S. National Institutes of Health, that uses science to inform the development, evaluation, and sustainable implementation of technology-based tools for behavior change targeting a wide array of populations and health behaviors. These tools are designed to deliver engaging and effective health monitoring and health behavior interventions to collectively lead to transformations in the delivery of science-based behavioral health care.

Aaron Josephson is the senior director of ML Strategies, a consulting subsidiary of the law firm Mintz Levin. Prior to joining ML Strategies, he was a senior policy advisor at the FDA’s Center for Devices and Radiological Health.

David Barash, MD, is the chief medical officer for the GE Foundation and executive director of its Global Health Portfolio. The Foundation’s Developing Health initiatives are approached with the belief that simple interventions, along with strong partnerships and leaders, are often the answer to some of healthcare’s most complex problems. Dr. Barash is also a practicing emergency medicine physician with more than 30 years’ experience, and has focused a great deal on understanding how new technologies can be commercialized and delivered to effectively close the gap between brainstorm and bedside.

Please visit mclean.org/itp to learn more about the McLean Institute for Technology in Psychiatry.