Regulatory Innovation

Navigating Mental Health

By Dr. Nick van Terheyden aka Dr. Nick
Twitter: @drnic1
Host of Dr. Nick: The Incrementalist – #TheIncrementalist

On this episode I talked to Ekaterina Malievskaia MD MScPH, Chief Innovation Officer and Co-Founder of COMPASS Pathways (Navigating Mental Health Pathways). Ekaterina is an entrepreneur dedicated to bringing about positive change in society with a particular focus on health and wellbeing and driven to address the challenge of access to brain health services.

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Ekaterina shares her personal experience with accessing mental health services for her son in the US – a journey that took years and left her and her family feeling there had to be a better way. As part of her research, she found a small study on 9 patients with OCD treated with Psilocybin. Thanks to regulatory categorization research have been limited but what has been shown offers great promise for “transdiagnostic” potential for these classes of drugs. In fact, Sandoz manufactured and sold Psilocybin (IndoCybin) for a number of years withdrawing from the market for economic reasons before the worldwide crackdown.

We discuss the work of Compass and their team of researchers who are focused on driving

Patient Access to evidence based interventions

This is a big part of how and why they are able to drive innovation and access with a team-based approach that includes regulators and payers alongside clinicians and patients. They moved the focus from the substances such as Psilocybin to a focus on patients and how they can bring positive outcomes. We talk about the breakthrough status awarded to their psilocybin therapy program for treatment-resistant depression, a major feat given the statistics, and their phase 2B trial that has 20 sites in 9 countries.

We discuss their approach which as Ekaterina describes as living and breathing the incremental approach:

“The Day in a life of a small agile innovation company is full off incremental steps”

which only become noticeable as they look back since they become part of the fabric of their innovation journey.

Listen in to hear about their future which is anchored on “Regulatory Innovation” with their partnership approach and is essential to success to allow them to make the “highly technical climb” involved in this area.

About the Show
For years Dr. Nick van Terheyden aka Dr. Nick, has served as a voice on the impact of new technologies on healthcare, earning a reputation as a leading authority on where the future of medicine is going. Combining powers of observation and real world experience, Dr. Nick has seen many predictions come true and makes the case that innovations in healthcare can be accomplished incrementally, not just by moonshot events. Tune in to hear Dr. Nick: The Incrementalist and his guests discuss what the future of healthcare looks like, how we will get there, and what it will take to improve healthcare for all.

This article was originally published on the Dr. Nick – The Incrementalist blog and is republished here with permission.