You are currently viewing Inside the World’s Most Active Psychedelic Therapy Site: A Conversation with Sunstone Therapies

Inside the World’s Most Active Psychedelic Therapy Site: A Conversation with Sunstone Therapies

With a purpose-designed facility in Rockville, Maryland, Sunstone Therapies is at the leading edge of psychedelic therapy trials and care delivery. In fact, it might just be the world’s most active site for such studies.

The team at Sunstone has administered psychedelics to patients across eight mental health indications—from generalised anxiety disorder and PTSD to those in palliative care—and six compounds, including the likes of psilocybin and MDMA but also shorter-acting psychedelics like 5-MeO-DMT.

Through those studies, the group has partnered with a whole host of psychedelic biotechs, trained over fifty therapists, and completed more than 250 sessions in the last 18 months alone.

This puts Sunstone in a unique position, with hands-on experience in delivering not only a half-dozen psychedelics to patients with various mental health indications, but also many of the extra-pharmacological protocols that sponsors specify.

That’s why Psychedelic Alpha Editor Josh Hardman was pleased to sit down with Sunstone co-founders Manish Agrawal (CEO) and Kim Roddy (COO) to tease out some of those learnings, both on the medical and operational side.

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In this Interview

  • Backgrounds, founding story
  • Post-trial support
  • Sunstone’s trial experience, portfolio; coordination complexities
  • Training psychedelic practitioners
  • Levels of psychological support
  • Managing disappointment
  • Managing costs, realising benefits
  • The inadequacy of endpoints and scales
  • Scaling Sunstone, the importance of place
  • Thoughts on different psychedelics, protocols

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Backgrounds, founding story

Josh Hardman, Psychedelic Alpha: Can you share a little about your backgrounds and how you came to found Sunstone Therapies?

Manish Agrawal: I’m a medical oncologist with a strong belief in the power of both medicine and human connection. My interest in blending the science and humanities goes way back. I did my internal medicine residency training and a Masters in Philosophy at Georgetown University, then a Fellowship in Oncology and Bioethics at the National Institutes of Health as well as a Masters in clinical trials from Duke University. After my fellowship at the NIH, I stayed on faculty with a joint appointment in the Genitourinary branch at the NCI and Bioethics Dept at the Clinical Center. My focus was on early drug development as well as the ethics of Phase I oncology trials. But I missed patient care and thus left the NIH and joined a large oncology practice in Rockville, MD and led the research team. During this time, the use and potential of psychedelic-based treatments was nowhere on my radar.

After almost two decades in practice, it became increasingly clear that we were taking care of the physical aspects of cancer patients but not the emotional dimensions. It’s like an iceberg: above the water was chemotherapy, surgery and radiation, but so much of the quality of life of patients was determined by aspects below the waterline, determined by how they felt, and we really didn’t have any great tools for that.

That led me to begin looking for other solutions, which led me to learn about psychedelics. The more I learned, the more intrigued I became that psychedelics could play a vital role in actually addressing the issues that we were seeing every day in our oncology practice. It also brought together my interest in philosophy and ethics and science. That led to the first group study ever conducted using psilocybin in cancer patients with MDD, which we published in JAMA Oncology in 2023. We saw such profound changes in our patients’ lives. The MADRS scores improved and even more, their lives and emotional experiences changed dramatically. Fundamental questions about being human were being raised in participants trying to make sense of their cancer diagnosis and I was hooked.

That experience led me to leave my full-time oncology practice and start Sunstone Therapies. I knew that pursuing that work in a new and understandably challenging therapeutic field would require deep business and organizational expertise, and that’s why I was delighted that Kim, who then was managing the oncology practice, agreed to partner with me.

Kim Roddy: My whole career has been about changing healthcare for the better, always with a focus on compassionate leadership and making sure we’re truly patient-centered. I started as a phlebotomist, earning degrees in medical technology and biology. Always delighted by making complex things run more elegantly and efficiently, I decided to earn my MBA to gain more access into leadership in healthcare organizations.

I moved into oncology and clinical trials, growing research programs and then large oncology practices. I met Manish when I moved to Maryland to run his oncology practice, and grew that practice into the largest in Maryland. When Manish shared his interest in psychedelics and its role in treating the entire patient, I knew that was the way to address the heart of healing, and I wanted to be a part of bringing this innovative care to patients who need it most.

In addition to the clinical issues that Manish was talking about, I knew there would be a bunch of related systems issues that needed to be addressed as we moved in this new direction —basically,  the entire system that we were working in. I would see our staff having to navigate all of the ancillary issues — from the billing to the front desk — which were adding to the emotional turmoil that our patients were going through. In other words, we would need a major rethink of the system processes as well as the clinical issues.

In my opinion, to do the work we wanted to do would require a much more holistic approach to care. I also knew from my years of work in oncology care that we were uniquely suited to be able to develop and implement this kind of interdisciplinary care, which enabled me to see what we would need to do organizationally in order to make the overall program, including our new treatment center, work.

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