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Explore Leadership and Compliance in Psychedelic Therapy | November 2025 Newsletter

Explore Leadership and Compliance in Psychedelic Therapy | November 2025 Newsletter

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Nov 1, 2025

Nov 1, 2025

“When do you think there will be an FDA approved psychedelic therapy?” I’m asked at least once a week. Ketamine derivatives notwithstanding, everyone is making bets about which companies, compounds, and indications are most likely to get through the process first. As the conversation unfolds, a larger pattern emerges around a better question: What are we collectively building to be prepared for this upcoming turn of events?

The success of widespread access to psychedelic therapies and related treatments for the thousands of patients who need them rests on the professionalism of trained practitioners. But without an infrastructure of organizations to support the rollout, professionals won’t have the tools and support that’s needed. Without the business models and structures to ensure practitioners can operate sustainably, psychedelic therapies won’t be as widely available to those in need of relief as they could be. As a business leader, I believe it is an ethical responsibility to establish solid foundations for a sustainable future and likewise support others in doing the same.

The challenges of building a network of sustainable businesses in the field of psychedelic therapy, at the crossroads of cutting edge healthcare, policy change, and reimbursement structures, are immense. Although backing has come through for a number of organizations, a recent Psychedelic Alpha survey documented more investment in those focused on drug development and less emphasis on those involved education. This may set this evolving field up for critical problems down the road. If psychedelic and adjacent therapies are approved, the infrastructure to support rollout to clinicians and communities must be in place to ensure equitable access and widespread success.

Fluence sits at the juncture of education and workforce development, developing the technology to deploy scalable training solutions that can serve drug developers and practitioners working in the community at all stages. Because of this broad base of services we’ve been able to build a sustainable model whereby our complementary programs include research study training, CE programs, and licensure qualifying facilitator programs. Our ethos is to welcome as many therapists and facilitators as we can, with open doors and programming that fosters a true career shift towards this field. We don’t succeed unless you do.

I recently heard from a graduate of our first cohort of our psilocybin certificate program, Jayne Laszewski, MD, in Oregon. Together with another program graduate, she’s set up a successful KAP practice drawing on what she learned in her training–highlighting how Fluence training can be applied across a variety of professional paths. Two more of her classmates, Kayli Howard and Mandy Miller, are now teaching in our current psilocybin program—based in Colorado—alongside trainers like Brian Pilecki and Alex Camargo, who were some of the first people to attend Fluence workshops circa 2019. Many of our other trainers, like Mia Sarno and Joseph McCowan, came to Fluence through one of our research clinician training programs and now work consistently as educators in our research and CE programs. These inspiring careers took time, dedication, and a sustained community of relationships formed partly in and around Fluence. We’re proud to support them.

This month, to further support the development of your career in the field, we’re featuring a fascinating webinar with our director of product, Dan MacCombie, LPC and Justin Botillier, an accountant and business consultant who will share thoughts and strategies for building your sustainable business in the field. Whether you are working for a larger organization or founding your own, starting a solo practice or a group, or have some other model in mind entirely, join us for a lively and inspiring discussion.

Thanks for reading,

Elizabeth Nielson, PhD

Fluence Co-Founder

As psychedelic therapy grows, clinicians and practitioners face not only clinical questions but also complex financial and regulatory considerations. This webinar will explore key financial strategies for running a sustainable practice, with a focus on compliance, planning, and growth. Attendees will gain insights into navigating business structures, tax considerations, and financial planning while building a responsible and scalable practice.

In this webinar, we’ll be joined by Justin Botillier, founder of Calyx CPA, an accounting and advisory firm with a focus on the unique needs of professionals working in the emerging field of psilocybin services. Justin Botillier brings over twenty years of experience working with small business owners and entrepreneurs. He was an early advocate for the cannabis industry and, in 2016, shifted his focus full-time to supporting plant medicine businesses. Today, Justin works with psychedelic therapy practitioners and psilocybin businesses to navigate the financial complexities of operating in federally regulated spaces.

A central part of the discussion will focus on IRS Code Section 280E, a tax provision that penalizes businesses engaged in federally illegal “drug trafficking.” Misunderstandings about 280E often lead to unnecessary fear and even overpayment of taxes. The webinar will clarify what 280E really means for psychedelic therapy businesses and highlight legal strategies to reduce its impact.

This conversation will highlight:

  • Key financial and operational considerations for psychedelic therapy practices.

  • How to navigate compliance, regulation, and taxation in this new field.

  • Strategies for building a sustainable practice that balances accessibility with viability.

  • Best practices for managing finances in psychedelic therapy practices.

  • Legal and tax considerations for businesses operating in federally regulated spaces.

This CE-granting session will benefit clinicians, students, researchers, and anyone interested in how psychedelic-assisted therapy is evolving across contexts.

The webinar will conclude with a live Q&A. A recording will be sent to everyone who registers, so sign up even if you can’t attend live.

Register today!

Date: November 20, 2025
Time: 1:00 PM – 2:00 PM ET
Hosted by: Dan MacCombie, LMFT, Director of Product at Fluence
Special Guest: Justin Botillier, founder of Calyx CPA
Format: Live Webinar via Riverside
Cost: Free with Registration
CE Credit: 1 CE Hour Available

We’re excited to share early access to the Fluence Clinical Site Toolkit, a practical, on-demand learning program designed to help treatment and research sites build readiness for psychedelic, neuroplastogen, and adjacent therapy work. This toolkit will enable your team to gain structured, foundational training through video modules, handouts, and checklists covering participant engagement, medical monitoring, ethical and cultural considerations, and operational excellence.

Launching February 2026, the Toolkit helps every member of a multidisciplinary team, from leadership to reception, build a shared understanding of compliance, care, and collaboration.

If your site is preparing to engage in psychedelic or adjacent therapies, pre-register now to receive updates and early access when the Toolkit becomes available.

Pre-register Now

Curious about training in psychedelic therapy but unsure where to begin?

We’d love to help you gain clarity on how one of our courses fits into your path. Schedule a free 1-on-1 Zoom call with Kabir Cooppan-Boyd, dedicated to guiding you on your learning journey.

During your call, Kabir can answer your questions and explain how our courses connect to professional certificates in:

  • Psilocybin Facilitation

  • Ketamine-Assisted Psychotherapy

  • Psychedelic Harm Reduction and Integration (PHRI)

If you’re a clinician with questions or curiosity about our programs, this personalized conversation is the perfect way to find your best next step.

Schedule your free 1-on-1 Zoom call with Kabir

Start your journey now and move toward certification in Psilocybin Facilitation, Ketamine-Assisted Psychotherapy, or Psychedelic Harm Reduction and Integration at the current, lower rate.

All certificate programs start with our six-week Essentials of Psychedelic Therapy course, with the November cohort taught by Sarah Zoghbi, LPC.

Certificate Programs

Psilocybin Facilitation

Nov 4, 2025 - Sep 1, 2026

Learn more

Ketamine-Assisted Psychotherapy

Nov 4, 2025 - May 12, 2026

Learn more

Psychedelic Harm Reduction and Therapy

Nov 4, 2025 - Jul 13, 2026

Learn more

Rebecca is a licensed Clinical Social Worker and founder of Plant Parenthood, a digital and in-person community of parents who use psychedelics. At her private practice in Brooklyn, NY she works with creative professionals using mindfulness and experiential techniques to address depression, anxiety and life transitions. In addition, she works in the re-emerging clinical space of psychedelic harm reduction and integration, helping clients prepare for psychedelic experiences, incorporate insights or cope with challenges post-experience. Her experience includes Mindfulness-Based Stress Reduction, Mindfulness for Clinicians, Psychedelics 101 & 102, and Beyond Experience Psychedelic Integration Workshop.

Watch her Spotlight video

New York lawmakers consider legalizing psilocybin for medicinal use

New York’s state assembly held its first public hearing into psilocybin legalization, discussing licensing of facilitators and supervised therapeutic access—potentially putting New York next in line after Oregon and Colorado.

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Long-term follow-up: Psilocybin-assisted therapy shows sustained remission in major depression
In a follow-up study of participants treated with psilocybin-assisted therapy for major depressive disorder, approximately two-thirds remained in full remission five years later, offering promising signals about long-term durability of therapeutic outcome. 

Read the article →