Now that psychedelics have taken hold in the consciousness of medicine as an approach to better mental health—with psychedelics-assisted therapy showing mostly positive results in more clinical trials by more companies—maybe now is the time to accelerate the building of an infrastructure for getting it to people that need it.
Some companies primarily focused on research and development are building on a strategy of infrastructure development by establishing clinic networks and digital platforms to build the infrastructure for clinical trials and the delivery of psychedelic-assisted psychotherapies.
A report by LEK, a business development consultancy, included a quote from Lars Wilde, president, CEO, and co-founder of Compass Pathways (NASDAQ: CMPS), a mental health care company accelerating patient access to evidence-based innovations in mental health with its psilocybin therapy: “The big hurdle to the success of psychedelics is now in their commercialization and delivery,” Wilde said. “You need to have the physical spaces to deliver psychedelic therapy, and this poses a different challenge from country to country. Some companies are using digital platforms to explore how we can improve therapy and this is an interesting approach.”
One way to build those pathways to commercialization and delivery is to organize professional associations whose members can collaborate about what they need as an industry, and how to go about getting it while presenting a sort of unified voice to achieve such goals as infrastructure development together.
A Unified Voice
For example, there is the American Psychedelic Practitioners Association (APPA), endorsed by Multidisciplinary Association for Psychedelic Studies (MAPS), the California Institute of Integral Studies (CIIS), the Psychedelic Research and Training Institute and others.
The APPA’s mission is to “support practitioners and beneficiaries in developing and integrating safe, effective and accessible psychedelic medicine services for the advancement of healthcare and collective wellbeing.”
CIIS’ Center for Psychedelic Therapy and Research does its own work to educate the public and professionals about the research and clinical use of psychedelic medicine, offering a certificate in psychedelic-assisted therapies and research to educate licensed psychotherapy and medical professionals on the use of psychedelic medicine in FDA-approved clinical studies. CIIS also offers lectures and programs to the public on psychedelic medicine and therapies several times a year.
The National Psychedelic Practitioner Certification Board (NPPCB) is another organization creating board certification for psychedelic medicine practitioners and educating practitioners, the health care system, and potential consumers about the inherent value of the certification process. “As an emerging field in healthcare, psychedelic medicine has no current metrics to assess skill and competency,” according to the NPPCB. “This certification will be used by healthcare systems, insurance companies, and even state regulators to assess a professional level of competency for practitioners in this arena.”
More psychedelics companies are throwing their collective hats into the infrastructure development ring.
Enthea is a non-profit benefit plan administrator that provides health plan benefit riders and single case agreement services for psychedelic healthcare. It’s the first-ever partnership between a health plan administrator and leading U.S. company to offer employee coverage for ketamine assisted therapy to promote mental health, according to the press release announcing the partnership. “We hold practitioner wellbeing and equitable access to psychedelic healthcare as central, guiding tenets to our mission and vision,” according to Enthea’s mission statement. “Enthea will be on the cutting edge of providing access and affordability of psychedelics-assisted therapy. In so doing, we will pave the way for other companies to follow, putting infrastructure in place for them to leverage.”
There are other companies who realize that it’s time to focus on commercializing and distributing access to psychedelics therapy to help accelerate the growth of the industry in general.
For example, Numinus, a Vancouver-based company working on the integration of psychedelic-assisted therapies into mainstream clinical practice, recently acquired Novamind in a deal expected to close this month (June). Novamind is a mental health company enabling safe access to psychedelic medicine (ketamine) through a network of clinics and clinical research sites.
The combined Numinus/Novamind company will operate 13 wellness clinics in focused geographies across the U.S. and Canada, and “will continue developing and scaling innovative psychedelic therapy protocols and procedures for screening, preparation, dosing and integration targeting difficult-to-treat mental health conditions, including post-traumatic stress disorder (PTSD), COVID-19 burnout, depression, addiction and eating disorders,” according to the press release.
How this combination of two companies benefits the psychedelics industry infrastructure development is by its use of a centralized client care center for managing client inquiries, scheduling clients with appropriate providers, coordinating physician referral intakes, fulfilling prescription requests, and facilitating insurance authorizations.
The combined company will also operate four clinical research sites and a bioanalytical laboratory, all of which are currently supporting leading drug developers in psychedelic medicine with critical infrastructure and services.
“What we want to establish is the real-world help, create the real-world infrastructure,” Payton Nyquvest, CEO of Numinus, said during an interview that also featured MAPS founder and executive director Rick Doblin. “There are lots of clinical trials going on. There’s lots of research on all different kinds of things. And I think for Numinus, our focus has really been around accessibility. What does this really, really look like at the end of the day? We’re really focused on the person that is going to, in a real-world context, come through the doors of a Numinus facility. And what does that look like and how can we do the best job for those people? I think if we look at the space, down the road, ultimately the groups that are really, really focused on client or patient outcomes are going to be successful.”
Another Vancouver-based company, Mindcure, a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health, has developed software-as-a-service digital therapeutics and psychotherapy clinics, working on a model of establishing clinic networks and digital platforms alongside pharmaceutical R&D that also contributes to the infrastructure development for the industry.
Mindcure is positioning its software program, called iSTRYM, as the industry’s distribution network for science-based, evidence-backed protocols and artificial intelligence data systems. They released the minimum viable product (MVP) version of iSTRYM into partner clinics across North America, and plan to begin full commercial deployment by mid-2022.
Another infrastructure development example is MAPS and Vine Ventures, announcing the creation of a novel, social impact Special Purpose Vehicle (SPV), called the Regenerative Financing Vine (RFV), that will infuse $70 million into patient access infrastructure and research for MDMA-assisted therapy for PTSD.
There are already dozens of ketamine infusion clinics in most states across the U.S. (ketamine was approved by the FDA in February 1970), offering an early glimpse into how a psychedelics infrastructure works.
All of these actions are driving where psychedelics is going, how it’s going to get there, and what that delivery infrastructure looks like. It’s a sort of Psychedelics 2.0 gaining momentum across the globe.
For example, Australia is looking for organizational help going to this next phase of psychedelics industry development. Australia proposes the establishment of a multidisciplinary Australian Advisory Committee for Psychedelic Therapies, representing research, clinical, regulatory, industry, and community interests that would provide guidance to government, professional organizations, and other stakeholders in training and accreditation, infrastructure development, community education, and regulatory matters.
With this ongoing infrastructure development, there is some concern that it could be outpacing what is really happening in the labs. Is the industry jumping the gun and getting ahead of the science?
A viewpoint article in the Journal of the American Medical Association’s Psychiatry publication in January 2022, spells it out: “There may be tension between avid advocates of this class of compounds and the deliberately slower pace of adoption encouraged by the scientific method, but rigorous research is necessary to more fully understand the risks and benefits involved in any presumptive clinical application,” the report’s authors noted. “The first wave of psychedelic research was disrupted by conflict between cultural and political forces. The current wave of psychedelic research could be susceptible to an emerging conflict between entrepreneurial enthusiasm and scientific deliberation.”