Wonderland 2022: Experts Talk Clinical Trials, Next Steps After Approvals

FDA speaks unofficially on psychedelics

One of the most significant talks at Wonderland was given by Commander Gene Gunn, a bioresearch monitoring specialist with the US Food and Drug Administration (FDA) and US Public Health Service.

Gunn spoke at length about the clinical trial process, including what the FDA does and doesn't want to see. But he also opened up about his own mental health struggles and the positive experience he has had with new psychedelic therapies. After facing a few losses close to home, Gunn found his way back thanks to ketamine-assisted therapy for mental health.

“I didn’t really think they were going to let me (come),” Gunn said about his discussions with the FDA about speaking at Wonderland. In the end, he was able to attend as an advocate wanting to share his personal experience, but could not comment on the FDA’s current review process for any psychedelics-based compound drug trials.

Gunn's talk was significant in highlighting the varied types of patients who turn to psychedelics-focused therapies and how passionate they tend to become about these treatments.

Corporatization of psychedelics sparks debate

Politics served as the backdrop for a significant number of conversations during the week of panels.

While various industry stakeholders are eager and even giddy to see the research and clinical trial process move ahead, many people on the Wonderland show floor expressed reservations about this rigorous pharmaceutical process.

Speaking at a panel discussing the politics of psychedelic medicines as a whole, a tense back and forth was sparked when Gregory Ferenstein, CEO of Frederick Research, pushed back against the accepted notion that pursuing medical approval with regulators like the FDA is the only way for the industry to move forward and treat more patients.

Most publicly traded psychedelics companies are using this model, but some experts have expressed frustration at the delays it is causing for patients who may not have time to wait around for approvals to see the light of day.

Ferenstein outlined a state-by-state approach in which programs could be built to push legalization bills that could open the doors to therapies that patients need, but that they may not be aware of or have the tools to access.

At the state level, the psychedelics industry recently achieved key victories in Colorado, where voters approved psilocybin-assisted therapy, and Oregon, which validated its existing laws by rejecting county bans on psilocybin.

“We have consistently demonstrated that it's almost impossible to get anything done at the federal level,” Courtney Barnes told INN. Barnes is a partner and lawyer with Barnes Caplan, and she also spoke on the panel.

Therein lies the crux of a key issue for the psychedelics sector — the industry's goal is to help patients with plant-based drug treatments, but corporatization means approvals won't come without massive amounts of research, time and money.

Najla Guthrie, CEO of Wellbeing Digital Sciences (NEO:MEDI), pushed back against Ferenstein’s comments by stressing how vital the clinical research being conducted at the moment will be for the industry.

“We need the regulatory framework to happen responsibly. And we need the industry to rally around behind that,” Guthrie told INN before her speaking slot at Wonderland. The expert also expressed excitement about the amount of research being produced and how it will help fuel an industry that’s bigger that any one single company.

Investor takeaway

The psychedelics industry is on the verge of being catapulted into an even bigger spotlight thanks to imminent scientific results, but questions remain about what comes after that data reaches the light of day.

Investors are beginning to see the pillars of the industry emerge as these much-anticipated approvals approach. And at a larger scale, financiers and those looking for new business opportunities all seem aware of how exciting and potentially magnifying this entire endeavor could be for the right stakeholders.

For now though, there's tension between eager enterprise makers and passionate advocates looking for a less corporate approach to the psychedelic drug business.