Interviewer: Barron, Natania (UBC)
Interviewee: Josh Hardman, Founder of Psychedelic Alpha
Date: December 3, 2025
UBC sat down with Josh Hardman, founder and editor of Psychedelic Alpha, an independent media and consultancy firm devoted to the psychedelics industry—from business and drug development through to policy reform and scientific research.
Through Psychedelic Alpha, Hardman and his team have built publicly available databases that collate company profiles, drug development, policy, and patents. These resources that have become essential for anyone navigating the psychedelic space. During the interview with Hardman, we talked about where the industry stands today, what’s shaping its future, and what he’s watching most closely.
UBC: Thank you for joining us today, Josh. To start, could you introduce yourself and tell us a bit about what you do?
Josh Hardman: Absolutely. I’m Josh Hardman. I run a website and consultancy firm called Psychedelic Alpha. For five years now, I’ve been covering primarily psychedelic drug development, but also policy and research. It’s been all I’ve done for five years, and it’s been a curious time to be in the space. We’ve gone from having three companies back in 2020 to now having dozens exploring this area. It’s been an interesting ride.
UBC: What inspired you to focus on this angle of drug development?
Josh Hardman: My undergraduate studies were in social sciences at the London School of Economics. I spent a year abroad at UC Berkeley, where I studied social history and came across the counterculture and Native American use of psychedelics. When I returned to London, I encountered the early stages of rigorous scientific research into psychedelics at places like Imperial College and King’s College. My first reaction was skepticism—I wondered if these trials could work outside their historical and social contexts. I started as a skeptic, but after years of learning and meeting thoughtful trialists, I became more of an analyst. We’re not advocates or enthusiasts; we cover the research and hope it succeeds, especially for mental health disorders, but we maintain an analytical perspective.
UBC: That’s a fascinating approach. Could you talk more about the intersection between the anthropological and scientific aspects of drug development?
Josh Hardman: Certainly. When I worked on the investing side, one of our main theses was that the exploration of psychedelics for medical uses had been artificially stopped due to prohibition. There was some use in the mid-century, but it wasn’t rigorous or controlled. In the 1970s, research was shut down. Now, there’s a black box of potential uses beyond mental health, possibly in headache or neurodegenerative disorders. The stigma around psychedelics meant much of the research was funded by people with personal positive experiences, but now we’re seeing less advocacy-related funding, which is positive. Public funding, like the EU’s Horizon Fund, is helping shift perceptions and reduce bias. Most trial site psychiatrists are excited not because of personal experiences, but because their patients have run out of options.
UBC: When consulting, how do you approach maintaining balance, given the buzz and market perceptions around these drugs?
Josh Hardman: It’s a delicate balance. Early on, many in the field played into the hype, which led to inflated expectations among investors and clinical trial participants. Many patients entered trials expecting transformative results, which isn’t always realistic. With investors, especially in healthcare, a lot of the work is education—explaining that what they’ve seen in contexts like ayahuasca retreats isn’t what the medical model looks like. It’s about integrating these treatments into the healthcare system and patients’ lives.
UBC: There’s also a therapeutic angle—these treatments require hands-on therapy, not just medication. How does that affect study design?
Josh Hardman: In the 50s and 60s, psychedelics were often used as catalysts for psychotherapy. Now, because regulators like the FDA and EMA appraise drugs, not psychotherapy, sponsors have tried to downplay or remove psychotherapy from studies. In practice, psychotherapy will likely be added back in over time if it proves effective. Sponsors have had to slim down protocols to make them commercially attractive and simple for healthcare systems, but after approvals, we’ll probably see evidence-based psychotherapies integrated into treatment.
UBC: You mentioned REMS (Risk Evaluation and Mitigation Strategies). What challenges are sponsors facing with REMS in development and safety planning?
Josh Hardman: One challenge is understanding how much REMS depresses off-label use. Psychedelics may have transdiagnostic potential, but practitioners tend to stick to on-label indications when there’s a REMS. Sponsors are considering how to collect data on different indications without launching multiple phase three programs. Registries associated with REMS could help collect real-world data and signal other indications or long-term durability. The expectation is that REMS requirements will be less specific than initially feared, but it’s almost certain these drugs will be approved with REMS.
UBC: There’s also stigma in patient recruitment and adoption, even post-market. Are there educational strategies to address this?
Josh Hardman: In the UK, prescribing cannabis-based medicines is very low, partly due to stigma among practitioners. The research into cannabis applications slowed once state-level legalization occurred, which some in the psychedelics world worry could happen here. The way to avoid this is rigorous approval through large, well-controlled phase three studies. Convincing prescribers—especially those earlier in the referral chain—is key. There’s still trust in PCPs and psychiatrists, so sponsors will need to focus on education at that level.
UBC: Looking ahead, what are you anticipating or hoping to see in 2026?
Josh Hardman: The next 18 months will be very eventful, especially in the US. There are genuine regulatory tailwinds, and half of the open INDs in psychiatry are for psychedelics. I hope there are no political concessions and that approvals are based on rigorous science. We could see two or three approvals, like MDMA products or psilocybin, and more behind that. In Europe, there’s interesting work on integrating psychotherapy and enhancing drug benefits. The main goal in the US is to get a minimum viable product approved, while Europe is exploring real-world models.
UBC: So much of this centers on the patient, especially given the lack of innovation in psychiatric assistance over the past decades. Recruitment is challenging, but for the right profile, these treatments could be life-changing if approached with scientific rigor and skepticism.
Josh Hardman: Absolutely. The field owes it to patients to do the science rigorously. Just because you’re a believer doesn’t mean you can imprint that on patients. We owe them the best scientific methods, and that will help with credibility as well.
About UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services and is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product.
