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Nick Kadysh

PharmAla is a manufacturer of GMP MDMA and a researcher of novel pharmaceuticals in the MDXX class of drugs

Tell us about yourself?

My background is in regulatory. I’ve spent the past decade as an executive at a number of blue-chip companies, including Red Bull, GE, and JUUL Labs. At all of them, I was responsible for the regulatory, government relations and public policy aspects of launching novel, highly regulated products. So from that perspective, getting into highly regulated pharmaceutical products was a logical move.

In terms of why, honestly, everyone who is truly committed to working in this space does it because they believe in the power of molecules like MDMA to change lives, improve people’s mental health, and treat trauma. There are easier ways to make a buck than to do this professionally – it’s incredibly challenging to be on the cutting edge.

If you could go back in time a year or two, what piece of advice would you give yourself?

Don’t take your company public! It adds opportunity, but it also takes a lot of control away from you as a founder.

What problem does your business solve?

PharmAla Biotech

We are the only publicly-traded manufacturer of MDMA, and we’re hard at work developing safer variants of MDXX molecules than MDMA. Today, we support all kinds of businesses that are researching or treating patients. With our novel molecules, we hope to open up new indications for patients. Specifically, we’re looking to launch a trial into social anxiety in an autistic population.

What is the inspiration behind your business?

I was inspired by the incredibly high-quality scientific evidence for the efficacy of MDMA in the treatment of PTSD. That research was developed by the Multidisciplinary Association for Psychedelic Studies (MAPS), and it was so persuasive that the FDA granted MDMA “Breakthrough Therapy” status.

We solve two major problems: for today, clinic operators and researchers need access to high-quality, clinical-grade drug product. We’re the only ones in the world, other than MAPS, who can do that for them. In May, we became the first company in Canadian history to be authorized to treat a patient with MDMA outside of a clinical trial through the Special Access Program. We’re also supplying into the Australian market, which will be the first “commercial” market for MDMA and Psilocybin, through our joint venture with Vitura Health, Cortexa.

For tomorrow, we’re developing novel and safer variants of molecules which are similar to MDMA. MDMA has some toxicology issues, including cardio- and neuro-, and we think we can improve on those issues in order to open up new treatment options for patients. The example I usually use is that patients with heart conditions are usually disqualified from MDMA-assisted psychotherapy, and as you can imagine, there are definitely PTSD patients who could benefit from MDMA therapy if we can solve the cardiac issues.

What is your magic sauce?

We basically focus on three main pillars:

  1. We are a “regulatory first” organization. We work in a highly regulated space, so we focus on making sure that we really understand the regulatory environment. I think that this is “table stakes” for an industry and entity like ours.
  2. Speed. We really focus on making sure we are first, although not at the expense of doing the job right. In just over two years, we’ve achieved a surprising number of firsts: First publicly traded company to make GMP MDMA, the first company to make available two Psychedelic APIs to our research customers and partners (through our partnership with Mindset Pharma), and the first company to be legally authorized to provide MDMA to a patient outside of a clinical trial in Canada.
  3. Safety. There is a lot of research on the “psychedelic renaissance”, but we have a somewhat unique research area: we focus on safety. Most research is on novel effects, but our belief is actually that the effects of “known” molecules like MDMA are great, and we haven’t even begun to explore their potential. But safety is always something we can improve on, and improved safety will lead to both greater acceptance and more potential patients!

What is the plan for the next 5 years? What do you want to achieve?

The next five years will be one of the most exciting times in modern mental healthcare. I believe that the Australian, Canadian, and UK examples will set the stage for the mass adoption of Psychedelic molecules like MDMA and Psilocybin once people truly see how impactful they can be. There will also be a massive amount of new entrants in the space – clinic operators and researchers.

For our part, I think we have two major goals:

  1. Remain a global leader in MDMA supply to all duly licensed entities
  2. Push forward on Phase 2 clinical trials for our ALA series of molecules and complete preclinical research on PharmAla-1 (one of our most exciting molecules and one for which we should have lots of research shortly).

What is the biggest challenge you’ve faced so far?

We never set out to manufacture MDMA. We were entirely a research organization until we heard from researchers that there was a lack of supply of clinical-grade material. Then we pivoted into doing both.

Manufacturing, for those who have never done it, is so bloody hard. I am often reminded of an interview by Trey Parker and Matt Stone where they basically said, “If we had known how hard it is to make a movie with puppets, we would never have done it.” That’s how I feel about manufacturing.

How can people get involved?

If you’re looking to partner or are seeking a supply of either MDMA or Psilocybin, you can email us at outreach@pharmala.ca or give us a call at 1-855-444-MDMA (6362)