A Psychedelic Path To CDMO Selection?

By Louis Garguilo, Chief Editor, Outsourced Pharma

Be prepared. Structured. Work in a systematic fashion towards your CDMO selection.

Attending trade shows and events can feel like shopping in a mall for t-shirts. You have so many choices.

Therefore, getting to your short list of potential CDMOs is a process requiring a disciplined plan of attack to address prerequisites, short- and long-term goals, and operational and cultural styles.

That’s a paraphrasing from accomplished outsourcer Anthony Grenier, Sr Director CMC, Reunion Neuroscience.

Reunion is pursuing the development of novel, synthetic psychedelic molecules with the aim of FDA approval. The company’s first target is a molecule to treat postpartum depression, called RE104.

Readers initially met Grenier and Reunion in part one. Here, we’ll continue our conversation with more detailing of Grenier’s thoughts on outsourcing practices, and more on Reunion.

Following A Psychedelic Path

“There was a point not long ago in Canada tinged with a certain ‘craziness’  when it became clear that the cannabis industry was entering an age of acceptance and legalization. We had many companies pursuing recreational products, but some were trying to develop pharmaceutical products. While some companies and investors may have benefited financially from the craziness, very few of either found commercial success.

My company benefitted from an investor who in fact had been successful in the field, and decided to invest into a psychedelics company. At the time, there were perhaps dozens of related companies in Canada. I’d estimate there are now half that.  

One of them, based in Toronto, had clinics providing Ketamines and other substances to patients. They had a facility for growing mushrooms, and a small part of the business was seriously pursuing new ideas for utilizing psychedelic molecules for indications for pharma products. The goal was to create FDA-approved products. That became Reunion.

“I've been with the company for two years. We're purely virtual, with less than 20 employees. I'm in Montreal, my boss in Toronto, and my colleagues are spread throughout the U.S. This small group has managed the development of a novel psychedelic small molecule through Phase 1, and we haves entered  Phase 2 in postpartum depression; the trial RECONNECT is currently running in the U.S.

My job is CMC, and I’m currently preparing for success of the postpartum trial and entry into Phase 3. This involves process improvement, scale-up, managing multiple vendors in different jurisdictions, assisting in patent strategy, and other tasks. It’s exciting, rewarding, and things are going well.

But to be successful, we need to differentiate.

We did that first by defining a new psychedelic molecule with intellectual property, something that will ensure market exclusivity in the future. This will avoid genericization and allow for expansion into multiple indications, and increased commercial success.

We chose to develop a psychedelic molecule that only produces a short psychedelic trip, making it more convenient for patients and physicians.

There are other unique aspects of our development program, including our choice of postpartum depression as a target indication. The product’s profile was ideal for this underserved population of mothers with depression.

While I started as a consultant for the company, managing scale-up for Phase 2, Reunion invited me to become part of the team, part of the family. I was, at first, hesitant.

I enjoy the variety that comes with consulting and the rewards of helping these small companies navigate through the drug development process. It was the greatest experience of my life managing all these projects with different types of sponsors.

Nonetheless, I felt a real connection to Reunion. Specifically, I was well aligned with my boss on the approach to CMC, and the idea of creating and working in a dynamic environment with entrepreneurial mindsets.”

CDMOs Challenged 100%

“You must work in a phase-appropriate fashion. What I like about Reunion is that there were no preconceived or pre-formatted ideas telling me we should work with certain CDMOs.

When I arrived, we had already completed Phase 1, had a CDMO to produce our drug substance, and another to manufacture drug product. We challenged them one-hundred percent to be sure they fit the needs of Phase 2 and perhaps beyond.

Our Phase 1 drug substance manufacturer was too small and would struggle to follow us into Phase 2. 

Our drug product manufacturing vendor was excellent but was not entirely comfortable working with psychedelics at larger scale.

We knew we would need to change.

I’d describe us as not conservative. We don't stay at the same place simply because it's comfortable, or because it's risky to change. Sometimes being more aggressive when outsourcing can be rewarding. And that was our approach.

6 Steps To Selection

Grenier says he ended up with plenty of CDMO options for Phase 2. Here's his (abbreviated) six-step guide to Reunion’s selection process to wrap up.

1. We first sought companies with the appropriate expertise, then narrowed to the right-sized CDMOs eager to work with us, and that were flexible and responsive.
2. We sought companies working in jurisdictions where regulations around psychedelics are not too onerous. Most psychedelics are Schedule 1 substances; obtaining licenses can be time consuming. 
3. We shortened our list mostly based on the above factors, but included a few “dark horses” that might be outside our comfort zone, yet had excellent reputations.
4. Then we started the RFP and quoting process. The best CDMOs excel at clear, concise and complete quotations for the required work. Test them here to see how fast they can get to their best offer; it gives you an idea of how they handle their internal processes and their structure and processes.
5. Then it was down to costing and deeply examining expertise, followed by meetings. We wanted to understand from them directly if they could continue with us into future stages.
6. All the above was synthesized, and a recommendation provided to the internal team for important buy-in. This forces you to consider every angle of the decision, or perhaps propels you to further discussions with the CDMO if needed.