There’s a lot of buzz around the psychedelic medicine industry. Recent market pullback aside, the industry is growing exponentially, with new players coming on the scene every month.
For the casual investor this growth may seem somewhat straightforward, with new companies magically popping up on their news feeds and Robinhood accounts. But the reality of the biotech road is long and winding. From clinical trials to lab work, to tweaking formulations and jumping through regulatory hoops, there is an endless amount of work going on behind the scenes, with expertise required at every step of the chain.
Which is why companies like KGK Science are integral components of any industry, especially a fledgling one like psychedelics.
Here are some highlights from KGK Science’s presentation at Microdose’s recent Psychedelic Capital event.
A little about KGK Science
KGK Science is a full-service contract research organization (CRO) supporting the nutraceutical, cannabis and psychedelic industries. In business since 1997, KGK has an experienced team of scientific researchers, consultants, and regulatory specialists to develop customized claim substantiation and path-to-market strategies.
From clinical study design to impactful product marketing, KGK offers state-of-the-art clinical research facilities, clinical staff, researchers, and regulatory experts. They’ve guided hundreds of companies from product concept to clinically proving claims, helping them through complex regulatory bodies including Health Canada, FDA, and FTC.
Some company highlights:
- 350 Clinical Trials Across 40+ Indications
- 150 Publications
- 10 million Data Points Collected
- 23 Years In Business
- 85 Full Time Employees
- 25,000 Participant Database
Navigating the landscape of drug & product development
From KGK Science President and CEO, Najla Guthrie:
“We provide regulatory solutions at any stage of your product development cycle. And it might be the basic science stage, preclinical animal model stage, proof of concept stage, or just before you go into human clinical trials. Or you might want market distinction of your ingredient. Or an IND (Investigational New Drug application with the FDA).
“Or you may need a road map of studies with costs and timelines as to how to get that IND. Your investors and board might benefit from a pathway to market to understand all of the nuances your product could fit into.”
And this was just the tip of the developmental iceberg. As glimpsed in the figure below, KGK’s presentation shows how many stages and requirements there are to navigate in getting a product to market.
“We will assist you wherever you are in this life cycle spectrum. Some companies are starting at the beginning, others are at the clinical phase, and yet others need help finding vendors to do toxicity studies for their scheduled substances. Additionally, there is the added variable of psychotherapy, which in itself may require development in efficacy testing in conjunction with the particular drug you’re testing. There are a number of opportunities to leverage partnerships with existing science and technology.”
Having an experienced partner available to consult on or completely handle some of these steps can be a crucial asset.
For more information, see KGK’s complete Psychedelic Capital presentation here. You can also visit their website here.
