The Challenge in Creating Ethical Pharmaceuticals from Cannabinoids
The Bracken Group
There are more than 160 naturally occurring cannabinoids that have been isolated from cannabis and hemp. Except for the tetrahydrocannabinol (THC) variants, a majority are not psychoactive and, in many cases, they have demonstrated therapeutic properties. In fact, the effects they produce have potential for use in many branches of medicine, but exploration and development have long been hindered by the fact that use of cannabis was illicit and conducting the clinical studies necessary to elucidate the clinical benefit were difficult to perform. Until recently.
With a more tolerant attitude toward cannabis and its derivatives and increasing scientific knowledge of their potential clinical utility, laws to control distribution and consumption have relaxed, as seen with the ‘Farm Bill’ of 2018. Now, more companies are embarking on the process of performing the requisite clinical development programs that will provide legal basis to bring these molecules to market as ethical pharmaceuticals.
That’s good news for the patients who could benefit from the drugs that might result, but finding a viable, commercially feasible path to market remains a challenge for would-be drug makers in this space. In addition to navigating changing laws in the U.S. and abroad, particular challenges include answering these important questions:
Which cannabinoid of the scores available represents the best opportunity for you?
Will you use a botanical source or synthesize your molecule? (Both options have significant pros and cons.)
How can you ensure that your end product can be patented? (In other words, how will you support intellectual property (IP) in your offering?)
What clinical indication should you pursue? (The wrong choice will sink you quickly.)
Do you understand the regulatory environment well enough to navigate it successfully in a timely fashion? (This is far more challenging than most people think.)
In short, while cannabinoids might seem like a can’t-lose opportunity at this moment, success is not easy to achieve. And, while you might have a great idea, or even strong evidence of therapeutic potential, there are many serious challenges between that position and commercial viability.
Successful drug development is a complex and costly process under the best circumstances. Insightful application of knowledge in science, regulatory affairs, business, manufacturing, and marketing is essential, especially in areas as volatile as cannabinoids are today.
The good news is that we at The Bracken Group have had experience in helping entrepreneurs navigate this exciting space. If your organization might benefit from this experience, reach out to us. We’re ready to help.