Carey Turnbull is Chair of the advisory board of the NYU Center for Psychedelic Medicine, and has assisted in the founding of Yale University’s extensive psilocybin research program. He is a member of the Board and President of Heffter Research Institute and a member of the Board of Usona Institute, both of which promote research on psychedelic plants and drugs at leading University research departments. Since 2010 Mr. Turnbull has worked in commercial early-stage drug development for half a dozen companies variously as an investor, founder, and CEO. He founded Ceruvia Lifesciences and B.More to transform psychedelic research into cutting edge medicine. Most recently he founded Freedom to Operate to protect psychedelic science and medical development for the public benefit.
Mr. Turnbull provides time as an adjunct advisor to the legal defense of the Native American Church and other indigenous people’s rights to the practice of their religion, ceremonies, and beliefs free from cultural, religious and legal pressure.
What made you personally interested in psychedelics and its potential as a medicinal therapy?
I grew up during the 1960’s, so have some personal understanding of the power of psychedelics to profoundly alter mood and cognition. It was about 16 years ago that I became aware of a tentative resurgence of research on psychedelics as medicines. I began to see several elite universities publishing studies on their potential to treat of a range of mental health disorders.
I believe the first study I came across was Roland Griffiths seminal 2006 paper, titled “Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance”. Roland’s paper and the fact that many of the study participants attributed their experience as one of the most meaningful of their lives, resonated with me. The results that Hopkins published were remarkably telling about the potential of these drugs.
Having reached out to a few of these institutions, I was surprised to discover the researchers spearheading these early studies were struggling for resources, something I was fortunate to be able to support them with. One thing led to another and here I am 16 years later having founded Ceruvia Lifesciences and the non-profits B.More and Freedom to Operate, the former two of which are undertaking clinical research to develop treatments for underserved patient populations, such as those struggling with OCD, headache disorders and substance abuse, all things that dominated the previous research era of the 1950-60’s.
How will your experience founding and running Amerex translate and help you in your leadership and advisory roles at various psychedelic organizations?
My time at Amerex and the other businesses I helped found and build provided two things that have been valuable in terms of my involvement in psychedelics. The first is an understanding of how to build and run a business at scale, something that is obviously critical in a complex area like drug development, particularly considering the novel nature of the treatments and the long timelines involved in securing regulatory approvals. The second is an understanding of the value of interacting with large institutions, which was the focus of our work at Amerex as an interdealer broker dealing with Fortune 500 customers. Much of my work in the psychedelics space, both as a philanthropist and founder, has been focused on leveraging the wealth of experience and credibility that large institutions like Yale, Harvard and NYU are able to bring to the table in advancing the development and eventual approval of psychedelic medicines. At Ceruvia and B.More, we now have a long history of partnership with those three institutions, which is central to our drug development efforts.
You have been involved with a number of organizations focused on researching psychedelics, such as the Heffter Institute, Usona Institute and the NYU Center for Psychedelic Medicine and you were an early donor for the John Hopkins Center for Psychedelic Research. Why did you become involved in these organizations?
I had a chance to the meet with various credentialed professionals from each of these organizations early on in my involvement with psychedelics and was deeply impressed by the caliber of their work, as well as the commitment, rigor and professionalism they brought to the task of advancing the development of psychedelics as medicines. It was obvious to me that each of these organizations were going to a play a key role in delivering on the promise of these drugs. With that in mind, it was easy to see that time and money invested in supporting their work would be well spent.
What is Freedom to Operate? What does it seek to achieve and how is it related to the Open Science document?
FTO is a non-profit I founded with the purpose of advancing science and education, specifically to support and facilitate scientific research, in the public interest and for the public benefit. FTO is not anti-patent, nor does it oppose commercialization of psychedelics. It opposes inappropriate monopolies on classic psychedelics because they are rarely in the interest of the public, but in the interest of a small group of shareholders. That’s of unusual importance when considering the psychospiritual nature of the benefits associated with psychedelics.
One of FTO’s core missions is to ensure that publicly available research and development concerning psychedelics, and their use as a treatment for a range of conditions for which conventional medical treatments have not been effective, remains in the public domain for use by patients.
How does FTO’s unsuccessful patent challenge and the U.S. Patent Trial and Appeal Board’s response effectively narrow the scope of Compass Pathway’s broad psilocybin patent?
While the U.S. Patent Trial and Appeal Board (PTAB) disallowed our petitions for post grant review of the Compass patents, they have nonetheless served an important purpose in providing a clear pathway for generic psilocybin producers to ensure the psilocybin they manufacture or sell is not at risk of infringing Compass’s “Polymorph A” patents. In its decisions, the PTAB interpreted Compass’s "Polymorph A" claims extremely narrowly, ruling that they only cover psilocybin that has exactly the x-ray powder diffraction (XRPD) peaks as claimed. Most patent owners in litigation involving claims with XRPD peaks seek to give their claims some range beyond the exact peaks stated in their claims, because often a product that the patent owner wants to allege violates their patent doesn’t have those exact peaks. However, because of the Board’s decision, Compass can’t reasonably take that approach. This will greatly limit their ability to wield their patent as a tool with which to stifle competition.
Can you share why you believe that there shouldn’t be a patent on psilocybin as a substance and the ability to use it medically?
“Freedom to operate” is a term of art in the field of intellectual property law, and refers to the ability to develop, manufacture, and market products without legal liabilities to third parties who claim intellectual property rights in those products. There is an important public policy interest in invalidating bad patents and promoting free competition that does not infringe on validly granted patents and other intellectual property rights. Issued patents are presumed valid and so operate to discourage investment by others into the same or similar subject matter. The public is benefited when potentially incorrectly issued patents are challenged or invalidated.
What is B.More? What does it seek to achieve and how?
Founded by my wife Claudia and me in 2017, B.More is a non-profit, clinical-stage biopharmaceutical company with a mission to develop better treatment options for individuals struggling with alcohol use disorder (AUD) and other substance use disorders. Named after Claudia’s brother, Brett Moore, who died of a drug overdose 50 years ago, B.More is focused on the development and commercialization of psychedelic medicines that offer the potential to significantly improve the lives of those for whom current treatment options have not proved effective.
Currently, we are focused primarily on the development of psilocybin to treat AUD and have just submitted an FDA Investigation New Drug (IND) application to conduct a Phase 2b clinical trial to assess the 24-week efficacy and safety of synthetic psilocybin (SYNP-101) in treating moderate to severe AUD. The trial, which will be initiated in early 2023, will be led by Principal Investigator Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine, who is a world leader in this area of research. With a planned 226 participants, it will be the second largest psychedelics clinical trial ever conducted and will provide critical data as we move toward Phase 3 of the FDA process.
What are you working to build at Ceruvia Life Sciences?
Ceruvia Lifesciences is a clinical-stage biopharmaceutical company developing neurotransformational treatments for underserved patients suffering from neurological and psychiatric disorders. We are in the process of advancing our clinical development program with two molecules, SYNP-101 (synthetic psilocybin) and NYPRG-101, which is known in the literature as BOL-148, a non-hallucinogenic analog of LSD that was first synthesized by Albert Hoffmann in 1957 and was used as a placebo in early LSD trials.
With respect to our psilocybin program, we are developing treatments for OCD and cluster headaches. We recently received FDA approval for an IND application for our OCD Phase 2 clinical trial, which will commence in the second half of 2022 and will be led by Principal Investigators Dr. Benjamin Kelmendi and Dr. Christopher Pittenger of Yale University School of Medicine. With BOL-148, we are focused on prevention of migraine and recently submitted an IND application for a Phase I clinical trial that will also commence in the second half of 2022.
With a long history of partnership with leading researchers at Yale University School of Medicine, NYU School of Medicine and Harvard Medical School, we have managed to assemble a team of world-class researchers who serve as a key pillar of our drug development program.
Why has Ceruvia chosen to offer GMP LSD free of cost to academic research sites?
One of the ways to make BOL-148 is to first produce LSD, which is then brominated to produce BOL-148. Having made a large quantity of the world’s first GMP LSD for this purpose, we discovered that both Johns Hopkins and NYU were struggling to find a source of LSD to use in the first in-human clinical trials to be conducted in the United States in over 40 years. Understanding the complexities of sourcing Schedule I drugs of GMP quality we agreed to supply it to them at no cost. Recognizing that other qualified researchers would benefit from access to GMP quality LSD we established a program to supply it free of cost.
What do you believe is the public benefit of psychedelic medicine and therapies and why does access to psychedelics need to be protected?
While psychedelic medicines will certainly not work for everyone, research undertaken to date suggests that they offer not just an improvement but a vast improvement in terms of their efficacy in treating a range of psychiatric and neurological disorders. With so many millions of individuals struggling daily, often for years, with addiction, anxiety, OCD, cluster headaches, depression or other conditions, we are looking at a significant leap-forward in terms of how modern medicine is able to improve the lives of many of those for whom there are currently few good treatment options available. The benefit to these individuals, their loved ones, communities, and society at large is difficult to overstate. Having said that, we still have a long way to go in advancing these drugs through the regulatory approval process and in building the infrastructure necessary to deliver treatments to large numbers of patients. It is necessary that we do that with the care, scientific rigor and patient focused approach that such an endeavour demands.
What do you believe is the most important thing for people to understand about the future of psychedelics as medicine?
First and foremost, I want people to understand that there is a future for psychedelic medicine. That is without doubt. However, I think one of the things that is underappreciated is the scale of the task required to get these drugs approved as medicines. In the early days of the psychedelic renaissance, we were able to leverage relatively small amounts of philanthropy to get us to where we are today with dozens of companies, academic institutions and other organizations working to create access for patients. Looking back, those early efforts were somewhat quixotic and its remarkable that we were able to take a few tens of millions of dollars and create the psychedelics renaissance as we know it today. The next stage, getting these drugs through the randomized control trials required to get them approved as medicines, will require something on an entirely different scale. The expense will be extraordinary and will require hundreds of millions if not billions of dollars in additional investment in the industry.
Who is doing important work in the world of psychedelics that you think more people should be aware of?
So much of the focus over the last several years in terms of psilocybin research has been on progress made with respect to the treatment of depression but major advances have also made in treating addiction and neurological disorders. This has been largely underreported and the work of people like Michael Bogenschutz at NYU and Ben Kelmendi, Chris Pittenger and Emmanuel Schindler at Yale has not received the attention it deserves. I suspect this will change dramatically as the trials they are working on progress and the results of their work make it into the public domain.
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