Why Independent Cannabis Research is Profoundly Important
CHJ: Welcome Daniel to Cannabis Health. We appreciate thoughtful ventures in the medical cannabis industry, particularly those involved in research as we believe that the more we know about the potential of cannabinoid science, the more likely we can find targeted therapies to a variety of ailments. Would you mind sharing with our audience some background about Milestones Research?
DK: Milestones Research has two divisions, one with virtual/global services such as writing protocols, statistics, and other advanced support services. Our long-term goal is to have researchers in most of the countries around the world. The other is ISCRI, which is short for the International Scientific Cannabis Research Institute, and will be dedicated to the clinical investigation of the non-psychoactive aspects of cannabis derivatives such as cannabidiol (CBD).
CHJ: Does your choice of physical location, in Denver, Colorado, have bearing on your objectives? Do you have a website in which interested parties can view your work and progress?
DK: Yes. In research you have to consider one key question above all others. Where will the participants come from and can the population support either in indication or volunteering for a research study? In the case of CBD, we have one of the highest level of CBD consumers when considering the recreational side as well as many children and families moving here specifically for CBD. Yes, our website offers some insight into our operations. But most of the work we are conducting is not in the public domain. Readers can go to www.milestonesresearch.com where one can find out about our management and sales team, along with our scientific advisory board and our strategic advisors. We’ve got a great team and their dedication has been incredible in moving us along.
CHJ: Daniel, please tell us about Milestones Research’s operations and your current role.
DK: Milestones Research has focused extensively on process and infrastructure (of the operations) for most of the last year. As Director, my focus is in launching the research site. With so many team members, partners, etc. (not to mention the cannabis aspects), (it) really requires more on the operations side as we launch. For this reason, we will need to rely on my tenacity as we continue to push forward in launching a site. Launching a cannabis clinical research facility is an incredible challenge and it’s safe to say while we anticipate a good bit, we couldn’t have predicted some of the curve balls that have been thrown at us. Nor could anyone else for that matter.
CHJ: Do you have a team of researchers who are actively studying Cannabis sativa, are you focused on cannabis and/or hemp?
DK: Yes, and ahead of moving into our facility we have a very long punch list of items we are working towards. It is mind boggling when I stop and think about how much we have done and how much is left to do. We are focused entirely on the non-psychoactive aspects of cannabis both on the systems/receptor side as well as the medicines used to treat indications. We have and continue to partner with organizations on all sides of the discussion, but with one commonality across them all. We are all committed to protecting, informing, and supporting patients through research, oversight, testing and access of safe treatment options. Our scientists have careers in different areas with a couple that have some expertise in cannabis. But, what is even more important is our understanding of the funding systems and how the US research industry operates. This allows us to do and be more for our client’s in delivering cutting-edge trials.
CHJ: Would you mind sharing further details? Most often we find that there’s a lot of well known institutions partnering with, for example, the ArcView group or Privateer Holdings, or someone along those lines. Is it similar in scope to those organizations?
DK: I would say that right now our partnerships are very much focused in Denver. To deliver world-class research, from where we sit we have a whole lot more to consider than anybody in the cannabis industry or anybody starting a ‘basic’ research facility. We have to consider both sides right, so this makes our job doubly more challenging. I can tell you we are highly aligned with the scientific and medical community in our approach to investigating cannabis. While most outside of Denver probably think that everyone in Denver gives a ‘green’ light on the topic, this couldn’t be further from the truth. Images and relationships in the medical communities here are taken very seriously and many are very Leary of any association with marijuana. We absolutely require a partner like ArcView for investment, expertise, and supporting our work that only they can provide. We continue to reach out to many organizations for support. Some in the media, others advocates for patients, and others focused on ensuring the safety of products.
There are many organizations that we’re finding in Denver. I don’t know how much news gets out from Denver, but ‘sitting’ in the beating heart of the industry we are seeing two groups emerging in the CBD industry. There’s those that are aligning, very much dedicated and focused to patients and then you have those that are (struggles) how do I put it kindly, they’re just — there’s some bad things going on in the industry frankly. There is a serious need for correction and oversight. There is the group that’s emerging, taking responsibility by compassionately and passionately aligning with the (needs of) patients and parents of patients that are coming to Denver. That’s what’s driving me personally as the CEO of the company. I think that we really need to find answers really quickly. We along with our partners are committed to excellence in our products and services and understand that patients depend on this level of accountability.
CHJ: We really appreciate that because it gives us a little bit more insight into your objectives, your passion and what your impetus is, for lack of a better word, to move in this direction. Does Milestones Research wants to create or obtain venture capital to have a lab, to actively study cannabinoids, or are you looking to sponsor a lab that will do this work, and then they’re an entity that reports to you?
DK: We will outsource those areas that make sense, but we aim to be a comprehensive closed loop system of services that will meet the needs of our clients. In that we can support securing funding such as grants, trial management, etc. But yes in general, we will be the one delivering and managing all of the research services. Currently we offer a couple hundred services, once launched thousands of services, and we will continue to expand our capabilities as driven by client needs. It is important to point out that we will not be selling products. While we may use products, services, or devices to deliver the clinical research, we are committed to remaining as independent and unbiased as possible. Although, bias is reduced and handled largely through rigorous trial controls.
CHJ: Okay, so you already have the individuals so to speak, that will be conducting this research. You’re in the final stages of acquiring the necessary venture capital, for lack of a better word, to actually start working?
DK: Correct. We are engaging investors and previously anticipated this to go very quickly. But, we have a very unique challenge that requires telling the very complex story about clinical research trials. And that’s before we even discuss cannabis. But when you go down the lists of checkboxes for a good opportunity, we feel we have them covered. While I may be dreaming, we are looking for the investors who will be willing to have a discussion. That is, they see the need, and understand the vision. This is too big, to tackle in a few slides. That’s like trying to pitch a corporation as if it were one specific product.
While conducting trials is our core service offering and focus, informing and educating the country as a whole on what’s going is important to us as well. Part of this education process is informing consumers about the products they are using. Until you start peeling back the layers, then you finally get to the bottom you say, oh wow, this is unbelievable. Whether it be on the cultivation and the methodologies that are being used, or the manufacturing distribution, we’re talking about CBD that either has far less concentration than what it says, or it may have toxic impurities, or it may have no CBD at all.
CHJ: You’re absolutely right. We know that it’s a ‘Wild West’ of sorts with regards to the state laws, with concern to dispensaries and with concern to the medications, edibles, and whether the exact quantities of THC/CBD/terpenes as well as all the “contaminates” that may be present in cannabis. We think Colorado, all things considered, has done a magnificent job of leading the way in that regard. They require lab testing of recreational edibles (for public safety concerns), but thus far not medical.
DK: Much of the compound testing and processing is our partners area of focus, because they’re actually testing these compounds. When you’re talking about any research, whether it’s antibiotics or aspirin, you have assurance of quality control guarantee or assurance of the product that you’re using right? And that’s even like an automobile or anything else, everything has to operate as indicated, and so we have put a lot of emphasis in ensuring that our partners: (1) are delivering in the highest grade CBD and (2) only using the highest medical grade CBD, not so much in terms of concentration but in terms of purity and (3), (being a) clean product for patients and consumers.
There is also a continuation of rigorous testing throughout the entire product cycle and research cycle, because we haven’t identified shelf-life/half-life, we haven’t identified is it better – how long will it be stored in freezers, fridges, room-temperatures and things like that, there are so many questions to be answered and we don’t take them all on (laughs). We are focused on a few which are more than enough for our lifetime.
DK: Oh great, absolutely. I think that the term I more recently identify with is that of a serial entrepreneur. It defines my lifelong passion quite well, it’s something I’ve been all my life. I’ve enjoyed the excitement of products and creating new entities, but it’s always been a side thing I’ve done in parallel to my work as a researcher. I went to graduate school and have conducted research in a number of different organizational models: universities, the largest CRO (contract research organization), and in a large pediatric non-profit hospital. Collectively that afforded me a global perspective on research that I think is unique. These two combined is why I love my day job and I never stop moving. I had that ‘a-ha’ moment when I realized the time had come to unite my passions as an entrepreneur and research. Like me, I think most researchers are drawn to research with the potential to impact thousands of lives. It’s a pretty incredible and exciting thing.
CHJ: Why cannabis? You have an extensive background in clinical research which is your passion and obviously you have a talent in that arena. Why cannabis research? I think that’d be also helpful to know.
DK: The cannabis industry in general was always a target client such as supporting their operations, cultivation, financials through statistics / business intelligence. But, as I started to talk with folks in the industry and as the CNN reports, a lot of these stories came out which (Cannabis Health) have put on your website, I started to do what I do and that’s research, that’s read. I looked in the places that you look to find legitimate sources of good quality research (pubmed) and then your clinical trials (clinicaltrials.gov) or for those that are reporting the clinical trial. As I kept digging and digging I said to myself, I have to be missing something. I concluded we don’t have one good randomized control with CBD and epilepsy and as you may know randomized control trials are the gold standard. That was further supported by the American Academy of Neurology as stated in their literature review (2014). When you look at the country on the whole of the top 10 [of 50] organizations conducting trials, 80% of the 60 [conducted by the top 10] are addiction trials. The remaining 40 [of the 50] organizations have one (1) trial each which are mostly studying only the synthetic version [and others]1. At this rate, patients today will certainly never have the answers they desperately need (www.clinicaltrials.gov).
That’s really the initial trigger, these heartbreaking stories of these parents with children with epilepsy. I had no idea, I knew nothing about epilepsy and when I heard that some of these children were having 60+ epileptic seizures a day I was shocked. I was profoundly moved by this and deeply touched. I have children of my own; I have a son and three little girls, and just to know how challenging that must be, not only for the child but for the parents, impacted me in many ways I’m a very passionate person, I care a lot about people and humanity and my life goal is to be able to do something good for people, but that’s what started it and it really became a snowball effect whereby we haven’t let up in our speed as we move after this goal. A goal to impact humanity through research.
CHJ: I think that’s very powerful in terms of your background and how it helps the mission. Why did you decide to research cannabidiol? we will be delivering (some) very cutting edge and innovative technologies to deliver very exciting data outcomes.
DK: So broadly speaking, the catalyst was the heart wrenching stories on TV and I think what differentiates a researcher from a non-researcher is knowing where the sources of information are to find answers, and as I started to pursue that I realized that we don’t know a lot about this. (I also) was a psychology major so I also understand when parents with need and hope are watching these type of media presentations, they miss any caution or caveats that might have been mentioned, because all they see is hope. It’s our responsibility as researchers to provide data driven, scientifically supported information, so that’s what got me started on cannabis in general. Even now I’m looking around asking where is the medical and scientific community? It was also the recognition that Milestones Research, joined by many other organizations, will be researching CBD for many lifetimes to come. I can’t think of anytime in history, in the United States at least, that there has been a product that has been touted to cure and deliver on so many different levels and has such early promise. It’s all exciting and I think that’s kind of a long-winded answer but I think all that kind of wrapped up really set the stage for a really exciting opportunity, which was why we started down this path.
CHJ: What is unique about what Milestones Research is doing as it relates to cannabis research?
DK: I would say, for starters, currently in the US and as best as we can tell in the world, we’re slated to be the first independent for-profit scientific and medical research facility dedicated to the investigation of CBD. That’s kind of a mouthful, I know, but there’s some keywords in there that really are important. The key differentiator and those currently conducting trials on university campuses and within pharmaceutical companies is that we’re truly independent. Being independent affords us the opportunity to service or partner or collaborate with virtually everyone who has an interest in CBD. This is important as a research organization even beyond cannabis because we feel this model is the future of human research exploration in the US. This really stems from understanding the beating heart of the state of research in this country. Being for-profit, we feel allows us to give back to those like-minded organizations, investors, supporters, and so we can share our success with scientists, and team members. But ultimately a for-profit model provides the needed revenues to deliver answers without excuses and of course we want to be competitive in all possible areas. All of which we feel are critical in delivering these high-quality research trials with clean data to help drive medically sound decisions as related to CBD.
we will be delivering (some) very cutting edge and innovative technologies to deliver very exciting data outcomes.
CHJ: Well that’s excellent that you guys are creating jobs.
DK: (laughs) Well, that’s right and we have a somewhat aggressive model, we will continue to expand our team and operations to meet the global clinical research demand in cannabis. We want to be the best, and that requires bringing in the brightest minds with (with competitive salaries). We are very excited about expansion opportunities.
CHJ: What types of research will you be able to perform at the facility?
DK: We’re a niche full-service contract research provider, so what makes us unique is our ability to develop investigator initiated research trials. I think in general most aren’t really familiar with this, particularly if they’re not in research, but these often require years of expertise and training. It’s not something you can pick up and do, and more specifically we provide everything from developing trials from scratch, identifying funding sources, on-site trial management, statistics and the list goes on. Beyond the research basics we will have advanced testing equipment on site and between our in-house capabilities and our partners, we’ll have the ability to deliver the most advanced diagnostic and assessment technologies in the state of Colorado. Between our network and partners in Colorado it’s really our mission to meet the needs of the scientific and medical community – not only in Colorado and the US but globally as well. Really, when you think about us, we will be delivering (some) very cutting edge and innovative technologies to deliver very exciting data outcomes.
CHJ: What is your relationship with universities and how are you different?
DK: This is a good question, partly because the university is the birthplace of Milestones Research in a way. It was in the university setting that I was able to engage in research and our scientists and almost every researcher as far as I know, comes out of the university so it’s kind of the bedrock foundation of research around the world. Of course these universities have incredible networks and vast partnerships; that’s one way we’re different. They have these long histories and incredible campuses and we aren’t trying to outdo them in this respect. A fundamental part of the services we provide is really a focus on the efficiency and delivery of research services. The universities have so much to offer in terms of services and research and infrastructure so it’s really our goal to help provide those services to what I call our entrepreneurs of medicine, who don’t have that research infrastructure but very much are interested in engaging in research. But we will always look to partner with universities as we have similar goals.
CHJ: Are you at all concerned about the politics and legal challenges you may face on the horizon?
DK: I think I get this question daily almost in some form or another. Here’s what we know: we know it’s a very fluid and dynamic situation nationally in the US. Legalization is really sweeping across the country and so all indications seem to point to this is not going to be reversed, this is going one way. We have scientists with expertise with the FDA, legal counsel that is focused on performing clinical research properly, and many behind the scenes guiding us every step of the way.
CHJ: Hopefully that’s forward….
DK: Right, right, absolutely. We’ve engaged legal counsel at length and have discussed a very exciting strategy that we’ll be taking, it’s actually on a trial by trial basis. I would say though I think that the FDA and the government gets a bad rap, frankly. I’m not defending them on anything per se, but I will say I am in part sympathetic to the challenges they face. We’re talking about a policy that’s been in place for quite some time. For these massive agencies to all of a sudden say — I mean sweeping legalization — there’s a lot of thought that needs to go into this and a lot of due diligence and, frankly, what you hear is a lot (of) attacks against the FDA and NIDA, and the DEA, and I think that we’re going to be positioned real nicely. They all want to make sure that who they’re entrusting with licensing and conducting trials are going to be engaging in high quality research. I know the history of the cannabis advocates work, but I think we need to move forward and be forward thinking. That’s where I come with my perspective in that I’m very much a forward thinker and I think they have a tough job and they’re getting there. It takes a long time to turn a big ship around. We are confident our organization will be well received by the FDA as we are going beyond the basics to demonstrate our eagerness to win their support.
CHJ: That connects one point. If there’s one thing you could really accomplish, what do you hope to accomplish with your team of researchers?
DK: Goodness, there are so many things we want to do. I think that if we can deliver on any one of the key and core areas of CBD needs in patients we will have succeeded. Part of that decision tree of those areas of research will certainly be driven by our client’s interests. Whether it be epilepsy, PTSD, oncology trials, or what have you, but we also internally, our researchers will have their programs of research they’re going to be developing and focusing on key areas. Simply put, we just want to impact lives, to inform, educate, and help facilitate sound prescriptions for the medical and scientific community.
CHJ: Who do you anticipate will request your services? Who do you think is going some of your key clients?
DK: I think that’s really where we are going to shine. A critical aspect of our model is remaining independent. What does that really mean? That means we don’t have a stake or opinion about it, but certainly a lot of our scientists do have opinions (about it) but from a scientific point of view they’re independent. The real importance of this is we don’t have a product line. We’re not selling a device or a drug or anything like that. We don’t have an interest in the outcome beyond delivering the highest level of data that we can to our clients. For this reason we’re in discussions with many in the cannabis industry, universities, medical organizations, advocacy groups on both sides, for and against, governments, pharmaceutical companies, pretty much everyone in between and beyond. I think that’s really an exciting position to be in, to be able to really support all those who are willing to come to the table and have a discussion and who are really interested in understanding what the research outcomes will be.
CHJ: The research you’re going to perform, is going to take advantage of the classic methodologies, the double-blind studies, etc. so you can get the good answers that are going to be clinically relevant? Studies that the FDA would pay attention to. It’s ultimately your goal to conduct the research, as it’s currently not being (sanctioned) conducted because of the federal government’s classification of marijuana being a schedule one substance. Their mission right now is just to have the one facility, at the University of Mississippi do their research. The research this university is doing until very recently was constrained in terms of the strains (they were testing) when we know in the real world there are so many other hybridize products that are being used (for research) are showing drastically different outcomes. What are your thoughts on that and is that a really, a Holy Grail objective, for lack of a better word?
DK: So for the first question, I would actually differ in my assessment of the legal climate if you will; there are people conducting research trials with marijuana in the United States, and so you go through the process if you’re getting your DEA license and so on and so forth. As related to CBD, we have a lot of activity going on right now. The FDA just came out recently and said, ‘well you know, even though it’s under the department of agriculture, we’re still gonna have a hand in it.’ It was my read of that, and certainly not a legal interpretation of that but I think it really has to be framed in two ways; one is we’re going to take it step by step, and we’re going to do everything we have to do to ensure we’re in compliance of federal, state, and local laws. Where I think there needs to be some kind of separation is between the THC plant side and the CBD oil side. These two tend to follow different courses in terms of attention they – because the THC is obviously a hot button issue. –Our assumption is all trials have to go through the FDA regardless, so that’s not anything new to us. Did that answer your question?
We’re not selling a device or a drug or anything like that.
We don’t have an interest in the outcome beyond delivering the highest level of data that we can to our clients.
CHJ: It does. I think the thoughtful analysis that you wish to provide in the study of this plant is ultimately one day going to have your research studies actually be acknowledged by a government entity, as being something interesting or valid. I don’t know if that’s a fight for you, but based on the construct of how you are intending to build this facility, based on your previous experience, it would be of interest to me that that would fall in line with an ultimate objective.
DK: Part of it is, assessing the situation today, but also being successful is some level of prediction about tomorrow. So within that framework, I feel that as a country, as a state and a city, we have an ethical and moral responsibility to test this stuff before it’s going into people’s bodies. It’s unprecedented frankly that we’re allowing children to be taking doses in back rooms and ‘in the dark’ and parents are afraid of openly talking about it, and this is wrong. There’s no way around it and I’m not going to budge from that position, because these parents, they need support, and they need answers.
CHJ: What would the best place for our audience or people that are curious about Milestones Research, be the best place for them to reach you and ask questions?
DK: Our website (www.milestonesresearch.com), that would be easiest, you could go to the website and just fill out the contact us page.
CHJ: We can’t thank you enough for reaching out to us and sharing this story. We believe (this story) is in keeping with our mandate and it’s also relevant in terms of what we do, which is to give a proper balance. We try to stay away from the politics and we do a good pro/con that informs our audience, who are mostly medical or regulated cannabis users so they understand everything involved when it comes to their medicine and the promise therein. We do truly believe that cannabis in particular does have the ability to heal society, economically as a well as medically.
DK: Perfect, excellent, thank you. I just want to say before we go (that) it’s tough to take a staunch position on the scientific medical side, but there is no other position that can deliver with credibility and rigorous standards. I really appreciate the work you all are doing and the approach you’re taking by recognizing the importance of this and the need for patients to be informed.
CHJ: Daniel, thank you very much for your time and this enlightening conversation. Our audience will appreciate the dialogue.
DK: Yes, thank you. I really appreciate the opportunity to share about our passion and what we’re moving fast to launch, and I think it is an incredible need and I’m really excited about the future.
1 This statement was amended to include details on the number of institutions conducting clinical trials as of this writing and to give a
more complete picture of the focus of such trials.