After receiving approval by the Pennsylvania Department of Health to conduct research on medical cannabis grown by a clinical registrant, and then signing an eight-year, $15.5 million contract with the clinical registrant, the Chester-based Agronomed Biologics LLC, Drexel University has now opened a new Medical Cannabis Research Center (MCRC) to begin conducting evidenced based-research on effects medical cannabis has on patients with specific medical and behavioral maladies.
The patients will be volunteers from Agronomed’s medical cannabis dispensaries. Under current regulations, Drexel has not been approved to house, dispense or compound cannabis, or otherwise physically study cannabis’s organic properties. Drexel faculty will not be housing or dispensing any medical cannabis to patients; Agronomed will exclusively handle all aspects of dispensing cannabis to patients involved in Drexel research studies, which will start at the first Agronomed dispensary (The Healing Center) scheduled to open in Chester, Pennsylvania, in April 2021.
The outcomes will inform the Commonwealth of Pennsylvania’s Medical Marijuana Program and the medical community at large to make better clinical decisions for its patients. Currently, there is few data on the efficacy of medical cannabis, which has been legal in the Commonwealth of Pennsylvania since 2016, due to restrictions around studies for cannabis, which is still classified as a schedule I drug by the federal government. That classification offers no medical benefits at federal level, which has significantly limited rigorous clinical research. The Drexel-Agronomed research partnership seeks to expand known health effects of medical cannabis (in its various forms) used to treat 23 state-approved physical and psychological medical conditions including HIV, neuropathies, autism, opioid dependence and PTSD.
“Cannabis has been used to treat a variety of medical and behavioral maladies for at least 2,000 years. To date there are very few controlled scientific studies demonstrating its efficacy to treat any malady,” said Executive Vice Provost for Research & Innovation Aleister Saunders, PhD. “We are excited to bring modern scientific approaches to study the clinical effects of cannabis on the state-approved conditions. If our studies can demonstrate efficacy of medical cannabis, there are a large number of patients whose physical and psychological conditions can be treated with a new therapeutic approach. The potential to improve the lives of millions of citizens is very real. Therefore, we are very excited about having real and positive impacts on society.”
The partnership funds an integrated and interdisciplinary set of research activities enacted through the MCRC, which will function as an overarching administrative unit charged with enacting the vision and mission of the partnership and will be an incubator to generate additional research at the University over time. Key components of the research partnership include a patient registry study, a clinical core and pilot studies.
The MCRC is a collaboration between the Dornsife School of Public Health and Drexel College of Medicine: Dornsife School of Public Health Professor and Associate Dean of Research Stephen Lankenau, PhD, is the director of the MCRC, and College of Medicine Professor and Chair of Psychiatry Wei Du, MD, is the co-director.
Lankenau, who has led multiple large-scale, NIH-funded grants focused on medical cannabis in young adults in California since 2013, will oversee a patient registry study starting in April. It will follow patients who are members of Agronomed’s dispensaries to understand their demographics, prior health concerns and prior cannabis or other drug use practices, as well as what impact using cannabis medically has on their health. All patients will first be vetted by one of the state’s physicians approved to administer cannabis, and they will register to use Agronomed’s products to treat qualifying health conditions.
“Our vision is to improve patient population health by balancing the scientific understanding of cannabis and its medical applications,” said Lankenau. “Our goal is to partner with Agronomed, learn from their patients and potentially figure out what types of cannabis formulations work the best for different conditions. And as we learn those facts, that could then lead to more in-depth trials and studies.”
Du, who is also chair of the Department of Academic Psychiatry at Tower Health and the Department of Psychiatry at Brandywine Hospital, is an expert in addiction medicine and will oversee the clinical trial core. Preliminary study proposals are still being finalized and refined, but Du plans to leverage Drexel’s expertise in clinical research, public health and translational science.
“I think, as a physician and a scientist, that a leading academic institution like Drexel should play a role in terms of advancing the science behind medical cannabis, which is an area in which we need a lot of understanding now that there is a huge push for cannabis legalization in multiple states,” said Du. “I think this is the right time for us to put in the effort and resources to design clinical research and clinical trials so that we can work with our partner to rigorously study the medical benefits and also assess the potential risks of cannabis, and then present the findings to the community so physicians and the patients as well as their families can be informed based on science and evidence.”
Drexel had been planning to apply for this type of research partnership since the Commonwealth of Pennsylvania first approved a new research program around medical cannabis with the Pennsylvania Act of 2016, though legal disputes and other setbacks over the years meant that the state wasn’t able to designate Academic Clinical Research Centers (ACRC), of which Drexel was one of the first, to conduct this type of research until June 2019. The intention to create what is now the University’s Medical Cannabis Research Center had also been in the works for a long time: the partnership between Drexel and Agronomed was finalized last winter and the COVID-19 pandemic slowed progress on the dispensary opening as well as the start of the research program. Now, the timing has finally worked out for Agronomed and Drexel faculty, professional staff and students to work together, with both organizations equally splitting the intellectual property ownership of research findings.
Agronomed, which had opportunities to partner with other schools, even ones that wouldn’t require the company to sponsor the research, decided to work with Drexel for exactly that reason.
“Even though we have a sponsored arrangement with Drexel in which we are funding the University and the program, it feels like much more of a partnership because it’s so collaborative,” said Jon Cohn, CEO of Agronomed Pharmaceuticals LLC, which is the parent company of Agronomed Biologics, a joint venture with The Healing Center, a medical cannabis dispensary group based in Western Pennsylvania. “We have the dispensary side and can provide the product and the patients, and Drexel will supply the research staff and consultations. It just seemed like the perfect opportunity for us.”
Agronomed is now working to open six dispensaries in the state, with the first opening in April 2021 in Chester, which is also the site of its cultivation and processing facility. It has set up the infrastructure needed to facilitate the patient registry research.
In addition to the clinical trials and patient registry research, Drexel’s Medical Cannabis Research Center enables University faculty, professional staff and students to propose small pilot studies that would be funded by the partnership and could grow into larger studies that could ultimately receive external funding. All of this will be beneficial to the general public and to this emerging field, according to College of Medicine Vice Dean for Research and Professor of Pharmacology & Physiology Kenny Simansky, PhD, who was one of the first people at Drexel to start working on the University’s application for this kind of endeavor back in 2016.
“We need research in this area, and the Commonwealth’s legislation has enabled that research,” said Simansky. “What hasn’t happened yet is that we haven’t had a public realization that virtually everything we know about medical cannabis is anecdotal. There are too few data from rigorous research on the efficacy and safety of medical cannabis — in its many variants — and we will participate with our commercial partners in clinical research and population science to expand that knowledge.”