New medical cannabis research center in Drexel supports groundbreaking research partnership | Now

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After the Pennsylvania Department of Health received approval to conduct research on medical cannabis grown by a clinical registrant and then signed an eight-year contract for $ 15.5 million with the clinical registrant, Chester-based Agronomed Biologics LLC, Drexel University, Now Opened A new Medical Cannabis Research Center (MCRC) is set to conduct proven research into the effects of medical cannabis on patients with specific medical and behavioral disorders.

Patients will be volunteers from Agronomed’s medical cannabis dispensaries. According to the applicable regulations, Drexel is not approved for the storage, distribution or combination of cannabis or for any other physical investigation of the organic properties of cannabis. Drexel Faculty will not ingest or distribute medical cannabis to patients. Agronomed will deal exclusively with all aspects of the supply of cannabis to patients involved in Drexel research studies. These will begin at the first Agronomed pharmacy (The Healing Center), due to open in Chester, Pennsylvania in April 2021.

The results will inform the Commonwealth of Pennsylvania’s medical marijuana program and the entire medical community in making better clinical decisions for its patients. There is currently little data on the effectiveness of medical cannabis, which has been legal in the Commonwealth of Pennsylvania since 2016, due to the limitations of studies on cannabis, which is still classified as a List I drug by the federal government. This classification offers no medical benefits at the federal level, which has severely constrained rigorous clinical research. Drexel and Agronomed’s research partnership aims to expand the known health effects of medical cannabis (in its various forms) for the treatment of 23 government-recognized physical and mental illnesses including HIV, neuropathies, autism, opioid addiction and PTSD.

“Cannabis has been used to treat a variety of medical and behavioral disorders for at least 2,000 years. So far, there are very few controlled scientific studies that prove its effectiveness in treating diseases, ”said Dr. Aleister Saunders, Executive Vice Provost for Research and Innovation. “We are pleased to introduce modern scientific approaches to investigate the clinical effects of cannabis on government-approved conditions. If our studies can demonstrate the effectiveness of medical cannabis, there will be large numbers 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. That is why we are very excited about real and positive effects on society. “

The partnership funds an integrated and interdisciplinary set of research activities carried out by the MCRC. These act as an overarching administrative unit charged with implementing the vision and mission of the partnership and will serve as an incubator to generate additional research at the university over time. Key components of the research partnership include a patient registry study, clinical core, and pilot studies.

The MCRC is a collaboration between the Dornsife School of Public Health and Drexel College of Medicine: Professor and Associate Dean of Research of the Dornsife School of Public Health Stephen Lankenau, PhD, is the director of the MCRC and Professor at the College of Medicine and Chair of Psychiatry Wei Du, MD, is the co-director.

Lankenau, who has led several large-scale, NIH-funded medical cannabis grants in young adults in California since 2013, will oversee a patient enrollment study beginning in April. Patients who are members of Agronomed’s pharmacies will be followed to understand their demographics, past health concerns and practices of cannabis or other drug use, and the effects of medicinal cannabis use on their health. All patients are first screened and registered by one of the state doctors licensed to administer cannabis to use Agronomed’s products to treat qualified health conditions.

“Our vision is to improve the health of the patient population by reconciling the scientific understanding of cannabis and its medical uses,” said Lankenau. “Our goal is to work with Agronomed, learn from their patients and possibly find out what types of cannabis formulations work best in different conditions. And when we learn these facts, it could lead to more in-depth experimentation and study. “

Du, who also chairs the Department of Academic Psychiatry at Tower Health and the Department of Psychiatry at Brandywine Hospital, is an expert on addiction medicine and will oversee the core of the clinical trial. Preliminary study proposals are still being finalized and refined, but you plan to leverage Drexel’s expertise in clinical research, public health, and translational science.

“As a doctor and a scientist, I think a leading academic institution like Drexel should have a role to play in advancing the science behind medical cannabis. This is an area where we need a lot of understanding given the large scale of pushing for cannabis legalization in multiple states, ”Du said. “I think this is the right time for us to invest the effort and resources to design clinical research and clinical trials so that we can work with our partner to carefully examine the medical benefits as well as the potential risks of Evaluate cannabis and then present the results to the community so that doctors and patients as well as their families can be informed based on science and knowledge. “

Drexel had planned to apply for this type of research partnership since the Commonwealth of Pennsylvania first approved a new medical cannabis research program with the Pennsylvania Act of 2016, though litigation and other setbacks over the years resulted in the state not being in was able to designate Academic Clinical Research Centers (ACRC) by June 2019, of which Drexel was one of the first to conduct this type of research. The intention to create what is now the university’s medical cannabis research center was also in the works for a long time: the partnership between Drexel and Agronomed was concluded last winter and the COVID-19 pandemic slowed the progress of the pharmacy opening as well as the beginning of the research program. Now the time has finally come for the faculties of Agronomed and Drexel, specialists and students to work together, with both organizations sharing the intellectual property of research results equally.

Agronomed, which had the opportunity to work with other schools, including those where the company did not have to sponsor the research, decided to work with Drexel for precisely this reason.

“Although we have a sponsored agreement with Drexel in which we fund the university and the program, it feels a lot more like a partnership because it’s so collaborative,” said Jon Cohn, CEO of Agronomed Pharmaceuticals LLC, the parent company of Agronomed Biologics, a joint venture with The Healing Center, a medical cannabis pharmacy group based in western Pennsylvania. “We have the pharmacy side and we can take care of the product and the patients, and Drexel will provide the research staff and consultations. It just seemed like the perfect opportunity for us. “

Agronomed is currently working on opening six pharmacies in the state. The first opening will take place in April 2021 in Chester, where the cultivation and processing facility is also located. It has put in place the infrastructure necessary to facilitate patient registry research.

In addition to clinical trials and research in the patient registry, Drexel’s Medical Cannabis Research Center enables the university, professionals and students to propose small pilot studies that could be funded by the partnership and grow into larger studies that could ultimately receive external funding. All of this will benefit the public and this emerging field, according to Assistant Dean of Research at the College of Medicine and Professor of Pharmacology and Physiology, Kenny Simansky, PhD, who was one of the first at Drexel to work on the university’s application for that kind of endeavor in 2016.

“We need research in this area, and Commonwealth legislation made that research possible,” Simansky said. “What hasn’t happened yet is that we haven’t publicly recognized that virtually everything we know about medical cannabis is anecdotal. There is too little data from rigorous research on the efficacy and safety of medical cannabis – in its many varieties – and we will work with our commercial partners in clinical research and population science to expand this knowledge. “