The ability to leverage new research methods and scientific discovery is key to advancing medical knowledge.

A perfect example of that push for innovation will be found in a new research effort by the USF Health Taneja College of Pharmacy (TCOP) that will explore potential therapeutic benefits in medicinal botanicals.

Called the Botanical Medical Research and Education Consortium (BMREC), the new initiative aims to contribute to the body of science already known about medicinal plants and to impact patient care with treatments and potential cures.

Launched in 2019, the BMREC took major steps forward when the Farm Bill (2018) and following the direction set by national officials from the Food and Drug Administration (FDA) removed industrial hemp from the Schedule I regulation. This allowed Florida to establish the Industrial Hemp Pilot Projects that permitted Florida’s state universities to begin studying industrial hemp (a form of cannabis).

“That shift has now provided the opportunity to more freely examine the medicinal potential of this plant,” said Kevin Sneed, PharmD, senior associate vice president for USF Health and dean of the Taneja College of Pharmacy. “It is this science that will help us better understand the potential medicinal value for patients, while discovering new delivery methods involving nanomedicine platforms for medical uses.”

While in its early phases, the BMREC has already built partnerships with hemp growers in Florida. Plans include building more collaborations, including with medical practices, and taking active roles in initiating clinical trials.

Marijuana and industrial hemp are different forms of the same species of plant. The difference is the amount of tetrahydrocannabinol (THC) present, the chemical that produces the euphoria in people. Industrial hemp must have less than .3% THC – anything above that threshold is considered marijuana.  This very small amount is not enough to produce the euphoric sensation in people. There is also the phytochemical cannabidiol (CBD) in the plant, which most probably has the medicinal value sought by patients.

“There are a lot of anecdotal stories suggesting that people who have smoked marijuana have reduced pain and other beneficial effects, but there really isn’t a lot of science behind that story,” said Mark Kindy, PhD, FAHA, professor in the Department of Pharmaceutical Science in TCOP and Senior Research Career Scientist in the VA. “We’re in the process of looking at CBD, and other cannabinoids and terpinoids (found in hemp) to see what are the best growing conditions, best delivery methods, including nano-delivery. The key to this is finding the right growing conditions here in Florida.”

Dr. Kindy explained that growing conditions have a tremendous impact on the amount of compound produces. Factors such as watering, fertilizing, and amount of sunlight all play roles on the amount of CBD and THC will be produced in a single plant.

“Most medications on the market today originally came from some kind of plant-based compound,” Dr. Kindy said. “We’re not trying to re-create the wheel. We’re simply trying to put some science behind the stories. Our focus is currently on industrial hemp and CBD. But, I can see this expanding into other compounds as more research-based evidence becomes available.”

The consortium was launched by Dr. Sneed, Dr. Kindy and Juan Sanchez-Ramos, MD, PhD, professor of neurology in the USF Health Morsani College of Medicine. The group is working to build the consortium into something bigger to expand the research and educational opportunities for current and prospective students. In addition to industrial hemp, the group also plans to gain insights into other botanical compounds that could be valuable to the medical field.

“We will focus on three things: new nanomedicine delivery systems, bioinflammatory identification of diseases, and eventual clinical trials” Dr. Sneed said. “If this leads to new discoveries that reduce opioid dependence and improve mental health conditions with safer alternatives, we can make life better for people in countless communities.”

The USF College of Pharmacy hosted a research symposium with top scientists and experts to discuss medical cannabis and its impact on patient health.

The event, held on April 28 at the USF Patel Center for Global Solutions, focused on separating the medical cannabis stigma from science.

Kevin Sneed, PharmD, founding dean of the USF College of Pharmacy.

“We’re thrilled to bring together worldwide experts, scientists and clinicians to have an open conversation about medical cannabis,” said Kevin Sneed, PharmD, dean of the USF College of Pharmacy. “Our goal here is to discuss cannabis research, current regulations and policies, and how it could help people with various medical problems.”

Florida voters approved the medical marijuana constitutional amendment for patients with debilitating conditions on Nov. 8, 2016. However, the bill (HB 1397) has not been fully passed through the Florida Senate and House of Representatives.

A diverse group of experts from USF Health and around the world gathered to discuss the issue, including Michael Dor, MD, medical director for the Medical Cannabis Unit at the Ministry of Health in Israel, and Juan Sanchez-Ramos, MD, PhD, professor in the Department of Molecular Pharmacology and Physiology at the USF Health Morsani College of Medicine.

(L to R). Nissim Garti, PhD, CEO of Lyotropic Delivery Systems, Michael Dor, MD, medical director for the Medical Cannabis Unit at the Ministry of Health in Israel, Mark Rosenfeld, PhD, CEO and CSO of Ananda Scientific, Juan Sanchez-Ramos, MD, PhD, professor in the Department of Molecular Pharmacology and Physiology at the USF Health Morsani College of Medicine, and Mark Kindy, PhD, professor in the Department of Molecular Pharmacology and Physiology at the USF Health Morsani College of Medicine, answer questions from the audience.

During the event, which was hosted in collaboration with Ananda Scientific, a company that produces nonpsychoactive and nonabusive oral cannabinoid health products, experts emphasized the importance of cannabis research in the areas of safety, quality and effectiveness that are critical to the treatment of a variety of diseases.

“We’re trying to distinguish between the stigma, which is marijuana, and the science, which is cannabis,” Dr. Sanchez-Ramos said. “Medical cannabis can be useful for a limited range of conditions. But, as clinicians and scientists, we need to conduct research that carefully defines those conditions, the doses, and the dose schedules that will work for the patient.”

That’s why USF College of Pharmacy is hoping to take the lead in conducting top-quality research on medical cannabis and find the correct oral formulation that’s beneficial to the patients and their overall health.

“We want to stay true to our expertise and our profession of pharmacy,” Dr. Sneed said. “Our goal is to find the proper formulation that does not involve hallucinogenic or euphoric side effects, but hopefully will involve something anti-inflammatory and medicinal that helps improve patients’ health.”

This is not an easy solution; however, the symposium is a first step, Dr. Sneed said. The USF College of Pharmacy hopes to work closely with USF researchers, clinicians and local business partners, taking a structured evidence-based approach to conduct research on medical cannabis.

Dr. Kevin Sneed speaks to the media about the symposium.

“We want to be the solution to the problem,” Dr. Sneed said. “Through our evidence-based approach, we want to conduct research to effect policy and provide clear evidence about the value of medicinal cannabis to improve the lives of patients and our community.”

Story by Vjollca Hysenlika, USF Health Communications and Marketing
Photos by Eric Younghans, USF Health Communications and Marketing