TILRAY'S APPROACH TO CLINICAL RESEARCH
Tilray is committed to furthering our understanding of the therapeutic value and risks of cannabinoid-based medicines and acknowledges our responsibility as a medical cannabis company to contribute to the body of clinical data that will inform best treatment practices and address an urgent need for improving the quality of life of our patients and their families. Toward that end, our clinical research program focuses on developing safe, oral preparations of well-characterized and specifically defined cannabinoid and terpene profiles that meet regulatory agencies’ standards for clinical research. Importantly, we characterize the pharmacokinetic and safety profiles of these preparations to provide clinicians and patients with a clear understanding of appropriate dosage, therapeutic potential and possible risks or adverse events.
The psychoactive use of cannabis by humans can be traced back almost 5,000 years (1,2). By the late nineteenth century, cannabis-based preparations were widely marketed internationally for medical use3. The past decade has witnessed a dramatic increase in interest in the therapeutic properties of cannabis, and a growing body of preclinical and anecdotal evidence mandates further research into the many uses of cannabinoid-based medicines for a range of symptoms and conditions, including pain, nausea, epilepsy, multiple sclerosis, diabetes and cancer (4,5,6,7).
Tilray is currently engaged in several activities to facilitate clinical research globally:
- Developing specific cannabinoid and terpene profiles for study drugs based on preclinical and clinical data;
- Generating relevant pharmacokinetic parameters of study drugs;
- Establishing and maintaining a pharmacovigilance database; and
- Launching partnerships with experts in relevant disease areas.
Tilray is currently supplying products for several different clinical trials:
AUSTRALIA - In partnership with the University of Sydney and the New South Wales Government – Safety, tolerability and efficacy of cannabinoids for Chemotherapy-Induced Nausea and Vomiting – Phase 2 & 3
CANADA – In partnership with Toronto’s Hospital for Sick Children (SickKids) - Safety, tolerability and efficacy of cannabinoids in children with Dravet Syndrome – Phase 2
CANADA - In partnership with the University of British Columbia – Safety and tolerability in post traumatic stress disorder (PTSD) for Canadian military veterans, law enforcement officers and sexual assault survivors – Phase 2
AUSTRALIA - In partnership with the University of Sydney – Effects of medical cannabinoid use on driving safety (DUID)
AUSTRALIA – In partnership with the Government of Victoria - Safety, tolerability and efficacy of cannabinoids in children with severe epilepsy
MEET CATHERINE JACOBSON
DIRECTOR OF CLINICAL RESEARCH
Catherine identifies opportunities for clinical research partnerships that will provide a better understanding of the therapeutic benefits of precise cannabinoid preparations for specific diseases and furthers Tilray’s commitment to partnering with physicians and medical institutions to generate data that will inform best treatment practices. This data includes information on appropriate dosages, potential adverse effects, and any other considerations important to a specific patient population given the particular symptoms and natural history of each disease.
Director of Research Investment for The Epilepsy Foundation
Prior to joining Privateer Holdings, Catherine led a venture philanthropic fund addressing the lack of adequate drugs and devices to treat pediatric epilepsy.
Post-Doctoral Fellow, University of California – San Francisco
Catherine established GW Pharmaceutical's Expanded Access Investigational New Drug Application (IND) for Epidiolex for the treatment of children with serve medically refractory epilepsy as a post-doc fellow at UCSF.
Post-Doctoral Fellow, Stanford University
Catherine also conducted the first published account of the parental use of cannabis to treat severe pediatric epilepsy.
University of Colorado, Boulder: BA, Psychology
Oregon Health and Science University School of Medicine: PhD, Cell Biology, Neuroscience
Contact Catherine to learn more about partnering with Tilray to conduct clinical research:
1 Fankhauser, 2002
2 Russo, 2007
3 Grinspoon & Bakalar
4 Ben Amar, 2006
5 Grotenhermen & Russo, 2002
6 Hazekamp & Grotenhermen 2010
7 Lucas et al., 2013