dsm-firmenich
POSTER PRESNTER
MEDICINE
Pharmacokinetic (PK) study for comparing bioavailability of a solid and an oily CBD formulation
Background
Cannabidiol (CBD) is an effective API for the treatment of epilepsy in children. The current marketed drug is an oily solution. For clinical practice, a tablet is considered more patient-friendly. Therefore, > 160 different solid formulations of CBD have been produced and tested in vitro. A spray-dried nano-emulsified prototype was selected for the planned pharmacokinetic (PK) study.
Objective
The objective was to generate a robust clinical study design to compare an oily to a solid CBD formulation.
Methods
To achieve a robust study design, the ICH GCP guidelines with integrated Addendum E6 (R2) were applied.
Learning Objectives:
- Generate a robust clinical study design to compare an oily to a solid CBD formulation
- A solid CBD formulation can increase compliance due to the simplicity of intake (patient-centered solution)
BIO
Mary Ellen Johnson holds an MBA from East Carolina University and a Bachelor of Science in Chemical Engineering from the University of Maryland. She started her career in technical sales and marketing at Fuji Silysia Chemical in 2006, promoting micronized silica gel into the pharmaceutical and personal care industries. Since then, she has worked for other global pharmaceutical companies, including Budenheim USA (phosphates), Capsugel (now Lonza) (empty hard capsules) and IMCD US (excipient distributor), focused on business development and sales. While at Lonza she was also Global Product Manager focused on the OTC industry and capsule and tableting equipment. Since June 2024, she joined dsm-firmenich’s global pharma team, dedicated to continuing to develop and execute the business strategy of the expanded API portfolio, including Cannabinoids.
ATTENDANCE IS LIMITED. THE OPPORTUNITIES ARE NOT.
