Cannabis, one of the oldest and most commonly used drugs in the world, is derived from the cannabis sativa plant and contains hundreds of active ingredients. These include the most abundant active constituents, tetrahydrocannabinol (THC), which is the primary psychoactive component of cannabis, and cannabidiol (CBD) which has therapeutic effects but less psychoactivity.

Research has shown that these constituents interact with various systems in the body where cannabinoid receptors are located, leading to a range of therapeutic effects within the central nervous system and its periphery.

Though it has become difficult to conduct clinical research involving cannabis, Canada became the first country in the G20 to introduce a legal framework regulating the use of cannabis by adults for non-medical purposes, creating a large-scale natural experiment that the world continues to study.

In Issue 2 of The Altascientist, we explore the science, therapeutic potential, and regulatory considerations for cannabis-based medicinal products, including:

• Supporting clinical facts and research;
• Altasciences’ experience and innovative approach to cannabinoid studies; and
• a case study on the safety and tolerability of the first cannabis extract developed for regulatory submission.

Reducing the incidence of motor vehicle accidents (MVAs) caused by drug-impaired driving is a public health priority. With more than 20,000 FDA-approved drugs on the market, many containing psychoactive or sedative ingredients, systematically identifying those that may impair driving is critical for safe and effective drug development.

The FDA guidance emphasizes pharmacological/toxicological, epidemiological, and behavioral assessments to determine potential drug-related driving impairment. Early trials previously relied on self-reported adverse cognitive effects, but the FDA now mandates direct measurement to ensure accurate evaluation.

The inclusion of these assessments represents a dramatic shift in the design of early-phase studies as most only assessed self-reported adverse events related to cognition, while the guidance requires direct measurement of the effects.

In Issue 1 of The Altascientist, we look into the importance of evaluating drug effects on driving ability, including: 

• Driving Simulation Testing and CNS Side Effect Specificity
• Cognitive Studies With State-of-the-Art Driving Simulator
• Regulatory Recommendations and Requirements
• Case Studies