Cannabinoid-based therapies are reshaping the treatment landscape for patients with rare and refractory seizure disorders. In this exclusive interview hosted by Rare Disease Advisor, Dr. Marcus S. Delatte, former senior pharmacology/toxicology at the FDA’s Office of New Drugs, offers regulatory insight into how these therapies are evaluated for approval—particularly in the context of rare pediatric populations.
What you’ll learn:
- Regulatory expectations for cannabinoid-based products
- Design considerations for rare disease trials
- Challenges in pediatric seizure disorder studies
- FDA’s approach to evidence generation in small populations
Whether you’re advancing a cannabinoid program or developing novel therapies for rare neurological conditions, this discussion provides valuable perspective on regulatory strategy, trial design, and translational science.
Listen to the full interview here
Marcus Delatte, PhD
VP, Regulatory Strategy, Regulatory & Drug Development Consulting
Dr. Delatte served as a Senior Pharmacology/Toxicology Reviewer at the US FDA for 12 years. He is an established expert in translating nonclinical data to inform clinical program design, including dose selection, safety monitoring, inclusion/exclusion criteria for clinical protocols, and informed consent forms. Dr. Delatte has extensive experience in creating and implementing strategies for regulatory pathways in the US, as well as preparing and creating strategies for formal FDA meetings. His expertise and experience span multiple therapeutic areas including psychiatry, neurology, pain, rheumatology, infectious disease, immunology, cardiovascular, pulmonary, and oncology.
Request a Proposal
Share This
