Seizures are complex and potentially life-threatening events that can lead to debilitating neurological injuries. Drug-induced seizures often cause the immediate termination of a drug development project when they occur. Seizure profiles are constantly changing due to human plasticity and external factors, making it crucial to utilize the gold standard of assessment methods to keep a pulse on this ever-present safety risk. Any drug substance or chemical has the potential to be toxic depending on a multitude of nuanced factors. Thus, identifying and minimizing the risk of drug-induced seizures should be prioritized in your clinical trial strategy.
In this recent podcast, former FDA reviewer Marcus Delatte, PhD (VP, Regulatory Strategy), sat down with the American College of Toxicology to discuss the scientific and regulatory aspects of seizure liability in pharmaceutical development. Listeners will gain unique insights into:
- Risk factors for experiencing a seizure
- Identifying warning signs and salient features of seizures
- Assessing your risk of seizure liability
- Understanding the seizure profile of an innovative substance
Start listening to this podcast by clicking the play button below
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.
If you are interested in learning more about assessing and managing CNS risks in drug development, view our recent webinar “Risk Assessment of Novel Neurotherapeutics: Mechanistic Translation of Preclinical Safety and PK/PD Data to a Clinical Setting” or read our blog, “Neurotoxic Risks in Therapeutics: Nonclinical Considerations”
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