Vice President, Regulatory Strategy
Allucent
Marcus S. Delatte has more than 13 years evaluating toxicities related to cannabinoids that include cannabidiol, as well as helping to create nonclinical and regulatory strategies for these and other products. In his current position as Vice President, Regulatory Strategy at Allucent, he has responsibility for providing nonclinical and regulatory strategic consulting services to biopharmaceutical companies seeking to advance complex development programs for therapeutics intended to treat a wide variety of diseases (e.g., CNS, pulmonary, cardiovascular, oncology), which include serious conditions under IND and marketing applications.
Prior to this role, he served as a senior pharmacology toxicology reviewer at the FDA and gained extensive experiences in the regulation of CNS therapeutics and served on multiple scientific committees that included the Cannabis Working group during a 11.5-year period. This experience included evaluating cannabinoids administered via various routes and in different animal species. He has served as a thought leader on the assessment, communication, and management of risks related to various types of products (e.g., small molecules and biologics) and the individual components of them. These experiences have allowed him to make numerous presentations at international meetings and to publish several peer-reviewed publications evaluating the effects of cannabinoids in different animal species.
Disclosure information not submitted.
Considerations for Cannabidiol Product Development: The Regulatory Landscape and Safety Concerns.
Thursday, October 5, 2023
8:00 AM – 9:15 AM EDT
Biosimilar Regulatory Standards in the ICH Regions: Implications for Global Biosimilar Development
Thursday, October 5, 2023
2:00 PM – 3:00 PM EDT