Marcus DeLatte
Vice President of Regulatory Strategy at Allucent and former Senior Pharmacology/Toxicology Reviewer at the US FDA, specializing in CNS drug development.
2
APPEARANCES
2
PODCASTS
Sep 1, 2026
Meredith LandryHOST
When scientific innovation begins moving faster than existing regulatory frameworks, how does the agency adapt to evaluate entirely new approaches?
Marcus DeLatteGUEST
So the agency relies very, very largely on following the lead of sponsors that they're engaging.
Marcus DeLatteGUEST
So the sponsors bring the technology innovation to the agency within the form of some sort of product.
Marcus DeLatteGUEST
One of the things that's very important that the agency does is they typically will assign reviewers to build up expertise in different areas.
9 MINS LATER
Meredith LandryHOST
So as sponsors pursue increasingly novel mechanisms of action, what does strong early engagement with FDA look like, particularly during the pre-IND stage?
Meredith LandryHOST
When scientific innovation begins moving faster than existing regulatory frameworks, how does the agency adapt to evaluate entirely new approaches?
Marcus DeLatteGUEST
So the agency relies very, very largely on following the lead of sponsors that they're engaging.
Marcus DeLatteGUEST
So the sponsors bring the technology innovation to the agency within the form of some sort of product.
Marcus DeLatteGUEST
One of the things that's very important that the agency does is they typically will assign reviewers to build up expertise in different areas.
9 MINS LATER
Meredith LandryHOST
So as sponsors pursue increasingly novel mechanisms of action, what does strong early engagement with FDA look like, particularly during the pre-IND stage?