CORE is a Clinical Operations Retreat for Executives - an event intended for senior decision-makers organized by Halloran Consulting Group. Our focus is on the pressing issues that keep you and your peers up at night.
Register for the 2018 Clinical Performance Metrics & Analytics Summit. Todd Johnson, Principal Consultant at Halloran Consulting Group, is a panelist. Use code HALLVIP for 15% off of your registration.
A successful Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT) meeting with CBER paved the way for the early product manufacturing activities and very early preclinical safety and efficacy evaluations. A pre-Investigational New Drug (Pre-IND) meeting provided additional clarity on the IND-enabling activities needed to support an initial IND submission in support of a Phase 1 first-in-human (FIH) study.