Preparing for an IND Filing for a Phase 2 Clinical Trial Using the 505(b)(2) Regulatory Pathway

The main goal of this project is to assist SLBST Pharma Inc. in preparing to file an Investigational New Drug (IND) application for a Phase 2 clinical trial on a repurposed drug using the 505(b)(2) regulatory pathway. This will involve several different steps for the students, including: - Researching the 505(b)(2) regulatory pathway and the requirements for filing an IND. - Developing a comprehensive plan for the clinical trial, including a timeline and budget. - Preparing the necessary documents for the IND filing, including the Investigational Plan, Protocol, Investigator's Brochure, and Clinical Study Report. - Assessing the risks associated with the clinical trial and developing strategies to mitigate them. - Researching potential clinical trial sites and developing a recruitment strategy.