IND HeartWorks Template Capstone Project
Program: Applied Biotechnology Master's
Host Company: ReGen Theranostics
Location: Rochester, Minnesota (onsite)
Student: Mikayla Hall
HeartWorks wishes to submit an IND application for a new biologic’s product, an autologous iPSC derived cardiac product. This product does not have a precedence set for what an IND application should look like due to the novelty of the product. In effort to not only have a successful IND application, but to also limit time and energy for HeartWorks staff in formatting and understanding the requirements of the sections of the IND, this capstone project is designed to create defined templates for each section of the IND submission with descriptions and defined requirements for each section. These templates will also be formatted consistently to show professionalism throughout the IND submission. The creation of these templates will occur by reviewing literature, FDA guidance documents, and ICH guidelines to ensure all the pieces are there to have a successful IND submission. These templates will also be used for annual submissions and can be translated to other products with ease.