Workshop on Clinical Translation
Tuesday, 13 June, 2017, 8:45 - 12:00
Room 205ABC, Boston Convention and Exhibition Center
How to Get From the Bench to the Clinic: Practical Advice for Completing an Investigational New Drug (IND) Application
This first step towards obtaining permission from a regulatory agency to administer an experimental cellular therapy to humans is a multi-layered process that requires developing a comprehensive plan, managing data, documentation and timelines, and meeting with regulatory officials. This workshop is intended to help investigators understand and better navigate this process. Although the workshop is organized around working with the U.S. Food & Drug Administration, the principles are broadly applicable around the world and key points of overlap will be addressed.
Who Should Attend?
This half-day workshop held in advance of the ISSCR 2017 Annual Meeting, is open to anyone, regardless of career stage, who is looking to bridge their preclinical research findings to the clinic, to work or collaborate on translational projects or who has a general interest in how a treatment can emerge from biomedical research.
Melissa Carpenter, PhD, Carpenter Group Consulting
Chris Mason, PhD, AvroBio
A final agenda will be added when completed