Under China’s new Order No. 818, investigator-initiated trials (IITs) have become a faster, lower-cost path to first-in-human data for cell and gene therapy developers. This white paper from Dark Horse Consulting Group covers what the new framework means for sponsors, when a China IIT makes sense, and how to design one so the data still supports future FDA and EMA filings. Download it to see whether a China IIT could speed your path to clinical proof of concept.
Please check the highlighted fields and try again.
Please enter your first and last name.
Please enter the name of the company or institution you work at.
Please enter your mailing address.
By submitting this form, you consent to Cell & Gene Therapy Review storing your email address and contact information and transmitting your contact information to the content sponsor. You may request to be removed at any time.