9th Annual World ADC in Review
The workshop, titled “Filing a Successful ADC IND – from Discovery to First in Human Study” covered various unique aspects of the ADC IND for successful initiation of the first-in-human study. Antibody-drug conjugates are complex products containing a targeting antibody conjugated to a highly potent cytotoxic agent with linker. This complexity requires consideration of a wider set of regulatory guidance and expectations for successful initial IND preparation. The topics included general ADC IND considerations, unique aspects of the ADC eCTD structure, Pre-IND Consultation, CMC requirements and challenges, nonclinical study expectations and first-in-human study design considerations. Karen Cha and her co-presenter, Bruce Hart, Independent Consultant, ClearMatter Regulatory Consulting LLC, have both filed numerous ADC INDs, and shared anecdotes based on first-hand experience and Agency interactions.
World ADC is an excellent collaboration between sponsors pursuing ADC development, as well as vendors servicing those companies.
You can learn more about the ADC World Congress here.