This project has been archived.
Antibody Drug Conjugates (ADC) Working Group
The goal of this group is to gather information about the ADME package prepared for ADCs at the IND and NDA stages by member companies and to identify best practices. This group aims to write a white paper and communicate it to the EMA and the FDA. Dependent on the outcome of the discussion with the FDA, this team could include representatives from the FDA.
Topics to be Considered:
• Type of ADME package required for such molecules – EMA vs FDA.
• What are the best practices we need to employ to support such packages.
• Preparation of a white paper around these findings to facilitate discussion with the regulatory agencies.