FDA INTERACT Meetings: Early Interactions For Cell And Gene Therapy Sponsors

By Annette F. Arlinghaus, Director, Regulatory Operations and Stacey A. Ayres, PhD Vice President, Regulatory Strategy

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. These therapies frequently target diseases in patients that are rare (affecting fewer than 200,000 people in the US), serious, and representing an unmet medical need. As a result, programs to develop them often meet the criteria for expedited product development and review and can benefit greatly from early interactions with the FDA to avoid unnecessary and potentially costly preclinical or other preparatory studies.

The INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting offers sponsors of biologics (industry and investigators) an avenue for engagement with CBER in an early development discussion.