On November 1st, ARM convened key stakeholders from the Cell & Gene Therapy industry and held a Scientific Exchange meeting with FDA to improve the time and resource efficiency of development and regulatory review by leveraging elements that can serve as building blocks across programs. This exchange explored the implementation of platform technologies (among other building blocks) as tools to streamline CGT development and manufacturing. Case studies across three technology areas (AAV, LNP, and iPSCs) were presented and discussed among representatives from industry, academics, and regulators.
The meeting took place from 9 AM to 4 PM and was live streamed for public viewing.
The following brief reflects the facilitated discussion in the all-day scientific exchange on November 1, 2023, co-sponsored by the Alliance for Regenerative Medicine (ARM) and The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).