Attracting nearly 2,000 attendees both in-person and streaming live, ARM’s Cell & Gene State of the Industry Briefing is a gathering of key stakeholders in the field includes ARM’s annual update on the sector’s progress and two noteworthy sessions featuring top executives highlighting anticipated inflection points for cell and gene therapies in the coming year
333 O'Farrell St.
San Francisco, CA 94102
ARM, ISCT, and Danaher will convene key stakeholders to explore how to advance gene editing platforms. This Scientific Exchange with the FDA seeks to make progress on therapeutic development for rare conditions that are scientifically feasible but commercially non-viable. The Exchange will review case studies from academics and industry developers focused on gene editing, with the objective of defining repeatable platforms that streamline development and regulatory requirements across multiple therapies for rare populations. Successful platforms hold promise to deliver faster and broader patient access to novel gene therapies while maintaining favorable risk-benefit balance and appropriate regulatory rigor. The attached background materials provide additional context.
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.
The Alliance for Regenerative Medicine held a 1-day workshop on Tissue Engineering and Therapeutics on September 6, 2023, in the Rockville, MD area. This workshop highlighted scientific advances, CMC and regulatory insights, and funding perspectives.
5701 Marinelli Rd. Rockville, MD 20852
The event will focus on the revision of the EU pharmaceuticals legislation and the EU Joint Clinical Assessment of ATMPs and how these policy initiatives will affect Europe’s competitiveness in the cell and gene therapy sector.
ARM and USP held a 1.5 day workshop on AAV Analytical Characterization on March 8-9, 2023, in the Washington DC area. This workshop covered various topics on AAV quality, including full / empty capsid characterization, potency assay, and titer measurements.
12601 Twinbrook Pkwy
Rockville, MD 20852
The Alliance for Regenerative Medicine and MEP Dr. Stelios Kympouropoulos held an event on November 29 at the European Parliament to outline how the EU can reverse its declining competitiveness and ensure patient access to transformative cell and gene therapies.
On October 19th, ARM and ASGCT will hold a meeting with FDA on the topic of potency assays for cell and gene therapies. The meeting will take place from 9 AM to 4 PM and will be live streamed for public viewing.
