The 27th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) to be held on 7-11th May , in Baltimore is set to welcome a staggering 8,000 attendees this week, making it the largest gathering of gene and cell therapy professionals to date. The event promises to be a comprehensive exploration of the opportunities and challenges within the industry, drawing stakeholders ranging from therapeutic developers and investors to patient advocates, policymakers, and regulators.
With a record-breaking 2,000 abstracts slated for presentation, ASGCT 2024 reflects the exponential growth and advancement within the field. ASGCT President Jeffrey Chamberlain anticipates a robust discussion showcasing the increasing number of approved therapies, highlighting over 20 gene therapies and more than 60 cell therapies globally, with a significant portion approved in the United States.
Regulatory progress has been notable, with the FDA’s Center for Biologics Evaluation and Research, led by Peter Marks, spearheading efforts to adapt regulatory frameworks to accommodate the rapid pace of innovation. Marks will participate in sessions addressing regulatory flexibility, global convergence, and the evolving landscape of cell and gene therapy regulations.
Beyond clinical and regulatory realms, ASGCT 2024 will spotlight pivotal advancements in basic science and translational research. Keynote speaker Kevin Campbell will delve into the mechanism of muscular dystrophies, underscoring the crucial interplay between basic research and therapeutic development.
The conference will also shed light on initiatives like the Bespoke Gene Therapy Consortium (BGTC), aimed at accelerating the delivery of gene therapies for rare diseases by optimizing vector technologies and enhancing therapeutic efficacy.
While excitement about the potential of gene and cell therapies abounds, the sector faces its share of challenges. Safety concerns, exemplified by the FDA’s recent push for warnings on certain CAR T-cell therapies, underscore the importance of vigilant risk assessment alongside therapeutic innovation.
Notable developments, such as the accelerated approval of Sarepta’s Elevidys for Duchenne muscular dystrophy, despite subsequent efficacy concerns, highlight the complexities of regulatory decision-making and the ongoing quest for effective treatments.
ASGCT 2024 represents a pivotal moment for the gene and cell therapy sector, with discussions spanning from cutting-edge research to regulatory considerations and clinical challenges. As the industry continues to evolve, collaborative efforts and interdisciplinary dialogue remain essential in driving progress and realizing the transformative potential of gene and cell therapies.