The cell and gene therapy (CGT) sector in the United States is expanding rapidly with a growing clinical pipeline and rising FDA regulatory submissions.
Leadership at the FDA’s Center for Biologics Evaluation and Research projected an exponential growth in filings, prompting a 2023 reorganization to manage the surge. This restructuring reflects the need for regulators to plan ahead and stay agile as innovative technologies reshape the health landscape.
ARM is working closely with regulators, industry experts, and other stakeholders to anticipate and navigate regulatory challenges and identify emerging technologies within the sector that require novel solutions over the next decade.
Through efforts like horizon scanning, ARM identifies scientific advances that could transform the CGT landscape, ensuring the sector is prepared for breakthroughs that will shape the future of biotechnology.
ARM conducted a horizon scan to identify several groundbreaking approaches poised to shape the regulatory future of cell and gene therapy.
ARM currently conducts a periodic ‘Lunch & Learn’ webinar series for FDA staff. Each webinar focuses on emerging technologies from our horizon scan.
Each quarter, ARM surveys the cell and gene therapy landscape, identifying new trends and technologies that reach the clinic.
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