The current workforce lacks the skills to move these biological treatments through the regulatory and production pipeline, a new report finds.
Cell and gene therapies offer great promise to treat rare and debilitating diseases. In 2023, the European Commission approved Vertex and CRISPR Therapeutics’ exa-cel, a CRISPR therapy for β-thalassemia and sickle cell disease. The same therapy is up for possible approval by the FDA in December. This agency is also scheduled to review nine additional cell and gene therapies (CGT) that address type 1 diabetes, amyotrophic lateral sclerosis (ALS), metastatic melanoma, and Duchenne muscular dystrophy.
Despite the positive steps forward, Alliance for Regenerative Medicine (ARM) published a report in March that found the sector’s workforce is lacking in technical skills, such as development and manufacturing. The workforce is also deficient in key areas of production, like artificial intelligence (AI) and automation, the report stated, as well as quality control and assurance analytical development. ARM cautioned that if this trend persists, it could threaten the sector’s ability to reach its full potential.
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