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FDA CBER Webinar: A Closer Look at the Finalized Guidance for Human Gene Therapy Products Incorporating Genome Editing

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Medriva Correspondents
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FDA CBER Webinar: A Closer Look at the Finalized Guidance for Human Gene Therapy Products Incorporating Genome Editing

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A Webinar to Discuss the Latest Guidance on Human Gene Therapy Products

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The Center for Biologics Evaluation and Research (CBER) under the FDA is organizing a webinar on February 29. The webinar will focus on the recently finalized guidance for professionals working with human gene therapy products that incorporate human genome editing. Participants are encouraged to submit their queries ahead of the event. The registration link and event details are available at https://t.co/q3odh2yO8U.

The Scope of the Webinar

The webinar is designed to shed light on the key considerations in the final guidance for Human Gene Therapy Products Incorporating Human Genome Editing. The guidance offers recommendations for sponsors developing these products, including insights on product design, manufacturing, testing, safety assessment, and clinical trial design. This is a unique opportunity for industry professionals to gain a deeper understanding of the regulatory framework and ethical considerations involved in developing these therapies.

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Key Considerations in Chimeric Antigen Receptor (CAR) T Cell Products

The webinar will also highlight key considerations in the final guidance for the development of Chimeric Antigen Receptor (CAR) T Cell Products. The guidance provides specific recommendations for chemistry, manufacturing, and control, pharmacology and toxicology, and clinical study design for CAR T cell products. Furthermore, it offers recommendations for analytical comparability studies. The guidance aims to assist sponsors in developing CAR T cell products and related product types like CAR Natural Killer (NK) cells or T cell receptor (TCR) modified T cells.

Insights into the Regulatory Framework and Ethical Considerations

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The final guidance on human gene therapy products incorporating human genome editing has significant implications for the development and approval of innovative gene therapy products. The guidance provides insights into the regulatory framework and ethical considerations, with a focus on data, impartiality, and compassion. This underscores the importance of prioritizing patient welfare in the development of these therapies. The guidance covers recommendations on safety and quality of investigational products, nonclinical safety assessment, clinical trial design, and implications for CAR T-cell products.

Regulatory Aspects of Gene Therapy

The FDA's Center for Biologics Evaluation and Research (CBER) recently hosted a webinar to provide guidance on the regulatory aspects of gene therapy. The webinar covered topics such as preclinical and clinical development of gene therapy products, manufacturing and quality control considerations, and regulatory submissions. The guidance aims to facilitate the development and approval of gene therapy products while ensuring their safety and efficacy. This webinar is another step in CBER's ongoing efforts to provide comprehensive and accessible guidance to industry professionals.

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