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  • Feature ArticlesFeature Articles

    Overcoming the Challenges in Getting Cancer Vaccines to Market

    This article discusses advances in the development of “personalized” cancer vaccines and reviews the many challenges that need to be overcome to get new cancer vaccines approved and on the market. The authors highlight FDA’s “Regenerative Medicine Advanced Therapy” (RMAT), a comprehensive policy framework aimed at providing oversight for cancer vaccines and regenerative medicine products, including novel cellular therapies. Introduction Cancer continues to be one of the...
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    Regulatory and Economic Challenges for Gene Therapy Utilization

    This article addresses pricing and reimbursement challenges associated with clinical utilization of approved gene therapies. The authors recommend potential approaches to resolve these challenges, the implementation of which may help solve issues related to the high cost of these therapies and encourage continued innovation and further development of advanced gene therapies. Introduction Gene therapy is an experimental technique using genes to treat or prevent diseases ...
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    Resolving Gene Editing Technology's Ethical and Regulatory Challenges

    This article provides an overview of biomedical applications of gene editing technology, addresses ethical and regulatory challenges associated with its implementation for therapeutic development, and proposes approaches for overcoming these challenges. Introduction Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology is a genetic "editing" tool aimed at altering DNA sequences and modifying gene function. It offers promising opportunities for ...