LSHC Horizons Brochure 2024 - Flipbook - Page 20
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Cell, Tissue, and
Gene Therapies
Collaborative strategies for ATMP development through
Investigator-Initiated Trials
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FDA’s efforts to support CTGT products
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Laboratory developed tests under FDA scrutiny
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Medical device regulatory considerations for novel
cell-based gene therapies, Casgevy and Lyfgenia, FDA
approved as biologics
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Negotiating cell, tissue, and gene therapy agreements
with HCOs
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Patient finding initiatives: Legal considerations
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Product sameness considerations for cell, tissue,
and gene therapy products
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The convergence of high-tech emerging technologies
in precision medicine: Human organ chip systems
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The hospital exemption scheme for advanced
therapy medicinal products in reform of the
EU pharmaceutical legislation
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