Spring Intro 2023

06/03/2023

ATMP Summary

• Advanced Therapies are subject to many of the same guidelines as other biological products • Guidelines for Advanced Therapies are not standalone • Genetically Modified Products need to be thought of slightly differently and need to have additional requirements considered in addition to the standard requirements for biological products – National guidelines at CTA level need careful consideration • ILAP and PRIME available to ATMPs in EU/UK. FDA has RMAT designation

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Overview

• What is a biotechnology product

• Key regulatory aspects to consider

• Filing Biotechnology Products

• Advanced Therapy Medicinal Products

• Hot Topics and Conclusions

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