Spring Intro 2023

06/03/2023

Clinical

• Antibody analysis is important • Clinical trial costs can be very high ● Investigational Medicinal Product (IMP) costs if additive therapy e.g. PD-1/PDL-1 ● Hot areas can make trial recruitment difficult e.g. immuno-oncology • Increased expectation for biomarkers to be evaluated in clinical programs for targeted therapies • Pediatric studies may be deferred or waived depending on indication (see Regulation (EC) No 1901/2006) ● Concern that some oncology products are waived when there is a paediatric need • National controls for Advanced Therapy Medicinal Products (ATMPs) and Genetically Modified Organisms (GMOs) still variable and can cause problems for global/regional trials

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Overview

• What is a biotechnology product

• Key regulatory aspects to consider

• Registering Biotechnology Products

• Advanced Therapy Medicinal Products

• Hot Topics and Conclusions

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