Module 9 2024

03/09/2024

Concluding Remarks

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Concluding Remarks (1)

⚫ Vaccines present additional challenges (compared to small molecule pharmaceutical drugs)

⚫ Biological nature (inherently variable); combination products; long life cycle

⚫ Clinical/Non-Clinical

– Given the use of vaccines, safety is paramount; pre-licensure databases are very large

– Efficacy data may not be required; can use immunological markers to surrogate for efficacy

– Non-clinical data needed but often reduced compared to small molecules (depends on indication)

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