Module 9 2021

23/03/2021

Conclusions (1)

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

 Due to the biological, and thus inherently variable, nature of the products themselves; 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 – Pre-clinical data needed but often reduced compared to small molecules (depends on indication)

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Conclusions (2)

 Technical

– Data as for biotech/biological

– But as combination vaccines and include other components like adjuvants (which have own production), technical data often complex

 As such LCM is a significant challenge which is made more complex by long life cycles  Despite the challenges, vaccines are fantastic products to be involved with!

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