Module 3 Presentations

14/05/2024

Plan for the Market Early

 CMC development takes time and planning: o DS synthesis and DP formulation for early trials unlikely to be market products  Involve all necessary disciplines as soon as a potential market candidate is identified: o Chemical development for feasible synthetic routes o Formulation development and marketing for desired commercial image that can be made at scale o Clinical for desired pharmacokinetics

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How to Achieve these Aims?  Learn from everything done in the past o Build on knowledge from Phase I, II, III etc and similar products from your company o No one person is the fount of all knowledge – take advice whenever needed (project team work and cross project team experience sharing) o Simplicity is always best – don’t add unneeded complexity such

as modified release tablets unless critical o Don’t be afraid to stop and start again • Problems will occur for unexpected/unknown reasons • Time and money spent on problem solving may not be a good investment • Projects die for more than safety/lack of efficacy reasons

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