An End-to-End Pharmaceutical Development Pathway to Rapidly Bring Poorly Soluble New Chemical Entities to the Market

27 September 2022 10:20 - 10:50

  • End-to-end pharmaceutical development of poorly soluble compounds
  • Enabling formulations for clinical and market formulations
  • Integrated CMC services to expedite formulation development
  • Development and manufacture of bioavailability-enhancing formulations
  • Case studies including spray-dried dispersion and nanoformulation
This presentation outlines an end-to-end pharmaceutical development pathway to rapidly bring poorly soluble compounds to the clinic and to the market. The pathway encompasses the use of bioavailability-enhancing formulation platforms as well as integrated CMC services. Various bioavailability-enhancing formulation approaches are available to facilitate development and manufacture of clinical supplies. The development can be accelerated further by leveraging integrated CMC services that include drug product with drug substance as well as analytical and regulatory functions. Case studies covering early-stage and late-stage development of spray-dried dispersion and nanoformulation will be provided.

Santipharp Panmai, Vice President & Head of Early-phase Formulation Development, WuXi STA

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