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Discovery & Development Drug Delivery, Clinical Trials, Formulation

It Doesn’t Have To End In Tears

Pharma companies are closely scrutinizing existing products to discover if they have activity for new indications, possibly through new routes of delivery. Repurposing comes with challenges as developers must go back to the drawing board to optimize the product for its new purpose, which may require a new formulation or delivery mechanism. However, repurposing also has many advantages:

  • existing drugs are likely to have large portion of their non-clinical packages in place
  • regulatory authorities offer simpler submissions (e.g., FDA via 505b(II) submission)
  • greater understanding of basic biology in other therapeutic areas is uncovering overlaps in certain pathways and targets, especially in immunology and inflammation
  • legislation and social media has made orphan indications more attractive.

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About the Author

Jeremy Drummond

Jeremy Drummond is Senior Vice President, Business Development, MedPharm Ltd, UK.

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