Adaptive Licensing: a useful approach for drug licensing in ... - TOPRA

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Adaptive Licensing: a useful approach for drug licensing in ... - TOPRA

Adaptive Licensing: a useful approach for drug licensing in ... - TOPRA

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Evolution of life<br />

Mutation<br />

Selection<br />

Evolution of <strong>drug</strong> regulation<br />

Catastrophe<br />

Clamp Down<br />

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Evolution of life Mutation Selection Evolution of <strong>drug</strong> regulation Catastrophe Clamp Down 4

Knowledge, <strong>in</strong>vestment The b<strong>in</strong>ary nature of <strong>drug</strong> regulation Current model of <strong>licens<strong>in</strong>g</strong> “The Magic Moment” Evidence vs. access trade-off Time (years) 5

Page 1 and 2: Adaptive Licensing: a useful approa
Page 3: Trend in actual clinical developmen
Page 7 and 8: EMA Road map to 2015 […] a key is
Page 9 and 10: NEWDIGS - Collaborators (NEW Drug D
Page 11 and 12: Millions Gilenya Case Study Results
Page 13 and 14: Adaptive Licensing AL is a prospect
Page 15 and 16: “Precursors” to Adaptive Licens
Page 17 and 18: Adaptive Licensing - a ‘systems a
Page 19 and 20: The O2 problem Obstacles and Opport
Page 21: Thank you! 21