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A new paradigm for TB drug development? A regulator’s perspective

A new paradigm for TB drug development? A regulator’s perspective. Hans-Georg Eichler Washington, October 2012 CPTR. What’s in this talk. Research 101 The message from the gatekeeper-regulator: It can’t be done The message from the enabler-regulator: It can be done - maybe. Research 101.

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A new paradigm for TB drug development? A regulator’s perspective

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  1. A new paradigm for TB drug development?A regulator’s perspective Hans-Georg Eichler Washington, October 2012 CPTR

  2. What’s in this talk Research 101 The message from the gatekeeper-regulator: It can’t be done The message from the enabler-regulator: It can be done - maybe

  3. Research 101 Temperature Concentration of substrate Concentration of inhibitor … Experiment: all factors except one are kept constant

  4. Too many steps at once?

  5. (Too) many unknown variables? Endpoint: surrogate (predictive?) Unit of development = regimen (new-new combo) Treatment shortening potential? Populations (DS, MDR, XDR?) Optimal dosage/ combination? Post-licensing utilisation? 5

  6. Too many unknown variables “It can’t be done !” Please solve this equation and, by the way, all variables are unknown… 6

  7. The drug development / licensing paradigm Learn – confirm - license Learn – license - confirm Lifecycle approach to research and licensing

  8. (Too) many unknown variables? Endpoint: surrogate (predictive?) Develop BM qualification program Plan to define B/R of components(?) Unit of development = regimen (new-new combo) Long term follow up Treatment shortening potential? Parallel /Subsequent RCTs; Registries Populations (DS, MDR, XDR?) Optimal dosage/ combination? Post-lice. observation Restricted distribution Post-licensing utilisation? 8

  9. Maybe it can be done… • but show me: • a complete development plan including the (post licensing) ‘confirming’ phase • a BM (endpoint) qualification plan • infrastructure is in place to monitor post-licensing treatment experience • infrastructure is in place to monitor post-licensing drug utilisation • infrastructure is in place to manage post-licensing drug utilisation

  10. Thank you!(EMA, Canary Wharf, London) 10

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