1 / 10

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.

ltruman
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related