faster proof-of-concept in the clinic !!!

Getting the most PoC data in Phase I cancer studies    Webinar | June 12 | 11am ET / 8am PT  The hunt for proof-of-concept data is steadily moving upstream in the clinic. Join FierceBiotech on June 12th as three clinical trial experts tackle the question of how you can best design a Phase I study to get a readout on efficacy.  In place of a surrogate endpoint, developers will also be able to pursue an approval on an endpoint that can be "measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit." This process, the bill continues, should allow for "fewer, smaller, or shorter clinical trials for the intended patient population or targeted subpopulation without compromising or altering the high standards of the FDA for the approval of drugs."   While the House and the Senate now have until October 1 to reconcile the two bills, both include language aimed at prodding the FDA to move more quickly on the approval process, mandating increased face time with developers and offering biopharma companies a chance of moving to the market sooner. But the House bill also includes a fast-track provision for disapprovals, allowing regulators a chance to yank a drug that hasn't been put through promised post-marketing studies or treatments that may have been improperly touted by the drugmaker.    Over the next 12 months we'll get a chance to see exactly how flexible the FDA will become. We'll also be able to see which therapies win the broader fast-track regulatory path as they blaze a trail for others to follow.