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. Register Now! For instance, one of my panelists, Anna Protopapas, executive vice president of global business development at Takeda Pharmaceutical, didn't think that her company would have bought Avila Therapeutics under the terms that Celgene did early this year. Protopapas noted that the key asset in the deal, Avila's Phase I Btk inhibitor, is a third-in-class compound, and first-in-class cancer drugs have an edge because of the difficulty that later drugs in the same class face in besting them. Did Celgene--which shelled out $350 million upfront and promised up to $575 million more in milestones--overpay for Avila?   3. Big Pharma can be your friend. Sure, we know about the monumental problems large drugmakers face from expiring patents on key drugs and assaults on their old business models. And, yes, drugmakers are entertaining all kinds of diverse deal structures with biotech companies to soften the blow. Yet every week or so we learn of another strategy drugmakers are using to efficiently develop products. Pfizer's Gutierrez-Ramos shared one with me (though it wasn't covered during the panel). He's now looking for biotech partners that are interested in taking over development of drugs from Pfizer's pipeline. He's offering the compounds for free and willing to share in the success of the programs down the line.   Of course, Pfizer's strategy here builds on the Center for Therapeutic Innovation, which the drug giant expanded last year through several collaborations with academic groups, which work with CTI on translational research. Like CTI, externalizing clinical development of Pfizer compounds at biotech companies, including venture-backed startups, lets the drug giant tap expertise that doesn't reside under its own roof.   "I think the misperception is that," outside of large buyouts and tiny deals, "Pfizer is not a great partner to work with because, due to the big acquisitions, we are product-driven [and] that the perception out there is that we just want products," Gutierrez-Ramos said. "And what we have been trying to re-prove over the last two years is that the new Pfizer is not like that." -- Ryan McBride