The drug industry is struggling with more than expiring patents and shrinking sales forces, Millennium Pharmaceuticals CEO Deborah Dunsire told industry watchers in March. Rather, it's wrestling with a top-to-bottom revolution.
In her keynote address to the MM&M Virtual Summit, Dunsire said that to succeed, the industry should stop trying to medicate vast swaths of patients. Instead, the industry should pursue personalized medicine and be honest about which patients will benefit from which medications.
Dunsire said industry executives will find that this strategy is “easy to say but not always easy to do,” but emphasized that blockbuster treatments have been built on medications aimed at small patient populations.
Dunsire said the conversations executives need to have about their mission must change because it's no longer enough to get regulatory approval and patient buy-in, because payers like NICE and CMS are the gatekeepers to market access.
“I'm trying to remember even one molecule with tremendous impact for patients that even went through NICE on the first go-round,” she said, as an example of the additional promotion that is now a requisite part of the industry's marketing process.
Dunsire also noted that regulatory and payer agencies are increasingly teaming up. As an example, she said FDA and CMS are collaborating on joint review for medical devices.
“Even though they maintain that price is really not a prerequisite for approval and there isn't a focus on price during the approval process, it does portend a change in the way things are going to be done in the US,” she said.
Dunsire said that while costs are rising and early-stage investors are skittish, there is opportunity for innovation if the focus is on unmet needs and being able to prove the treatment's value.
“We really have to think and collaborate and talk with our regulators and our investigators on an ongoing basis,” as a way to ensure success, said Dunsire.