“The FDA is a public service. They absolutely want to hear from patients and the public,” said Jakob Dupont, Chief Medical Officer, OncoMed Pharmaceuticals.
“If you think of the mission of regulators reviewing the packages we submit, they absolutely want to hear from patients, to see if the clinical benefit is there for approval,” he told participants at BIO-Europe Spring® during the opening plenary session.
The Head of Strategy, External Innovation & Science Policy for Global R&D at Sanofi, Maya Said, noted that while pharmaceutical companies have been saying for years that they put the patient at the center of everything they do, it’s time to get real.
“Today there has been an evolution in how quickly we can reach patients and engage directly with them,” she said.
“We have fundamentally changed how we do things. We bring patients into the innovation process, talking about needs with the R&D organization, or using using social media and crowd-sourcing on specific topics. And then looking at how we adapt our development processes,” she added.
Joseph Truitt, Executive VP for Business Development and Chief Commercial Officer at Achillion Pharmaceuticals, suggested there is an advantage in being a smaller company with an ability to connect more easily with patient groups.
“We engage not only patients but patient organizations very early on, from the earliest discovery process. Today we always engage patients, as well as key opinion leaders and payers. Our management team actually meets with patient advocacy groups so we can understand what they want,” he said, adding a caution that companies become invested financially and psychologically in developing a drug that they imagine, but perhaps not the drug that patients want.
Moderated by Antoine Papiernik, Managing Partner for the Paris-based venture capital firm Sofinnova Partners, the plenary session offered BIO-Europe Spring participants a wide-ranging discussion of market access, regulatory pathways, and whether there is a pendulum-swing change underway from the narrow niche-busting orphan drugs of recent years toward a potential for more widely applicable, if not blockbuster, drugs.
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