Insights from Better Science, Better Health: New Healthcare Models
On October 26th and 27th at the Better Science, Better Health: New Healthcare Models meeting in Washington D.C., European and American health care leaders met in the US Congress to consider how new scientific breakthroughs such as targeted therapies, big data, and precision medicine will change drug development, approval and use. A consistent theme was the role of the patient in shaping regulatory and access policy. Hans-Georg Eichler, senior medical officer for the European Medicines Agency (EMA), stated “patient power will become very important,” citing the impact of rare disease groups. They are the “innovation pushers,” stated Pierre Meulien, the new executive director of the Innovative Medicines Initiative, who pledged to bring more patient advocates – and also payers – to the programs funded by this European Commission key partner. Conversation turned more lively when Dr. Eichler and others asked which groups speak for patients, noting that regulators “get blasted” by some consumer groups who feel EMA is moving in the wrong direction when it comes to data privacy, approval pathways and the like. Who speaks for patients was not answered.
Missing from the dialogue on these and other topics were the American peers of the senior regulatory and NGO representatives from Europe. No one from FDA or NIH spoke at the meeting on day one. The Deputy Commissioner for the FDA cancelled his appearance on the second day. While Europe moves to include real world evidence in drug approval, use and access, nothing was heard from the US except from leaders of innovative study groups such as I-SPY and external stakeholders such as NORD and the Personalized Medicines Coalition.
The second day “Better Science, Better Health” began with a presentation of FDA’s priorities given by Dr. Carol Linden, director of regulatory science and innovation, a substitute for Dr. Rob Califf, deputy commissioner whom some believe can say very little publicly while his nomination for the commissioner’s office is under review by Congress. Europeans continued to dominate the discussion. Presentations centered on big data and real world evidence. The final session on new models of improving research participation led many speakers to call for more patient-centricity, integration of patients in review of proposals, shared decision making among doctors and patients, and more. New and innovative ideas for implementation were scarce on the ground. Jocelyn Ulrick, director scientific and regulatory affairs for PhRMA may have unexpectedly presented an important challenge to us all: It’s hard to measure the impact of awareness and education initiatives and so far, she reported, it has not translated into more patient participation in studies.
The sessions on day two provided a useful overview of the changing and often innovative landscape of European regulatory policy and access plans. What this means for the US is less certain.
While the “Better Science, Better Health” conference sought to increase collaboration between US and Europe, the dialogue was strictly one sided.
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