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Volume 37, Issue 7
Three messages that resonated from this year’s annual meeting of the Drug Information Association.
Every June, the Drug Information Association (DIA) brings together global thought leaders and innovators from industry, academia, regulatory and government agencies, health, patient, and philanthropic
organizations to discuss the compelling healthcare and R&D issues of the day. Ahead, members of Pharm Exec’s editorial team who were on hand for last month’s 53rd annual gathering in Chicago, share their biggest takeaway messages from the event.
Lisa Henderson, Editor-in-Chief
Real-world evidence. That’s my three-word takeaway from the DIA conference. Whether it was in the learning sessions or in the exhibit hall, gaining the insights needed for making decisions after a drug is developed or informing a new entity in clinical trials, was top of mind. Real-world evidence spans the use of long-term observational registries, analytics, and insights into current claims or EHR data, as well as the basis for current and future value-based contracts between health plans and manufacturers.
Sessions spanned standardizing outcomes for patient registries to breaking down the wall for global regulators to leverage real-world data to value-based conversations with payers. Innovators in real-world evidence from the exhibit floor included IBM Watson Health, Evidera, and QuintilesIMS. Poster sessions included Developing Research Networks with Health Networks for Real-World Evidence Generation, presented by Nancy A. Dreyer, PhD, global chief of scientific affairs, head, Center for Advanced Evidence Generation, QuintilesIMS Real World Insights. Dreyer was also named to the DIA Fellows Class of 2017 for her long history in shaping real-world evidence in the pharmaceutical industry.
Mike Christel, Managing Editor
One message that hit home with me was debunking, in a way, the notion that the FDA is never flexible in its evaluation of new drugs-and from a rare disease context, and the controversial approval late last year of Duchenne muscular dystrophy (DMD) drug Exondys 51, the damned if you do, damned if you don’t sentiment that FDA must feel at times. Learning more about the background of the Exondys 51 approval made me rethink the popular narrative. Yes, the drug can potentially help only 13% of DMD patients (those with a gene mutation amenable to exon 51 skipping), but, as we found out, during testing, it slowed the progression of the disease noticeably for some of the young men afflicted, giving them at least a chance at a few more years of quality of life. Putting aside pricing issues that have arisen since, what’s really wrong with that? As one speaker noted, it’s okay for the FDA to be flexible as long as the science is good. And “flexibility equals clinical judgement.”
Not speaking to Exondys 51 directly, Sudip Parikh, senior vice president and managing director of DIA Americas, told me of the FDA: “They don’t want to be a bottleneck, they want to be a well-oiled machine that does the right regulatory work, protects the patient, but is not selling it down anymore than necessary.”
Michelle Maskaly, Senior Editor
The future is now. The days of talking about patient centricity, advanced technologies, cutting-edge drugs, artificial intelligence, and other initiatives in terms of just ideas, are over. These buzzwords have now become a reality. “Yesterday’s conversation is today’s science,” Debra Lappin, head, health bioscience practice at FaegreBD Consulting, said at the meeting. During a Pharm Exec video interview with Barbara Lopez Kunz, global chief executive of DIA, she agreed with the sentiment, while touting all of the advances going on in the industry and the commitment to bring technology not just into the labs, but everywhere-including to the patient.
Conversations centered around the various ways companies were including patients in everything from clinical trials to postmarketing opportunities, including independent social networking sites dedicated to creating a community for those with chronic diseases.
Another common theme of the conference was the four-way intersection of healthcare, pricing, politics, and policy-and the uncertainty around it all. While advanced science and technology is leading the way for all these new therapies to become available, it is also bringing up a lot of questions about how they will be priced, what will be covered, and who will be paying for them.