During the last week of June, the Drug Information Association held its 52nd Annual Meeting in Philadelphia. As one of the largest conferences in our industry, DIA covers a wide range of topics over the entire spectrum of drug development, and it would be nearly impossible to provide a comprehensive accounting of the meeting. However, I will try to share the most notable trends and themes from the meeting.
Big data was possibly the hottest topic this year. Not only did FDA Commissioner Dr. Robert Califf participate in a panel session on the topic, but when listing his top four priorities, one of them was greater use of existing data in EMR/EHR systems. At DIA, people were really talking about big data from a handful of sources—electronic medical records data, data from wearables, data from social and digital media and genomics (and other -omics) data. FDA is taking a lead role in the use of big data and real world evidence through initiatives like Sentinel, which enhances the FDA’s ability to proactively monitor the safety of medical products on the market, and precisionFDA, a community platform for next generation sequencing (NGS) assay evaluation and regulatory science exploration. Big Data is an idea that has been talked about for some time, but based on this year’s meeting it is clear we’ve moved beyond idea to reality. For anyone wondering how soon we might see full genomic sequencing of all patients in a clinical trial, you will be interested to learn that the cost is now on par with a chest x-ray, Genentech has sequenced 30K genomes to date, and AstraZeneca recently entered into a partnership with Human Longevity to sequence 500K genomes over the next 10 years.
Patient Centricity is Still Big
Patient centricity was the theme of last year’s meeting, and continued to play a central role in this year’s meeting. But while last year was big on ideas and optimism, this year saw early adopters sharing lessons learned from programs already up and running. Patients and patient advocacy groups made up a noticeable group of attendees and were outspoken during sessions. Several companies including Bristol Myers Squibb (BMS) and GlaxoSmithKline (GSK) shared specific programs and tactics they’ve been using to move to a more patient focused research model. Some examples include creating frameworks that allow greater number of employees to engage with patients and the public about the work they are doing and developing minimum standards for patient engagement that reflect geographic and cultural differences. From a regulatory perspective, patient-centricity made Dr. Califf’s list of his top four priorities.
The Swinging Pendulum on Outsourcing
For many years now, it seemed the trend was always to more and more outsourcing with innovator companies keeping fewer and fewer activities in house. Several of this year’s outsourcing sessions are hinting that the pendulum on that trend may be starting to swing back. From internal frustrations with outsourcing groups, to dissatisfaction with vendors in terms of both quality and performance, to the failure of preferred provider relationships to deliver on expected savings and improvements, the talk from a number of pharmaceutical and biotech companies is that they are keeping more work in-house. That said, there certainly is not agreement among sponsors or vendors/suppliers on this issue. Many pointed to issues at sponsor companies such as refusal to hear feedback from CROs on the feasibility of their budgets, timelines, or study designs as well and disagreement between outsourcing personnel and study team personnel about the providers being selected.
Drug Development as a Calling
DIA opened with keynote speaker Dr. Larry Brilliant, a physician and epidemiology who participated in the World Health Organization’s (WHO) successful small pox eradication program. Dr. Brilliant talked through a number of health research and outreach efforts that have dramatically changed the world for the better, including the small pox and polio eradication programs, the development of electrolyte solutions to treat cholera and diarrhea, and more recently the efforts of the Carter Center to eradicate guinea worm. He brought into sharp focus the idea that what each of us in the pharmaceutical industry does has the potential to change the world for the better. The idea of drug development as a calling was furthered by Dr. Califf’s call to all of us to donate the information in our electronic health records for the betterment of research and medicine—a reminder that we should be willing to open ourselves up in the same way that we ask patients and research participants to do. Finally, several of the patient-centricity speakers focused on the value of identifying employees who themselves were patients or care-takers of patients in their private lives in addition to being part of the research and development process. These people are uniquely qualified to help us better understand the patients’ needs and experiences.
Greater Engagement by FDA
Finally, it was interesting to me to see the level of participation by the FDA in this year’s meeting. While they always send some presenters and a larger number come just to attend, this year did seem different. Dr. Califf presented in multiple sessions and was open and engaging during Q&A sessions. Additionally, numerous sessions included speakers and panelists from the FDA providing valuable insight into their point of view.
Did you attend DIA this year? If so, let me know what you thought.