It was such a pleasure to be in Boston, my old stomping grounds, for the 2013 DIA Annual meeting in late June. With our Clinical and Regulatory Optimization Practice represented by Jamie O’Keefe, Chris McSpirrit and me, we soldiered through intense humidity and plentiful distractions (great Gatsby!) to have insightful discussions with dozens of interesting people, give away a ton of dancing robots, and come away with the following impressions from walking the show floor and sitting in on a slew of presentations.
CLINICAL, CLINICAL, CLINICAL – some attendees had the perception that there was a heavier than usual session emphasis on clinical trial topics this year. Maybe true, as we had a difficult time choosing between many compelling concurrent sessions, including GCP and Inspection Readiness, Changing View of Electronic Data Capture (EDC) and Implications for Data Quality, Approaches to Risk-based Monitoring, Evaluating Sites for Optimum Site Selection and Performance, eTMF, and more.
TRANSCELERATE, TRANSCELERATE, TRANSCELERATE – three sessions detailing progress out of the five workstreams: training, data standards, and risk-based monitoring. No surprises, great progress; details from the June Press releases here: http://www.transceleratebiopharmainc.com. Looking forward to portal workstream announcements anticipated this summer. Many other sessions referenced the Transcelerate initiatives and the impact they are having on life science companies as they plan future technology implementations.
RISK BASED MONITORING: RBM was a major conference theme featured in several well-attended presentations, with perspectives from life science companies, CROs and vendors. My take-away: many are adding remote monitoring / data crunching capabilities to site visits, but no major wins yet on site visit reductions. Some speakers shared their perspective that reduced site visits isn’t an RBM goal; rather to have both remote and on-site monitoring activities improve site/study quality and reduce risk.
BIG DATA - The industry cares about Big Data, desperately wants insights from big data, knows there’s incalculable value in big data and hasn’t yet made any ground breaking strides out of big data. Came away with the impression of so much activity that success stories / use cases will be featured at next year’s show. Michael Rosenblatt from Merck participated in a panel discussion and made the audience both think and laugh with his slides such as “Why are so many men pregnant?” in discussing the criticality of big data quality.
CLOUD – Conversely, cloud use in drug development has arrived. Value is now incontrovertible, perceived security qualms are calming, success stories abound. The cloud gestalt has gone from “prove it to me” to “don’t leave me behind”. It seems that almost every technology vendor in the exhibition hall had some level of cloud capability…and those that don’t yet are talking about availability in the near future.
EHR – Data from electronic health records (EHR) are proving value in safety signal detection, trial feasibility and recruitment efforts, outcomes, but not-so-much headway in the biggest value proposition EHR to EDC data. My gut – industry is many years away from getting submissible data from EHRs in a large global trial. Too many EHR systems, built for separate business purpose (patient care vs. research), with data produced to differing levels of rigor (quality questions again). Strong support from FDA, yet Medicare Meaningful Use will not focus on outcomes / clinical research until 2016. In a completely unFran-like fashion, I would love to be wrong about the speed of innovation here; chime in if you can point to trial successes in EHR-EDC interoperability.
INNOVATION – PCAST PANEL: Transcelerate’s Dalvir Gill joined an impressive panel that included Kenneth Kaitin, Kenneth Getz, Andy Lee, Tomasz Sablinski, Bernard Munos, and Robert Franco discussing reinvention of the R&D Business Model. While many wise words were spoken, I found Dr. Sablinski’s statements on open collaboration, intellectual honesty and innovative clinical trials most refreshing, especially as he is walking the talk at Transparent Life Sciences. The TLS crowd-sourced protocol, tele-monitored subject trial IND was recently approved by the FDA.
FDA eCLINICAL AND eHEALTH: Traditionally, the regulatory agency sessions are packed with attendees and with information. The start-of-the-day FDA eClinical/eHealth panel was incredibly valuable, but had a regrettably light turnout. After each FDA panelist (Ron Fitzmartin, Mitra Rocca, Leonard Sacks, Jonathan Helfgott) gave a few minute overview, they then invited the two dozen or so attendees to speak up – “tell us what can we do to support innovation” - and opened the floor for feedback. Bottom line, the FDA supports innovation, and industry should take advantage of the opportunity at hand – the need is recognized, the door is open, the regulators are ready to talk.
BACK TO THE FUTURE: the keynote address by Daniel Kraft was a mind bending odyssey into the current capabilities and future possibilities of disruptive technologies in health and medicine.
INNOVATION = CLINICAL ARCHITECTURE: While heartened by innovation happening today at places like Transparent and NanoBio (great session on their paperless trial), can we move fast enough to take advantage of the advances? If regulators support it, smaller companies are doing it, and the technologies enable it, can we disrupt the long and expensive timelines for clinical development?
We know from our work that sustainable innovation, both large and small scale, is reliant on a solid grounding in a robust clinical architecture. It is critical to have a well-defined and agile business and technical architecture foundation and roadmap, in order to not only meet the current business needs, but provide a foundation for emerging needs and to enable rapid innovation adoption. We know that all of the hot topics listed above require a robust Clinical Architecture to be effective and fully enabled across people, process and technology.