DIA 2015 – Day Two Recap

Today was my first full day at DIA 2015, and it was a whirlwind. I managed to see sessions on Regulatory, Manufacturing, Clinical, and PV and have some substantive one on one discussions with Medical Affairs and Safety folks as well. And on top of all that, I met with a number of very interesting vendors and service providers to pick their brains about “THE FUTURE OF PHARMA”…no wonder it feels like Thursday already.

My morning session was Social Media: Opportunities and Challenges in PV and Clinical Research. And although there was a huge amount of valuable information on that specific topic, I found myself imagining the larger impact of social media monitoring for life sciences organizations. Carrie Pierce, from Epidemico, presented a case study where she analyzed publicly available social media data for a Type 2 diabetes drug. Her goal was to show how a PV function could manage the seemingly overwhelming volume of social media data to arrive at a workable subset for PV purposes.

To do so, she showed rich examples of actual Tweets and Facebook posts from patients. Again, while the value to PV was clearly apparent, this patient information had much wider applicability. There was information about how to “game” trials, user problems with drug delivery (e.g., pen malfunctions), off label applications (e.g., skin clearing up, losing weight), and ideas for improving trials from a patient’s perspective. All of these would help a life sciences organization improve front office, value chain operations, not simply “do PV better”. And all of these would help life sciences organizations get more truly patient centric–something everyone is working hard to do.

I also saw a fascinating session on Continuous Improvement and Innovation in Manufacturing Approaches that was all real life case studies (from Pfizer, GSK, and Vertex). Both Pfizer and GSK talked about how they’re using self-contained, pod-based, modular manufacturing equipment that allows them to set up a manufacturing line in a matter of days rather than months and with a footprint significantly smaller than traditional batch production approaches. Vertex shared how they’re using Quality by Design (QbD) to speed their manufacturing capabilities, which was less about futuristic technology and more about the people/process scaffolding that allows them to leverage their traditional manufacturing technology in a more agile way. To me, given how behind the curve life sciences manufacturing has been in terms of process efficiency relative to its peers in other manufacturing subverticals, this was a tremendous leap forward and great to see at DIA. It made me hope that in future years we might see some SMEs from other manufacturing domains present in order to enable some cross fertilization and to continue to evolve life sciences’ lean/six sigma/continuous improvement maturity.

There was also a session on Bringing Clinical Trials into the 21st Century, which, as you might imagine, spoke a lot about patient centric approaches to clinical trials. But what occurred to me during the session, and what was confirmed in other conversations with PV, Regulatory, Clinical, and Medical Affairs folks, as well as with vendors in the mobile, document management, and CRO domains, is that patient centricity will require more than simply life sciences organizations getting involved to be realized. Here’s what I mean…

For me, patient centricity boils down to making sure patients get the care and therapies they need and that those care and therapies are effective. Given this, true patient centricity requires the involvement of life sciences, of course, because they develop the drugs and devices that help patients get healthy; but it also requires the involvement of providers, because they deliver care (and often the drugs and devices) that contribute to patient health; it requires the involvement of payers, because they fund the cost for drugs, devices, and care that help patients get healthy; it requires the involvement of employers, because they often foot the bill for insuring patients and stand to benefit from good outcomes; it requires the involvement of patient advocate groups, because they work to ensure that the voice of the patient is heard; it requires the involvement of regulators, because they are charged with ensuring that all patient health stakeholders behave in ways that protect patient safety; and it requires the involvement of vendors and service providers, because they create products and services that enable these other stakeholders to be effective.

Given all this, the real way forward to patient centricity is larger than life sciences and will have an impact beyond corporate revenue (although it will also do that).

So much for my take on DIA 2015 day two. Looking forward to what tomorrow brings…