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A gathering of global perspectives… a look at DIA’s annual meeting: Post 2 of 2
Posted on July 18th, 2016 by Christy J. Wilson in Pharma R&D
As referenced in my last post, the Drug Information Association (DIA), held its annual conference in Philadelphia at the end of June with this year’s theme being “A Gathering of Global Perspectives.” In follow-up to that post, I want to share with you what I gleaned from two additional noteworthy sessions. The first of these two was entitled Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment. Among the panelists were, Dr. Robert Califf, the current FDA Commissioner, representing the Regulator’s view; Luke Dunlap from IMS Health, representing the Market view; and Denise Esposito of Covington & Burling, representing the Legal view. The session was moderated by Joseph Scheeren, PharmD, Global Head of Regulatory Affairs, Bayer Pharma & Consumer.
Dr. Califf, very early in his session, made a plea for the need to be more precise in the use of terminology – especially when it comes to “Big Data” and “Real World Evidence.” In particular he pointed out that “Real World Data” does not equal “Real World Evidence.” Much of the ensuing presentation from Dr. Califf was around various ways in which big data was being used in different FDA initiatives from Precision Medicine to Food Safety to Post Market Surveillance (including the FDA Sentinel initiative) and more. He closed by sharing a list of “calls to action” related to creating more secure, scalable, and efficient use of big data in support a learning healthcare system.
Representing the market view, Mr. Dunlap’s IMS health presentation outlined three different real world examples that employed big data the first of which was Evidence Driven Clinical Development Planning (CDP) defined as using data and modeling tools to evaluate time, cost & complexity of clinical trials, as well as simulations of clinical trials based on end points, target countries, enrollment, study costs & cycle times. The other two examples shared by Mr. Dunlap were using real world data to connect genomic data to patient phenotype and outcomes data; and the use of pattern recognition technologies in conjunction with real world data to find rare disease patients.
From the Legal view, Ms. Esposito of Covington & Burling, like Dr. Califf, opened her presentation with a discussion of definitions, asking simply “What do we mean by big data?” and then proceeded to suggest as a possible definition: “data collected outside of adequate and well-controlled clinical investigations.” This definition is particularly noteworthy in the context of the regulatory environment as Ms. Esposito pointed to: FD&C Act §505(d) and the definition of “Substantial Evidence” and to the FDA Regulations: 21 CFR §314.126: and the standard related to “Adequate and Well-Controlled Studies.” She reiterated many of the big data challenges for regulators– reliability (data collection methods, validation, data quality and integrity, etc.), interoperability, interpretation (consistent methodology), and transparency vs. confidentiality — but ultimately she acknowledged many use cases for the regulators and posited the following question to her audience: “If we move away from two adequate and well-controlled clinical trials as the principal basis for regulatory decision-making, how do we ensure data quality and the integrity of the drug review framework?” Her presentation closed by sharing additional legal considerations outside the FD&C Act, as well as commercial considerations related to creating strong contacts.
Both the Next Generation Collaborations (covered in my first post) and the Envision the Future session around big data did a good job in laying out the industry context and providing a glimpse into both the opportunities and the challenges that need to be addressed. Leaving these sessions I felt there was so much more to know and do. Certainly each one of these topics could have been the basis for an entire event and that speaks to the dynamism of the life sciences industry. And to that point I want to close my “account” of the DIA Annual Meeting with a brief glimpse into Dr. Larry Brilliant’s presentation in the plenary.
This was my first exposure to a Dr. Brilliant presentation and, in my view, he comes by his surname naturally because his presentation was brilliant. In the wake of the fallout from the Brexit vote, the Orlando tragedy, and whatever other unsettling events may have been happening in the world at a macro or micro level, Dr. Brilliant focused on selling optimism (an approach not unusual for him, as I see from his Ted talks and certainly if your work involves eradicating smallpox and other diseases, optimism is a good quality to possess).
He began his session, Bad Bugs, Good People, and Big, Bold Ideas, with a number of different assertions that seemed implausible, yet he assured us we would believe these assertions upon leaving his session. What sort of assertions? How about, “humanity has been udderly saved from a killer by a little cow pus” or “doing almost nothing for 40 days during a pandemic saved medieval cities from collapse” or “millions of blind people see again because of an RAF plane shot down in WWII”? He then took his list of assertions, one-by-one, and provided the historical context or “story” behind them that resulted in a commonly accepted medical approach today. For the three examples I shared, the resultant medical approaches, respectively, are vaccines, quarantine, and cataract surgery. What tied these stories together? Each was the result of an individual or group being incredibly observant and the tying of that observation (or big, bold idea) to an experiment that generated a desirable outcome. And while Dr. Brilliant’s examples were from history, they characterize traits that are at the heart of what motivates industry researchers today. Specifically, the hope and ambition to be at the heart of discovering a new medical breakthrough — especially when faced with the odds. This does indeed require, and inspire, optimism.
All opinions shared in this post are the author’s own.
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Christy J. Wilson
Sr. Director, Pharma and Biotech Segment
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