Conversations on Today’s Priorities!
Thought-provoking, worldwide issues will be deconstructed by acclaimed panelists representing multiple stakeholders from around the world in this growing ecosystem of life sciences. DIAmonds represent rare opportunities to listen to open conversations on controversial topics such as owning health data, innovation in global health, and international regulatory collaboration.
Monday, June 24
Part of the Opening Plenary and Keynote
Session Chair: Craig Lipset, MPH, Former Head of Clinical Innovation, Pfizer
Data is the fuel for modern medical research. From enabling precision medicine to innovative uses of real world data, regulators, researchers, and the bio-pharmaceutical industry are increasingly dependent upon access to data sets of increasing size and scope. Consumers today are increasingly sensitive to how their data is used and monetized, largely in the wake of Facebook/Cambridge Analytica and other high-profile scandals. Use of personal health data is not immune from these concerns, from GDPR and California Consumer Privacy Act to the rise of state bills challenging ownership over personal health data even if de-identified.
These consumer and policy trends are raising new questions and challenging norms -- Who should be the legal owner of personal health data? Should patients be notified when their data is monetized even if it lacks identifying information? If personal health data is being sold, should patients be able to participate in the monetization or would this practice exploit underserved populations? What are the potential implications of this shifting landscape on medical research and public health?
Thursday, June 27
Session Co-Chairs: Sandra Kweder, DrMed, MD, Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA, and Tânia Teixeira, PharmD, EMA Liaison Official at FDA, European Medicines Agency (EMA), European Union
How do large regulatory agencies collaborate? What are the challenges they face, in organizations with different structures and working under different legislative frameworks, and in finding ways to align to facilitate and enhance global medicines development? This forum brings together pairs of experts from FDA and EMA to launch discussions in such context, with focus on several themes that will provide a foundation for discussing challenges and successes in communication and collaboration covering four areas. These include how we have collaborated on urgent public health issues (with valsartan contamination as an example) and, from there, are working to address shared goals of enhancing global focus on quality manufacturing. From a more clinical perspective, both agencies have matured in experience managing programs for advising companies on potentially important products that could address unmet medical needs, as well as scientific challenges of how to design clinical trials that will be robust and informative in that setting of urgency.
Session Chair: Sudip Parikh, Senior Vice President and Managing Director, DIA Americas, DIA
This forum will include discussions and updates from FDA leadership on regulatory issues and the audience will be invited to submit questions of general interest.