DIA 2019 Global Annual Meeting

Component Type: Forum
Level: Basic
CE: ACPE 1.50 Knowledge UAN: 0286-0000-19-730-L04-P; CME 1.50; IACET 1.50; RN 1.50

Join us for the DIA 2019 Global Annual Meeting Keynote Address and Opening DIAmond Session!
Keynote speaker Dr. Gibbons oversees the third largest institute at the NIH, with an annual budget of approximately $3 billion and a staff of nearly 2,100 federal employees, contractors, and volunteers. NHLBI provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so they can live longer and more fulfilling lives.

Advancing Discovery Science for Public Health Impact
Dr. Gibbons will address the value of implementation science that turns discovery science into improved population health, as well as the innovation of evidence-based initiatives in the treatment of chronic disease, to balance the scales of health equity in all populations.


DIAmond Session: Who Owns My Health Data: Patients, Data, and the Future of R&D
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?


Learning Objectives

Review the evolving relationship of patients and health data, from access and sharing to privacy and ownership; Discuss the consumer and policy trends that may reshape expectations when personal health data is monetized; Discuss the data dependence of drug development today and the implications for medical research tomorrow.

Chair

Barbara Lopez Kunz, MSc

Speaker

Honorary Chair Welcome
Guido Rasi, MD

Honorary Chair Welcome
Joanne Waldstreicher, MD

Keynote Address
Gary Gibbons, MD

DIAmond Session: Who Owns My Health Data - Patients, Data, and the Future of R&D
Craig Lipset, MPH

Panelist
Harlan M. Krumholz, MD

Panelist
Doug Peddicord, PhD

Panelist
Deven McGraw, JD, LLM, MPH

Panelist
Donna R. Cryer, JD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-728-L04-P; CME 1.25; IACET 1.25; RN 1.25

How do large regulatory agencies collaborate? What are the challenges they face, in organizations with different structures and working under different legislative frameworks, 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 discussion 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.

This 75-minute session will engage the audience as a priority, drawing on the extensive experience and expertise of the panel. The audience is invited to submit questions both on the topics explored. Please come prepared with your questions for the EMA/ FDA Question Time panel. You may submit questions in advance to annualmeetingprogram@diahome.org, and include “EMA/ FDA Question Time” in the subject line.

Learning Objectives

Discuss scientific and regulatory challenges of coordinating a response to product contamination on a global scale; Describe factors in developing a strategic approach to globally applicable product quality standards; Identify how the FDA and EMA share information about expedited development scientific advice today and opportunities for the future.

Chair

Sandra L. Kweder
Tânia Teixeira, PharmD

Speaker

Panelist
Anthony Humphreys, MPharm

Panelist
Andrew Thomson, PhD, MA, MS

Panelist
Zahra Hanaizi, PharmD, MPharm

Panelist
Agnès Saint-Raymond, DrMed, MD

Panelist
Brad Leissa, MD

Panelist
Laura Lee Johnson, PhD

Panelist
Christopher Joneckis, PhD

Panelist
Peter P. Stein, MD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-729-L04-P; CME 1.25; IACET 1.25; RN 1.25

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.

Learning Objectives

Discuss regulatory issues and updates to include hot topics.

Chair

Sudip Parikh, PhD

Speaker

Panelist
Patrizia Cavazzoni, MD

Panelist
Christopher Joneckis, PhD

Panelist
Tamy Kim, PharmD