Plenary Sessions
Monday, May 21, 2018
8:30 AM - 10:30 AM
Room: Hall A (Level 100)
FIRST PLENARY SESSION: INFLECTION POINT FOR REAL-WORLD EVIDENCE? THE TRANSFORMATIONAL ROLE OF DIGITAL HEALTH
In the last 10 years, we have witnessed an exponential increase in the generation of digital health data from electronic health records (EHRs), claims, billing and patient- and device-generated data. At the same time, it’s being increasingly recognized that traditional clinical trials are expensive, lengthy, and do not adequately study the patient’s specific characteristics (e.g. age, gender, ethnicity, co-morbidities) treatment preferences. The promises of real-world evidence – lower cost; higher quality (including retaining randomization); near real time; regulatory, coverage, and clinical support; and patient decision making – are being addressed on many fronts in a number of transformational and innovative programs. Experience and resources developed on the technical, governance, and policy fronts are supporting accelerated learning. Are we finally at the inflection point to deliver on the promises of real-world evidence and digital health?  The panel is composed of a number of leaders who have been working in this area on cutting-edge initiatives and will be interviewed on what they have learned to date, current barriers to the use of real-world evidence, and what the future holds both within and outside of the United States.
Moderator: Rachael L. Fleurence, PhD
Executive Director, National Evaluation System for Health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium (MDIC), Arlington, VA, USA
Speaker: Adrian F. Hernandez, MD, MHS
Vice Dean, Clinical Research, Duke University School of Medicine, Durham, NC, USA
Speaker: Michelle McMurry-Heath, MD, PhD
Worldwide Vice President and Global Head, Regulatory Affairs, Johnson & Johnson Medical Device Companies, Washington, DC, USA
Speaker: Danica Marinac-Dabic, MD, PhD, MMSc, FISPE
Director, Division of Epidemiology, Center for Devices and Radiological/OSB, U.S. Food & Drug Administration, Silver Spring, MD, USA
Speaker: Sally Okun, RN, MMHS
Vice President, Policy & Ethics, PatientsLikeMe, Cambridge, MA, USA
Tuesday, May 22, 2018
8:30 AM - 10:30 AM
Room: Hall A (Level 100)
SECOND PLENARY SESSION: DIGITAL HEALTH - HELP OR HYPE?

There is increasing availability and use of digital technologies such as smart phones, social media platforms, and wearables that potentially allow for significant increases in participation in both health-related research and general tracking of health metrics.  This session will provide a balanced overview of where there is reliable evidence that digital technologies have improved health and where there is mainly hype.  The session will address the following questions:

Does the empirical evidence confirm that digital health has actually improved public health?
What evidence is there regarding the global impact of digital health on research?
Has digital health helped to close health disparities’ gaps?
What are ethical concerns surrounding tracking health data and how are they being managed?

Moderator: C. Daniel Mullins, PhD
Professor & Chair, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, USA
Speaker: Chris A. Jones, DPhil, MSc, FRSM
Network Director Venture Investments, University of Vermont Health Network, Burlington, VT, USA
Speaker: Ejim E. Mark, MD, MPH, MBA
Chief Executive Officer & Founder, Access Healthcare Foundation, Rockville, MD, USA
Speaker: Nadia A. Sam-Agudu, MD
Assistant Professor, Pediatrics, Institute of Human Virology and University of Maryland School of Medicine, and Senior Technical Advisor, Pediatric and Adolescent HIV, Department of Prevention, Care and Treatment and International Research Center of Excellence, Institute of Human Virology Nigeria, Abuja, Nigeria
Wednesday, May 23, 2018
10:00 AM - 11:45 AM
Room: Hall A (Level 100)
THIRD PLENARY SESSION: EXAMINING THE ROLE OF PATIENT PREFERENCES TO INFORM REGULATORY DECISIONS
The US Food and Drug Administration (FDA) user fee agreements (MDUFA IV and PDUFA VI) require the FDA to develop systematic approaches to develop fit-for-purpose tools to collect meaningful patient input that can be incorporated into regulatory review. The Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) have taken different but complementary approaches to incorporate views of patients. CDRH has worked to understand quantitative preference elicitation methods to ascertain patients’ views about benefits and risks of medical products. CDER has focused on the qualitative preference elicitation methods. Preference researchers argue that when carefully conducted, stated-preference studies generate valid scientific evidence on patients’ views about relative desirability of harms, risks, benefits, and other features related to treatment alternatives. However, critics of preference research point out that humans often rely on decision heuristics, have poor numeracy, and fail tests of internal consistency. The panel will debate the strengths and limitations of stated-preference research and the extent to which patients’ views on benefit-risk tradeoffs for medical therapies can be relied upon to inform regulatory decisions.
Moderator: Shelby D. Reed, PhD, RPh bio
2017-2018 ISPOR President & Professor, Duke University, Durham, NC, USA
Speaker: Bennett Levitan, MD, PhD
Senior Director, Benefit-risk Assessment, Department of Epidemiology, Janssen Research & Development, Titusville, NJ, USA
Speaker: Matt Reaney, FRSPH, MSc
Global Head of Clinical Outcomes, Sanofi, Guildford, Surrey, UK
Speaker: Jeff Shuren, MD, JD
Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA
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