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Virtual

Jun 05, 2023 11:00 AM - Jun 05, 2023 12:30 PM

(US Eastern Standard Time)

Digital Health Technology and Meaningful Change

Join industry and regulatory experts in a discussion about meaningful change thresholds and ways to forge a path towards establishing digital endpoints.

Presenters

Keith  Wenzel

Keith Wenzel

Volunteer, DIA Study Endpoints Community, United States

Mr. Wenzel worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working with and for contract research organizations, technology partners and clinical trial sponsors. His areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials. He has been on the program committee of several Drug Information Association meetings and is chairing a session at this year’s DIA Annual Meeting.

Matthew  Reaney, PhD, MSc

Matthew Reaney, PhD, MSc

Head of Science and Analytics, Patient Centered Solutions, IQVIA, United Kingdom

Matthew Reaney is Scientific Lead of Patient-Centered Endpoints at IQVIA, where he works to amplify the patient's story through science and technology to improve outcomes in clinical drug development and routine clinical practice. He is also the co-Chair of the DIA Study Endpoints Community, a Chartered and Practitioner Health Psychologist, a Chartered Scientist, a Fellow of both the Royal Societies of Medicine and Public Health, and an Associate Fellow of the British Psychological Society. Matt is particularly interested in understanding and embracing patient heterogeneity in defining outcome measures such as benefit-risk and patient perception and preference.

Cheryl  Coon, PhD

Cheryl Coon, PhD

VP, Clinical Outcome Assessment Program, Critical Path Institute, United States

Cheryl D. Coon, PhD is a psychometrician with 15 years of experience as a consultant in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments, with particular interest in score interpretation, and leads the statistical analysis of clinical trial PRO data. Her psychometric and statistical expertise has allowed her to support regulatory communication across a broad range of therapeutic areas. Dr. Coon earned her PhD degree in Quantitative Psychology at the University of North Carolina at Chapel Hill, focusing on item response theory and the early work on PROMIS.

Bill  Byrom, PhD

Bill Byrom, PhD

Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom

Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 80 publications and two industry textbooks on ePRO. Bill serves on 2 ISPOR task forces, the C-Path working group on CHF, the DIA's working group on meaningful change, and is a member of the C-Path eCOA Consortium where he previously served as Industry Vice Director. Bill is an advisory board member of the LABDA research program on sensor-derived movement behavior analysis, and a Senior Visiting Professor within Nottingham Trent University's Medical Engineering Design Research Group.

Emuella  Flood

Emuella Flood

Director, Patient-Reported Outcomes, AstraZeneca, United States

Emuella Flood is co-chair of the DIA Study Endpoints Community and has been working in the field of patient-centered outcomes for over 20 years. She recently joined AstraZeneca as PRO Director, with a focus on PRO strategy and implementation in women's cancer. Prior to joining AstraZeneca, Emuella was Senior Principal of Patient-Centered Outcomes (PCO) for ICON Clinical Research, where she led the US East Coast PCO research team, providing strategy and guidance to capture the patient experience.

Marie  Mc Carthy, MBA, MSc

Marie Mc Carthy, MBA, MSc

Digital Endpoint Lead, Novartis, Ireland

With over 12 years’ experience supporting the use of digital health technologies in drug development studies and clinical research. I have spent these years not only evangelizing the value and benefit of digital endpoints derived from digital health technologies but also supporting multi-stakeholder teams successfully implement these technologies in trials. I am passionate about ensuring that the patient voice is not lost in the digitizing of our studies and that we continue to ensure that the technologies we deploy are low burden, easy to use, passive and generate data that is meaningful to study participants.

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