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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.


  • Keith  Wenzel

    Keith Wenzel

    • Volunteer
    • DIA Study Endpoints Community, United States

    Mr. Wenzel has 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 and speaking at this year’s DIA Annual Meeting.

  • Matthew  Reaney, PhD, MSc

    Matthew Reaney, PhD, MSc

    • Head of Science and Analytics, Patient Centered Endpoints
    • 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
    • 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 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable technology and BYOD eCOA in clinical trials. Bill is an active member of the C-PATH ePRO Consortium, is a member of the scientific leadership board of the Digital Medicine Society, and leads a group on wearable technology within DIA's Study Endpoints Community. Bill provides eClinical commentary on LinkedIn and Twitter (@billbyrom).

  • Joan  Buenconsejo, PhD, MPH

    Joan Buenconsejo, PhD, MPH

    • Head of Cardiovascular, Neuroscience and Early Development Biostatistics
    • Bristol Myers Squibb, United States

    Joan Buenconsejo is VP, Head of Cardiovascular, Neuroscience, and Early Development Biostatistics at Bristol Myers Squibb (BMS). Prior to BMS, she was a strategy lead at AstraZeneca and a statistics team leader at CDER, FDA. She is a long-time DIA member, has chaired the DIA Statistics and Data Science Community, has worked with the Advisory Council of North America, and served as program chair and steering committee member for the Annual FDA/DIA Statistics Forum, and track co-chair for the DIA Annual Meeting. Dr. Buenconsejo received a master’s degree in mathematical statistics from University of California, Irvine, and a MPH and PhD in biostatistics from Yale University.

  • 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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