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Complimentary - A Visual Model of Patient Engagement in Benefit-Risk Assessment Through the Medical Product Life Cycle

How are we engaging patients, and how can we do better? A new visual model depicts the current state and highlights where stakeholder efforts can improve patient outcomes.


  • Robyn R. Lim, PhD

    Robyn R. Lim, PhD

    • Senior Science Advisor, Health Products and Food Branch
    • Health Canada, Canada

    Dr Lim’s focus is modernizing Canada’s federal drug regulatory system, developing the benefit-harm-uncertainty evidence standard for Canada’s amended Food and Drugs Act. Her interests are scientifically and socially-responsible patient-focussed and life-cycle approaches for therapeutic product development and decision-making. She assessed CNS drugs (TPD, HPFB, 1996-2006) and developed TPD’s Good Review Guiding Principles, receiving awards for regulatory assessment excellence and creativity/innovation. She holds a Ph.D. in Molecular Neurophysiology (Physiological Laboratory, Cambridge University, Trinity College, Cambridge, U.K), B.Sc.H. and M.Sc. in Biochemistry (Queen's University, Kingston, Ontario).

  • K. Kimberly  McCleary

    K. Kimberly McCleary

    • Founder and Chief Executive Officer
    • The Kith Collective, LLC, United States

    Kim McCleary has been at the forefront of patient engagement for nearly 30 years. She is a nationally regarded subject matter expert on patient-focused medical product development, patient-centered benefit-risk assessment, and organizational change. McCleary serves on numerous advisory and planning committees and speaks regularly on topics including patient-centered benefit-risk assessment, patient-focused medical product development, and changing organizational culture to be more patient-centered. Kim is a member of DIA’s Advisory Committee for North America and the steering committee for the Medical Device Innovation Consortium’s Patient-Centered Benefit Risk project.

  • Marilyn A. Metcalf, PhD

    Marilyn A. Metcalf, PhD

    • Patient Engagement Lead
    • GlaxoSmithKline, United States

    Dr. Metcalf leads GSK’s Centre of Innovation to enhance pharmacovigilance, benefit-risk evaluation, and collaboration with patients. The Centre strives to advance insight, communication, and work practices by engaging with partners inside and outside the company. Dr. Metcalf is a member of GSK’s Global Safety Board and Central Safety Department Leadership Team. She participates in patient/industry/academic alliances including Patients as Partners, DIA Patient Engagement, and TransCelerate.

  • Debra  Michaels, MS

    Debra Michaels, MS

    • Associate Director, Scientific Programs & Patient Engagement Lead
    • DIA, United States

    In her content-focused role at DIA, Debra Michaels provides guidance on educational content strategy and development across the DIA Americas portfolio of educational programs as well as subject matter expertise in selected areas. She is the lead for DIA’s Patient Engagement thought leadership initiative and has collaborated on several projects to advance patient-centric practice among stakeholders. Debra brings clinical, public health, and biopharmaceutical industry experience to her current role, including work as a patient advocate for the Pompe and MPS Disease communities in a rare disease biopharma company.

  • Meredith Y. Smith, PhD, MPA

    Meredith Y. Smith, PhD, MPA

    • Global Risk Management Officer, Global Patient Safety
    • Amgen Inc., United States

    Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience in the pharmaceutical industry. She has served on numerous FDA expert panels and on CIOMS WGs VIII, IX and XI. Currently, she is the Pharmacovigilance Track Chair for the 2019 DIA Annual Meeting Planning Committee. Recently, she led the effort to develop the RIMES Statement, a set of quality reporting guidelines for risk minimization evaluation studies.

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