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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

    • 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. Kim has authored scores of publications, served on dozens of steering committees and advisory boards, is a sought-after speaker, and has an extensive network of leadership contacts. Her passion for this work is rooted in personal experience, lived and as a family caregiver. To speed adoption of patient-centricity by life science companies, not-for-profit organizations, and academic research teams, in early 2018 Kim established a professional services firm, The Kith Collective, LLC.

  • Marilyn A. Metcalf, PhD

    Marilyn A. Metcalf, PhD

    • Senior Director, Patient Focused Development, Global Medical
    • 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 L. Michaels, MS

    Debra L. Michaels, MS

    • Associate Director, Scientific Programs
    • 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  Smith, DrPH, PhD, MPA

    Meredith Smith, DrPH, PhD, MPA

    • Director, Risk Management, Global Drug Safety, Research and Development
    • Alexion Pharmaceuticals, United States

    Meredith Smith is Risk Management Director at Alexion, Inc. where she leads a team responsible for medicinal product benefit-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, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER. 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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