Complimentary - A Visual Model of Patient Engagement in Benefit-Risk Assessment Through the Medical Product Life Cycle
Robyn R. Lim, PhD, PMP
- Senior Science Advisor, Office of Legislative and Regulatory Modernization, HPFB
- Health Canada, Canada
Originally a Health Canada safety and efficacy reviewer for CNS drugs, Dr Lim joined Health Canada's Progressive Licensing and Modernization initiatives in 2006 and developed the proposed new benefit-harm-uncertainty evidence standard and Progressive/Provisional Licensing strategies.
K. Kimberly McCleary
- Managing Director
- FasterCures, A Center of the Milken Institute, United States
Kim McCleary leads the Patients Count: Science of Patient Input program through which FasterCures aims to improve health by expanding opportunities for patients’ perspectives to shape the processes by which new therapies are discovered, developed and delivered. 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
- 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, MSc
- Senior Manager, Content Strategy and Policy Assessment
- DIA, United States
As a Senior Scientist for DIA, Debra Michaels provides guidance on educational content strategy and development. 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 2 years as Associate Director for Patient Advocacy with a rare disease therapy development project.
Meredith Y. Smith, PhD, MPA
- Global Risk Management Officer, Global Patient Safety
- Amgen Inc., United States
Meredith Smith is Global Risk Management Officer, Global Patient Safety & Labeling at Amgen, Inc. where she leads a team of scientists responsible for medicinal product benefit-risk assessment and risk management. Trained as a health services researcher, Dr. Smith has over 15 years of experience in the pharmaceutical industry in the areas of benefit-risk assessment, health outcomes and health economics, health policy, risk management, clinical research and development, drug safety, and patient-focused drug development. She has been an invited member of numerous FDA expert panels on benefit-risk management-related topics and has published widely in the peer-reviewed literature.