Presenters
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
Founder and Chief Executive Officer, The Kith Collective, LLC, United States
Kim McCleary has been at the forefront of patient engagement for more than 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
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
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 Yearsley Smith, PhD, MPA, FISPE
Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology, and a faculty member at the Alfred E. Mann School of Pharmacy & Pharmaceutical Sciences at the University of Southern California. Meredith has been an invited participant in numerous risk management workshops and panels sponsored by the US FDA, and has served as a member of CIOMS IX Practical Approaches to Risk Minimisation for Medicinal Products, CIOMS XI Patient Involvement in the Development and Safe Use of Medicines and IMI-PREFER.
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