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).

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.

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.

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, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years of experience in health outcomes, drug safety and regulatory policy in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER and is an adjunct professor at the University of Southern California School of Pharmacy. She has been a pioneer in the application of Implementation Science methods within the context of drug development and has published widely in the peer-reviewed literature.