title: Culture and Process Change as a Priority for Patient Engagement in Medicines Development.
abstract: Patient Focused Medicines Development (PFMD) is a not-for-profit independent multinational coalition of patients, patient stakeholders, and the pharmaceutical industry with interests across diverse disease areas and conditions. PFMD aims to facilitate an integrated approach to medicines development with all stakeholders involved early in the development process. A key strength of the coalition that differentiates it from other groups that involve patients or patient groups is that PFMD has patient organizations as founding members, ensuring that the patient perspective is the starting point when identifying priorities and developing solutions to meet patients' needs. In addition, PFMD has from inception been formed as an equal collaboration among patient groups, patients, and pharmaceutical industry and has adopted a unique trans-Atlantic setup and scope that reflects its global intent. This parity extends to its governance model, which ensures at least equal or greater share of voice for patient group members. PFMD is actively inviting additional members and aims to expand the collaboration to include stakeholders from other sectors. The establishment of PFMD is particularly timely as patient engagement (PE) has become a priority for many health stakeholders and has led to a surge of mostly disconnected activities to deliver this. Given the current plethora of PE initiatives, an essential first step has been to determine, based on a comprehensive mapping, those strategic areas of most need requiring a focused initial effort from the perspective of all stakeholders. PFMD has identified four priority areas that will need to be addressed to facilitate implementation of PE. These are (1) culture and process change, (2) development of a global meta-framework for PE, (3) information exchange, and (4) training. This article discusses these priority themes and ongoing or planned PFMD activities within each.
authors.affiliation: National Health Council, Washington, DC, USA.
authors.forename: Marc
authors.initials: M
authors.lastname: Boutin
authors.affiliation: UCB Biopharma, Brussels, Belgium.
authors.forename: Lode
authors.initials: L
authors.lastname: Dewulf
authors.affiliation: Amgen (Europe) GmbH, Zug, Switzerland.
authors.forename: Anton
authors.initials: A
authors.lastname: Hoos
authors.affiliation: European Patients' Academy on Therapeutic Innovation, Brussels, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Geissler
authors.affiliation: Parkinson's Disease Foundation/Clinical Trials Transformation Initiative, New York, NY, USA.
authors.forename: Veronica
authors.initials: V
authors.lastname: Todaro
authors.affiliation: Pfizer Inc, New York, NY, USA.
authors.forename: Roslyn F
authors.initials: RF
authors.lastname: Schneider
authors.affiliation: AstraZeneca, Cambridge, United Kingdom.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Garzya
authors.affiliation: GlaxoSmithKline, Brentford, United Kingdom.
authors.forename: Andrew
authors.initials: A
authors.lastname: Garvey
authors.affiliation: Merck Sharp & Dohme Ltd, Hoddesdon, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Robinson
authors.affiliation: National Kidney Foundation, Washington, DC, USA.
authors.forename: Tonya
authors.initials: T
authors.lastname: Saffer
authors.affiliation: CANCER 101 Foundation, Society for Participatory Medicine, Health Collaboratory New York, NY, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Krug
authors.affiliation: Ismedica Ltd, Staffordshire, United Kingdom.
authors.forename: Ify
authors.initials: I
authors.lastname: Sargeant
keywords: patient engagement priorities medicines development