We are now witnessing a paradigm shift in patient engagement. Instead of contemplating the risk of doing patient engagement, growing numbers of decision-makers in medicines development are speaking of the risks of not doing patient engagement.

Building synergies, one cause at a time. The Synergist 2018 report

The The Patient Engagement Quality Guidance

We are now witnessing a paradigm shift in patient engagement. Instead of contemplating the risk of doing patient engagement, growing numbers of decision-makers in medicines development are speaking of the risks of not doing patient engagement.

The co-developed Patient Engagement Quality Guidance has been embraced by the patient engagement community which has shared it internally and beyond and utilised it for patient engagement projects.

Read more

The SYNaPsE platform

In 2018, the SYNaPsE platform has evolved from mapping Patient Engagement initiatives to also connecting the whole Patient Engagement ecosystem of experts and their organisations to initiatives and related resources.

Read more

Reasonable Legal Agreements

The project aims to improve legal agreements between both parties while providing adequate protection and rules for all sides.

Read more

Introduction

Message from the Programme Director

We are now witnessing a paradigm shift in patient engagement. Instead of contemplating the risk of doing patient engagement, growing numbers of decision-makers in medicines development are speaking of the risks of not doing patient engagement.

Behavioral science, patient engagement capacity, and real-world evidence support the evolution towards a new model that integrates patient engagement at all levels. With FDA building expectations of patient input and how to generate it, we are approaching a tipping point where co-creation with patients is on the verge of becoming the default option throughout the system.

Momentum is behind the patient engagement community and we are now getting into the nuts and bolts of making PE work. Whether it’s the WECAN initiative on reasonable legal agreements between patient advocates and drug companies; forthcoming initiatives to determine the Fair Market Value of patient input; the EU-backed PARADIGM partnership; or the patient-centric focus of The Economist Intelligence Unit’s new report on the future of drug development, it is clear that PE is becoming internalised by the medicines development system.

PFMD has been playing its part in driving change in the patient engagement community. 2018 was a pivotal year for our collaborative initiative, preparing the way for a new phase in our shared history - where we can build on the PE Quality Guidance as the robust foundation to develop more specific ‘How-to’ material, training modules, contract templates and fair market value assessment, plain language summaries, and more.

Nicholas Brooke,

Chief Executive Officer The Synergist

Achievements

PFMD saw its membership growby 5 organisations in 2018. The membership is now 30 strong, welcoming Servier, Arthritis Foundation, Sant Juan de Deu Research Foundation, American Migraine Foundation, and Sheffield Biomedical Research Centre. This has increased the project’s geographic and stakeholder group reach.

The framework-building work stream produced Patient Engagement Quality Guidance that has been shared within and beyond organisations, referred to in conferences and used as a tool to plan patient engagement projects and assess the quality of ongoing and completed projects.

The co-developed Patient Engagement Quality Guidance has been embraced by the patient engagement community which has shared it internally and beyond and utilised it for patient engagement projects. These initiatives spanned the full medicines-development continuum, the lifecycle of medicines, and care continuum in both health and social research. Member organisations have adopted it for various purposes, on a project basis or as a tool to design, assess and manage all their patient engagement activities. Other non-member companies have simply downloaded the document and worked through it step by step.

Currently, the Patient Engagement Quality Guidance Quality Guidance is in the piloting phase with 5 projects in Europe and the United States by 2organisations with diverse expertise including patient advocacy, medical affairs, pharmaceuticals, research and charity, healthcare services and consultancy. The outcomes of these projects will help us understand and explore the impact Patient Engagement Quality Guidance can bring to users. It can also improve its usability and help us incorporate it into Synapse, allowing you to manage all your PE projects in one place.

To continue building the PE Metaframework, the public consultation that was conducted over the summer of 2018 gave us valuable information on how and which of the 150 PE activities identified in the literature review phase should be prioritised. The consultation received 133 responses from 26 countries (taking us beyond the Europe and US) with all stakeholder groups represented.

Another relevant output of 2018 was the Book of Good Practices, which offers a set of 8 cases that exemplify one or more of the 7 PE Quality Criteria introduced in the Patient Engagement Quality Guidance. We will continue to feed it as a source of best practices and case studies for ongoing and new PE projects.

The SYNaPsE platform has evolved from mapping Patient Engagement initiatives to also connecting the whole Patient Engagement ecosystem of experts and their organisations to initiatives and related resources. The platform has grown 18% from 2017 in initiatives and 30% in organisations, further adding to the diversity of the tool. This kind of growth tells us the impact Synapse has for those working in patient engagement - it can bring efficiency and productivity to companies and organisations by enabling users to share their patient engagement projects, knowledge and reports in one coordinated place, available 24/7. A new relationship management function is piloted to allow any user to map, connect and now operate patient engagement. This allows them to shape, plan and assess patient engagement projects with partners, to keep tracks of relationship with partners and who they have been in touch with within your organization, and finally to aggregate the bigger picture of your organization’s activities and its performance.

In terms of reach and impact, PFMD Communication in 2018 has focused on reaching not only the patient engagement enthusiasts, but also the early majority that might not yet have fully embraced patient engagement. In order to advance a more systematic, high quality and meaningful patient engagement, we need to create a mindset shift on a larger scale and not talk only to the “converted”. PFMD’s relevance and reputation continues to grow with a milestone publication on understanding stakeholders’ expectations of patient engagement across the medicines lifecycle. PFMD also published 45 insightful blogs, of which 22 were guest posts from members and collaborators receiving over 7,000 views by the PE community. Constant communication with members and other interested groups has always been one of the focal points for PFMD and this continued in 2018 with 7 internal and external newsletters sent out reaching more than 4,000 patient engagement enthusiasts. Moreover, PFMD participated in 18 external conferences all over the globe, of which 12 included speaking opportunities.

2018 was a pivotal year for our collaborative initiative, preparing the way for a new phase in our shared history - where patient engagement goes mainstream. Various initiatives within the patient engagement landscape have begun aligning with PFMD, joining efforts to maximise the global impact. This collective approach will be both a cause and a consequence of patient engagement going mainstream.

To ensure adoption and viable partnership between pharmaceutical companies and patient advocates, WECAN with the support of PFMD, initiated the multi-stakeholder project “reasonable agreements between patient advocates and pharmaceutical companies” (RAPP). The project aims to improve legal agreements between both parties while providing adequate protection and rules for all sides. Collaboration between PFMD and WECAN on RAPP has produced the very first deliverable - “The Guiding Principles” - that aims to help companies working with patients and patient organisations to formulate agreements that are reasonable for both parties. The work continues with drafting contract templates that can be adopted by all stakeholders, starting with contract templates for Patient Advisory Boards and then collaboration, consulting and speaking agreement.

2019 Approach

The need for PFMD remains present and is even increasing.

Since the beginning, PFMD has developed a systematic approach that ensures co-creation upon existing knowledge and balanced collaboration with all relevant stakeholders. Not only does this approach allow us to work in iterations and involve many collaborators in the co-creation process, it also prevents us from deviating from agreed objectives as checkpoints are frequent in each iteration. And finally, it allows us to move away from the isolated and fragmented practices to bring all good practices into a unified coherent framework. The next step in making patient engagement happen systematically sees PFMD building on existing working groups to deliver “How-to Modules” for patient engagement activities, skills and and development phases. We are taking a collaborative leadership role in defining and co-creating a patient engagement training programme for the pharmaceutical industry.

The planned training will be developed to take into account the complexities in big and small companies as well as the differing needs of patient engagement capacity-building in every company. The content and delivery method of the training will be created to match user and company needs.Interested people and organizations have the opportunity to join this work in 2019.

PFMD will focus on expanding the patient engagement ecosystem through strategic collaborations with other stakeholders who are working towards the same goal. This translates into continued positive discussions with the FDA on potential synergies, in particular about the system changing work on Patient Focused Drug Development (PFDD) in increasing the demand and creating the conditions for all stakeholders to adopt Patient Engagement systematically. Specifically, the opportunities to support the ongoing Clinical Outcomes Assessment (COA) project will be the starting point in 2019.

One of the most exciting projects in 2019 will be the collaboration with European and US-based groups to develop a calculator for fair market value (FMV) compensation for patient input and expertise. PFMD will be the international connection to the regional work groups - the National Health Council (NHC), EFPIA Think Tank, and WECAN - and will act as the platform to globalise the FMV solutions created. First outcomes are expected in the summer.

Compensation for Patient Experts at Fair Market Value

Tackling together the patient engagement hot topic

Take me to the survey

Latest content on the blog

Europe highlights patient role in innovative medicines

+ Find out more

Cancer patients to advise on Ireland’s oncology services

+ Find out more

The wide-ranging impact of patient access

+ Find out more

“Our ultimate goal is to bring access to patients in a much more efficient way for new medicines.”

“I truly believe what we’ve seen so far is many individual initiative that have really not talked to each other, that sometimes duplicated the work and here with PFMD our ultimate goal is to bring access to patients in a much more efficient way for new medicines. PFMD can bring all these stakeholders together. First of all can map all the initiatives, secondly reach a consensus what the best instruments, the best framework would be, the best tools would be to really create meaningful patient engagement. And third, it can then develop a framework that would be applicable for all stakeholders and would ultimately again lead to much much better medicines to patients."

Tony Hoos

Head of Medical, Amgen Europe

“Our ultimate goal is to bring access to patients in a much more efficient way for new medicines.”

“Lorem ipsum dolor sit amet, consectetur adipiscing elit. Aenean auctor leo sit amet enim euismod, ut venenatis magna euismod. In convallis ipsum quis aliquet porta. Aliquam sapien nibh, tempor sit amet risus a, lacinia facilisis turpis. Interdum et malesuada fames ac ante ipsum primis in faucibus. Praesent lacinia lectus sed sapien convallis, ut lacinia lorem posuere. Sed at ipsum vitae risus iaculis commodo eget et ante. Proin leo augue, lacinia sit amet fermentum a, suscipit at lorem. Cras eleifend dignissim sem, ut tristique ligula dignissim non."

Tony Hoos

Head of Medical, Amgen Europe

The PFMD Team

Board members and PFMD team

The PFMD Board consists of:

Nicola Bedlington

Secretary General, European Patients Forum

Veronica Todaro

Vice President, National Programs, Parkinson’s Disease Foundation

Graeme Johnston

Patient Advocate, Individual/ Patient

Alexandra Moutet

Global Head of Patient Affairs, UCB

Roslyn Schneider

Global Patient Affairs Lead, Pfizer

Andrew Benzie

Secretary General, EHead Of Patients In Partnership Programme, GSK

Luther Clark

Deputy Chief Patient Officer, Global Director, Scientific Medical And Patient Perspective (SMPP), MSD/ Merck

Katherine Capperella

Global Patient Engagement Leader, Janssen

Rebecca Vermeulen

Head Global Medical Liaisons and Communications, Roche

Elisa Ferrer

Patient Engagement Manager, EURORDIS

Kelli Collins

Vice President Patient Engagement, National Kidney Foundation

Kimberly McCleary

Kimberly McCleary Managing Director, FasterCures

Lode Dewulf

Consultant, Permanent Guest

Paula Wray

Senior Public Involvement Manager, NIHR INVOLVE

The PFMD Executive Team consists of:

Marc Boutin

Chief Executive Officer, National Health Council

Jan Geissler

Director, EUPATI

Tony Hoos

Head Of Medical, Europe, AMGEN

The PFMD Team consists of:

Nicholas Brooke

Executive Director

Eric Blanchet

Operations Director

Loïc Bonnevie

Product Owner and Functional Analyst (Freelance)

Jean-Christophe Capelle

Financial Director

Helena Harnik

Programmes Director

Chi Pakarinen

Project Manager

Roxana Radu

Communications Manager

Anne-Marie Hamoir

Head Of Membership And Project Management

Gulwish Ahmed

Communications Assistant

Leticia Erenas Ardanza

Project Coordinator

Lise Brooke

Growth Hacker

Bernadette Hendrickx

Scientific Advisor

Ify Sargeant

Editor In Chief

Geoffroy Ryckaert

Head Of IT

Laila Deeb

Web Developer

Our partners

They made all this possible

A total of 30 partners have decided to join forces to support and push forward our initiatives. This represents a major change in philosophy that has already started generating significant output on all projects.