2019 Preliminary Agenda

  • Co-Chair Welcome & Opening Remarks

    Lode DeWulf, MD

    Chief Patient Officer, Servier

    Andrew Garvey

    Global Patient Advocacy Lead, GlaxoSmithKline

  • Patient Keynote: Former English Footballer and Patient Advocate Keynote

    Geoff Thomas, former footballer who won nine caps for England and captained the Crystal Palace Football Club to the FA Cup final in 1990 was diagnosed in 2003 with chronic myeloid leukaemia and given three months to live. Thanks to great doctors, access to investigational medicines and a bone marrow transplant from his sister, Geoff, 15 years later is helping lead the fight to accelerate science for the benefit of patients. Geoff joins us to talk about his journey through professional sports, the fight against cancer and what he has learned and how he now advocates to help others. Geoff not only fought leukemia, but also helped change the health care system in the UK to get clinical trials as a care option for patients. Join us and find out how.

    Geoff Thomas

    Patient Advocate, Cancer Survivor and Former Professional Soccer Player

  • New Methodologies and Guidance in Patient Engagement New PFMD Guidance on How to Enhance the Quality of Patient Engagement throughout the Medicines Development

    In this session, Nicholas Brooke, CEO of Patient Focused Medicines Development will share the results and implications of the 2018 guidance on how to enhance the quality of patient engagement. The guidance was co-developed with the input of multiple stakeholders in patient engagement (Industry, Patients Associations, Researchers) to support the PE journey by using a robust methodology whose consequences will be to generate impactful results. Key focus:

    • When to use the tool? Planning and development; Quality and impact assessments; and Gap analysis.
    • How to assess the 7 quality criteria in your patient engagement practices
    • Show the aggregation of data, to date, on the impact of the guidance since it launched

    Nicholas Brooke

    CEO, Patient Focused Medicines Development (PFMD)

  • Don’t Do Different things – Do Things Differently! Key learnings from Santhera Pharmaceuticals when Piloting the PFMD Patient Engagement Quality Guidance

    In this session, Dr Vanessa dos Reis Ferreira, Head of Patient Advocacy Europe at Santhera Pharmaceuticals will share how, when and where the collection of patient insights is fully integrated into the medicines development process at Santhera. Dr dos Reis Ferreira will walk the audience through how her team has developed best practices through the use of the recently launched PFMD Patient Engagement Quality Guidance, and overall challenges and opportunities when integrating the patient voice.

    Vanessa Ferreira
    Vanessa dos Reis Ferreira, PhD, MBA

    Head Patient Advocacy Europe, Santhera Pharmaceuticals

  • Norgine Case Study: How to Develop Effective Relationships through Simultaneous Employee and Patient Engagement

    In 2018 Norgine held their inaugural patient meeting for a product to review the supporting materials and plain language summaries. During the meeting the patients were taken on a walkthrough of the office to meet the different people involved in getting the product to market. The exercise was designed to achieve a number of things:

    • Breakdown communication barriers between patients and pharma
    • Challenge pharma teams to consider how their job/role benefits or impacts patients
    • Educating pharma on how to communicate without promoting
    • Build useful and effective relationships

    In this session hear from both the patients and the Norgine team on their experience with this new strategy. How did it impact them as individuals but also as a group with shared goals in providing new treatment for the community.

    Led by:

    Liz Clarke
    Liz Clarke

    VP Medical Affairs, Norgine


  • Connecting Employee Centric Culture to Patient Centric Culture

    • What impact can engaged employees have on positioning the company as the preferred partner for patients and other collaborators?
    • How can this be done? And for what purpose?
    • How do you engage your employees and empower them to implement patient involvement strategies?
    • Inspiring employees to make change?

    Lode DeWulf, MD

    Chief Patient Officer, Servier

  • Panel: How to Ensure Excellent Patient Engagement in an Outsourced Clinical Trial?

  • Large Pharma Patient Engagement Methodologies: Demonstration and Review

    In this section we will hear from 3 companies on how they implemented three different methodologies:

    1. Focus Group
    2. Online Engagement (need to identify an example)
    3. Advisory Board (need to identify an example)

    Each presenter will walk the audience through the protocol that was implemented and lessons learned. The section will conclude with an open panel discussion with the patient perspective on what elements of each strategy they liked or felt could be improved upon.

  • How MSD is Integrating the Patient into their Protocol Design via Focus Groups

    In this session, Paul Robinson, Executive Director, Patient Innovation at MSD will walk the audience through how they integrated patient input in their protocol design process.

    • How and why did they decide on the focus group method
    • Why did they decide to outsource the recruitment
    • How they gained internal support and tips for doing so
    • Outline and demonstration of the “post-it” method
    • In reviewing timeline, cost and effectiveness, what would you do differently moving forward?

    Paul Robinson
    Paul Robinson

    Executive Director, Patient Innovation, MSD

  • Communicating with Patients Panel: What it the Process to Understand the Language of Patients - the Value of Health Literacy

    • Who is responsible for delivering the why and how of getting involved in medicines development? Pharma, regulators or advocacy groups?
    • What practical goals can the industry set to effect change?
    • How are we communicating the trial information to patients and care partners to help them understand and make informed decisions?
    • How can we address the communication challenges faced by patients and care partners while navigating the system?
    • Considerations for language used in adverse events reporting, informed consent and clinical trial summaries

    Jay Duhig

    Director of Patient Integration, AbbVie

  • Addressing the Urgent Need for Plain Language Summaries for Clinical Trials and Medical Publications

    • What type of information do the different stakeholders want communicated
    • Considerations for publishing a clinical trial summary for patients: format, type of data, language
    • What is considered appropriate language and/or graphics?

    Nicholas Brooke
    CEO, Patient Focused Medicines Development (PFMD)

    Representative from the British Medical Journal (invited)

  • How Pfizer is Driving its "Patient First" Global Initiative Across Multiple Departments and Teams

    • Outline of the initiative; implementation strategy, goals and impact
    • The impact of senior leadership support
    • Considerations and differences in getting buy-in from multiple departments
    • Making the initiative accountable
    • Steps to strategic versus operational patient input
    • Barriers or hurdles?

    Berkeley Phillips
    Medical Director, Pfizer

  • Advocacy and Patient Involvement in Clinical Research Pharma/Advocacy Collaboration Case Study: UCB and Parkinson’s UK

    The journey: challenges, hurdles, successes and lessons learned.

    Alexandra Moutet
    Alexandra Moutet, MD

    Global Head of Patient Affairs, UCB

    Natasha Ratcliffe

    Research Involvement Officer, Parkinson’s UK

  • Panel Discussion: Best Practices for Pharma - Patient Advocacy Partnerships

    In this session we hear from pharma and advocacy representatives on:

    •  Advocacy point of view on is what pharma is doing in clinical trials and medicines development truly patient centric?
    • How can advocacy groups work with the pharmaceutical industry to improve the clinical trial process?
    • How can advocacy get their foot in the door at pharma? Pharma’s advice.
    • How can pharma and advocacy better work together?
    • Explore the value of pharma reps spending time at an advocacy office to better understand what they do
    • How can this partnership impact patients and medicines development?

    Chris Macdonald

    Research Involvement Manager, Arthritis Research UK

  • EUPATI Patient Graduates: What Impact is this Having on Clinical Trials?

    • Industry experiences
    • Perspective on the pulse of the industry’s acceptance of patient input? Current barriers? Success stories?
    • A pulse on the impact?
    • Recommendations for all stakeholders moving forward

    Richard Stephens

    Patient/Consumer Lead, Chair Consumer Forum, NCRI


    Souzi Makri

    EUPATI Graduate and Patient Advocate

  • Kids Barcelona: the First Young Persons Advisory Meeting in Spain

    The YPAG works together with the Innovation Department with the goal to include the voice of children and families in research, clinical trials and innovation projects. The main goals of the network are:

    • Improve the capacity to collaborate with the different stakeholders involved in the process of research and development of innovative drugs: academia, regulators, ethics committees, pharma companies, etc.
    • To help to the European Medicines Agency to develop the “Framework of involvement of young patients” in their activities
    • To accumulate experience in relation with therapies for children and moreover in the most innovative treatments.
    • Promote the design and development of clinical research initiatives in children at a European level.
    • Unify the curriculum for training programs and empowerment of young, expert patients.
    • Promote and lead the creation of new groups.

    In this session, hear about how the YPAG has impacted clinical research in Europe to date.

    Begoña Nafría

    Patient Engagement in Research Coordinator, Hospital Sant Joan de Déu

  • Brexit: The Impact of Brexit on Patient Involvement Initiatives

    With the EMA focused on relocation and not on innovation or new guidance, what does this mean for the industry and the patient involvement movement? In this session, hear from multiple stakeholders on their perspective on the steps and considerations needed to ensure a smooth transition. More specifically:

    • How to keep the channels of communication open between industry and the EMA during the transition?
    • EMA point of view on the continuation of patient involvement initiatives?
    • How will Brexit impact the different stakeholders but more specifically patients?
    • How will relationships between UK and EU regulators evolve

  • Patient Data Ownership and Sharing What Does Patient Data Ownership Look Like, Shortcomings, Goals and Actions?

    • How does the industry define “ownership”?
    • What “rights” do patients have to their data and how they use it?


  • How do Patients Become Partners in the Sharing of Data to Advance Science?

    • How to encourage the sharing of suitably anonymized data to further medicines development for the benefit of patients?
    • What are the barriers/issues? Public mistrust of pharma? Language, medical records versus coded data?

    Richard Stephens

    Patient/Consumer Lead, Chair Consumer Forum, NCRI

  • How to Return Data to Patients

    • How do patients want to receive their data?
    • What is the best method to share data with patients?
    • What “type” of data do patients want to receive?
    • How can Pharma work with patients to ensure they are disseminating the information that is important to them?
    • Considerations for publishing a clinical trial summary for patients: format, type of data, language
    • What are the positive and negative outcomes of sharing data with patients in real time? (multiple perspectives)

  • The Monetization of Patient Data and Its Impact on Medicines Development

    • Who are the players? Intermediaries, Regulators, Patients and Patient Organizations.
    • Is a new industry emerging?
    • Intermediaries: no social or patient interest, solely focused on $$. How do prevent entrepreneurs from monopolizing patient data?
    • Regulators: will they allows patients to monetize their data? What are the pros and cons from the perspective of the regulator?
    • Patient Organizations: Pharma want representative data from the members of these organizations. The members are not representative of the entire population. What is the true value of this data?

    Lode DeWulf, MD

    Chief Patient Officer, Servier

  • Panel: Technologies for Reducing the Burden for Patients and Investigators in Clinical Trials