Agenda

  • 8:00 am

  • Registration

  • 8:30 am

  • Co-Chairs’ Welcome and Introduction of Patient Involvement Toolbox

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    Anton Hoos, MD, PhD, MBA

    Head of Medical, Amgen Europe

  • 8:45 am

  • Patient and Industry Perspectives on Making Patient Involvement a Standard Operating Procedure (SOP) in the Lifecycle of Medicines

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    Anton Hoos, MD, PhD, MBA

    Head of Medical, Amgen Europe

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    Eric Low

    Chief Executive, Myeloma UK

  • 9:25 am

  • A 360° Perspective on Innovative Ways of Patient Involvement in Medicines Development

    This multi-stakeholder session will delve into innovative approaches to patient involvement in clinical development and address opportunities and challenges.

    Patient Perspective:

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    Alastair Kent
    Director, Genetic Alliance UK

    Industry Perspective:
    hoos_anton-bw
    Anton Hoos, MD, PhD, MBA

    Head of Medical, Amgen Europe

    Regulatory Perspective:

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    Isabelle Moulon
    Senior Advisor on Stakeholders Engagement, EMA

  • 10:10 am

  • Networking Break

  • 10:55 am

  • EMA’s Methodology on Patient Involvement

    EMA’s collaboration and interaction with patients and consumers has been a progressive journey whereby the Agency has endeavoured to learn by experience. While these interactions are well established, there is always work to be done to ensure that the right expert is identified for each activity and that the right level of support is provided throughout the interaction with proper follow up. In this session, EMA’s Nathalie Bere will demonstrate how:

    • Engagement has increased not only in numbers but also in scope to ensure there are opportunities in place for the patient voice to be heard along the medicines lifecycle.
    • The framework of interaction between the EMA and patients, consumers and their organisations outlines the key objectives and the different methodologies for involvement; be it as representatives or as individual patient experts, depending on the nature of the activity.
    • Appropriate training is given to those participating and that there is a constant review of practices to ensure that the interaction is as fruitful as possible for all concerned.

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    Nathalie Bere, MSc

    Patient Relations Coordinator, European Medicines Agency

  • 11:25 am

  • Progress Report Discussion on the “Partnering with Patients in the Development and Lifecycle of Medicines: A Call to Action”

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    Nicholas Brooke
    Chief Executive, PFMD

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    Jan Geissler

    Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)

  • 12:15 pm

  • Lunch

  • 1:45 pm

  • Patient-focused Medicines’ Development to Inform Access Decisions

    • How do Early Dialogue/Scientific Advice processes focussed on HTA involve patients?
    • What works well?
    • What are the stumbling blocks?
    • What can we do differently?

    Moderator:
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    Karen Facey, PhD

    Founder / Coordinator, HTAi Interest Group for Patient & Citizen Involvement in HTA / HTAi Patient Involvement Methods and Impact Working Group

    Panelists:
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    Anne Beal, MD

    Chief Patient Officer, Sanofi

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    Eric Low

    Chief Executive, Myeloma UK

    moulon_isabelle-bw
    Isabelle Moulon

    Senior Advisor on Stakeholders Engagement, EMA

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    Victoria Thomas

    Head of Public Involvement, Public Involvement Programme, National Institute for Health and Care Excellence (NICE)

  • 2:30 pm

  • Patients Influencing Policy

    kent_alastair-bw
    Alastair Kent

    Director, Genetic Alliance UK

  • 3:00 pm

  • Networking Break

  • 3:45 pm

  • Shifting the Paradigm to What Matters the Most to Patients: Patient Centered Outcomes Beyond PRO's

    This session will address Sanofi’s shift from patient reported measures to patient centered measures and demonstrate the need to start with what matters the most to patients in terms of what is included in clinical trials. Key areas to be addressed:

    • Value as an added focus to demonstrate benefits
    • Improved outcomes for patients
    • Patient Prioritized Outcomes: Beginning with an understanding of patients needs and priorities can provide opportunities for a more robust assessment and measurement of critical patient outcomes
    • Tools and methods to measure outcomes that matter most to patients and answer their priority questions

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    Anne Beal, MD

    Chief Patient Officer, Sanofi

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    Aude Roborel de Climens, PhD

    PRO Lead, Health Economics & Outcomes Research (HEOR), Sanofi

  • 4:10 pm

  • The GSK Health Advisory Board: Bringing Patient Insights into GSK Since 2004

    This session will cover the objectives and history of GSK’s patient advisory board, the HAB – a strategic advisory board made up solely of patient organization representatives and how patients have influenced many aspects of GSK medicine’s initiatives. The session will:

    • Outline the objectives of the HAB
    • Demonstrate where and how patient input has has been implemented in new plans, strategies, policies and initiatives
    • Evaluate the results GSK has seen in their initiatives by having the patient HAB
    • Provide an outlook on GSK’s emerging patient engagement strategy and continued HAB involvement

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    Andrew Garvey
    Global Patient Advocacy Lead, GlaxoSmithKline

  • 4:30 pm

  • Case Study: Advancing Patient-Centered Clinical Trials

    This session will provide a real world example of what Roche/Genentech did to examine, select and implement patient centric services. They will walk through each phase of the evaluation, selection and implementation process and provide details on the actions taken, and outcomes achieved. The discussion will also address the obstacles, both internal and external, the steps taken to overcome them when implementing trials that are patient centered. Attendees will learn the process Roche went through, how they got internal customers buy-in and the plan moving forward.

    Gail Adinamis
    Gail Adinamis

    Founder and CEO, GlobalCare Clinical Trials

  • 4:45 pm

  • The Inspiring Hope Ideathon: Solutioning the Clinical Trial Awareness Gap

    To advance society’s ability to respond to future healthcare challenges and advance medical innovation we must increase awareness of clinical research and study participation. Clinical research is vital to the development of new drugs and treatments but is dependent on patient participation. The “Inspiring Hope Ideathon” was the first initiative of its kind designed to generate new and unique ideas. The participation and results were groundbreaking and will be shared here!

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    Christine Phillips

    Senior Director, Site & Patient Access, INC Research

  • 5:00 pm

  • Patient Involvement Sources and Solutions

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    Pete Chan

    Head of Research and Analysis, Raremark

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    Melissa Harris

    Senior Account Director, Langland

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    Dr William van’t Hoff

    Consultant Paediatric Nephrologist, Great Ormond Street Hospital for Children

    Orlane Doumbe-bw
    Orlane Doumbe
    Young Person’s Advisory Group, Great Ormond Street Hospital for Children

  • 5:35 pm

  • Networking Reception

Agenda

  • 8:00 am

  • Breakfast

  • 8:30 am

  • Co-Chairs’ Opening Remarks and Recap of Patient Involvement Toolbox

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    Clare Grace, PhD

    VP, Site and Patient Access, INC Research

    Marleen-Kaatee-BW
    Marleen Kaatee

    Training Graduate / Founder and President, EUPATI / PSC Patients Europe

  • 8:45 am

  • Panel Discussion: How Industry and Patients Can Work Collaboratively to Achieve Joint Goals in Medicines Development

    Patients, advocacy and pharma each describe a vision for patient involvement. Key talking points include:

    • Identifying what patients and industry want in patient involvement and why
    • Patient perspectives on industry efforts
    • What can industry do to enhance patient involvement across the development pipeline?
    • How are decisions formed based on patient input?
    • What is getting in the way? Identify hurdles?
    • How can we work through this collaboratively?
    • How can we sustain patient involvement?

    Moderator:
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    Professor Andrew Miles, MSc, MPhil, PhD, DSc [hc]

    SVP and Secretary General, European Society for Person Centered Healthcare

    Panelists:
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    Claire Bale

    Head of Research Communications and Engagement, Parkinson’s UK

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    Sabine Bongardt

    Global Lead, Lupus Policy and Advocacy, UCB

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    Tanja Keiper
    Director, Global Clinical Operations, External Innovation, Merck

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    Pinal Patel

    Strategic Recruitment Lead, Bristol-Myers Squibb

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    Richard Stephens

    Patient / Consumer Lead, Chair Consumer Forum, National Cancer Research Institute

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    Oliver Timmis

    CEO, AKU Society

  • 9:30 am

  • Unlocking the Power of Patient Engagement within Clinical and Commercial

    The patient voice as a strategic driver is being included much earlier in the development process than ever before. In this session, pharmaceutical, biotech and device companies will gain insight into the value of smarter patient integration. We will explore the ‘how’ and ‘when’ for involving patients to enhance the development and delivery of innovative therapies. Key focus areas include:

    • The critical shift from drug-centric to patient-relevant
    • Pivotal patient touch points throughout clinical development and launch planning that will maximize both clinical and commercial outcomes
    • Positive impact of integration on efficiency and commercialization

    Duncan Arbour-bw
    Duncan Arbour
    Digital Strategy & Innovation for Healthcare, inVentiv Health Communications

  • 9:40 am

  • Examining European Public & Patient Perceptions of Experiences with Clinical Trials

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    Ken Getz, MBA

    Director of Sponsored Research / Founder, Tufts CSDD / CISCRP

  • 10:00 am

  • Patients View on Why They Are/Are Not Participating in a Clinical Trial

    This panel will include both clinical trial participants and patients who have not volunteered in order to explore the thought processes behind entering a clinical trial. For those who don’t sign on, is it lack of awareness or have they considered a study and consciously rejected the idea? For those who have participated, what compelled them to take part? This panel will dive deep into the patient perspective to discover what really works — or doesn’t — when it comes to the recruitment and awareness-raising efforts for your studies.

    Moderator:
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    Abbe Steel, MSc

    Founder and CEO, HealthiVibe LLC

    Patient Speakers:
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    Taelor Bennett

    Patient and Advocate

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    Rosemary Najim

    Patient, Co-chair and Patient Lead, Surrey Arrhythmia Support Group (Surrey ASG)

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    Barry Pinnington

    Patient and Advocate

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    Christine Robinson

    Patient and Advocate

  • 10:40 am

  • Networking Break

  • 11:10 am

  • Patient Centricity in Clinical Development: A Case Study on Key Learnings from Patient Advisory Board Meetings and New Ways to Bring Patient Centricity to the Next Level through Stakeholder Engagement

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    Tanja Keiper
    Director, Global Clinical Operations, External Innovation, Merck
  • 11:30 am

  • Case Study: Incorporating Patient Insights to Co-Create Solutions in R&D

    Astrazeneca’s Guy Yeoman will provide examples of how AZ has incorporated patient insights, co-created solutions with patients and measured the impact of the initiatives implemented as a result of patient involvement.

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    Guy Yeoman

    VP, Patient Centricity and Global Medical Affairs, AstraZeneca Europe

  • 11:50 am

  • The PEN Initiative: BMS’ Patient Engagement Network & The Life of a Drug Through Approval

    BMS developed the Patient Engagement Network (PEN) as a means to proactively facilitate the continuous flow of insights provided by patients, caregivers, and study sites to the clinical program, aligned to a timely need for interactive feedback during the life a drug development program. This session will address the following:

    • Key learning from 2 PENs with a focus on what was learned and how we responded to better meet the needs of the patients
    • Emphasis on the need to ‘listen to’ and ‘communicate with’ the patients
    • Continue using the PEN model to get insights into diverse populations

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    Pinal Patel

    Strategic Recruitment Lead, Bristol-Myers Squibb

  • 12:10 pm

  • Considering Diverse Patient Needs in Clinical Trials

    Clinical trials are often planned more for investigators and scientists than for patients. Even so-called “patient-centric trials” are likely to be designed for a single patient type. A more effective approach is to take into account the needs of patients from all of the geographic regions and cultures involved in the study.

    This session outlines an approach for obtaining actionable patient insights to design protocols and patient recruitment/retention programs. The method includes steps to verify and adapt findings regionally to meet the diverse needs of patients. Using examples and case studies, audience members will learn how incorporating cultural diversity into study design has been used to ensure successful patient experiences in multiple countries and regions.

    Kelly Franchetti BW
    Kelly Franchetti, RN, CCRN, CEN

    VP, Global Patient Insights and Engagement, Patient Centered Sciences, Mapi Group

  • 12:30 pm

  • Lunch

  • 1:10 pm

  • Integrating Patient Needs Into a Shared Patient Community Beyond the Trial

    In this session, Thomas Klein, Founder and CEO of Be the Partner will discuss how they took a “patient first” perspective in building its platform, using patient input and feedback. Key focus areas include:

    • Results from an initial pilot of the platform in a study conducted by a large pharma sponsor
    • Leveraging the success of the pilot of learnings from it and further patient input, Be the Partner will discuss the future of the platform and the opportunity for pharma to create a pre-competitive, patient-centric asset

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    Thomas Klein
    Founder and CEO, Be the Partner

  • 1:30 pm

  • Advancing the Informed Consent Process for the Benefit of the Patient

    • How to improve the interaction between patient and investigator and importance of training/educating investigators
    • How to educate the patient on how to be prepared for the conversation with investigators on informed consent
    • How the industry prepares that collaboration and interaction and how they support this

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    Dr. med. Ingrid Klingmann, FFPM, FBCPM

    Chairman, European Forum for Good Clinical Practice (EFGCP)

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    Sini Eskola, MSc

    Director of Regulatory Affairs, European Federation of Pharmaceutical Industries and Association (EFPIA)

    Marleen-Kaatee-BW
    Marleen Kaatee

    Training Graduate / Founder and President, EUPATI / PSC Patients Europe

  • 2:15 pm

  • How Patients are Changing What Research Gets Published in High-Impact Journals: Improving Research Quality

    The British Medical Journal’s (BMJ) Patient Partnership Strategy aims to change the way healthcare research and medical education is created and reported. The journal’s Patient Editor, Rosamund Snow, will describe the rationale behind this policy and the practical steps that have been taken to make embed patient expertise across the BMJ.

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    Rosamund Snow

    Patient Editor, British Medical Journal

  • 2:35 pm

  • Networking Break

  • 3:00 pm

  • How EUPATI Trains Patients to Put Them in the Position of Influence

    In this session, EUPATI’s director, Jan Geissler, discusses the EUPATI initiative that trains approximately 50 patients a year on the skill sets needed to put them in a position to have a meaningful impact when it comes to involvement in medicines development and regulation. The 1st group of patients graduated in the Autumn of 2015. Key talking points include:

    • Overview of EUPATI Patient Training Initiative
    • How patients are trained to discuss endpoints, portfolio management, regulatory issues, etc.
    • Data will be shared from EUPATI graduates on how the program changed their level of engagement in clinical research

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    Jan Geissler

    Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)

  • 3:30 pm

  • Patient & Advocate Perspective: Putting EUPATI Training into Action

    First year EUPATI training graduates discuss their experience of the program and how it has helped them have a greater influence in medicines development and regulation.

    Moderator:
    Marleen-Kaatee-BW
    Marleen Kaatee

    Training Graduate / Founder & President, EUPATI / PSC Patients Europe

    Panelists:
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    Jan Geissler

    Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)

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    Roald Nystad

    Training Graduate / Founder and Managing Director, EUPATI / The Norwegian Melanoma Patient Association

  • 4:00 pm

  • Conference Concludes