2022 Agenda

  • *All sessions are in Greenwich Mean Time

  • Co-Chairs

    • Michaela Dinboeck
      Head, Center of Excellence for Patient Engagement, Novartis

    • Lesley Gosden
      Lesley Gosden
      Parkinson’s Patient and Advocate

    • Alfred Samuels
      Clare Grace, PhD
      Chief Patient Officer, Parexel International

  • 9:00 am

  • Platform Opens

  • 9:30 am

  • Opening Remarks & Welcome

  • Patient Keynote

  • 9:45 am

  • How a Patient Researcher Changed a Clinical Trial in MS

    When Robert Joyce’s journey as an MS patient took an unexpected turn, he began searching for something that would keep him going and give him motivation for life.  So he turned to patient advocacy and eventually became the first embedded patient researcher in an MS trial in Ireland.  In this fireside chat, Robert shares how and why he became involved in research and what he’s learned that can help the industry in its efforts to achieve better outcomes for patients.

    Robert Joyce
    MS Patient Advocate, Embedded Patient Researcher, National University of Ireland, Galway


    Andrew Garvey-2020
    Andrew Garvey
    Global Patient Advocacy Lead, GSK

    Alfred Samuels
    Clare Grace, PhD
    Chief Patient Officer, Parexel International


  • 10:10 am

  • UCB and Parkinson’s UK Report on Outcome Measures that Matter to Patients

    UCB joined forces with Parkinson’s UK and Parkinson’s Foundation to develop the latest tools to assess outcomes for Parkinson’s patients in their clinical trials.  Learn about this model of patient engagement for developing patient-reported outcomes that matter most to patients and the results of this successful collaboration in developing these new outcome measures.

    Thomas Morel, PhD
    Director Patient-Centred Outcomes Research & Policy, Global Clinical Development, UCB


    Natasha Ratcliffe
    Research Involvement Manager, Parkinson’s UK

  • 10:35 am

  • Moving From Pockets of Excellence in Patient Engagement to a Company-Wide Approach

    Novartis implemented a new operating model for patient engagement to increase proficiency in patient-centricity across the entire medicines life-cycle.  A core element was the creation of the “Center for Excellence in Patient Engagement” to ensure a unified approach in four focus areas:

    • Establishing standards for patient engagement
    • Capability building for patient engagement
    • Converting patient insights into action
    • Measuring impact

    Michela Dinboeck will share learnings and challenges in making a company-wide approach to patient engagement a reality.

    Michaela Dinboeck
    Head, Center of Excellence for Patient Engagement, Novartis

  • 11:00 am

  • Ten-minute break

  • 11:10 am

  • Guidance on Leveraging Patient Experience Data to Strengthen Regulatory Submissions

    There is no effective patient experience data without the direct engagement of patients.  However, difficulties can include confusion with the terminology itself. Patient engagement, patient experience, patient preferences, and patient-reported outcomes are interchanged while each delivers different outcomes.  This session will cover the practices necessary to generate the right patient experience data to aid regulatory decision-making.

    • What data and in what format do regulators want when submitting a file for approval? 
    • How will regulators utilize patient experience data?  
    • What data is being planned for and when is it collected from patients?
    • How do we ensure data is from diverse and representative patient populations?
    • What is most meaningful to patients?

    Speaker TBD

  • 11:35 am

  • Rotating Session Choices

    Attendees will have a choice of three moderated breakout topics.  These breakout sessions are 25 minutes each and attendees can rotate between two topics.  The breakouts are designed to be interactive.   Sessions TBA.

  • 12:35 pm

  • Lunch Break


  • 1:15 pm

  • Partnering with Your Compliance Teams to Advance Meaningful Collaboration with Patients

    Compliance with rules and regulations in patient engagement while necessary can also be an impediment to meaningful collaboration.  We’ll hear from companies that have taken steps to work through compliance challenges internally and the efforts by associations such as ABPI to enable more collaboration.  More specifically:

    • Where do the problems still exist in contracting with patient organizations?
    • What are solutions we can match to some of the problems?
    • What are some case studies of successful collaboration between patients and pharma that we can learn from?
    • What tools are available that can assist?

    Moderated by:

    Natalie Bohm, MD, PhD
    UK Medical Director, External Engagement, Pfizer


    Kate Downey
    Patient Engagement & Advocacy Manager, Janssen

    Alex Potlog
    Legal Director, UK & Ireland, AbbVie

    Jayne Spink, PhD
    Translational Research Director, Prostate Cancer Research

    Victoria Bates
    Patient Engagement Lead, ABPI

  • 1:45 pm

  • A Multi-Stakeholder View on Taking Patient Involvement to the Next Level

    In this session, pharma, patient advocacy and service providers share roadblocks that need addressing to take patient engagement to the next level.

    Moderated by:

    Mihaela Militaru
    Sr Director EU Patient Insights & Advocacy, Oncology & Endocrinology, Merck KGaA


    Pascale Cavillon
    Global Patient Centricity Director, Ipsen

    Antonella Cardone
    Director, European Cancer Patient Coalition

    Lisa La Luna
    SVP, Patient Advocacy, SME & Senior Advisor, WCG Clinical

    Susan Daniels
    Director and Head of Patient Engagement, Cello Health Communications

  • 2:10 pm

  • Virtual Face-to-Face Networking

    Attendees have a choice of breakout Q&A sessions to virtually meet face-to-face with R&D service providers and technologists offering solutions to engage and support patients in medicines development.  Please check back as we add companies.

  • 2:35 pm

  • How Hybrid Trials Can Further Reduce Patient Burden Through Flexibility in Protocol Design and Data Generation

    This panel will share their thoughts on how we can make trials even less burdensome to patients by allowing for a “mix and match” approach within a given trial, including options for generating data in the home that are typically required to be collected at the site.

    • What are the possibilities and logistical hurdles?
    • How does an investigator manage both virtual and in-person patients without introducing bias in clinical decision-making?
    • What are the regulatory considerations? (Sample size, bias, statistical power, etc.)
    • What’s the right balance between flexibility for patients and efficiency for study management? Is there an elephant in the room?
    • What governance will be required and have the right metrics and KPI’s been identified to assess the result of hybrid trials?

    Moderated by:

    Bert Hartog, PhD
    Sr Director Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceutica, NV

    Panelists TBD

  • 3:10 pm

  • Diversity and Inclusion in Clinical Research - Where are We Today and What are Next Steps?

    At the 2021 meeting, we brought forward patient voices from diverse communities to discuss ways to reduce inequities in marginalized communities.  In this session, panelists discuss where we are today in forming meaningful engagement with diverse groups and share the latest examples in making clinical research more inclusive and representational.

    Moderated by:

    Tara Gipp
    Associate Director Clinical Trial Optimization, Regeneron Pharmaceuticals, Inc


    Carol Akroyd
    Sr Program Manager, The Centre for Ethnic Health Research

    Alfred Samuels
    Al Samuels
    Prostate Cancer Patient Advocate

    Trishna Bharadia, BA (Hons), MFPM (Hon)
    Health and Patient Engagement Advocate & Consultant

    Ash Rishi
    Co-Founder & CEO,
    COUCH Health

  • 3:45 pm

  • 5-Minute Break

  • 3:50 pm

  • Peer-to-Peer Interactive Round-Table Discussions

    The day will conclude with 30-minute small roundtable discussions on different topics.  These interactive discussions are first come first serve and have limited capacity.  Attendees may choose one discussion group to attend.  Registration is required in advance.

    Working Through Challenges as a Biotech in Developing Patient-Centric Trials

    Noema will lead a discussion on the challenges in setting up hybrid clinical trials as a small or medium-sized biotech with the involvement of the patient community.  

    • What were your challenges when setting up hybrid trials?
    • What are your expectations on key players?
    • How can we make this transparent, cost effective and efficient, without losing sight of the rationale why we are doing it in the first place?

    Renata Lazarova, MD
    VP Development, Pediatric Programs, Noema Pharma

    Simon Roitt
    VP Development, Clinical Operations, Noema Pharma

    How to Measure the Success of Patient Engagement – KPIs vs KII (Key Impact Indicators)?

    • The difference between measuring project impact and project performance (KPIs v KIIs) when working with patients
    • How to define the impact and value delivered by several patient-centric initiatives
    • Existing patient engagement frameworks and conceptual models, their implications and implementation status
    • Towards a unified approach and consistent methodology: what must be done?
    • Best practices and collaborative efforts

    Oleks Gorbenko, MD
    Global Patient Centricity Director, Ipsen

    Check back as we add more roundtable topics

  • 4:20 pm

  • Day One Concludes

2022 Agenda

  • Co-Chairs

    • Michaela Dinboeck
      Head, Center of Excellence for Patient Engagement, Novartis

    • Lesley Gosden
      Lesley Gosden
      Parkinson’s Patient and Advocate

    • Alfred Samuels
      Clare Grace, PhD
      Chief Patient Officer, Parexel International

  • 9:00 am

  • Platform Opens

  • 9:30 am

  • Opening Remarks


  • 9:40 am

  • How Gilead is Beginning to Move the Needle on Patient Involvement in Turkey and Eastern Europe

    In this session, Gilead will provide an update on the patient engagement landscape in Turkey and Eastern Europe and provide examples of their efforts to begin bringing the patient voice forward in R&D as well as suggestions for advancing clinical research as a whole on this part of the continent. 

    Veronica Krongauz, MD
    Medical Lead, HIV, Associate Director, Eastern Europe Hub, Gilead Sciences

    Berna Özelgün,  MD
    Medical Lead for Patient Engagement, HIV, Associate Director, Turkey, Gilead Sciences


  • 10:10 am

  • Open session

  • 10:35 am

  • How Pierre Fabre is Driving Better Patient Engagement Through A Holistic Approach Including Support Tools for Patients

    Pierre Fabre has been collaborating with patients in the development of innovative treatments, while also supporting their well-being with tools to help better manage their diseases.  Pierre Fabre will share why they developed this approach, how they engage with patients in dermatology, and what the impact has been in particular on patients with Chronic Inflammatory Dermatosis.

    More specifically:

    • How they co-designed a trial with patients on Psoriasis
    • How they developed an app with patient input to better manage their condition
    • How they’ve created educational programs to train nurses and caregivers to better treat patients with Atopic Dermatitis
    • How they engaged with patients during Covid-19 to evaluate the impact of mask-wearing

    Markéta Saint Aroman, MD
    Head of Corporate Medical Direction Pharma, Dermocosmetics Care, Head of Corporate Patient Centricity, Pierre Fabre


  • 10:55 am

  • Ten-minute break

  • 11:05 am

  • EMD Serono’s Innovative Use of Social Media to Assess Carer Burden and to Gain Patient Insights

    Bladder cancer is the 10th most common cancer in the world. Few studies have assessed its burden on carers.  Hear how Merck leveraged social media to gain insights from this group and learn how to apply this same innovative approach to gain patient insights to inform clinical research.  Key takeaways:

    • The social listening technique to collect social media data in the public domain
    • The qualitative research methods used to analyze social media data
    • Insights that can be generated to inform interventions and policies 

    Murtuza Bharmal
    Head, Executive Director, Oncology Brands, Global Evidence & Value Development, EMD Serono, Inc

  • 11:30 am

  • Rotating Session Choices

    Attendees will have a choice of three moderated breakout topics.  These breakout sessions are 25 minutes each and attendees can rotate between two topics.  The breakouts are designed to be interactive.   Sessions TBA.

  • 12:30 pm

  • Lunch Break


  • 1:10 pm

  • From Carer to Trailblazer: One Man’s Fight to Impact Clinical Research

    When Claas Röhl’s 12-year old daughter was an infant, she was diagnosed with Neurofibromatosis Type 1 (NF), a rare genetic disorder that causes tumors to form along nerves. With no prior background in research, Claas founded NF Kinder and became an advocate for his daughter and patients impacted by this rare disorder. Claas will discuss his involvement in research, how he helped set up the first pediatric department for NF at a major medical University in Austria, and his efforts to create a national registry of NF patients. He will share lessons learned and offer insights on how best to engage carers to impact clinical research.

    Claas Röhl
    Chairman, NF Kinder, EUPATI Austria, NF Patients United


    Renata Lazarova, MD
    VP Development, Pediatric Programs, Noema Pharma

  • 1:35 pm

  • EU-PEARL: A Roadmap For Involving Patients in the Design and Execution of Platform Trials

    EU-PEARL, funded by Innovative Medicines Initiative (IMI), is setting up four different platform trials in four disease areas allowing multiple pharma companies to test their candidate drugs simultaneously against a shared placebo group.  Learn the ways in which patients are partners in this process by contributing to the design of the platforms and educating other patients about the benefits of platform trials. 

    Ann Van Dessel, MPharmSc
    Sr VP, Johnson & Johnson Regulatory and Clinical Operations, Johnson & Johnson  

  • 2:00 pm

  • Takeda, Ipsen and EMD Serono’s Initial Learnings on Incorporating the Patient Voice in the Pre-Clinical Phase to Drive Better Outcomes

    At the 2021 meeting, PFMD’s How-to guide for patient engagement in the early discovery and preclinical phases was presented.  This resource was the result of a 2-year collaboration between pharma and patient advocacy groups and provides step-by-step recommendations on involving patients in specific activities in early development.  In this session, Takeda, Ipsen and EMD Serono will share their initial learnings in implementing these guidelines in the early discovery phase when direct input from patients is so critical to the success of subsequent clinical trials. More specifically:

    • Applying principles from the How-to guide for indication selection
    • Learnings from a pilot implementation of the How-to guide
    • Adapting target product and target value profiles (TPP and TVP) to incorporate the patient’s voice
    • How to monitor and assess value-add of patient engagement activities in early development
    • Implementing the “Patient meaningfulness/ value for the patient” as a sole criterion for strategic decision-making within asset/medicine development and portfolio management

    Vivian Larsen
    Director R&D Patient Engagement, Takeda  

    Oleks Gorbenko, MD
    Global Patient Centricity Director, Ipsen  

    Erica Spies
    Director, Strategy Innovation & Capabilities, EMD Serono, Inc 

  • 2:30 pm

  • 10 Minute Break


  • 2:40 pm

  • Fair Market Value: What to Consider When Remunerating the Patient Community for Their Interactions with Pharma

     A PFMD working group made up of pharma and patient organizations is in the late stages of developing a global toolkit for compensating patients, patient organizations, advocates, patient experts and caregivers for patient engagement activities. This toolkit will build upon existing work undertaken by Efpia, NHC, IFPMA and the WECAN/MPE/PFMD collaboration.  This session will introduce a set of Global Principles finalized in late 2021 and highlight the methodology in determining fair compensation for patient engagement activities.  Attendees will gain a deep understanding of how to compensate stakeholders for their time, expertise, level of experience and complexity of required tasks.

    Laura McKeaveney
    Former Global Head of Patient Engagement & Patient Advocacy, Novartis International

    Šarūnas Narbutas
    Co-Founder and Chairman, Youth Cancer Europe

  • 3:05 pm

  • Taking Patient Involvement in Clinical Publications to New Heights: How Pfizer is Working with Patients to Co-Author Scientific Publications

    For many years, Pfizer has been a leader in the writing of plain language summaries. Now they’re partnering with diverse patient advocates to develop guidance on how to co-author scientific publications that are relevant to patients and written in language they can understand. Hear how Pfizer is working with patient advocates to co-develop this internal process and what the impact has been so far in involving patients in this new way.

    Angela Sykes
    Director, Team Leader, Publications Management Team, Pfizer

    Trishna Bharadia
    Health and Patient Engagement Advocate & Consultant

  • 3:30 pm

  • Conference Concludes