2019 Agenda

  • 7:45 am

  • Registration

  • 8:15 am

  • Co-Chair’s Opening Remarks: Demonstrating the Impact of Patient Engagement

    This session will begin with opening remarks from the program co-chairs on the evolution of patients as partners and what is coming next. Immediately following, Suzanne Schrandt will share her experience working with an esteemed research organization on a patient engagement effort that involves patients to obtain feedback on research proposals. This talk will address the following:

    • Evaluation of the original patient engagement request and why it was the wrong approach
    • What needed to change with the approach in order to get the most out of the patient feedback?
    • A Step-by-step guide on how Suzanne Schrandt worked with researchers to uncover what they wanted to get out of the patient’s review
    • Brief introduction to the onsite mock clinical trial exercise on day one

    Suzanne Schrandt, JD

    Director, Patient Engagement, Arthritis Foundation

    Jan Nissen

    VP, Patient Innovation and EngagementMerck

    Cynthia Verst, PharmD

    President, Design and Delivery Innovation, IQVIA

  • 8:40 am

  • Judy Perkin's Immunotherapy Trial: A Cancer Veteran's Remarkable Story

    In 2003, Judy Perkins was diagnosed with early-stage breast cancer and had a mastectomy. Ten years later, it came back as stage IV breast cancer. After numerous failed treatments from chemo and hormone therapy, she had prepared for the worst. Her doctors gave her 3 years to live. In 2015, Judy learned of an immunotherapy clinical trial at the NCI. She began the IO trial that December and by May 2016, Judy had been cleared of all cancer. Judy Perkins is the first person to be declared free of metastatic breast cancer after a course of immunotherapy and joins Patients as Partners to share her journey.

    Moderated by:

    Mary Stober Murray, MBA

    Associate Director, Diversity and Patient Engagement, BMS

    VIP Fireside Guest:

    Judy Perkins

    Metastatic Breast Cancer Veteran and Patient Advocate

  • 9:00 am

  • Appraising Initiatives to Raise Public and Patient Awareness and Education

    In this session, Ken Getz, Director of Sponsored Research Programs, Tufts CSDD and Founder and Board Chair of CISCRP provides a review of global initiatives that have been implemented during the past 10-15 years to raise public awareness and public literacy about clinical research; evaluation of their impact; and identification of improvement opportunities.

    Ken Getz, MBA
    Director and Associate Professor, Tufts CSDD / Founder and Board Chair, CISCRP 

  • 9:30 am

  • Morning Networking Break

  • 10:20 am

  • Mapping Out the Patient Decision Journey

    If we truly want to bring patients in as stakeholders, we have to start at the beginning by understanding patients, their lifestyles and how the trial protocols are developed to reflect that. Furthermore, we need to better understand the decision making process a patient goes through when considering their treatment options, including clinical trial participation. Understanding these dynamics will help industry design appropriate initiatives that help meet its goals while aligning with patient’s needs. This session addresses:

    • What can we learn and what resources can we use to develop a baseline understanding of patient lifestyles?
    • What can sponsors do throughout trial protocols that can help support patients, help alleviate their worries/concerns?
    • What is the decision making process a patient goes through when considering treatment options?
    • What do patients consider when determining to participate/not participate in a clinical trial?
    • How can pharma help support/provide tools that will help patients while deciding which treatment pathway they choose?
    • How can advocacy groups support this and how do they help inform patients?

    Moderated by:

    Marilyn Metcalf, PhD

    Patient Engagement Lead, GSK

    Robert Long
    Robert Long

    Director of Rare Disease EngagementUplifting Athletes

    Lilly Stairs
    Patient Advocate & Head of Growth & Partnerships, Savvy Cooperative

    Mary Stober Murray, MBA

    Associate Director, Diversity and Patient Engagement, BMS

    Hannah Watson Eccard
    Hannah Watson Eccard

    Research Manager, Inspire

    Robert Weker
    Robert Weker

    Three Time Cancer Survivor

  • 10:50 am

  • Chief Patient Advocate / Officer Fireside Chat: Driving Culture Change from the Top Down

    • How do you create a culture that enables new strategic, operating and organizational models to flourish?
    • How do you drive a patient-centric organization while continuing to execute on business imperatives? How do you balance that?
    • How do you drive a patient-centric agenda through the value chain?
    • How do you engage your employees and empower them to implement patient involvement strategies? And, how do you enlarge the outlook of employees who are stuck in status quo?

    Moderated by:

    Ken Getz, MBA

    Director and Associate Professor, Tufts CSDD / Founder and Board Chair, CISCRP


    Julie Gerberding
    Julie Gerberding, MD, MPH

    EVP and Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health, Merck

    Jayne Gershkowitz

    Chief Patient Advocate, Amicus Therapeutics

  • Pharma Case Studies: Applying Patient Engagement Initiatives and Demonstrating Impact

    Attendees have a choice of six case studies to choose from where pharma companies share tangible examples of how patients were involved in clinical development and trial initiatives, how they implemented patient input, challenges faced and the outcomes to the initiatives as a result of including patients.

  • 11:20 am

  • Track Sessions

    • Track A

    • 11:25 am

      Partnering with Patients on Clinical Development Protocols

      In this session, Linda Kollmar, Executive Director, Scientific Medical Patient Perspective – Oncology, Merck, shares with the audience, Merck’s experience with bringing on a patient, as an equal stakeholder of their clinical development team, to provide patient input in protocol development and trial design. Dr Kollmar walks the audience through how this was done, the role of the patient partner and the impact it has to date on the clinical development initiatives.

      Linda Kollmar

      Executive Director, Scientific Medical Patient Perspective – Oncology, Merck

    • 11:45 am

      Optional Track Change

    • 11:50 am

      Takeda Moves from Developing Medicines for Patients to Developing Medicines with Patients: What’s Happening?

      Many organizations set patient-centricity as a core value but how does a pharmaceutical company move this from words to actions?  Learn how Takeda has made this shift and has conducted over 25 patient engagement activities across R&D. Understand Takeda’s approach and how patient engagement has been embedded in the organization. Examples of activities will also be described including their impact on patients and study teams.

      Jessica Scott, MD, JD

      Head of R&D Patient Engagement, Takeda

    • 12:10 pm

      Optional Track Change

    • 12:15 pm

      Site-Less Trials: Janssen’s Direct-to-Patient Approach

      A direct-to-patient model (or site-less/remote trial) allows patients to participate in clinical trials from their home. Depending on the complexity of the trial, patients may take medicines themselves or rely on a home healthcare nurse for support. This type of model reduces the burden on patients having to travel to investigator sites and increases participation and retention. Additionally, technologies, such wearable, sensors and other mHealth/digital technologies play an important role in collecting data, monitoring health throughout the trial and enabling patients to complete assessments that would typically occur in the clinic. In this session, the audience will come to appreciate the benefits and challenges of setting up this type of model and how to engage your key internal business partners to make it truly a reality in your organization.

      Tammy Guld
      Senior Director, Janssen Clinical Innovation, Janssen

    • Track B

    • 11:25 am

      GSK’s Approach to Improving Diversity in Clinical Trials

      More clinical trials are now being performed than ever before, involving study sites from all over the world.  Despite this, diversity in clinical trials remains exceptionally poor, with >80% of all trial participants being Caucasian.  This talk will review the scope of this problem, and also the strategies that have been proposed to improve it.

      Alistair Lindsay, MD, MBA, PhD
      Director, R&D and Cardiologist, GSK

    • 11:45 am

      Optional Track Change

    • 11:50 am

      Engaging Priority Populations in Clinical Research As Part of Study Design

      This case study will provide an overview and delve into specific examples of Gilead’s efforts to engage patients/communities in clinical research design to ensure use of culturally competent language, protocol and engagement.

      Douglas Brooks

      Executive Director, Community Engagement, Gilead Sciences

    • 12:10 pm

      Optional Track Change

    • 12:15 pm

      How Novartis Includes Patient Input into All Aspects of a Clinical Study

      This case study will demonstrate how the patient perspective was included from the earliest planning of a clinical trial and how it impacted the design, trial sites and the patient experience throughout the study.

      Thérèse Johnsen

      Associate Director of Patient Engagement Management, Novartis

  • 12:35 pm

  • Lunch & Birds of a Feather Roundtable Discussions

    Birds of a Feather roundtables provide a gathering place and informal discussion forum for those interested in the same patient engagement issues and concepts. Each table will have a moderator leading the discussion and will include a patient representative who will provide their insight to the topic at hand.

    1 . Building Patient Engagement into Systematic Processes

    • How do we look at patient engagement like we look at quality interventions?
    • How do we build patients into our systematic process?

    Led by:

    Mary Stober Murray, MBA

    Associate Director, Diversity and Patient Engagement, BMS

    2. Connecting Employee Centric Culture to Patient Centric Culture

    • How do you engage your employees and empower them to implement patient involvement strategies?

    Led by:

    Beth Zaharoff

    Director, Patient Focused Drug Development, TESARO

    3. Interactive Mock Clinical Trial Protocol Exercise: Involving Patients for Protocol Reviews

    Attendees will have an opportunity to participate in a mock clinical trial protocol activity. The objective will be to uncover how to obtain feedback from patient partners on protocols. These learnings can be applied outside the researcher/patient scope and be applied to several types of patient engagement initiatives.

    Led by:

    Suzanne Schrandt, JD

    Director, Patient Engagement, Arthritis Foundation

  • 1:35 pm

  • Panel: Partnering With CROs/Sites to Create a Delightful Patient Experience Starting with Engagement

    As we know, most studies are outsourced to CROs/Sites and many of these partners have made serious investments towards greatly improving patient engagement capabilities  This panel will discuss how sponsors and sites are advancing their work to excel at patient engagement to create greater efficiencies and better outcomes for patients. More specifically:

    • How do you build patient engagement into your Sponsor/CRO policy and procedures?
    • What should that partnership look like?
    • Patient perspectives on what would make a delightful patient experience


    Jimmy Bechtel

    Senior Project Manager, Society for Clinical Research Sites (SCRS)


    Veronica Alcine

    Global Head Patient Recruitment and Engagement, Covance

    Gretchen Goller
    Gretchen Goller

    Global Head Patient Recruitment Solutions, ICON

    Rosamund Round

    Director, Patient Innovation Center, Medical and Scientific Services, PAREXEL International

    Bob Tufts

    Patient Advocate, Former Major League Baseball Player and Clinical Assistant Professor, Sy Syms School of Business, Yeshiva University

    Stephen Yates

    Global Clinical Development & Medical Affairs / Head, Patient Engagement Working Group, UCB / TransCelerate

  • 2:15 pm

  • Applying Collaborative Insights to Transform Clinical Research/Care Delivery

    In this session, we track the patient journey across the spectrum of clinical development demonstrating how patient partnerships and perspectives enhance their experience, encourage participation (and retention), improve outcomes, and build towards bringing the continuum of care full circle. To this end, as technology continues to revolutionize so many aspects of our lives, the patient journey is no exception. To link all points and hard-wire patient engagement into the end-to-end drug development process, we are working to facilitate a seamless ecosystem for the overall patient experience, while promoting the convergence of clinical research and clinical care.

    Cynthia Verst, PharmD
    President, Design and Delivery Innovation, IQVIA

  • 2:35 pm

  • Taking the Study to the Patient – A True Patient-Centric Service

    Patient recruitment and retention remain the greatest challenges in clinical trials in the traditional clinical trial model.  GlobalCare creates opportunities for patients to participate in a location that is both convenient and comfortable. By conducting selected protocol visits at the patient’s home, work-place, school, travel destination, or other alternate-location, more patients are willing and able to participate and remain in a study. 

    • How does this service model work and can it be easily implemented
    • Successful case studies incorporating these patient-centric services
    • Win-win benefits for all stakeholders to speed the development of life-enhancing products to the market

    Gail Adinamis

    CEO, GlobalCare Clinical Trials

  • 2:50 pm

  • What Does a Patient-Focused Clinical Trial Really Look Like?

    Despite modest and incremental innovations, the clinical drug development paradigm remains unsustainable, excessively costly, and suffers from diminishing returns on investment.  A new clinical trial paradigm, that builds upon the lessons learned in other sectors, can create a more consumer-focused approach, clinical trials that are patient-friendly, and utilize technology that allows clinical research to fit into the day-to-day lives of the patients we serve.  Patients need new therapies now and we need to accelerate the way in which we develop and deliver these new treatments.

    Scott Schliebner

    SVP, Center for Rare Diseases, PRA Health Sciences

  • 3:05 pm

  • Reducing the Burden to Patients: An Interactive Audience "Pop-up" Session

    This session highlights services and technologies that help diminish patient challenges within a clinical trial. 

    Each roundtable in the general session will contain a tent card with the name of the company participating as a “pop-up”. Our MC will lead this session by giving each company one minute to share how they are helping reduce burdens for patients. After each company completes their one-minute pop-up, the audience will spend the remainder of the session visiting the tables that can help with their patient engagement initiatives.

    Moderated by:

    Craig Lipset, MBA

    Head of Clinical Innovation, Pfizer

    Participating Companies:


    Katie O’Neill
    , VP Engagement Solutions

    Pulse Infoframe

    Femida Gwadry-Sridhar, PhD
    , CEO and Founder


    Jena Daniels, Director of Research


    Greg Candelmo, Director of Sales


    John Corcoran
    VP, Clinical Services

  • 3:25 pm

  • Afternoon Networking Break

  • 4:05 pm

  • The Democratization of Patient Data Ownership: Returning Results

    We anticipate a future with secure patient data ownership, where patients are empowered to provide permissions. In this series of talks on patients ‘donating’ data, patient data ownership, data rights, and why this is a disruptive force in advancing clinical trials, we address the need to ensure we have the appropriate systems, security, and ability to withstand a Facebook/Cambridge Analytica scenario.

    Craig Lipset, MBA

    Head of Clinical Innovation, Pfizer

  • Technology & Policy Supports for Patients to Access and Control their Data

    Mark Scrimshire

    Entrepreneur in Residence, NewWave, on assignment as Medicare Blue Button 2.0 Innovator, CMS

  • Patient Perspective on Patient Data Access, Control, Ownership & Non-health Data

    Bray Patrick-Lake, MFS

    Director of Stakeholder Engagement, Duke Clinical Research Institute

  • 5:00 pm

  • Panel: How to Return Data to Patients and Inform Patients Throughout Trials

    • Patient Preferences and Concerns — What do patients want? What insights have been gathered?  Can data return/access be harmful for patients?
    • Timing for Data Return  — When can data be returned for observational versus interventional research?  What data can be shared and when?  Is data return itself an “intervention”?  How do we minimize the time gap and latency so that data return is most meaningful?
    • The “How’s” of Data Return — Is this about data “viewers”?  Data “downloads”?  Or authorizing “data sharing”?  What is the role of PI and their concerns?  How does this scale globally?
    • Goals and Success Criteria — How do we measure success (patient experience? # of downloads? or otherwise?)?  Is there an ROI to patient data return?

    Moderated by:

    Craig Lipset, MBA

    Head of Clinical Innovation, Pfizer


    Jessica Scott, MD, JD

    Head of R&D Patient Engagement, Takeda

    Scarlet Shore

    Head of Product and Platform Lead, Project Baseline, Verily

    Cynthia Verst, PharmD

    President, Design and Delivery Innovation, IQVIA

    Thomas Wicks

    Chief Strategy Officer, TrialScope

  • 5:40 pm

  • Bridging Commercial and Clinical Efforts to Enhance Patient Engagement

    Jean McCoy

    SVP, Partnerships, Health Perspectives Group LLC

  • 6:00 pm

  • Annual Networking Reception

2019 Agenda

  • 8:00 am

  • Registration

  • 8:30 am

  • Co-Chair’s Opening Remarks

    Jan Nissen

    VP, Patient Innovation and EngagementMerck

    Suzanne Schrandt, JD

    Director, Patient Engagement, Arthritis Foundation

    Cynthia Verst, PharmD

    President, Design and Delivery Innovation, IQVIA

  • 8:40 am

  • FDA Efforts on Fully Integrating the Patient Voice in Drug Development

    Pujita Vaidya

    Senior Advisor, Patient-Focused Drug Development Program, Office of the Center Director, (CDER), FDA

  • 9:05 am

  • FDA Patient Engagement Synergistic Efforts

    This multi-center FDA panel focuses on patient engagement and regulatory decision making.

    • What is each center doing in terms of patient engagement? What initiatives are underway and what is the impact they will have?
    • What are the synergistic efforts across the FDA centers?
    • How are the patient involvement initiatives within the FDA moving the needle forward in order to create greater efficiencies and better outcomes for patients?


    Anindita Annie Saha
    Anindita Saha

    Director of External Expertise and Partnerships (EEP), Center for Devices and Radiological Health (CDRH), FDA


    Megan Moncur, MS

    Senior Advisor, Science of Patient Input, Center for Biologics Evaluation and Research (CBER), FDA

    Michelle Tarver, MD, PhD

    Director of Patient Science & Engagement, Center for Devices and Radiological Health (CDRH), FDA

    Pujita Vaidya

    Senior Advisor, Patient-Focused Drug Development Program, Office of the Center Director, (CDER), FDA

  • 9:45 am

  • Morning Networking Break

  • 10:25 am

  • Case Study: ALL OF US Initiative

    All Of Us is a US Precision Medicine program from the NIH that aims to enroll a million Americans and follow them for 10 years, during which time participants will contribute biological, environmental, and lifestyle data that will help accelerate research and improve health. Furthermore, the data will be returned to trial participants.  Learning objectives:

    • About All Of Us – context, objectives, progress to date, and what’s to come
    • What we’ve learned so far
    • How might pharmaceutical companies become involved in the years ahead?

    Elise Felicione, MPH, MBA

    Scientific Collaborator / Sr. Director, Scripps Translational Science Institute / Janssen R&D

  • 10:40 am

  • Panel: Engaging with Communities to Educate and Enroll Diverse Populations

    This multi-stakeholder panel will discuss the complexities of diversity and what actions we can take to raise clinical trial awareness and enrollment that is reflective of the demographics of the populations.

    • What are some examples of how industry has approached diversity such as developing partnerships, education and awareness to identify and address the barriers of diversity?
    • Is industry and advocacy engaging on the community level? If so, how?
    • How has advocacy helped with outreach, awareness and recruitment of diverse populations for clinical trials?
    • How do we engage with patients who are without technology access or those globally whereby the latest technological advances are not the norm?
    • Additional examples of what have been done that has worked and is scalable.


    Jan Nissen

    VP, Patient Innovation and Engagement, Merck


    Caroline Donovan, MPH

    Manager, Patient Engagement, Lupus Therapeutics, an affiliate of Lupus Research Alliance

    Lisa Fitzpatrick, MD, MPH

    Patient Advocate & Co-founder, The Community Wellness Collective

    Kelly Franchetti, RN

    VP, Global Head of Patient Insights and Engagement, ICON plc

    Tara Hiley, PhD

    Senior Patient Insights/Clinical Scientist Lead, Genentech

    Patricia Roselle

    Global Head, Patient Network ManagementSanofi

  • 11:20 am

  • Mindfulness in Design: Leveraging the Patient Perspective to Optimize Technologies for Clinical Trials

    Patients are continually adapting and embracing technology and are more tech-savvy and ready for the next evolution in clinical research.

    But in the haste to give patients every portal, wearable device, and app for data capture possible, could it be too much of a good thing? This talk will explore how a richer understanding of your patients can lead to a more discerning selection of technologies to facilitate your study. Not all bells and whistles are created equally, and hearing patient feedback on details as simple as the color and size of a button on an app can strongly impact your trial design in ways you’ve never considered. This session will provide case studies of how patient feedback provided insights into selecting the most effective and patient-friendly tools and devices to support and optimize a clinical study.

    Abbe Steel, MSc

    CEO, HealthiVibe

  • 11:35 am

  • Building a Digital Home to Provide Patient Support, Education and Clinical Trial Awareness

    This session will include perspectives from rare disease advocacy, pharma and former FDA regulatory veterans on the importance of creating a digital home, the role of verified patient communities, why “one-size” does not “fit-all” and how authentically designed custom communities can make a difference by driving empowerment through emotional support, education from vetted resources and access to clinical trials. 

    We will present and explore shaping community stewardship:  
    • What are the attributes of a rare digital home?
    • Why is building a rare digital home valuable to ALL stakeholders?
    • How does the community work together to build a rare digital home?
    • How can the rare digital home be adopted to other therapeutic areas?

    Daniel Donovan

    CEO and Co-Founder, rareLife Solutions

  • 11:50 am

  • How Might Biopharma Help Patients Become Knowledgeable Partners

    To have a real impact on the pipeline of new treatments, patients, advocates, and care partners need to learn the language, norms, roles, constraints, regulations, and politics of Biopharma R&D.  There appears to be real need in the US to provide consistent, high quality education for patients who want to get involved and bring their A-game. 

    Industry is not well positioned to provide this education directly without the appearance of undue influence. Likewise, very few Patient Advocate Organizations have the resources to fund the development and delivery of such education alone. 

    This talk will discuss:

    • The value of equipping patients with the knowledge, skills, and confidence to be strong partners,
    • Challenges of investing in effective patient education not connected to a product or company
    • Creative ways to overcome this conundrum.

    Kevin Freiert, MBA

    Owner and Principal, Salem Oaks

    Nicole Horvath

    Regulatory Manager, Global CMC – New Products, Pfizer

    Jean Walsh
    Jean Walsh

    Ambassador, Friedreich’s Ataxia Research Alliance

  • 12:05 pm

  • Mobile Clinical Trials: CTTI Recommendations for Engaging Patients as Partners

    Mobile technologies hold tremendous promise for improving the quality and efficiency of clinical trials, reducing burden and increasing participant engagement. To help maximize these opportunities, the Clinical Trials Transformation Initiative (CTTI) developed evidence-based recommendations for engaging patients and investigative sites throughout the planning and execution of mobile clinical trials. Attendees will learn about these newly-released recommendations and actionable tools, understand unique considerations for participants in mobile trials, and realize opportunities to effectively engage patients during trial planning.

    Cindy Geoghegan

    Patient Advocate and Project Team LeadCTTI

    Hassan Kadhim
    Director, Clinical Trial Business Capabilities / Project Team Member, BMS / CTTI

  • 12:20 pm

  • Lunch

  • 1:20 pm

  • Flipping the Funnel to Accelerate Enrollment Timelines in a Global Phase III Program

    Mark Summers

    President, Patient Engagement, WCG Clinical

  • 1:35 pm

  • The TransCelerate Patient Experience Initiative: New Tools to Enable and Encourage a More Systemic Partnering with Patients in the Development of New Therapeutics

    The TransCelerate Patient Experience (PE) Initiative has a vision to increase engagement and partnership between sponsors and patients and to create better experiences for clinical study participants. The PE team is developing two toolkits with the following goals – 1) to help sponsors better partner and collaborate with patients during study design and 2) to assist sponsors in collecting patient feedback while patients are enrolled and participating in clinical studies. These toolkits, have been developed by understanding study participant experiences using established clinical outcomes assessment (COA) methodology and feedback from various stakeholder groups (i.e., patient advisors, sites, CROs and sponsors). The toolkits include a sponsor-facing user guide, which is intended to support sponsors with operationalizing the tools in a clinical study. This interactive web-based interface will launch in early 2019 and will be open to the public. In this session, Stephen Yates, head of TransCelerate’s Patient Experience Working Group, walks the audience through new tools that provide step-by-step considerations on how to involve patients in the medicines development lifecycle.

    Stephen Yates

    Global Clinical Development & Medical Affairs / Head, Patient Engagement Working GroupUCB / TransCelerate

  • 1:55 pm

  • Panel: Improving Clinical Research and Trials Through Effective Pharma/Advocacy Partnerships

    • What are the key elements that make for an effective partnership between Industry and Advocacy Groups?
    • What is not getting done or being left on the table to increase partnership value?
    • What specifically could both groups be doing better to drive the next level of interactions for research/trial improvement?
    • In relation to clinical trials what can we and what must we learn from existing experiences in patient engagement that will help provide patients with the enhanced active role they deserve?
    • From an industry perspective there are generally three key decision-making points: research priority setting, design of clinical trials, and early dialogue that can benefit from various levels of patient engagement – are there other valuable areas we are missing here
    • From a patient advocacy group perspective in which areas should industry be improving its clinical research, trial development and planning?


    Pan Patel
    Pan Patel

    Director, Clinical Trial Patient Advocacy, Celgene


    Ellen Miller Sonet
    Ellen Miller-Sonet, MBA, JD

    Chief Strategy and Policy Officer, CancerCare

    Kristin Smedley

    President, Curing Retinal Blindness Foundation

    Tiffany Westrich-Robertson

    CEO and Co-Founder, International Foundation for Autoimmune & Autoinflammatory Arthritis (IFAA)

    Keri Yale
    Keri Yale, MBA

    Head, Patient Affairs and Engagement, Boehringer Ingelheim

  • 2:35 pm

  • How the Device Industry uses the Science of Patient Input to Impact the Total Product Lifecycle

    Medical device manufacturers and regulators are increasingly interested in “patient perspectives” on the development of new medical devices, but there lacks consensus on when and where is the best opportunity to incorporate this perspective.  This panel will explore how medical device companies and regulators are advancing the science of patient input and how patients can impact the development of medical devices along different stages of the product development lifecycle.


    Stephanie Christopher

    Program Director, Medical Device Innovation Consortium


    Dean Bruhn-Ding
    VP, Regulatory Affairs & Quality Assurance, CVRx

    Barry Liden

    VP, Patient EngagementEdwards Lifesciences

    Matthew McCarty
    Global Head of Patient Engagement, ICON

    Suzanne Schrandt, JD
    Director, Patient Engagement, Arthritis Foundation

  • 3:20 pm

  • Integrating Clinical Research as an Alternative Care Source

    In this two-part session, we hear from patients on what they are really up against when it comes to clinical research as a care option. Following the patient-led discussion, we are joined by physicians and researchers to learn more about how they can partner to better inform patients on clinical research and trial participation.

    3:20 pm – 3:35 pm

    1. What Is the Patient Really Up Against?

    • Identifying barriers
    • How do patients get access to clinical trials?
    • Reimbursement
    • Need for interoperability and “fit for purpose” health data to enable research that benefits patients
    • Awareness of clinical trials

    Cindy Geoghegan

    Patient Advocate and Project Team LeadCTTI

    Ellen Miller Sonet
    Ellen Miller-Sonet, MBA, JD

    Chief Strategy and Policy Officer, CancerCare

    3:35 pm – 4:15 pm

    2. Better Strategies to Inform Patients on Clinical Research and Trial Participation
    Bringing clinical research as a care option to patients is arguably the greatest change we can collaborate on to give patients the best choices of care and to help make clinical trial options easier for providers to access. This panel will explore how to collaborate to create better strategies to inform patients on clinical research and trial participation. Key talking points include:

    • Demystifying physician/research burdens. What are physicians really up against?
    • How to better inform physicians of clinical research and trials
    • How can more physicians get involved in research and communicate the offering of clinical trials?
    • Patient perspectives on clinical research as a care option


    Irfan Khan, MD

    CEO and Founder, TrialScout


    Alistair Lindsay, MD, MBA, PhD
    Director, R&D and Cardiologist, GSK

    Linnea Olson

    Patient Advocate

    Sanjay Sethi, MD

    Professor and Chief, Pulmonary, Critical Care and Sleep Medicine; Assistant Vice President for Health Sciences, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University of Buffalo

    Kelly Wade
    Kelly Wade, MD, PhD

    NeonatologistChildren’s Hospital of Philadelphia & CHOP Newborn Care at Pennsylvania Hospital and Associate Professor Clinical Pediatrics, University of Pennsylvania Perelman School of Medicine

  • 4:15 pm

  • Conference Concludes