Cambridge Healthtech Institute’s 13th Annual

Patient Engagement, Enrollment and Retention through Communities and Technology  

Patient-Centric Approaches to Participant Engagement and Trial Optimization

February 20-21, 2020


Patient engagement, enrollment planning, patient recruitment, and a more patient-centric approach to study planning and execution are critical to drug development programs and garner a lot of attention by study teams. However, once the hard work of identifying and recruiting a trial subject has been accomplished, they must be retained and remain in compliance. More importantly, industry should be actively listening, engaging and garnering insights from the volunteers who are the foundation and purpose of all of the research. The engagement, continuous exchange of knowledge, retention of patients, and continued engagement throughout the life of a clinical trial is essential to have complete data sets for your analysis and subsequent filings. There are strategies, tools, and data-driven techniques such as social media platforms and mobile technology, empowered patient communities, and a more informed and diverse patient population that need to be understood and engaged. CHI’s 13th Annual “Patient Engagement, Enrollment and Retention through Communities and Technology” will cover the topics one should consider when planning and strategically implementing a patient engagement strategy and retention plan in the digital age.

Arrive early and attend Part 1 (Wed - Thurs): Enrollment Planning and Patient Recruitment

Final Agenda

Thursday, February 20

11:30 am Registration Open

Praxis 12:30 pm BRIDGING LUNCHEON CO-PRESENTATION: Putting Patients & Caregivers First: An In-Depth Look at Strategic Partnerships in Executing a Successful Clinical Trial

Renzi_KarenKaren Renzi, Director, Strategy, Praxis Communications, LLC


Rogers_SamanthaSamantha Rogers, Patient Recruitment & Retention Lead, Takeda

Join us as we pull back the curtain to review strategies from a case study that highlights a patient-centric approach to drug development. We’ll discuss how to craft a strategic plan that resonates with both the patient and caregiver. This session will focus on tactics that were successfully executed as well as mid-study adjustments that were implemented in order to optimize patient recruitment and retention.

1:00 Coffee and Dessert Break in the Exhibit HallBioTelResearch

 

2:00 Afternoon Plenary Keynotes

3:10 Booth Crawl & Refreshment Break in the Exhibit Hall. Last Chance for Exhibit Viewing

ENABLE EMPOWERED PATIENTS IN CLINICAL TRIALS BY INTEGRATING THE PATIENT VOICE, HEALTH LITERACY AND CULTURAL SENSITIVITY

4:10 Chairperson’s Remarks

Chris Crucitti, Chief Commercial Officer, Signant Health

4:15 CO-PRESENTATION: Enable Empowered Patients in Clinical Trials by Integrating Health Literacy and Cultural Sensitivity

Myers_LaurieLaurie Myers, MBA, Global Health Literacy Director, Global Population Health, Merck & Co., Inc.


Staley_AliciaAlicia Staley, MBA, Trial Volunteer & Cancer Survivor

Health literacy is an essential tool to help empower patients to: find clinical trial information, understand the potential risks of a trial, know their commitment (time, visits), and improve the participation of underrepresented populations. This session will provide the perspectives of a patient advocate and a pharma health literacy leader, each of whom has been personally overwhelmed by clinical trial information. It will also highlight the importance of cultural sensitivity and of use of the “teach-back method” in reaching patients and training investigators.

4:45 CO-PRESENTATION: Partnering with Patients to Tackle Engagement Together

Saadat-Lajevardi_LeilyLeily Saadat-Lajevardi, Team Leader, Clinical Insights & Experience Group, Janssen R&D


Gregg_AlysonAlyson Gregg, MBA, Director, Patient Insights, Janssen R&D

As we know, the patient voice is critical to ensuring that the solutions that are put in place are meeting an actual need, alleviating a burden and/or are fit for purpose. In this presentation, we will discuss how we have adopted different methods to obtain that patient voice early across multiple therapeutic areas. We will also discuss what we have learned and what we have done as a result of these learnings to create a better experience for our most important stakeholders in clinical trials, the patients who volunteer their time and data for the better outcomes for all.


5:15 Presentation to be Announced

PATIENTS USING AI/DIGITAL TECH TO PERSONALIZE ENGAGEMENT/DO BENEFIT-RISK ASSESSMENT & UNDER-REPRESENTED COMMUNITY ENGAGEMENT

5:45 Patients Embracing Artificial Intelligence and Relevant Technologies in Clinical Trials to Personalize Engagement and Do Benefit-Risk Assessment

Pallapothu_RajRaj Pallapothu, mHealth Global Business Lead, Bayer Pharmaceuticals; mHealth Global Advocate

Patients are ready to integrate new tech and AI into their healthcare experiences, alongside numerous other digital patient engagement technologies, when it comes to personalized patient engagement. Patient engagement, which prioritizes the patient experience during trials, removes obstacles to treatment and helps patients take more ownership over their health during the course of the study. So, the desire to connect with patients and solicit their feedback is there, but many trials struggle to find an efficient means to do so. In addition, developing a better trial design for patients and benefits were at the top of their lists. Because patients benefit from effective treatments while also bearing the risks, their perspectives must be at the heart of trial design and benefit-risk assessment.

6:00 CASE STUDY: Under-Represented Community Engagement to Reach, Raise Awareness and Educate on Clinical Trial Participation

Chopra_NarinderNarinder Chopra, Director, Patient Feasibility, Enrollment & Retention Optimization, Global Clinical Operations, Biogen

tInvesting in relationships with trusted partners to enhance community engagement and participant outreach that raises awareness of clinical trial participation. However, beyond the hype are some operational challenges that must be understood before investing in digital approaches, technology or altering budgets/timelines with overly-optimistic expectations. This talk will share a specific application of traditional and digital engagement with under-represented patient communities to enhance awareness and education, ultimately to present research opportunities in these communities.

6:15 Networking Reception (Sponsorship Opportunity Available)

7:15 Close of Day

Friday, February 21

7:15 am Registration Open

7:45 Breakfast Presentation to be Announced

8:15 Session Break

ACTIVE LISTENING & TECHNOLOGY AS CONDUITS TO IMPROVED PATIENT-FOCUSED CLINICAL DEVELOPMENT

8:20 Chairperson’s Remarks

Jim Lane, Chief Business Officer, Longboat Clinical

8:25 INTERACTIVE CO-PRESENTATION: Moving the Mountain: A Large Pharma Approach to Tech-Enabled Site and Patient Trial Engagement

Lewis_AprilApril Lewis, Senior Director, R&D Technology, GSK


Charge_AlexandraAlexandra Charge, Senior Director, DevOps, AstraZeneca

This presentation will review how large pharma is taking steps to undergo technology enablement of critical and strategic site and patient engagement strategies. AZ and GSK will discuss their approaches to site and patient technology modernization, including adoption strategies, data and system orchestration, and change management. 1) Expected improvement in pharma to site/patient engagement, 2) organizational challenges and successes in technology adoption, and 3) overview of blue-sky future state.

8:55 CO-PRESENTATION: The Mutual Benefits of Active Listening

Teufel_MicheleMichele Teufel, Patient and Site Engagement Lead, Development Operations, AstraZeneca


Linnell_JohnJohn Linnell, Clinical Trial Participant and Member of AZ’s Patient Partnership Program

This discussion will be an opportunity to provide details on the interactions we, Sponsors-Patients, have had over the years and how both AstraZeneca and the patients have benefited. How has listening to and understanding the patient enhanced AstraZeneca’s ability to help patients? Why does active listening allow for a mutually beneficial partnership between the patient and sponsor companies?

9:25 CASE STUDY: Collaborating with Advocacy Organizations to Integrate Patient Perspective into Research

McGowan_MaryMary McGowan, Executive Director, The Myositis Association

This talk will share the why and the how of the development of a training manual for home care nurses that integrated the patients’ perspective and experiences to enhance the clinicians’ understanding of the lived experience by someone who endures the pains and challenges that come with a myositis diagnosis. The manual includes details on the day to day activities of patients and care partners, what it’s like living with the disease, and information on how the disease impacts one’s life. This information was integrated into the routine nurse protocol training for the clinical trial. TMA will demonstrate how prospectively integrating this information into home nurses’ training process results in a better patient clinical trial experience.

9:55 Presentation to be Announced

10:25 Networking Coffee Break

PARTNERING WITH PATIENT ADVOCACY GROUPS TO IMPROVE PATIENT ENGAGEMENT ACROSS DRUG DEVELOPMENT

10:55 Chairperson’s Remarks

Neil Weisman, President, Continuum Clinical

11:00 Partnering with Patient Advocacy Groups to Create Meaningful Patient Engagement across the Drug Development Continuum

Roman_ChristinaChristina Román, Senior Community Engagement Manager, Community Partnerships, Cystic Fibrosis Foundation

Including the patient perspective in drug development can improve study feasibility, reduce burden and ensure that research projects are directed toward questions that matter most to patients. This presentation will highlight innovative and practical approaches to developing collaborations between patients and the research community at every stage of drug development. In addition, the presentation will describe how patient advocacy groups can create and formalize opportunities for patients to meaningfully engage in research activities.

11:30 Presentation to be Announced

12:00 pm Transition to Shared Sessions

FACILITATING THE TRIALS OF THE FUTURE NOW VIA THE CONNECTED PATIENT & DECENTRALIZED TRIALS (SPECIAL SHARED SESSION)

Chairperson’s Remarks

Neil Weisman, President, Continuum Clinical

12:05 The Connected Patient: A “One Stop Shop” for Trial Information and Data

McBride_MeganMegan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson

Learn how we are creating a connected experience for trial participants before, during and after the trial where patients can access meaningful information, their individual data to share with their EHR, aggregate study results and provide ongoing feedback and insights to ensure a better experience for patients, caregivers and the site teams. Explore the possibilities to remain connected via communities to raise awareness around trials. The audience can gain insights as to the ins and outs of how we managed to create a platform to share data directly with patients– from legal, privacy, regulatory and other key stakeholder hurdles to our vision for broadening the scope of data sharing across industry.

12:35 INTERACTIVE PANEL: Translating Virtual to Reality: Decentralized Trial Transformation

Myles_JaneModerator: Jane Myles, Head, Operational Intelligence and Innovation, Roche


Akbari_BardiaPanelists: Bardia Akbari, PharmD, Senior Vice President, Clinical Operations, Science37


Hersch_GregGreg Hersch, PhD, Head, Innovation, Global Development Operations, Novartis


Melvin_CarrieCarrie Melvin, Vice President, Global Clinical Sciences and Delivery TA Head of Oncology, GSK/TESARO


FDA Panelist to be Announced

Our expert panel will include a variety of perspectives and the aim is to provide pragmatic solutions and actionable advice to make virtual trials a realistic option for your study needs. We’ll discuss strategic and tactical needs to help you determine how to navigate and implement virtual and decentralized options to drive your pipeline goals. Topics to be discussed include:

  • Discuss the settings for virtual trials and help define best fit options for study needs.
  • How and when does the regulatory strategy get set to enable a successful filing?
  • What are the challenges to drive both site and patient participation in virtual trials?
  • What are the timeline and cost differences in planning for and executing virtual trial components?
  • What are the key lessons learned from those who have been early adopters and champions?

1:05 Transition to Lunch

1:10 SCOPE Send Off Luncheon Presentation (Sponsorship Opportunity Available)

1:40 Closing Remarks

1:45 SCOPE Summit 2020 Adjourns

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

INTERACTIVE BREAKOUT DISCUSSION GROUPS

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing: www.scopesummit.com/breakouts