Cambridge Healthtech Institute’s 12th Annual

Patient Engagement and Retention through Communities and Technology

Empowering a Diverse Participant Population and Optimizing their Journey to Improve Trial Design and

February 9 - 10, 2022 ALL TIMES EST

Patient engagement, recruitment and retention, 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 a diverse set of 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 12th 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. Advisory Board: Brendan O'Neill, Senior Director Patient Recruitment Programs, Clinical Development & Operations & Global Product Development, Pfizer Kafayat Babajide, MBA, Associate Director, Patient Portals, Janssen Kimberly Richardson, Research Advocate, Founder of the Black Cancer Collaborative Laurie Myers, Director, Global Health Literacy, Merck & Co Inc Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Senior Director, Patient Engagement, Medidata, a Dassault Systèmes company Lori Abrams, Executive Director, Patient Advocacy & Diversity, WCG Adama Ibrahim, EMBA, Director, Digital Solutions, Novartis

Wednesday, February 9

ROOM LOCATION: Gatlin A1

BRIDGING LUNCHEON PRESENTATION

Klaira Simon, Managing Director, Clinical Trial Experience, Langland
Andrea Bartucca, Director, Trial Awareness, Forma Therapeutics
12:30 pm Coffee and Dessert Break in the Exhibit Hall (Gatlin Ballroom BCD)(Sponsorship Opportunity Available)

KEYNOTE LOCATION: Gatlin A1 & A2

DIVERSITY, EQUITY & INCLUSION (DE&I) AND SPEAKING THE LANGUAGE OF BUSINESS AND LEADERSHIP

1:30 pm KEYNOTE PRESENTATION:

Welcome Remarks from CHI and the SCOPE Team

Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)

Thank you all for being here from the SCOPE team: Micah Lieberman, Dr. Marina Filshtinsky, Kaitlin Kelleher, Bridget Kotelly, Mary Ann Brown, Ilana Quigley, Patty Rose, Julie Kostas, and Tricia Michalovicz

1:35 pm KEYNOTE PRESENTATION:

Why Advancing Inclusive Research is a Moral, Scientific, and Business Imperative

Meghan McKenzie, Principal, Inclusion, Patient Insights and Health Equity, Chief Diversity Office, Genentech

Our industry is rightfully focused on the importance of diversity, equity, and inclusion in clinical trials. Many of us have been focused on this in our work and/or in our advocacy, both inside and outside of our organizations for some time. Why is inclusivity so important to PIs and patients? Why is it both a moral and a business imperative? Learn why representation in clinical research matters for your patients and how it shapes good science. The face of the world is changing and your success is tied to reaching ethnic minorities.

2:00 pm KEYNOTE PRESENTATION:

Implicit Bias Around Advocacy and Decision Making: Metrics of DE&I and Speaking the Language of Business and Leadership

Panel Moderator:
Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

What is the perspective of Black professionals and patient advocates as the medical and scientific industries grapple with effective ways to engage minority population?  Where are their voices being heard and what can we learn from the cultural experiences they weave into their research methodologies and daily practices? Panelists will share their perspectives on how the Black voice should be included in advocacy and public and private aspects of clinical research. 

Panelists:
Karriem Watson, PhD, Chief Engagement Officer, NIH
Monique Phillips, Global Diversity and Inclusion Lead, Bristol Myers Squibb Co.
Nikhil Wagle, MD, Assistant Professor, Harvard Medical School, Dana-Farber Cancer Institute
2:45 pm Booth Crawl & Refreshment Break in the Exhibit Hall (Gatlin Ballroom BCD)

ROOM LOCATION: Gatlin A1

INTEGRATED PATIENT CENTRICITY IN R&D FROM DISCOVERY TO DELIVERY

Ivor Clarke, CEO, SubjectWell
3:50 pm

Evolving Model for Integrated Patient Centricity in R&D from Discovery to Delivery

Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi
Anthony Yanni, MD, Senior Vice President and Global Head, Patient Centricity, Astellas

Join former colleagues Vicky DiBiaso, Global Head, Patient Informed Development & Health Value Translation at Sanofi, and Anthony Yanni, Senior Vice President and Global Head of Patient Centricity at Astellas Pharma Inc., in their conversation on the evolution of patient centricity and what it means to holistically deliver value to patients from drug discovery to delivery.

4:20 pm

Leveraging Critical Insights from Patients and Care Partners in Trial Protocols to Create More Inclusive, Patient-Friendly Studies

Michelle Shogren, Senior Director Innovation, Pharma R&D Clinical Operations, Bayer HealthCare

Deploying patient-facing digital technology and incorporating patient and care partner voice in decentralized clinical trials enable the generation of critical insights. In this talk, TransCelerate will share best practices for deploying digital technologies in DCTs with a focus on understanding patient and care partner voice; they will analyze lessons learned from engaging patients, care partners, sites, sponsors, and regulators in conversations about deploying technology and improving patient experience with DCTs.

Ivor Clarke, CEO, SubjectWell

Decentralized clinical trials (DCTS) with all of their well-loved patient accommodations ironically pairs with a reduction in the role of sites, previously dedicated to patient care. This session explores the holes created by DCTs with sites’ reduced involvement. We’ll look at patients’ preferred accommodations based on extensive data from patient surveys. Plus, we’ll share case studies from recent DCTs, detailing the emerging education, technology and engagement solutions.

ACCESSIBILITY FOR DIVERSE AND UNDERSERVED PATIENT POPULATIONS

5:20 pm PANEL DISCUSSION:

Lack of Diversity in Clinical Trials is a Public Health Issue:  An Issue We Can NO Longer Ignore

Panel Moderator:
Lori B. Abrams, Vice President, Patient Advocacy & Clinical Research Diversity, WCG
The lack of diversity in clinical trials mimics the health disparities and racial health injustices that have been pervasive in our country for centuries. When looking for sustainable solutions that address underrepresentation in clinical research trials, we must examine the imbalance between multiple stakeholder actions and other factors outside of healthcare. This session will focus on issues that create barriers that ultimately translate into the under-representation of many non-Caucasian and other marginalized groups.  We will begin to share recommendations for change.
Panelists:
Allison Kemner, Vice President, Clinical Sciences and Operations, Tyra Biosciences
Jeanne Regnante, Chief Health Equity and Diversity Officer, LUNGevity Foundation
LaTasha Lee, PhD, Adjunct Professor, Clinical Research & Leadership, George Washington University
5:50 pm Close of Day

Thursday, February 10

7:15 am Registration Open and Breakfast (Gatlin Foyer)

ROOM LOCATION: Gatlin A1

LISTENING, CONNECTING, INFORMING AND EMPOWERING PATIENTS FOR IMPROVED TRIALS

8:25 am

Mining Real-Time Experience with My Trial Community

Kafayat Babajide, MBA, Associate Director, Patient Portals, Janssen Research & Development, LLC

My Trial Community is an insights-driven patient platform that is shaping the Janssen clinical trial experience by: educating Janssen trial participants on what to expect, empowering them with a selection of their own personal data and study results, and engaging them as valued stakeholders through more regular feedback loops. The Janssen team has learned a lot from patients and other stakeholders since initially launching the site in August 2021 and is happy to share key insights.

8:50 am

Incorporating Site and Patient Input into Clinical Development Planning

Michele Teufel, Patient & Site Engagement Lead, Development Operations, AstraZeneca Pharmaceuticals, Inc.

At AstraZeneca, our values guide everything we do and we are committed to improving the whole patient experience by embedding patient-centric thinking in the medicines, products, and services we develop. For clinical trials, this means that we engage and listen to our patients and sites throughout the clinical development planning, and during this presentation, you will hear more about how we are implementing this approach by setting up processes and by engaging early with key stakeholders.

David MacMurchy, Chief Executive Officer, Lightship Inc.

The biggest challenge in clinical trials that we still need to overcome is that only a small proportion of patients have access to clinical studies as a treatment option. Flexibility ensures that we can meet patients where they are; and where we can maximize their access, convenience, safety, and comfort. Prioritizing patient choice in clinical trials eases the burden on the patient and their caregivers to improve the clinical trial experience.

9:45 am

Our Journey in Developing a More Patient Centric Informed Consent Template

Jennifer Ribeiro, Director, Clinical Trial Model Documents & Informed Consent, Bristol Myers Squibb Co.

BMS has been working through a full revamp of our informed consent main template during 2020 and 2021. This was a process that required multiple cross functional stakeholders' engagement & change management in order to develop a more robust template.

Esther Howard, CEO, Bezyl Inc.
Mark Surles, CEO, ScienceMedia, Inc.

Efficiency, quality, endurance, speed. Those are the qualities needed for winning an Olympic medal—and what you should and can expect from active protocol compliance management. Through a dialog of industry trends and real-world experiences, learn ways to reduce key risks to study startup and site performance in the context of site-based and hybrid trials, and recognize how significant study-related education is to improving compliance.

10:40 am Networking Coffee Break (Gatlin Foyer)

THE “BEHAVIORAL ECONOMICS” OF PATIENT ENGAGEMENT

Melissa Easy, Vice President, R&D Technology Solutions, IQVIA
11:00 am

The “Behavioral Economics” of Patient Engagement in Clinical Trials: Understanding Patient Need and Behavior to Make Informed Decisions in Enrollment Planning

Karen Horgan, CEO & Co-Founder, VAL Health LLC

As our healthcare system continues to strive for best possible outcomes, we need to recognize that what we’ve always done isn’t working; as an ecosystem, we’ve been adding new tools based on how we want patients to act, yet what we really need is to design our solutions around how people actually behave. Telehealth, digital health tools, and patient portals are expanding initiatives, but we know that technology alone doesn’t drive behavior change as we see patients, providers, consumers, and other stakeholders struggle to begin to engage with the offerings, let alone to continue engaging with them in the long term.

Katie Shaw, Senior Director, Patient Recruitment & Enablement, Global Patient and Site Services, IQVIA
Elizabeth Powers, Vice President & Category Lead of Regulatory and Safety Offerings, Real World Solutions, IQVIA

The drug development industry has access to vast stores of real-world data (RWD) that reflect the healthcare journeys of millions of patients across the globe. And the scale of these assets grows exponentially every day. Armed with more information than ever about a patient’s health journey, means sponsors can accelerate recruitment, engage with diverse populations, and deliver a patient centric trial experience.

12:00 pm Transition to Shared Sessions or Brief Session Break

ENGAGING AND SUPPORTING PATIENTS AND SITES E2E WITH DIGITAL OUTREACH, VIRTUAL WAITING ROOMS, AND TECHNOLOGY

Melissa Easy, Vice President, R&D Technology Solutions, IQVIA
12:05 pm

What We Learned About E2E Trial Engagement through Smart Use of Technology

Maura Snyder, Global Head Clinical Trial Engagement, Clinical Insights & Experience, Janssen Pharmaceuticals, Inc.
Lieven Van Vijnckt, Head, Investigator & Patient Engagement, Infectious Disease and Vaccines (ID&V), Janssen Pharmaceuticals, Inc.

What we learned about E2E trial engagement through smart use of technology and Home Health Services in Janssen's phase 3 COVID-19 vaccine trial, ENSEMBLE 1. Janssen collaborated to engage several novel patient platforms for Ensemble 1, a phase 3 trial of Janssen's COVID-19 vaccine (Ad26.COV2.S.). New technology and services were leveraged end-to-end from participant referrals through enrollment, participant engagement and remote data collection. We will share what we have learned so far.

12:30 pm

Sponsors Supporting Sites with Digital Outreach and Virtual Waiting Rooms for Patients

Melanie Goodwin, Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer Inc.

The clinical research industry and innovators from sponsor/vendors/CROs/sites have responded to the Covid pandemic with grit and creativity. One of the outcomes is the continued drive to create and deliver truly patient-centric trials. Our team at Pfizer has learned a lot and challenged ourselves to enable faster, safer and more flexible trials that match patient need and the new reality of reduced timelines. This presentation will share some new work in digital outreach and virtual waiting room for patients.

1:05 pm Transition to Lunch
SCOPE SEND OFF LUNCHEON PRESENTATIONS

Come enjoy a luncheon with your peers while listening to your choice of two compelling industry presentations.

Nekzad Shroff, Vice President, Product Management, Saama Technologies
Aditya Gadiko, Director of Clinical Informatics, Saama Technologies

Today’s medical monitors are under tremendous pressure to quickly identify trends and signals that could impact patient safety and drug efficacy. This critical task is only getting more difficult as the volume of data–and the number of data sources–grows. This session will explore new approaches to medical monitoring, available now, that can simplify workflows and scale to meet the challenges posed by data volume, velocity, and variety.

Nicole Stansbury, Vice President, Clinical Monitoring, Central Monitoring Services, Syneos Health
1:45 pm SCOPE Summit 2022 Adjourns





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