2022 Archived Content

Cambridge Healthtech Institute’s 14th Annual

Enrollment Planning and Patient Recruitment

Predicting and Ensuring Diverse Enrollment through Evidence, Patient-Facing Tech, Digital Outreach a

February 8 - 9, 2022 ALL TIMES EST

Patient recruitment and up-front enrollment planning are critical to drug development programs. Patient recruitment, if not adequately planned for, can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order to have complete data sets for your analysis and subsequent filings. To optimize both, you have to have a plan and effectively leverage analytics and technology without losing site of the participant’s user experience. One must take into account the needs of different patient populations, the importance of diversity, how to use digital tech, challenges of consent processes, direct-to-patient models, and many other factors. CHI’s 14th Annual “Enrollment Planning and Patient Recruitment” will cover the topics one should consider when drafting and strategically implementing a patient recruitment plan for a patient-centric and inclusive clinical development program. 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

Monday, February 7

8:00 am SCOPE’s Inaugural Masters of Clinical Research Golf Tournament

Connect with your peers and colleagues at SCOPE's Inaugural Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.

9:00 am Conference Registration Open (Gatlin Foyer)

2:00 pm User Group Meetings (ROOM LOCATIONS: St. John's 30 & 31 & St. John's 32)

Co-locate your User Group, a Workshop or even your company's Annual Meeting with SCOPE Summit. CHI will help market the event and manage logistical operations. We will co-market prospective attendees and extend your users a discount to attend the entire SCOPE conference. We are here to work with you. Use SCOPE as your gathering point! Learn more on the SCOPE Summit website.

5:00 pm KEYNOTE PRESENTATION:

Organizer's Welcome Remarks

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

5:05 pmChairperson’s Introduction: Proven Technology and Services to Support a Seamless Clinical Trial Journey for Participants

Tarra Shingler, MS, Senior Vice President, Global Business Solutions, StudyKIK

5:10 pm KEYNOTE PRESENTATION: Engaging and Understanding Patient Behavior to Improve Accessibility, Retention and Outcomes

Panel Moderator:

Dana Edwards, Chief Commercial Officer, Circuit Clinical

Patient-centric drug development that incorporates patient experience coupled with behavioral science and real-world evidence is evolving the way in which sponsors and regulators bring new medicines to the patients. This executive panel will discuss emerging trends along with case studies that demonstrate how understanding patient need, beliefs and their healthcare journeys influences participation in clinical trials and impacts outcomes.

Panelists:

Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi

Brendan O'Neill, Senior Director Patient Recruitment Programs, Clinical Development & Operations & Global Product Development, Pfizer Inc.

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Thad Wolfram, President, Matrix Clinical Trials, Matrix Clinical Trials

5:45 pm KEYNOTE PRESENTATION:

SCOPE's 2022 Participant Engagement Awards Introduction

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

5:50 pm KEYNOTE PRESENTATION:

SCOPE's 6th Annual Participant Engagement Awards

Panel Moderator:

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Now in its 6th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials.

Participant Engagement Awards Judges:

Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata

Irfan Khan, CEO, Circuit Clinical

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Vice President, Patient Engagement, Medidata

Participant Engagement Awards Contestants:

Angie Caprise, Senior Scientist, Global Trial Optimization, Merck & Co., Inc.

Melissa Jane Bime, CoFounder & CEO, Infiuss Health

Melissa Gebhardt, Senior Director Business Development & CDx, Guardant Health

Fabio Gratton, Co Founder & CEO, CureClick LLC

Gwenn Oakes, Program Director, Global Trial Optimization, Merck

Adam Kleger, InVibe

Ian Greenfield, Tryl

Jeff Smith, Tryl

Panelists:

Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata

Irfan Khan, CEO, Circuit Clinical

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Vice President, Patient Engagement, Medidata

Angie Caprise, Senior Scientist, Global Trial Optimization, Merck & Co., Inc.

Melissa Jane Bime, CoFounder & CEO, Infiuss Health

Melissa Gebhardt, Senior Director Business Development & CDx, Guardant Health

Fabio Gatton, Co-Founder & CEO, THREAD Research (formerly inVine Labs)

Adam Kleger, Head, Client Solutions, inVibe Labs

Gwenn Oakes, Director, Global Trial Optimization, Merck & Co., Inc.

Jeff Smith

Ian Greenfield, CEO, Tryl

6:35 pm SCOPE's Kick-Off Networking Happy Hour (Gatlin Terrace)

7:45 pm Close of Day

Tuesday, February 8

7:15 am Registration Open (Gatlin Foyer)

7:15 am Morning Coffee (Sponsorship Opportunity Available)

8:05 am KEYNOTE PRESENTATION:

Organizer's Welcome Remarks

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

8:10 amChairperson’s Introduction

Peyton Howell, Chief Commercial & Strategy Officer & President, Consulting, Parexel

8:15 am KEYNOTE PRESENTATION:

Fireside Chat: Fit-for-Future Data Operations in a Post-Pandemic World

Demetris Zambas, Vice President & Global Head, Data Monitoring & Management, Pfizer Inc.

Darren Weston, Senior Vice President, Integrated Data Analytics and Reporting (IDAR)and Janssen Clinical Innovation (JCI), Janssen Pharmaceuticals, Inc.

Cynthia Pan, RPh, Senior Director, Therapeutic Area Operations Leader, Global Clinical Operations, Regeneron

The COVID-19 pandemic continues to reshape our world and our approaches to clinical trials. During the last 20 months, the risk-benefit ratios of many innovative methodologies and technologies have inversed. Risk-averse organizations have grasped the realities that these new innovative methods are now the only means to efficiently execute clinical trials. This new reality and the ongoing need for real-time data collection and consumption require new creative and live data flows. An additional ramification of this evolution has been a significant improvement in the level of collaboration required and realized within our organizations and with our external partners and technology providers. Let us discuss how we can cement this “New Normal” to not only maintain the momentum but to ensure these valuable innovations are sustainable.

9:10 am KEYNOTE PRESENTATION:

Case Study: Moving Beyond the Promise of Connected Health, Learning from Implementation at Scale

Adama Ibrahim, Director, Digital Solutions, Technology, Platforms, Data & Digital Global Drug Development, Novartis Pharma AG

Justin Wright, MD, Vice President, Global Head Connected Health, Novartis

At Novartis Global Drug Development, we have a vision to accelerate digital products by developing one or more “connected health” solutions (connected device, wearable, software as medical devices) into our drug programs over the next 5 years. This showcase of the Connected Health group, formed to deliver the vision, will focus on presenting the real work that has been done as a collaboration to bring these digital health tools to clinicians, patients, and to pharma research that improve the overall health care experience and improve access to trials. How does an integrated patient experience deliver more value to patients, providers, and payers? How do you give patients their own digital data so they can be more engaged in their treatment plans? How can Connected Health improve clinical workflow, communication, data exchange, and clinical research? How do you do this at scale, beyond a pilot?

9:55 am Grand Opening Coffee Break in the Exhibit Hall (Gatlin Ballroom BCD)

10:55 amChairperson's Remarks

Neil Weisman, President, Continuum Clinical

11:00 am

Developing and Deploying a D, E & I Strategy in Clinical and Beyond

Kim Hawkins, Head, Global Clinical Project Operations & Dossiers Delivery, Sanofi

Paul Cox, PhD, Country Head U.S. Clinical Study Unit, Clinical Science & Operations, Sanofi

Sanofi is committed to increasing diversity in clinical trials based on the belief that all individuals should have the opportunity to be included in clinical trials, particularly people from diverse populations who are often under-represented in clinical research. We will provide an overview of the current state and discuss how Sanofi has approached the barriers, challenges, and environment and developed a strategy and collaborations for increasing diversity in clinical trials.

11:30 am

How to Enroll Minority Patients: Disparities in Trials, Developing a Research Plan, Using Education and Technology

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

Ryan Nguyen, DO, Chief Hematology Oncology Fellow, University of Illinois Cancer Center

Cancer clinical trials have historically lacked equitable representation of racial and ethnic minority populations and have the potential to perpetuate outcome disparities. Barriers to equitable clinical trial enrollment are multi-level and include exclusionary clinical trial design, access to care, and provider bias and cultural competency. Patient-focused educational modules offer a technology solution to empower patients to make informed decision about clinical trial enrollment.

12:00 pm

Bridging the Diversity Gap in Clinical Trials

Adrelia Allen, PharmD, PMP, Director, Clinical Trial Patient Diversity, Merck

Lynne Howell, Associate Director, Clinical Research-Infectious Disease, Merck

The COVID-19 pandemic illuminated a spotlight on health disparities and the need to focus on the inclusion of diverse patients in clinical trials. Study teams did not let allow the COVID-19 pandemic prevent them from achieving their goal of enrolling a diverse population in three U.S. trials focused on enrolling underrepresented patients. Tt was clear the teams would have to work differently to achieve their goal. This case study will highlight the strategies implemented to make these trials more inclusive.

12:30 pmPatient Compensation Taboo: Navigating Compensation’s Impact on Patients’ Ability & Motivation to Participate in Trials

Ivor Clarke, CEO, SubjectWell

With limited industry discussion or standardization, each trial faces the challenge of setting appropriate patient compensation. We’ll share data on how varied compensation messaging and stipend amounts impact patients’ willingness and ability to participate in a trial. Plus, we’ll explore the complex relationship between diversity, clinical benefit, compensation, and enrollment.

1:00 pm Transition to Lunch

1:03 pmLUNCHEON PRESENTATION: Pandemics, Pipelines and Patients: A Fireside Chat with Takeda’s Patient Recruitment and Retention Team

Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC

Amanda Decoker, Director, Patient Recruitment & Retention Global Clinical Operations, Takeda Pharmaceutical Company Limited

The pandemic has made a permanent impact on how clinical research is conducted. Join this unplugged discussion focusing on key patient recruitment and retention takeaways from the pandemic and how to incorporate these learnings into strategic planning moving forward. We’ll explore how the adjustments tie into being able to work together to advance research and deliver results while keeping patients top of mind.

1:35 pm Coffee and Dessert Break in the Exhibit Hall (Gatlin Ballroom BCD)

2:30 pmChairperson's Remarks

Kent Siri, Vice President of Marketing and Head of Diversity Initiatives, Reify Health

2:35 pm

Encourage and Support Communities and Community Health Systems to Engage in the Clinical Trial Referral Process

Karen Correa, PhD, Vice President, Clinical Operations, Takeda Pharmaceutical Co., Ltd.

There are no standards or processes in place for how to effectively educate and motivate HCPs to be ongoing clinical trial referrers. This is an area of high potential and under-utilization. Engaging with communities and community health systems will help increase education, awareness and access to clinical trials in underrepresented populations. This presentation will focus on supporting these entities with a sustainable process.

3:05 pmIncreasing Site Enrollment Capacity: A Combination of Strategy and Augmentation that Works

Seth Halvorson, General Manager, WCG Threewire

Tyler Bye, Director, Program Strategy and Product Development, WCG ThreeWire

Each patient's journey begins with proper identification, but how are sponsors utilizing the right tactics to best support (and adapt) their enrollment strategy in the long run? In this session, our enrollment experts will describe how sponsors and sites have implemented tools and processes that fulfill evolving demands in study conduct. Learn how best-in-class knowledge across industry-sponsored trials has enabled sites to adapt and perform—even with never-before-seen resource constraints.

3:35 pm

How Insights Inspired Successful Recruitment and Retention Strategies

Maura Snyder, Global Head Clinical Trial Engagement, Clinical Insights & Experience, Janssen Pharmaceuticals, Inc.

Alyson Gregg, Director Patient Insights, Janssen Pharmaceuticals, Inc.

How insights inspired successful recruitment and retention strategies for Janssen's phase 3 COVID-19 vaccine trial, ENSEMBLE 1. Ensemble 1 is a phase 3 trial of Janssen's COVID-19 vaccine (Ad26.COV2.S.) involving approximately 45,000 adult participants. Hear how Janssen collaborated with the Centre for Information and Study on Clinical Research Participation (CISCRP) to develop insights that led to the development of successful operational strategies to support rapid enrolment of a diverse participant population and to engage and support them through the trial.

4:05 pmImproving the Research Experience for Patients through Omnichannel Engagement and the Decentralized Trial Method

Parag More, Executive Director, Healthcare Analytics Solutions, Quest Diagnostics

Traditional Clinical Trial recruitment has long struggled with the issues of inadequate enrollment, participant diversity, and retention resulting in underpowered and prematurely closed studies. Using multiple outreach channels (Omnichannels) Quest Diagnostics is establishing community based service locations to reach a more diverse population by meeting people “where they live”, including rural, culturally, and racially diverse communities.

4:35 pm Find Your Table and Meet Your Moderators

4:40 pm Interactive Discussions

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing. For virtual attendees, the format will be in a Zoom room. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

5:25 pm Welcome Reception in the Exhibit Hall (Gatlin Ballroom BCD)

6:40 pm Close of Day

Wednesday, February 9

7:15 am Registration Open (Gatlin Foyer)

BREAKFAST PRESENTATIONS

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

7:45 amPractical Approaches for Operationalizing DCTs Room Location: Gatlin A1

Kyle Hogan, President, Datacubed Health

Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring.

7:45 amOptimizing Clinical Trial Site Selection Utilizing Real-World Data  Room Location: Gatlin A2

Andrea Valencia Dremelj, Director BioPharma Business Operations, Biopharma, SOPHiA GENETICS

Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

8:15 am Session Break

8:20 amChairperson's Remarks

Rob Bohacs, Founder & Chief Solutions Officer, ClinOne

8:25 am

Leveraging Trustworthy Voices and Big Data to Improve Digital Outreach and Community Engagement

Mary Murray, Vice President, Collaborative Action Networks, National Minority Quality Forum

Social and other virtual media are proving to be critical drivers for forming communities around health information. For the clinical trial enterprise, it is important to unite communities by sharing accurate data and information through trustworthy voices in a way that brings more community members into the conversation. Successful collaborative communication strategies require clearly-defined goals, consistency of engagement, and open access to resources and materials. This session will share examples of successful strategies and campaigns, offering insights into effective practices, toolkit elements, and meaningful metrics to drive and track engagement down to the zip code level.

8:55 amImproving Oncology Clinical Trials with Technology to Connect, Inform, and Empower Patients

Rob Bohacs, Founder & Chief Solutions Officer, ClinOne

Amanda Siegert, Associate Director, Patient Recruitment, Medpace

It's no longer good enough to be "good enough." What are five simple things we can implement today to make it easier for patients to say "yes" to participating (and staying) in our clinical trials?

9:25 am

Improving Education, Awareness, and Clinical Trial Participation through Health Literate Digital Assets

Sara Pierson, Director, Patient Recruitment Programs, Pfizer Inc.

With no shortage of information available it became increasingly important to create a trusted, consistent place for someone seeking information about clinical trials and participation in a health literate manner. While the foundation of PfizerClinicalTrials.com is robust educational content about clinical trials, the heart of the platform is Find a Trial, the search engine for Pfizer's clinical trials. We'll explore key features of PCT.com.

9:55 amDiversity in Clinical Trials: Moving from Insight to Action, Earlier in the Funnel

Kent Siri, Vice President of Marketing and Head of Diversity Initiatives, Reify Health

Natalie Cheung Rotelli, Advisor of Diversity in Clinical Trials, Eli Lilly and Company

Neha Londoño, Director, Clinical Trial Diversity and Inclusion, Seagen

Improving clinical trial participant diversity is a key priority for the life sciences industry. But how can sponsors take corrective action with limited demographic data captured during a trial?A new category of solutions has emerged to provide race and ethnicity data earlier in recruitment, unveiling how trial design affects candidates throughout enrollment. D&I leaders will discuss strategies they are deploying to improve diversity, access, and equity across their trials.

10:25 am Coffee Break in the Exhibit Hall (Gatlin Ballroom BCD)

11:20 amChairperson's Remarks

Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis

11:25 amThe Making of Merck’s new Clinical Trial Finder website

Gwenn Oakes, Director, Global Trial Optimization, Merck

Neil Weisman, President, Continuum Clinical

Kara Monson, Sr. Scientist, Global Trial Optimization, Merck

In this case study, Merck and partner Continuum Clinical explore the challenges and opportunities uncovered in the making of Merck’s new clinical trial finder website. From planning to startup through development and execution, learn how Merck organized its ~1,700 ongoing clinical trials as part of an engaging platform that prioritized health literacy, the importance of participant diversity, and the demand for transparency while fueling trial enrollment and improving retention.

11:40 am

Protocol Design from a Site’s and Sponsor's Perspective: What Sponsors Should Know to Increase Diverse Populations in Their Trials

Audrey Escobedo-Escotto, MD, MPH, Director, Research, Emerson Clinical Research Institute

Inclusion of diverse populations in clinical trials has been brought more to light in these last years. Many sponsors have realized the importance of having specialized teams to develop tools to increase diverse populations in their studies. Today, sponsors will learn what they are missing in their protocols based on a site's experience in diversity enrollment. Strategies for inclusion, retention, protocol development, and more.

11:55 am Transition to Lunch

12:00 pmLUNCHEON PRESENTATION: Think Further: Platform Communications Across a Portfolio of Studies

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)

1:30 pm Close of Part A Conference. Join Plenary Keynotes and stay on for Part B of SCOPE Summit!*

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)