Recruitment & Engagement

Enrollment Planning and Patient Recruitment

Patient Engagement and Retention through Communities and Technology

患者募集は、臨床研究における最大のボトルネックの1つです。登録目標を達成できない場合、費用のかかる遅延が発生し、何より、新薬を必要とする患者の手に渡るまでの時間に影響を与えます。また、治験参加者の多様性と受容性を改善することが不可欠です。CHIの募集とエンゲージメントのトラックでは、治験計画と実施におけるこれらの重要なステップを改善するための最新の戦略と技術を提供します。パートA:登録計画と患者募集では、国際共同治験登録のための戦略、データ分析の活用による登録と多様性の改善、事前の登録計画を改善するための戦術などに焦点を当てています。パートB:コミュニティと技術による患者エンゲージメントとリテンションでは、多様な集団と契約するための道筋、施設の参加者ユーザーエクスペリエンスと潜在的技術の負担を見失うことがないよう技術を活用する方法、進行中のリソースの制約を考慮して施設をサポートするための戦略を探ります。

2月6日(月)

SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament* 8:00 am

Connect with your peers and colleagues at SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament.
*Limited space available. Separate registration and fee required for Golf.

Conference Registration Open9:00 am

Open Workshop: Introducing ClinEco, the New B2B Clnical Trial Community and Marketplace1:00 pm

Sit down with a small cross-industry group for a 45-minute hands-on session to learn about, share feedback, and register for free for the new B2B clinical trial community and marketplace. ClinEco unites sponsors, CRO's, service providers, and sites to streamline partnering and vendor selection. We are currently onboarding leaders in clinical research to: Explore the Ecosystem. Engage Partners. Exchange Capabilities. Walk-ins welcome. Open to all SCOPE attendees.

User Group Meetings2:00 pm

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.

Part 1: Enrollment Planning and Patient Recruitment

ADDRESSING RACIAL INEQUITIES IN CLINICAL TRIALS & PARTICIPANT ENGAGEMENT AWARDS

5:00 pm

Organizer's Welcome Remarks and 2nd Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

5:05 pm Plenary Keynote Introduction

Tarra Shingler, Chief Commercial Officer, StudyKIK

5:10 pm INTERACTIVE PANEL:

Lighting a “Beacon of Hope” to Address Racial Inequity in Clinical Trials, Health, and Education

PANEL MODERATOR:

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

Launched in July 2021 as a $33.7M commitment from Novartis and the Novartis US Foundation, Beacon of Hope began as a 10-year collaboration to increase diversity among clinical trial participants and investigators; improve access to high-quality education and promising jobs; address inherent bias in the data standards, and find actionable solutions to environmental and climate issues that disproportionately affect health among communities of color. This session brings together leaders from collaborating partner companies Novartis, Sanofi, Merck, and one of the participating HBCUs to discuss how Beacon of Hope aims to improve the quality and inclusivity of clinical trials.

PANELISTS:

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

Rajbir Singh, MD, Executive Director of Precision Medicine and Health Equity Trials Design, Meharry Medical College

Priscilla Pemu, Doctorate, MBBS MS FACP, Associate Dean Clinical Research at Morehouse School of Medicine

Kimberly Fookes, Global Head, Diversity & Inclusion in Clinical Trials, Novartis

Celia J. Maxwell, MD, Associate Dean for Research, Howard University College of Medicine, Medicine & Health Affairs, Howard University Hospital

Jaydutt Vadgama, Prof & Exec VP Research & Health Affairs & Chief, Cancer Research & Training & Internal Medicine, Charles R Drew Univ of Medicine & Science

Naikia Byrd-Atkinson, Director, US Clinical Trials Diversity and Inclusion, Sanofi

SCOPE's 7th Annual Participant Engagement Awards Introduction5:40 pm

5:45 pm

SCOPE's 7th Annual Participant Engagement Awards

PANEL MODERATOR:

Kelly McKee, Vice President, Decentralized Clinical Trials (DCT), Medidata

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

Now in its 7th 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. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2023 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: participant-engagement-award

PANELISTS:

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

Anne Marie Mercurio, Clinical Trial Volunteer and Patient Advocate

Marisa Rackley, Vice President, Clinical Site Start Up, Site Engagement, Trial Optimization, Takeda

Irena Webster, Vice President, Head of Development Operations, Forma Therapeutics

Kelly White, Senior Director, Head, Global Trial Optimization, Oncology, Merck & Co.

Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Co.

SCOPE's Kick-Off Happy Hour6:30 pm

Close of Day7:45 pm

2月7日(火)

Registration Open7:00 am

Morning Brew & Pastries to Jumpstart Your Day (Sponsorship Opportunities Available) or Morning Coffee7:30 am

THE REALITY OF A TRIAL EXPERIENCE & NAVIGATING A GLOBAL CRISIS

8:30 am

Chairperson's Remarks

Marina Filshtinsky, Conference Producer, Cambridge Healthtech Institute

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

8:35 am Chairperson'sPlenary Keynote Introduction

Jim Reilly, Vice President, Development Cloud Strategy, Veeva Systems

8:40 am

Would I Want My Mother to Be Part of a Clinical Trial?

Virginia Nido, Global Head, Product Development Industry Collaborations, Genentech, a member of the Roche Group

For many years, our industry has been talking about becoming more patient-centric and innovative in our approach to clinical trials and all the great things we are doing to make clinical trials more convenient for participants. But have we really changed the experience for patients or are we just continuing to admire the problem? Would you really want YOUR mother to be part of one of your clinical trials? We need to get real. It should not take a pandemic to make changes to our protocols and processes and ways of working. But we still have so far to go and together we must continue to drive an uncomfortable level of change.

9:05 am INTERACTIVE PANEL:

Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It

PANEL MODERATOR:

Balazs Flink, Senior Director, Clinical Development Operations, Daiichi Sankyo, Inc.

Running a complex clinical trial involves a lot of moving pieces, forward planning, modeling, allocation of resources, and a neverending ability to adjust while maintaining the highest standards. It has never been easy, but many of us in the clinical research profession know how to do our part. The advent of DCTs, novel tech and data sources, and then the pandemic put us all to the test. However, we are now facing supply chain disruptions and other human/material resource challenges that make everything even more complicated. What is a clinical ops leader to do?

PANELISTS:

Gaurav Sawhney, Vice President, Head, Clinical Partner Management, Takeda Pharmaceuticals, Inc.

Bryan O'Neill, Global Head, Clinical Supply Operations, Daiichi Sankyo, Inc.

Deborah Profit, PhD, Vice President, Clinical Management & Applied Innovation, Otsuka America Pharmaceutical, Inc.

Ken Getz, Executive Director, Tufts Center for the Study of Drug Development

Help Us Set A World Record: Join Everyone For Group Photo At 9:25 Sharp In The Keynote to Make History!9:30 am

Grand Opening Coffee & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available)9:35 am

BUILDING DIVERSITY, EQUITY, AND INCLUSION (DE&I) INTO CLINICAL TRIAL ENROLLMENT

10:35 am Chairperson's Remarks

Neil Weisman, President, Continuum Clinical

10:40 am

Strategizing to Achieve Diversity in Clinical Research - A Regulatory Perspective

Jamie Brewer, MD, Clinical Team Lead, Division of Oncology 3, Office of Oncologic Diseases, FDA

Presentation will discuss FDA’s recommended approach to developing a strategy to enroll diverse populations in clinical trials that support approval of FDA regulated medical products; and will provide an overview of currently implemented strategies that may drive success.

11:10 am

Transforming Clinical Trial Diversity Equity & Inclusion Goals into Action

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

Neha Londono, Director, Clinical Trial Diversity & Inclusion, Seagen, Inc.

This session will explore foundational elements of Seagen’s approach to clinical trial diversity equity and inclusion. Key components will include devising a personalized strategy founded in epidemiology, and centered in inclusive trial design, patient centric solutions, strategic site selection, site focused services, and collaboration with patient advocacy and trusted messengers.

11:40 am PANEL DISCUSSION:

Operationalizing Diversity in Clinical Trials: Cross-Functional Capabilities Needed to Recruit, Track, & Adapt for Meaningful Change

PANEL MODERATOR:

Jason Gubb, Clinical Operations Consultant and Co-Founder, Emergent Teams

Over recent years our industry has been on a journey to ensure appropriate Diversity, Inclusion and Equitable participation in our clinical trials. Much time is spent in designing trial entry criteria to ensure participation of diverse populations; however, we need to go beyond an intent and get real about how we can make a meaningful difference to reflect the population most likely to use the drug if approved. Our esteemed panel representing FDA, Pharma, Consortia and technology will share insights and discuss how we can proactively ensure our industry is truly future-ready including the people, processes and technology needed.

PANELISTS:

Jamie Brewer, MD, Clinical Team Lead, Division of Oncology 3, Office of Oncologic Diseases, FDA

Alekhya Pochiraju, Senior Product Development Lead, Clinical Operations, Genentech

LaShell Robinson, MS, Director Diversity, Equity & Inclusion in Clinical Research, Takeda

Sheila Rocchio, Digital Growth & Education, eClinical Solutions

12:10 pm Make DEI Part of the Plan: Strategies for the Successful Enrollment of Diverse and Inclusive Patient Populations

Gaby Grekin, Senior Director, Global Strategy, BBK Worldwide

Any meaningful commitment to diversity, equity, and inclusion (DEI) must be considered in the planning stage - not tacked on as an afterthought. Only an intentional and integrated approach will succeed. We will discuss making DEI a priority at the beginning of a trial; barriers to recruiting racially, ethnically, and socio-economically diverse populations; and share strategies for overcoming those challenges to ensure your trial includes and reflects populations that will ultimately benefit from them. 

Transition to Lunch12:40 pm

12:45 pm LUNCHEON PRESENTATION:Addressing Enrollment Challenges in Rare Disease and Oncology Research Studies

Amanda Decoker, Senior Director, Head of Patient Recruitment & Retention, Clinical Site Startup & Engagement, Global Development Office, Takeda

Deborah Howe, Director, Global Patient Recruitment and Engagement, Alexion, Astra Zeneca Rare Disease

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

Creating unique, customized programs is essential to clinical trial recruitment and retention especially in the fields of rare disease and oncology. Join us for a fireside chat with industry experts where we explore the nuances of tailoring an approach designed to meet these unique patient populations where they are in their journey in order to bring trial awareness and opportunities to them in a relatable and accessible way.

Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)1:15 pm

NEW APPROACHES TO SUPPORT ENROLLMENT GOALS

2:10 pm Chairperson's Remarks

George Dorsett, Vice President, Business Development, Clariness

2:15 pm

Geo-Mapping to Support DCT and Diversity in Clinical Trials

Katherine Broecker, Senior Director, Design Hub Data Insights, Eli Lilly & Co.

The Geo-mapping visualization tool has been developed to allow recruitment and engagement teams to combine multiple data sources visually to identify target patients, investigators, and decentralized capabilities that can expand enrollment reach. Data layers include DCT vendor locations, disease prevalence, demographic segments, and investigator locations. These elements viewed together can guide the user in their enrollment efforts to maximize reach and eliminate gaps in clinical trial recruitment and diverse representation. 

2:45 pm Impact of Socioeconomic Status on Clinical Trial Diversity

Ivor Clarke, CEO, SubjectWell

As an industry, we strive for a diverse, representative population for every trial, seeking to increase patient participation by offsetting burdens with medical value. Yet these barriers to participation are not experienced equally by all socioeconomic groups. Using data from recent patient surveys, this session explores the correlation between socioeconomic status (education, social class, and income), barriers to participation, and patient diversity.

3:15 pm PANEL DISCUSSION:

Overcoming Recruitment Challenges of Global Studies

PANEL MODERATOR:

Amy Froment, Head, Global Trial Optimization, Regeneron

There is no single patient - they are all individuals with different needs and perspectives in considering participation in a study. How can we ensure our messaging and information is inclusive and speaks to them but cost effective in a global study across multiple languages and cultures. How can we ensure global recruitment is indicative of patient population that will ultimately receive the treatment should it be approved for use? How can we achieve diversity goals?  How can we ensure that we can focus sites on utilizing recruitment tools and materials fully where they can be overwhelmed with novel technologies, platforms and their clinical workload?

PANELISTS:

Nanci Eannucci, Director, Clinical Trial Recruitment Strategy, Bristol Myers Squibb

Gwenn Oakes, Director, Global Trial Optimization, Merck

Cory Potts, Senior Manager, Site Engagement, Diversity Lead, Bayer

3:45 pm Improving Trial Recruitment & Engagement with Effective Use of Lab Data

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

Attend this session to learn how Quest Diagnostics Clinical Trials Solutions works with pharmaceutical organizations to provide data- and infrastructure-based solutions for site and investigator validation and identification, patient recruitment outreach, HCP outreach, DCTs, cohort profiling and analytics, patient-initiated screening (pre-testing), and more.

INTERACTIVE BREAKOUT DISCUSSION GROUPS

4:15 pmFind Your Table and Meet Your Moderator
4:20 pmInteractive 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. Please visit the Interactive Breakout Discussion Groups Page for more information.

Welcome Reception in the Exhibit Hall5:00 pm

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle* (Sponsorship Opportunities Available)6:30 pm

*Courtesy shuttles will be available Tuesday and Wednesday 6:30-10:30pm (last pick up), bringing you to and from The Pointe Orlando.

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop 6:30-10:30pm (last pick up) between Rosen Shingle Creek, Hilton Orlando, DoubleTree Orlando at SeaWorld, and Pointe Orlando. 
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

2月8日(水)

BREAKFAST PRESENTATIONS

8:00 amRegistration Open
8:30 am Breakfast Presentation Option #1Achieving the Impossible: Maximizing Patient Experience and Data Quality in a Complex Rare Disease Program

Caroline Jackson, Executive Vice President, Patient Services, mdgroup

Mobile health has a significant impact on patient retention and experience in clinical trials. However,it’s still under-utilized as there is a perception that more complex assessments and procedures cannot be conducted effectively in the home. This case study highlights how mdgroup worked with a client to implement complex sample collections in the homes of patients suffering from a rare disease, resulting in reduced travel burden and low dropout rates.

8:30 am Breakfast Presentation Option #2Strategies for Biopharma Companies to Boost Clinical Trial Enrollment

Dennis Akkaya, Chief Commercial Officer, myTomorrows

We would like to invite you to join us for an informative event about overcoming obstacles in recruiting patients for BioPharma clinical trials. During this event, we will delve into barriers such as lack of awareness and financial considerations that can impede clinical trial recruitment success. Additionally, impactful strategies to increase clinical trial participation and recruitment success will be shared.

9:00 amSession Break

LEVERAGING DATA AND TECHNOLOGY TO IMPROVE OUTREACH AND ENGAGEMENT

9:10 am Chairperson's Remarks

Matt Walz, CEO, Trialbee

9:15 am

CASE STUDY: How Otsuka Leveraged Data to Address Recruitment and Engagement during (and after) the Pandemic

Deborah Profit, PhD, Vice President, Clinical Management & Applied Innovation, Otsuka America Pharmaceutical, Inc.

Unprecedented times - unprecedented approaches. The struggle with assessing and monitoring the impact of COVID on studies (ex. site activations/enrollment) was a challenge for industry. A creative team at Otsuka leveraged internal and external data (e.g., CDC and open data sources) to develop visualizations that informed near/real time modeling, as well as storyboards for long term narratives of the what, why and when of COVID; then applied same, to RUS/UKN war.

9:45 am Adaptive Experiences in Clinical Trials - Why Providing Choice Drives Patient Compliance and Retention

Andrea Valente, CEO, ClinOne

Andrea Valente, CEO of ClinOne, will host an informative presentation examining the role of Adaptive Experiences in clinical trials and how they can provide choice to drive patient compliance and retention. Whether that means using technology at the site, paper at home, or anything in between, it is essential to trust all trial participants (patients, caregivers, sites, and study teams) and empower them to take control of their experience.

10:15 am Using Data and Analytics to Identify and Solve Site Enrollment Challenges

Nariman Nasser, Executive Vice President, Product & Partnership Solutions, Continuum Clinical

Site activation delays, an increase in competitive trials, and study coordinator labor shortages are a few of today’s challenges that are resulting in never-before-seen enrollment bottlenecks at study sites, leading sponsors and recruitment partners to think differently to achieve success.  This presentation will help sponsors maximize their enrollment efforts by identifying and mitigating commonly overlooked metrics in the recruitment funnel that lead to longer enrollment and lower ROI when left unattended. 

Coffee Break in the Exhibit Hall (Sponsorship Opportunities Available)10:45 am

CREATIVITY AND ENGAGEMENT IN RECRUITMENT AND RETENTION

11:40 am Chairperson's Remarks

Dawn Anderson, Managing Director, Life Sciences, Deloitte

11:45 am

Come for the Cure, Stay for the Community: Retention Strategies Centered around Participants and Results

Maggie Kuhl, Vice President, Research Engagement, Michael J Fox Foundation for Parkinsons Research

The ongoing Parkinson’s Progression Markers Initiative study enrolled more than 1,000 participants between 2010 and 2018 at 33 sites in 10 countries in a longitudinal, observational study involving repeat biological sampling, imaging scans and clinical assessments. A primary focus of our retention strategy is to involve and interact with participants, which aligns with the field’s current emphasis on patient-focused drug development. The audience will hear pillars of retention/engagement strategy and examples of varied approaches (e.g., in-person events, “share your story” forms, newsletters, conference calls, participant profiles) to consider in building their own study retention strategies..

12:05 pm

Strategies for Patient Recruitment by Therapeutic Area

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

 Many sponsors have been diligent about increasing the focus on enrollment planning for their studies - establishing a recruitment plan prior to FPFV with mitigations and budgets built in.  But is it truly proactive or are we still being reactive in our approaches?  This presentation will focus on how the industry needs to move to a more programmatic and even a therapeutic area approach to recruitment planning.  It will take a closer look at how pulling the enrollment focus even earlier will not only benefit each study and research site, but also our most important stakeholder - our participants.

12:25 pm

Rare Disease versus Chronic Conditions: Compare and Contrast Recruitment and Engagement Strategies

Deborah Howe, Director, Global Patient Recruitment and Engagement, Alexion, AZ Rare Disease

Michele Teufel, Site Management & Monitoring Therapy Area Strategy & Portfolio Delivery, Development Operations, AstraZeneca Pharmaceuticals, Inc.

Internet campaign for rare disease? Grassroots efforts for chronic conditions?  Or is it really vice versa?  This session will explore the similarities and differences in recruitment and engagement strategies for rare diseases and chronic conditions.  A variety of approaches will be discussed including patient centricity and insights, protocol feasibility, centralized and localized patient recruitment and retention tactics, support services, and much more. 

Transition to Lunch12:45 pm

Part 2: Patient Engagement and Retention Through Communities and Technology

12:50 pm LUNCHEON PRESENTATION:Connecting the Recruitment Ecosystem for Portfolio-Level Patient Engagement with OneStudyTeam and Eli Lilly and Company

Jeff Ramsey, Senior Director, Patient and Site Experience, Eli Lilly and Company

Eben Scanlon, Senior Vice President and Global Head of Customer Expansion, OneStudyTeam

Eli Lilly and Company is collaborating with OneStudyTeam and Carebox to develop a connected digital recruitment ecosystem. Lilly engages patients across its trial portfolio, refers patients directly into its sites’ workflows, and monitors campaign effectiveness with help from OneStudyTeam and Carebox. These partners are leveraging novel approaches to increase awareness and tools for patients to identify opportunities for trial participation while reducing workflow burden for sites.

 

Coffee & Dessert Break in the Exhibit Hall with "Best of Show Award" Winner Announcement1:20 pm

NEXT-GENERATION DATA SOURCES & BUILDING A ROADMAP FOR AN R&D ORGANIZATION

2:20 pm Plenary Keynote Introduction

Ivor Clarke, CEO, SubjectWell

2:25 pm

Faster, Better, Cheaper: The Increasing Role and Opportunities for Real-World Evidence in Informing Regulatory Pathways

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

An open dialogue on the facilitators, barriers, and open opportunities to effectively utilize RWE for informing regulatory pathways from a biopharma company perspective. Additionally, we will highlight some of the novel use cases and key lessons learned by biopharma companies in utilizing RWE for discovery and development purposes.

2:35 pm

Advancing Evidence Generation of the Future

Amy Abernethy, MD, PhD, President, Clinical Studies Platforms at Verily; Former Principal Deputy Commissioner, FDA

Clinical research is undergoing a major shift, as we move towards continuous evidence generation to support accelerated drug development and approvals. In this talk, Dr. Abernethy will share her firsthand experience with the evolving use of real-world data and evidence at FDA during COVID. She'll speak to the need for quality longitudinal data sets, the role of technology, and how new approaches are transforming the clinical research field.

2:45 pm

Fireside Chat: Next-Generation Data Sources

Amy Abernethy, MD, PhD, President, Clinical Studies Platforms at Verily; Former Principal Deputy Commissioner, FDA

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

2:55 pm

Fireside Chat: Future-Ready Operations: Building a Multi-Year Roadmap

Lynne M. Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs

Jane Hiatt, Executive Director, Site Management and Monitoring, Early-Stage Development, Merck

Ward Lemaire, Head of Data Management, Integrated Data Analytics & Reporting, Janssen, J&J

With increases in complexity and new trial modalities, organizations need to constantly assess what the future needs. This chat will focus on the strategic choices and approaches to be considered, and how to plan out such a multi-year roadmap.

Booth Crawl & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available). Last Chance for Viewing.3:25 pm

ENHANCING PATIENT CENTRICITY TO IMPROVE ENGAGEMENT AND RETENTION

4:25 pm Chairperson's Remarks

Matt Sowards, CIO, Scout Clinical

4:30 pm

One Year in: Creating an Internal Global Development Patient Engagement Team: Remit, Resourcing, & Relationships

Amy Froment, Head, Global Trial Optimization, Regeneron

Tara Gipp, Associate Director, Clinical Trial Optimization, Recruitment & Retention, Regeneron Pharmaceuticals

Regeneron has created an internal patient engagement capability to support clinical trials within its Global Trial Optimization function.  One year in, we have learned how to connect multiple stakeholders across the organisation and partner with external vendors and CROs to deliver meaningful change for patients, sites and study teams.  Creating a process to support study teams early during protocol development with clear accountability handovers provides a foundation to then develop efficient material development, diversity equity and inclusion solutions, decentralised tools and innovative patient and site engagement tools.  We will share how we defined our remit, how we maximised resource through internal and external partnerships and relationships by sharing real life examples and challenges.

5:00 pm

Innovating Patient Recruitment through Pharmacy Channel Outreach

Omar Abdelsamad, Executive Director, Patient Recruitment, Clinical Trial Services, CVS Health

Victoria Reid, Vice President, Freenome

The CVS Health pharmacy channel enables innovative clinical trial engagement via 100M+ patient connections. The pharmacist is the most trusted healthcare provider and the pharmacy is the most visited healthcare site among patients. Using case studies, this presentation demonstrates how this relationship with patients coupled with innovative outreach tactics enrolls referrals at 2x-3x the rate of traditional channels. Stakeholders will speak to these case studies and innovations.

5:30 pm Ensuring Enrollment Success via a Holistic, End-to-End Approach

Susan Campbell, Director of Patient Recruitment, Patient Recruitment Services, ICON, plc.

Each patient & study have unique challenges & opportunities that require a customised end-to-end approach. Patient needs & perspectives must be the foundation for successful strategy. An in-depth understanding is required to effectively communicate with patients, reduce study burden and meet patients where they are. This session will explore using a holistic approach & collaboration for a highly targeted, strategic recruitment campaign, proactively addressing patient & study needs and increasing enrolment.

6:00 pm

The Value of Incorporating Patient Voice, Obtaining Patient Feedback, and Demonstrating Gratitude throughout the Clinical Trial Journey

Kandria Harry, BSN, Manager, Patient Engagement and Clinical Strategy, Astellas Pharma US, Inc.

This session will focus on TransCelerate’s work to provide more effective ways to engage with and embed the voice of patients in the design and execution of clinical studies. In addition to highlighting the impact and value of TransCelerate’s existing Patient Experience Resources: The Patient Protocol Engagement Toolkit (P-PET) and the Study Participation Feedback Questionnaire (SPFQ) Toolkit, there will be an introduction to the newly developed Gratitude Toolkit.

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle* (Sponsorship Opportunities Available)6:30 pm

*Courtesy shuttles will be available Tuesday and Wednesday 6:30-10:30pm (last pick up), bringing you to and from The Pointe Orlando.

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop 6:30-10:30pm (last pick up) between Rosen Shingle Creek, Hilton Orlando, DoubleTree Orlando at SeaWorld, and Pointe Orlando. 
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

2月9日(木)

Registration Open7:15 am

BREAKFAST PRESENTATIONS

7:45 am Impacting Timelines vs Impacting Resources - It's Not Either / Or Anymore

Lisa Moneymaker, Chief Technology & Product Officer, Saama

Our industry is challenged to find the right resources to drive operational best practice. There is also an expectation to move at the “speed of Covid” for every trial. It feels like an either/or.

 

However, you can have both. You can accelerate timelines with fewer resources.

 

Join this exciting session to learn about:

  • The biggest time and resource drains on clinical trials

  • Applying AI/ML to improve efficiency

  • Challenging your own internal processes to get to market faster

Session Break8:15 am

ADVANCING CLINICAL INNOVATION AND PATIENT CENTRICITY THROUGH TECHNOLOGY AND PARTNERING

8:25 am Chairperson's Remarks

Jennifer Embury, Head of Customer Success, Business Development, Care Access

8:30 am

Is There Technology Overload? Finding the Right Balance for Patients and Sites

PANEL MODERATOR:

Michelle Shogren, CEO & Owner, Innovate in What You Do!

With the proliferation of digital health technologies, how can we determine the right mix to improve clinical research without overloading patients and/or sites? How do we lessen the technology adoption burden on sites? What's the future of finding patients? Facebook? Databases? Scanning EMRs? Physician engagement? 

PANELISTS:

Tom Julian, Innovation Integrator, Gilead

Amir Lahav, Head of Strategic R&D, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma America

Gayna Whitaker, Director, Strategic Feasibility, AstraZeneca

9:00 am

Patient-Centric Sampling at Merck: How the Patient Voice Shaped Our Sampling Strategy

Melanie Anderson, Principal Scientist, Translational Medicine, Merck

Jennifer Campbell, Principal Scientist, Preclinical Development, Merck

Over the past decade, Merck has conducted numerous trials involving patient-centric sampling, an enabling technology for decentralized trials. Patient preference questionnaires were included in multiple trials. Questionnaires revealed that at-home sampling methods with novel collection devices are preferred and preference is dependent upon sampling frequency, sampling methods, pain tolerance, and physiological condition. Data indicate that effective patient-centric sampling approaches should be painless, simple for users to execute, and minimize sample volume. This participant feedback has shaped our company’s patient-centric sampling strategy and has enabled us to implement sampling approaches that are truly patient-centric.

9:30 am When Does a Clinical Trial Start Being Just a Clinical Trial: A Path to the New Normal

Alison Holland, Executive General Manager, Digital and Decentralized Solutions, Medable

The industry is heading towards a place where digital elements (DCT’s) start to become standard as we operate trials. To achieve scale, and give patients a true choice, digital strategies need to be embedded early into drug development and embraced by sites, patients and sponsors. Join us as we discuss the path to the new normal for everyone in the clinical trials ecosystem.  

 
9:45 am Virtual Waiting Rooms - Early Progress and Potential

Ivor Clarke, CEO, SubjectWell

The clinical trial industry has been experimenting with Virtual Waiting Rooms (VWRs) in support of patient recruitment and enrollment, but today the use cases vary dramatically and the tools are still in the nascent stages of development. This session examines VWRs across several companies, the challenges VWRs address and current recommendations from early applications.

10:15 am The Next-Gen of Community-Based Clinical Trial Site Networks: Location & Trust Can Improve Recruitment & Diversity

Dawn Anderson, Managing Director, Life Sciences, Deloitte

The industry is looking to new site network models focused on community-based clinics. By being embedded in the community, new site networks may be able to increase patient recruitment & convenience, improve retention, & enhance diversity in clinical trials. We will discuss strategies and ways non-traditional site networks could transform the clinical trial delivery model.

Networking Coffee Break10:45 am

IT TAKES A LITTLE HELP FROM FRIENDS: PATHWAYS TO PATIENT ENGAGEMENT

11:05 am

Chairperson's Remarks

Marlene Peters-Lawrence, Clinical Research Project, NIH, NINDS

11:10 am

The Role of Patient Advocacy in Ensuring a Representative Patient Population 

LaShell Robinson, MS, Director Diversity, Equity & Inclusion in Clinical Research, Takeda

11:40 am eConsent? Yes. How about Flexible Consent?

Ian Greenfield, Chief Strategy Officer, Patient Engagement, YPrime

No matter what method is used, the goal of informed consent remains the same - to properly inform patients as efficiently and effectively as possible. In this session, we’ll explore how to use technology to improve the consent experience for sites as well as participants, regardless of whether it’s in the clinic, living room, or both.

12:10 pm

CASE STUDY: Pathways to Engagement - A Framework for Engaging Diverse Populations in Clinical Research

Marlene Peters-Lawrence, Clinical Research Project, NIH, NINDS

Tiffany Powell-Wiley, MD, Physician-Scientist, National Institutes of Health

Recruitment methods for engaging underrepresented populations into research incorporating digital health technology are limited. This case study presentation, we will describe how the Communication, Awareness, Relationships, and Empowerment research recruitment model helped to reduce challenges in recruiting predominately African American Washington, D.C communities. The model help build collaborations with community partners and enhance research team efforts to systemically address barriers to recruitment and retention of study participants. You will learn effective methods for the recruitment and retention of diverse populations and best practices used to engage individuals to participate in an NIH research project and the establishment of a community clinic.  


Transition to Lunch12:40 pm

12:45 pm LUNCHEON PRESENTATION:From Patient-Centric to People-Centric: How Exploring What Makes us Human Improves the Clinical Trial Experience

Lionel Bascles, SVP, Senior Vice President, Clinical Sciences & Operations, Sanofi

Tricia Buchheit, MSHS, Associate Director, Patient Recruitment, Global Trial Optimization, Alnylam Pharmaceuticals

Sarah McKeown-Cannon, Vice President Growth, Publicis Health

Angela Rochelle, Head of Diversity Initiatives, Publicis Health

 

All too often, our industry treats patients as simply a set of inclusion/exclusion criteria to meet a clinical endpoint. But truly understanding the whole person, not just their clinical features, is the key to unlocking the best clinical trial experiences yet. In partnership with our client partners, we will use examples from two recent, real-world projects to explore how we can better understand what motivates individuals to participate in research, how to build trust, and how to ensure we are designing clinical studies that are practical to participate in. 

Closing Remarks1:15 pm

Scope Summit 2023 Adjourns1:20 pm

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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