Recruitment & Engagement

2024 ARCHIVES

Enrollment Planning and Patient Recruitment

Patient Engagement and Retention through Communities and Technology

Patient recruitment is one of the biggest bottlenecks in clinical research. Failure to meet enrollment targets creates costly delays, and more importantly, impacts the time that it takes to bring new medicines into the hands of patients that need them. The Enrollment Planning and Patient Recruitment track highlights strategies to enroll for global trials, leverage data analytics to improve recruitment, retention and diversity, and tactics to improve up-front enrollment planning. The Patient Engagement and Retention through Communities and Technology track explores pathways to engage diverse populations, how to leverage technology without losing sight of the participant’s user experience and potential technology burden, and strategies to support sites given ongoing resource constraints.

Part 1: Enrollment Planning and Patient Recruitment

Part 2: Patient Engagement and Retention through Communities and Technology

Sunday, February 11

Part 1: Enrollment Planning and Patient Recruitment

SCOPE's 3rd Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)8:00 am

*Limited space available. Separate registration and fee required for Golf.

Registration Open9:00 am

– 1:45 pm [In-Person ONLY] Open Workshop: Introducing ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace1:00 pm

Sit down with a small cross-industry group for a 45-minute hands-on session to learn about and register for the new B2B clinical trial community and marketplace featuring 65+ companies. ClinEco unites sponsors, CROs, service providers, and sites to streamline partnering, vendor research, innovation, and learning. This year we are also introducing ClinEco Commons, a collaborative space where you can access, visit, and share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco Community. Join the ClinEco community now at: clineco.io/register. To register for the workshop, please opt into this workshop by selecting the checkbox under ‘Conference Selection.' Open to all SCOPE attendees.

– 2:30 pm [In-Person ONLY] The Path towards Sustainable Trials Workshop1:00 pm

Reducing the Environmental Impact of Global Clinical Trials
Developing frameworks to define and manage sustainability risks, and effective guidelines to reduce the carbon footprint of clinical trial operations is a collaborative effort. Beyond positive environmental impacts, sustainable approaches are expected from stakeholders and can be a deciding factor for customer selection and attracting talent. This workshop will discuss the current hotspots of carbon emissions in clinical research and suggest introductory reduction strategies in relation to each. To register, please opt into this workshop by selecting the checkbox under ‘Conference Selection.’ Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.

Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)

David Lumby, Executive Director, EHS, Thermo Fisher Scientific

3:00 pm

Organizer's Welcome Remarks & 3rd Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

3:10 pm PANEL DISCUSSION:Plenary Keynote Introduction

Fareed Melhem, Senior Vice President, Head of Medidata AI, Medidata

3:15 pm PANEL DISCUSSION:

The Next Horizon of Clinical Research: A Multi-Stakeholder Panel on Integrating Research into the Care Continuum

Uli Broedl, Senior Vice President, Head of Global Clinical Development & Operations, Boehringer Ingelheim

Janice Chang, CEO, TransCelerate Biopharma, Inc.

Christoph Koenen, Head of Clinical Development & Operations, Pharma Research & Development, Bayer

Katherine Taylor, Head, Risk Evaluation & Adaptive Integrated Monitoring, Merck & Co., Inc.

This presentation will foster discussion between a diverse set of biopharma leaders representing health authorities, sponsors, sites, and industry consortia on the current and future opportunities facing global R&D, clinical care, and patient satisfaction. Specific topics discussed will include opportunities and barriers to giving patients access to clinical research as part of the care continuum.

3:45 pm

SCOPE's 8th Annual Participant Engagement Awards Introduction

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

3:50 pm

SCOPE's 8th Annual Participant Engagement Awards

PANEL MODERATORS:

Kelly McKee, Vice President, Decentralized Clinical Trials (DCT), Medidata; Co-Creator or the SCOPE Participant Engagement Award

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

Now in its 8th 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 2024 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE.

PANELISTS:

Tricia Buchheit, Associate Director, Patient Recruitment, Alnylam Pharmaceuticals

Greg Christie, Chief Product Officer, StudyKIK

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

Otis Johnson, PhD, MPA, Principal Consultant, Trial Equity

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

Jeffrey Zucker, Principal Clinical Research Consultant

SCOPE's Big Game Tailgate4:35 pm

Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, in honor of the Big Game, rep your favorite team while joining SCOPE sponsors, speakers and attendees for a pre “Big Game” celebration at the Rosen’s outdoor Event Lot. Football jerseys or T-shirts encouraged, even if your team didn’t make the grade this year (for our European friends, YOUR football team jerseys are welcome too!). Sample some tailgate food, quench your thirst at the bar, and play some classic outdoor games. This event is always a SCOPE favorite, so please join us directly after the Sunday afternoon plenary session!

Close of Day5:50 pm

Monday, February 12

SCOPE’s Monday Morning Fun Run!7:00 am

Join SCOPE’s Coordinators for our 5K Fun Run!
All of us at Cambridge Healthtech Institute recognize the importance of integrating well-being and fitness into our work travel routines. We're excited to offer our support to faculty, sponsors, and attendees in fostering a culture of wellness. This is an easygoing, informal running (or walking) event. No time chips, running bibs, or energy bars—just a laid-back opportunity for a small group to start the day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk—the goal is to get up and get moving! Meet us in the Rosen Hotel’s front lobby near the birdcage at 7 am sharp!

RUN COORDINATORS:

Eileen Murphy, Associate Conference Producer, Production, Cambridge Healthtech Institute
Nate DePinto, Assistant Meeting Planner, Cambridge Healthtech Institute
Steve Wimmer, Vice President, Partnerships, Business Development, 1nHealth

Registration Open7:30 am

Morning Coffee7:30 am

Get Up and Go! Jumpstart your morning with a specialty made-to-order coffee and delicious treats, courtesy of our sponsors.

8:30 am

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

8:35 am Plenary Keynote Introduction

Chris Crucitti, Chief Revenue Officer, Citeline

8:40 am PLENARY KEYNOTE PRESENTATION:

Time Is Life: Pfizer’s Approach to Accelerating Clinical Development

Robert Goodwin, Senior Vice President, Clinical Development and Operations, Pfizer Inc.

How do we transform the development paradigm to make trials more accessible, more convenient for the participants, less costly, and most importantly, get us the answers we need faster? Because when you’re a patient waiting for a new treatment, every minute matters. Pfizer recognizes that time is life and has set a bold ambition to reduce three additional years off their development timelines, after successfully cutting down more than two years already since 2016. Hear from Rob Goodwin, Senior Vice President and Head of Clinical Development & Operations, on what it takes to accelerate development without compromising quality, compliance, or patient safety.

9:05 am INTERACTIVE PANEL:

Use Cases of Generative AI in Clinical Trials: Beyond Can We...Where and When Should We?

PANEL MODERATOR:

Brian Martin, Head of AI, R&D Information Research; Research Fellow, AbbVie, Inc.

Where are we now as an industry with integrating and utilizing AI in clinical research? What is next is an open question and the possibilities are many and the hype is loud, but the more important question to ask is “why should we?” in each and every case. AI is a tool, but not always the right one or the most efficient one. Where are you in the journey of bringing Generative AI into CT? Should teams focus on technology and use cases like Diversity in CT inclusion and other specific applications? Why? How was value measured? What risks exist? Where do we choose not to use AI in clin ops and why? Dive in with our expert panel.

PANELISTS:

Neil Garrett, PhD, Head of Regulatory Medical Writing, Johnson & Johnson

Samar Noor, Vice President, Head of Statistical Programming, Global Biometric Sciences, Bristol Myers Squibb Co.

Hoifung Poon, PhD, General Manager, Health Futures, Microsoft Research

Prasanna Rao, Senior Director, Global Head of AI/ML, Global Biometrics and Data Management, Pfizer Research & Development

Grand Opening Coffee & Refreshment Break in the Exhibit Hall Best of Show Voting Opens9:35 am

SCOPE’s exhibit hall is a one-of-a-kind experience. With 240 leading clinical trial technology and services companies represented it’s easy to find new, innovative companies to partner with, and don’t forget to visit your existing partners to see their latest and greatest. Take a minute to vote for SCOPE’s Best of Show, grab some refreshments, charge your devices, or ham it up in a photo booth, but above all, wear comfy shoes; you’ve got some miles to cover!

Special Book Signing10:30 am

Barnett’s 2024/2025 Good Clinical Practice: A Question & Answer Reference Guide
Edited By: Donna Dorozinsky, RN, MSN, CCRC President and CEO, Just in Time GCP

10:45 am Chairperson's Remarks

Tarra Shingler, Chief Commercial Officer, StudyKIK

10:50 am

A Paradigm Shift in Personalizing the Clinical Trial Experience for Patients and Their Care Partners

Jean Stimola-Sposaro, Director, Global Clinical Trial Industry Collaborations, Global Drug Development & Global Development Operations, Bristol Myers Squibb Co.

Clinical trial participants increasingly express interest in accessing the individual data they contribute during clinical trials; however, frequency, timing, and type of data returned to participants are inconsistent and not widespread. Enabling meaningful, flexible, personalized individual data return options may enhance trust in the research enterprise, facilitate partnerships, broaden understanding of clinical research, and support data ownership for informed decision-making. Learn about this topic and practical tools for consideration, including how cross-industry collaborations [TransCelerate BioPharma Inc, MRCT, IMI FACILITATE] have developed complimentary, practical tools and considerations for proactive strategies to maximize impact and reduce the burden on participants, researchers, care providers, and health systems.

11:20 am

Improving Enrollment in Oncology Clinical Trials via Clinical Engagement

Maureen M. Posik, Associate Director Global Trial Optimization, Global Trial Optimization, Merck

Slow accrual is a persistent issue in oncology studies. Site engagement and physician buy-in are consistently mentioned in literature as the most effective method to increase enrollment; however, many teams have the limited capacity to deploy activities to support these noted methods. Merck’s Global Clinical Trial Operations team has implemented a solution to boost PI engagement in our most challenging studies through physician calls, interactions, and case-based learning.This session will examine specific circumstances and key learnings from an initial pilot focused on educating and engaging PIs to boost study enrollment, and improve site efficiency and physician re-engagement in challenging studies.

11:50 am

Creating an Inclusive and Scalable Digital Recruitment and Awareness Platform

Nichole Noel, Associate Director, Digital Clinical Trial Recruitment, Merck & Co.

Merck developed and launched a global digital platform to organize and promote all of Merck’s clinical trials in a patient-centric, user-friendly manner, making clinical trial information accessible to a diverse global audience. Through partnership with our local in-country leads, we incorporate local culture and nuances into each build for our major global markets. This presentation will discuss the role of the digital platform in supporting inclusive communications, considerations when building a digital platform, and the value it can provide.

12:20 pm

CO-PRESENTATION:Investing in Patient Engagement & Recruitment as a Strategic Initiative

Matthew Holms, Vice President, Sales-Patient Engagement and Recruitment, Citeline

Jessica Washington-Moore, Senior Director, Implementation, Citeline

Krystyna Chmura, MPH, Clinical Trial Solutions Senior Advisor, Life Sciences Data, Evernorth

This session highlights scalable yet flexible solutions for optimizing enrollment planning, revolutionizing patient recruitment, and improving collaboration among multiple stakeholders across the trial lifecycle, with tips to help address the nuanced intricates of planning and executing successful clinical trials in this ever-evolving landscape.

Transition to Lunch12:50 pm

12:55 pm

LUNCHEON PRESENTATION:Promoting Trust among Diverse Populations through Patient and Community Insights

PANEL MODERATOR:

Robert Loll, SVP, Business Development & Strategic Planning, Praxis

Explore the transformative potential of meaningfully embedding patient and community insights into awareness, education, and outreach initiatives to improve trust among diverse populations. Praxis and CISCRP share how they carefully develop campaigns through acting on insights shared by diverse communities. To highlight our guiding inspirations, we will present findings from CISCRP's 2023 Global Perceptions and Insights Study of patient and public attitudes towards, and experiences with, clinical research.

PANELISTS:

Matt Low, Chief Creative Officer, Praxis

Behtash Bahador, Director Health Literacy, Health Communication Services, Center for Information & Study on Clinical Research

Savine DaCosta, Health Equity Lead, Biogen

Coffee & Dessert Break in the Exhibit Hall1:25 pm

Special Book Signing1:30 pm

Digital Health and Patient Data: Empowering Patients in the Healthcare Ecosystem
Authors: Disa Lee Choun and Anca Petra

2:20 pm Chairperson's Remarks

Neil Weisman, President, Continuum Clinical

2:25 pm PANEL DISCUSSION:

Reducing the Burden of Clinical Trial Execution via Site-Focused Support

PANEL MODERATOR:

Adrienne Walstrum, Program Director, Merck & Co.

As sponsors expand their portfolio by executing more clinical trials, the workload of clinical trial sites continues to increase. In support of Merck Clinical Trials, the company has created an “on-demand” suite of services to ease the burden of clinical trial execution for our partnering sites. Tailored based on site feedback, our "on-demand" services include solutions for site augmentation, patient chart management, and patient payment/reimbursement solutions.

PANELISTS:

Tiffany Grardi, Associate Principle Scientist, Global Trial Optimization, Merck & Co., Inc.

Anisa Khan, Senior Scientist, Global Trial Optimization, Oncology Early Development, Merck & Co., Inc.

Russell Lampman, Associate Director, Global Trial Optimization, Merck & Co., Inc.

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

2:55 pm CO-PRESENTATION:

Mindset Shift from Rescue to Acceleration: Early Planning and Engagement

Shannon Duffany, Clinical Trial Early Planning Lead – Global Oncology, Sanofi

Patricia Matthews, RN, BSN, Clinical Science Operations Project Leader, Sanofi

The mindset shift from rescue to acceleration in early planning and engagement involves a strategic shift in focus. Instead of solely focusing on reactive measures or rescue efforts, there is a transition toward proactively planning and engaging early to drive growth and progress. This approach emphasizes identifying opportunities, setting goals, and implementing proactive strategies to accelerate development and achieve desired outcomes.

3:25 pm

Improving Randomization Rates with Machine Learning and AI

Fred Martin, CEO, SubjectWell

Applying Machine Learning and Artificial Intelligence to patient recruiting: Find out why study data is more impactful on predicting recruitment success than patient data. Discover how to combine your model's results with your business strategy to create reliable recruitment.

3:55 pm PANEL DISCUSSION:

Engaging and Understanding Patients and HCPs to Improve Accessibility, Enrollment, Retention, and Outcomes

PANEL MODERATOR:

Kristine Koontz, PhD, Vice President, Global Clinical Operations, Daiichi Sankyo, Inc.

Explore emerging trends and case studies that demonstrate how understanding patient need, beliefs and their healthcare journeys influences participation in clinical trials and impacts outcomes. What technologies and processes can be leveraged? Gain insight into efforts to incorporate patient and site voice into trial planning, what has worked and what has not.

PANELISTS:

Tricia Buchheit, Associate Director, Patient Recruitment, Alnylam Pharmaceuticals

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

Alana J. Miller, Associate Director, Clinical Trial Diversity Program Lead, Merck

4:25 pm

Breaking through the Clinical Wall

Ian Greenfield, Chief Strategy Officer, Executive Leadership, YPrime

When it comes to the patient experience, a study is a single, long experience, from recruitment to post-study follow-up. Yet their experience usually involves myriad technologies, entities, and contacts, each one introducing an opportunity for them to become disengaged. How can we unify the patient experience, from beginning to end, and does that mean finally breaking through the clinical wall?

Welcome Reception in the Exhibit Hall4:55 pm

Close of Day6:15 pm

Evening Shuttles to Pointe Orlando6:30 pm

Shuttles will be available Monday and Tuesday 6:30-10:30 pm (last pick up), bringing you to and from Pointe Orlando.
Pointe Orlando is an open-air entertainment destination featuring local and brand-name restaurants, bars, nightclubs, 20-screen movie theater, comedy club, and family attractions.
Look for SCOPE shuttle signage at each of the SCOPE hotels: Rosen Shingle Creek, DoubleTree by Hilton Hotel Orlando at SeaWorld, Element Orlando International Drive, Residence Inn Orlando at SeaWorld, and Hotel Kinetic (soon being named Hotel Landy).

Tuesday, February 13

Registration Open8:00 am

8:30 am

BREAKFAST PRESENTATION OPTION #1:The New Frontier: How Intelligent Automation is Transforming Clinical Deployment

Colin Weller, General Manager, Evidence Generation Platform, Product, Medable

Join us as Colin Weller, GM, Evidence Generation Platform at Medable, unveils how intelligent automation technology reduces clinical trial deployment timelines and accelerates evidence generation at scale as shown in their latest results to reduce trial deployment timelines by 50%. Weller will discuss how Top-10 global pharmaceutical companies are benefiting from Medable’s novel technology, and how the expanded use of digital measures and biomarkers will continue to accelerate clinical development timelines.

8:30 am

BREAKFAST PRESENTATION OPTION #2:Medpace with Trialbee | How a Patient Recruitment Platform (PRP) Overcomes Global Challenges

Matt Walz, CEO, Business Operations, Trialbee

Miaesha Campbell, Senior Director, Patient Recruitment, Medpace

Join Miaesha Campbell (Medpace) and Matt Walz (Trialbee) for a practical discussion of global challenges a Patient Recruitment Platform (PRP) helps to overcome. Topics include….Data standardization across all recruitment sources; Consistent medical pre-qualification of all referrals; Human interaction with patients; Reducing burden on sites; and Actionable ROI analysis by channel. Attendees will learn how a PRP centralizes activity from all partners to improve recruitment globally.

Transition to Sessions9:00 am

9:10 am Chairperson's Remarks

Kate Shaw, Founder & CEO, Innovative Trials

9:15 am

Elevating Clinical Trial Outreach: Innovative Community Engagement Approaches

Joan Chambers, Consultant

This presentation highlights innovative methods for boosting clinical trial outreach through creative community engagement approaches. It underscores the crucial role of community involvement in accelerating clinical trials amidst evolving medical research. Attendees will learn about leveraging social media, as well as forging partnerships to effectively engage diverse demographics. Valuable lessons include trust-building strategies, early information sharing, and streamlined patient recruitment, fostering inclusivity in clinical trials. Case studies will be shared. The presentation provides valuable insights into the future of clinical trial outreach by aligning research initiatives with community needs and aspirations, offering attendees a roadmap for enhancing clinical trial outreach through innovative strategies.

9:45 am PANEL DISCUSSION:

Outreach and Engagement: Case Studies in Multi-Stakeholder Co-Development and Use of Educational Content

PANEL MODERATOR:

Behtash Bahador, Director Health Literacy, Health Communication Services, Center for Information & Study on Clinical Research

Improving Diversity, Equity, and Inclusion (DEI) in clinical research requires meaningful collaboration with the communities who have been underrepresented. This session provides insights from the co-development of an educational video and brochures together with Black and African American, Latino and Hispanic, Asian, LGBTQ+, and Native and Indigenous communities. Learn the key DEI principles and concepts that were embedded in the content and development process, including working with community members, and receiving feedback from 500 individuals from each community. Panelists will also share considerations towards championing the implementation of these materials in DEI and trial strategies.

PANELISTS:

Tony Pearson, Senior Director, Diversity & Inclusion in Clinical Trials, Eli Lilly & Co.

Tammy Wilkins, Senior Manager, Applied Innovation & Process Improvement, Otsuka Pharmaceutical Development & Commercialization, Inc.

10:15 am

Content + Technology = A Better Clinical Trial Experience for Participants and Sites

Kate Wheeler, Managing Partner, Langland

Jonathan Moshinsky, Co-Founder and CEO, Stitch

This joint session from Langland and UK clinical trial technology company Stitch will explore how creative content, delivered via an industry-first engagement and feedback platform, can reduce drop-out from the recruitment process, and improve the study experience for both participants and sites.

Coffee Break in the Exhibit Hall10:45 am

Special Book Signing10:50 am

The Patient Recruitment Conundrum
Author: Ross Jackson

11:40 am Chairperson's Remarks

Brett Kleger, CEO, Datacubed Health

11:45 am CO-PRESENTATION:

Participant Insights Inspired a Novel Approach to Community Engagement and Recruitment

Kevin J. Hudziak, Associate Director, Clinical Trial Design Capabilities, Eli Lilly & Co.

Allison Reddick, Senior Director Clinical Services & Capabilities, Clinical Trial Recruitment, Eli Lilly & Co.

Jordan Thompson, Director, Clinical Trial Patient Engagement, Eli Lilly & Co.

Gathering patient insights is critical to the design and execution of clinical trials. Understanding key barriers to diverse and representative trial participation created a novel approach to patient engagement that Lilly developed to educate and screen potential participants in a community setting. Lilly has streamlined novel recruitment tactics to enable faster, smarter, and more personalized patient recruitment while providing sites with highly qualified referrals.

12:15 pm PANEL DISCUSSION:

The Intersection of Patient Advocacy and Clinical Operations in Enhancing Patient and Community Engagement

PANEL MODERATOR:

Joan Chambers, Consultant

The future of clinical innovation depends on increasing enrollment of populations typically underrepresented in clinical trials and underserved in healthcare. Patient Advocacy Organizations play a unique role in supporting clinical trial diversity strategies. This presentation will explore the pivotal role Patient Advocacy Organizations can bring in elevating engagement, awareness, and trust-building with patients and communities.

PANELISTS:

Ella Balasa, Patient Advocacy & Engagement Consultant, Balasa Consulting, Individual Consultant

Savine DaCosta, Health Equity Lead, Biogen

Kelly Franchetti, Global Head—Growth & Insights, Savvy Cooperative

Kimberley Kallsen, Head of Patient & Site Engagement, Global Clinical Development & Operations, Boehringer Ingelheim

Transition to Lunch12:45 pm

12:50 pm

LUNCHEON PRESENTATION:Successful Participant Engagement on a Global Scale

James Riddle, MCSE, CIP, CPIA, CRQM, Senior Vice President, Global Review Services Operations, Advarra

How do region, country, and site specifics impact your participant recruitment and engagement strategies? These considerations can help you achieve better recruitment and retain patients throughout the study. Learn how international viewpoints on advertisements and language localization services, and analyze the ever-essential relationship between sites and their patient community.

Coffee & Dessert Break in the Exhibit Hall Best of Show Winner to be Announced1:20 pm

SCOPE’s hall this year is bigger than ever; there’s no way to cover it all in just one break. So, after lunch, grab some dessert and a cup of coffee and visit all those booths that you just couldn’t make it to this morning. Stay to hear our Best of Show Winner announcement and congratulate the winner!

Special Book SIgning1:25 pm

Quantum Kids Guardians of AI: Story Quest and Activity Book
Author: Angela Radcliffe

Part 2: Patient Engagement and Retention through Communities and Technology

2:20 pm

Organizer's Welcome Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute; Co-Founder, ClinEco

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

2:25 pm Chairperson's Remarks

Jie Wu, PhD, Co-Founder & CDO, Segmed, Inc.

2:30 pm PANEL DISCUSSION:

Fireside Chat with FDA on Modernizing Clinical Trials

PANEL MODERATOR:

Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Prospectively randomized, placebo-controlled clinical trials are often the most powerful tool that we have for answering fundamental questions about the safety and efficacy of new medical products. But greater efficiency is needed, as clinical trials are becoming more costly and complex to administer. Moreover, many of the new products that we’re being asked to evaluate aren’t easily evaluated using these traditional approaches. At the same time, new technologies and sources of data and analysis make better approaches possible. FDA has been engaged in a comprehensive effort to advance new innovations and to enable the modernization of clinical trials, so what does this mean to you and to our industry?

PANELISTS:

Kevin Bugin, PhD, Deputy Director, Operations, Office of New Drugs (OND), FDA Center for Drug Evaluation and Research (CDER)

Marsha Samson, PhD, Analyst, Office of Medical Policy, FDA

3:00 pm CROSS-INDUSTRY PANEL:

Intersection of Innovative Development Models and Investment Approaches That Move the Needle at the Portfolio Level

PANEL MODERATOR:

Jacob LaPorte, PhD, Co-Founder, Prisma Therapeutics

New to SCOPE 2024—we bring together for the first time, a business-focused panel of strategics from the pharma, investor, healthcare, CRO, and technology start-up communities, to discuss partnership models that drive much needed innovation in clinical trials and impact development at the portfolio level. How can Pharma manage risks and investments while continuing to remain at the forefront of drug development, clinical research, and trial technology? Which alternative business models and risk-sharing partnerships can support innovation in a resource-constrained environment? Where are the opportunities and the ROI from such partnerships? Which emerging technologies are showing growth and investment and are moving the needle in clinical research?

PANELISTS:

Angela DeLuca, Vice President, Head of Oncology & Cell Therapies Clinical Operations, Global Development Office, R&D, Takeda

Michael Greeley, Co-Founder & General Partner, Healthcare Technology, Flare Capital Partners

Michelle Longmire, Co-Founder & CEO, Medable, Inc.

Sam Srivastava, CEO, WCG

Booth Crawl & Refreshment Break in the Exhibit Hall (Opportunities Available) Last Chance for Viewing3:30 pm

Join your colleagues in the Exhibit Hall for one last visit. Enjoy SCOPE’s “Booth Crawl,” where sponsoring booths have a silent competition to see who can serve the most fun or fancy food and drink. Visit their booths to see for yourself! Take a final lap around the hall and enjoy time with your newfound friends and partners.

4:30 pm Chairperson's Remarks

Rachel Wagner, Head or Business Development, Care Access

4:35 pm

Physician Research Liaisons: A Vital Role for Site Research Recruitment and Support

Tania Alidina, PhD, Director, Network Development, Flourish Research

In the dynamic landscape of pharmaceutical research, building and sustaining effective connections between community physicians and research sites is imperative. This presentation explores the role of research liaisons in fostering these connections, underscoring their significance in enhancing site recruitment. Personal anecdotes from employing this model at the site level will be used to break down the way research liaisons engage physicians to foster study enrollment while adding value to physician practices to share cutting-edge research.

5:05 pm

Optimizing Patient Choice, Flexibility, and Outcomes by Personalizing the Clinical Trial Experience

Joachim Lovin, DCT Specialist, Novo Nordisk

While an important component of a person’s healthcare experience, participation in a clinical trial can be time-intensive and burdensome. The goal of personalized clinical trials is to integrate clinical trial requirements more seamlessly into the lives of our participants. Join us to learn more about a practical framework, including existing tools and considerations, to help the R&D ecosystem to improve patient choice and the streamlined implementation of options into the clinical trial process.

5:35 pm

CO-PRESENTATION:Partnering with Social Influencers to Drive Enrollment: Case Study

Aaron Fleishman, Senior Director, Growth, BBK, Publicis Health

Lara Lane, Director Clinical Operations, Ironwood Pharmaceuticals

When potential study participants distrust the healthcare system might they respond to social influencers’ introduction to a study of a new treatment option? In this Case Study, BBK and Ironwood will share their experience with a new approach to recruitment of patients suffering from the severe pain and reduced quality of life brought on by their condition. The session explores new avenues for influencer and referral-based marketing programs.

Close of Day6:05 pm

Evening Shuttles to Pointe Orlando6:30 pm

Shuttles will be available Monday and Tuesday 6:30-10:30 pm (last pick up), bringing you to and from Pointe Orlando.
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.
Look for SCOPE shuttle signage at each of the SCOPE hotels: Rosen Shingle Creek, DoubleTree by Hilton Hotel Orlando at SeaWorld, Element Orlando International Drive, Residence Inn Orlando at SeaWorld, and Hotel Kinetic (soon being named Hotel Landy).

Wednesday, February 14

Registration Open7:15 am

7:45 am

BREAKFAST PRESENTATION:Empowering Clinical Operations Professionals: Harnessing AI to Enhance Outcomes

Scott Chetham, CEO & Co-Founder, Faro Health, Inc.

Generative AI, machine learning, and large language models are all over the news and have the potential to impact every aspect of Clinical Development. As Clinical Development professionals, how can we differentiate the hype from reality and have an educated voice to assess the risk and rewards of these rapidly evolving technologies? Join Faro to explore current, upcoming, and hyped trends. Understand the challenges in adopting these technologies in Clinical Development.

Transition to Sessions8:15 am

8:25 am Chairperson's Remarks

Mike Martin, Principal, ZS

8:30 am PANEL DISCUSSION:

Hybrid Trials, DCTs, and Patient-Centricity: Where Are We Now and Where Are We Going?

PANEL MODERATOR:

Ebony N. Dashiell-Aje, PhD, Executive Director & Head, Patient Centered Outcomes Science, BioMarin Pharmaceutical, Inc.

Over the past few years, clinical trial decentralization has held much promise – to increase operational efficiency, reduce patient burden, and increase patient access. In addition to enhancing data quality, patient-centricity has been a primary focus to meet patients where they are and measure what matters most to them. Despite the advancements, challenges related to implementation remain. Organizations are still scaling up to accommodate DCT-specific infrastructure and sponsors are faced with increased the need to navigate complex process shifts to optimize trial efficiencies. Hybrid and full DCT models also come with added costs that some organizations are not ready or able to incur. In light of this, there have been questions about whether the promise of DCTs for patients has truly been actualized to date. In this session, we will reflect on patient-centricity within the context of DCT adoption, talk about the opportunities and challenges, and discuss the future for model optimization to keep patients at the center of it all.

PANELISTS:

Emily Epstein, LMSW, Trial Volunteer & Cancer Previvor, Research Coordinator, Genetic Social Worker, Division of Gynecologic Oncology , Genetics and Personalized Cancer Prevention, Weill Cornell Medicine

Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck

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

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, CEO, 4Biosolutions Consulting (Sci/Clin/Reg Affairs) & Co-Chair, EEE-SA, Clinical Trial Technology Modernization Network (CTTMN)

9:00 am

Microsampling and Shifting Paradigm of Decentralized Clinical Trials

Dmitri Mikhailov, PhD, Director & Global Head, Biomarker Coordination, Novartis Institutes for BioMedical Research, Inc.

Microsampling technologies enable clinical trials to reach broader populations, collect additional samples during or post-study, and help reduce patient burden. This presentation will review various aspects for implementation on clinical trials and will cover several topics, including the main areas for microsampling impact on clinical trials, operational planning for microsampling implementation, and considerations for microsampling approach in relation to bioanalytical utility and data interpretation.

9:30 am

CO-PRESENTATION:A Platform Based Approach to Patient Recruitment & Enrolment: Maximizing Patient & Sponsor Experience

Manuri Gunawardena, CEO, Executive, HealthMatch

Nick Spittal, COO, Executive, Velocity Clinical Research

HealthMatch & Velocity Clinical Research have embarked on a pilot as part of a strategic partnership to trial platform wide recruitment across over 100 trials. By employing HealthMatch across over 100 trials simultaneously, significant gains in recruitment efficiency and patient experience have been achieved. The speakers, representing leadership of both organizations will share on the partnership, the benefits and how sponsors can likewise benefit from a broader based approach.

10:00 am PANEL DISCUSSION:

Remote Blood Sampling Devices/Apps: The Next Transformative Approach to Optimizing Sample Data Collection—Are We There Yet?

PANEL MODERATOR:

Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS

We will discuss the current landscape regarding blood biomarker data collection focusing on enabling convenient, less painful, and patient-centric small-volume sampling (including bloodless), reducing the burden on patients, healthcare systems, and clinical trials. The speakers/panelists will review protocols, logistics, and regulatory acceptance for this approach. By harmonizing stakeholders and creating data-rich environments for ongoing research and innovation, true patient centricity moves one step closer to reality.

PANELISTS:

Kelli Aufderheide, Director, Decentralized Trial Solutions, Q2

Angela Tucker, Program Director, Decentralized Trials, Labcorp

Enaksha Wickremsinhe, PhD, Bioassay Development Lead, Bill & Melinda Gates Medical Research Institute

Networking Coffee Break10:45 am

11:05 am Chairperson's Remarks

Akiko Shimamura, Senior Vice President, Trial Design & Optimization, Clinical Sciences, TriNetX

11:10 am PANEL DISCUSSION:

Examining Site Activation and Patient Enrollment Benchmarks among Sponsors and CROs

PANEL MODERATOR:

Mary Jo Lamberti, PhD, Director and Research Associate Professor, Tufts Center for the Study of Drug Development (CSDD)

Sponsors and CROs are encountering significant challenges identifying and activating investigative sites and recruiting and retaining study volunteers. This session will examine some of the study and site-level metrics that Tufts has gathered on patient enrollment and site activation rates as well as global recruitment and retention tactics. A panel of sponsor companies will provide insights on the study results and discuss innovative practices and approaches being implemented.

PANELISTS:

Amanda Decoker, Senior Director, Head of Patient Recruitment and Retention, Takeda

Saartje Vansteenkiste, Executive Director, Clinical Portfolio Execution, CDO, CSL

Jacklynn Wong, Associate Director, Investigator and Patient Engagement, Johnson & Johnson

11:40 am

The Power of Adaptability: Engagement and Retention in Majority-Minority Communities

Don Harder, Head of Trial Solution Design, Care Access

If we are going to reach majority-minority communities with opportunities for research, it needs to be done on a grass-roots level with leadership from the communities of interest. Engagement must start with community leadership and be focused on a long-term commitment to the community. I will discuss the multiple levels of engagement that must be employed in order for any diversity-focused enrollment strategy to be effective.

12:10 pm

Patient Burden, and Net-Zero: How Environmentally-Friendly Patient Solutions Can Also Be Patient-Friendly

Michael J. Cohen, Senior Director, Environmental Sustainability, Strategy & Innovation, Thermo Fisher Scientific

Here we will discuss a pilot using self-driving, electric vehicles for patient travel to and from a site in a clinical trial through multiple lenses as we explore strategies for simultaneously reducing patient burden and carbon footprint. Bringing together experts from multiple stakeholders, we look forward to exploring key performance across environmental sustainability, patient and site experience as well as regulatory and other important factors uncovered in this pilot. The goal is to highlight lessons learned as we attempt to decarbonize patient travel while also improving patient experience in clinical trials.

Transition to Lunch12:40 pm

12:45 pm

LUNCHEON PRESENTATION:Unlocking Enrollment Success: Study Support to Accelerate Timelines

Seth Halvorson, General Manager, Site Solutions, Clinical Research Solutions, WCG

As protocols become increasingly complex, a persistent challenge arises when the capacities and timelines of sites do not synchronize with the study timelines envisioned by sponsors. Additional study support is often necessary to accelerate enrollment of participants to meet the study demands.

In this session, we will explore a range of strategies aimed at reducing the gap between expected and actual enrollment timelines while maintaining the balance between speed and quality.

SCOPE Summit 2024 Adjourns1:15 pm

2025 Conference Programs

◆ Sunday Golf, Kick-Off Keynote & Participant Engagement Award

◆SCOPE’s Kickoff Reception

◆Pre-Con User Group & Workshops

◆ Patient Voice in Trial Design and Protocol Development

◆ Developing and Executing Effective Diversity Plans

◆ Data-Informed Feasibility and Investigator Selection

◆ Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

◆ Enrollment Planning and Patient Recruitment

◆ Patient Engagement and Retention through Communities and Technology

◆ (NEW) Collaborative Strategies to Improve Trial Execution

◆ Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

◆ Clinical Trial Forecasting, Budgeting and Contracting

◆ Resource Management and Capacity Planning for Clinical Trials

◆ Mastering an Outsourcing Strategy

◆ Relationship and Alliance Management in Outsourced Clinical Trials

◆ Partner Selection and Trial Design

◆ Vendor Oversight & Resource Management

◆ Clinical Data Strategy and Analytics

◆ Data Science, ML, and AI

◆ Decentralized and Hybrid Trials

◆ DCTs and Clinical Innovation

◆ Digital Biomarkers and Endpoints in Clinical Trials

◆ Digital Measurements Implementation at Scale

◆ Accessing and Generating RWD

◆ Leveraging RWD for Clinical Research

◆ (NEW) Generative AI in Clinical Research

◆ (NEW) AI for Trial Optimization

◆ Risk-Based Quality Management

◆ Central and Remote Monitoring

◆ Modernizing Lab, Biomarker & Data Management Operations

◆ Biomarker & Biospecimen Technology & Innovation

◆ Data Technology for End-to-End Clinical Supply Management

◆ Clinical Supply Chain Strategies to Align Process, Products and Patients

◆ Clinical Trial Venture, Innovation & Partnering *
*Separate Registration Required

PRE-CONFERENCE WORKSHOPS

SUNDAY AFTERNOON PLENARY SESSION:
KICK-OFF MULTI-STAKEHOLDER PLENARY KEYNOTE AND PARTICIPANT ENGAGEMENT AWARDS

MONDAY MORNING PLENARY SESSION:
TRANSFORMING THE DEVELOPMENT PARADIGM & GENERATIVE AI IN CLINICAL TRIALS

PATIENT JOURNEY MAPPING: CRITICAL TO IMPROVING RECRUITMENT & RETENTION

PROACTIVE PLANNING AND ENGAGEMENT TO ACCELERATE CLINICAL DEVELOPMENT & IMPROVE SUCCESS RATES

BREAKFAST PRESENTATIONS

COLLABORATION TO IMPROVE OUTREACH AND COMMUNITY ENGAGEMENT

TUESDAY AFTERNOON PLENARY SESSION:
MODERNIZING TRIALS WITH FDA & INTERSECTION OF INNOVATIVE DEVELOPMENT MODELS AND INVESTMENT APPROACHES

ENGAGING HEALTHCARE PROVIDERS TO IMPROVE OUTREACH AND COMMUNITY ENGAGEMENT

BREAKFAST PRESENTATION

TRANSFORMATIVE NEW TECHNOLOGIES TO REDUCE PATIENT BURDEN AND REACH BROADER POPULATIONS

INNOVATIVE TACTICS TO IMPROVE ENROLLMENT & RETENTION: THE FUTURE OF CLINICAL TRIALS

PRE-CONFERENCE WORKSHOPS

SUNDAY AFTERNOON PLENARY SESSION:KICK-OFF MULTI-STAKEHOLDER PLENARY KEYNOTE AND PARTICIPANT ENGAGEMENT AWARDS

MONDAY MORNING PLENARY SESSION:TRANSFORMING THE DEVELOPMENT PARADIGM & GENERATIVE AI IN CLINICAL TRIALS

PATIENT JOURNEY MAPPING: CRITICAL TO IMPROVING RECRUITMENT & RETENTION

PROACTIVE PLANNING AND ENGAGEMENT TO ACCELERATE CLINICAL DEVELOPMENT & IMPROVE SUCCESS RATES

BREAKFAST PRESENTATIONS

COLLABORATION TO IMPROVE OUTREACH AND COMMUNITY ENGAGEMENT

TUESDAY AFTERNOON PLENARY SESSION: MODERNIZING TRIALS WITH FDA & INTERSECTION OF INNOVATIVE DEVELOPMENT MODELS AND INVESTMENT APPROACHES

ENGAGING HEALTHCARE PROVIDERS TO IMPROVE OUTREACH AND COMMUNITY ENGAGEMENT

BREAKFAST PRESENTATION

TRANSFORMATIVE NEW TECHNOLOGIES TO REDUCE PATIENT BURDEN AND REACH BROADER POPULATIONS

INNOVATIVE TACTICS TO IMPROVE ENROLLMENT & RETENTION: THE FUTURE OF CLINICAL TRIALS

SUNDAY AFTERNOON PLENARY SESSION:
KICK-OFF MULTI-STAKEHOLDER PLENARY KEYNOTE AND PARTICIPANT ENGAGEMENT AWARDS

MONDAY MORNING PLENARY SESSION:
TRANSFORMING THE DEVELOPMENT PARADIGM & GENERATIVE AI IN CLINICAL TRIALS

TUESDAY AFTERNOON PLENARY SESSION:
MODERNIZING TRIALS WITH FDA & INTERSECTION OF INNOVATIVE DEVELOPMENT MODELS AND INVESTMENT APPROACHES